Checklist for Assessment ISO 13485 & MDD & 9001 Ref: …€¦ · 9001 Requirement of the DIN EN ISO 9001:2008 ... way, please remember your audit training. The Checklist must be used

Checklist for Assessment

ISO 13485 & MDD & 9001

Ref: xxxxxx

410_09e_Checkliste_for_Assessment_13485_MDD.docx

Version: 1.0 1 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Checklist for the assessment based on the standards ISO 13485:2016 ISO 13485:2016 associate with EC Directive 93/42 EEC

Where applicable EC Directive 93/42/EEC Annex II/V/VI Company:

Audit date 1. Year

Auditor:

Name

Signature

Audit date 2. Year

Auditor:

Name

Signature

Audit date 3. Year

Auditor:

Name

Signature


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 2 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Explanations for the application of the DQS assessment check list

1. Applicable standards and marking

This assessment checklist is based on the requirements of the standards DIN EN ISO 13485:2016, DIN EN ISO 9001:2008, MDD 93/42/EEC, Annex II/V/VI and the German Medical Device Law (MPG).

The following references are used to address the requirements of the standards:

13485 Requirement of the DIN EN ISO 13485:2016

9001 Requirement of the DIN EN ISO 9001:2008

Special additional questions with regards to implants are marked with 13485 Impl. and special additional ques-tions relevant for sterile products are marked with 13485 sterile.

MDD/MPG: Questions related to the requirements of the MDD 93/42/EEC (MPG, Germany, resp.).

The numbering of the QM-Elements of DIN EN ISO 13485:2016 is used for the chapters.

2. Use of the Assessment Checklist

The questions of this checklist are addressed to the auditor, who evaluates and documents the fulfillment of the requirements. The auditor should formulate the questions asked to the company’s representative/s in a different way, please remember your audit training.

The Checklist must be used for the documentation of the assessment.

The checklist will also be used for 5 years (Certification period for MDD). Therefore 5 columns for the assess-ment results are given, one for each year. Certification period for 9001 and 13485 is 3 years.

In the 1st year audit every requirements of the standards must be assessed (if applicable).

In the 2nd to the 5th year the audit will be performed on a statistical basis, but in summery within these 4 years all requirements must be assessed.

The requirements regarding Management responsibility, Internal Audits, Human resources and Corrective & preventive actions must be audited every year.

The results of the assessment regarding the documentation and the realization of the QM-System has to be documented as follows:

1 = fulfilled 2 = partially fulfilled, acceptable 3 = partially fulfilled, not acceptable 4 = not fulfilled n.a. = not applicable 0 = not audited

3. Audit protocol

The results of the audit and the objectives/findings must be documented on the protocol “Findings”. In the row „Reference“ the objectives must be referenced to the nomenclature of the questions. Please use the numbers given in the checklist with 2 digits only (e.g. 4.2 for „Documentation requirements” of the ISO 13485). Additional pages, e.g. from the company’s documents should be added to the protocol and numbered as pages.

4. Important Notes / Exemptions

Because the regulatory requirements of the MDD 93/42 and the German Medical Device Law permit exclusions of design and development controls (see 7.3), this can be used as a justification for their exclusion from the quality management system.

If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to the nature of themedical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system, but a rational has to be provided [see 4.2.2 a)].


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 3 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system [see 4.1 a)].

These regulations can provide alternative arrangements that are to be addressed in the quality management system.

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

0 General

0.1 1.1 General questions for the certification

0.1.1 Is the guideline “Regulation for the use of the DQS certificate symbols, the IQ-Net symbol, the DQS documents and the DQS-symbol“ applied cor-rectly?

0.1.2 Are the improvement potentials to the QM-System, mentioned in the last audit report used?

0.2 1.2 Additional requirements of the 93/42/EEC to establish

the procedure

MDD/MPG 0.2.1 Does the company keep the correspondence with DQS?

MDD/MPG 0.2.2 Was the company completely informed about the previous and present (today’s) activities of the auditortor(s)? Is the declaration “ Auditors’/Experts’ Independence and Objectivity “ countersigned?

MDD/MPG 0.2.3 Are the company and the products registered to the legal authorities?

MDD/MPG 0.2.4 Is there a procedure in place to inform DQS about essential changes of the Medical Devices covered by the Quality Management System? (Advice company about the application forms 360.1.11 (Certification application) & 360.1.12 (Product application) and hand it out).

4 Quality management system

4.1 General requirements

MDD/MPG 4.1.1 Is the MDD 93/42/EEC Annex II/V/VI (and if necessary the MPG/the MPV for Germany) referenced correctly?

MDD/MPG 4.1.2 Is, if necessary, an authorized representative designated within the EEC?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 4 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001

4.1.3 Does the organization ensure the control of any outsourced processes, that affects product conformity with requirements and is the control of such out-sourced processes identifiable within the QM system?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 5 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 4.1.1 Does the organization document a quality management system and main-tain its effectiveness in accordance with the requirements of this Interna-tional Standard and applicable regulatory requirements?

13485:2016 Does the organization establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this Inter-national Standard or applicable regulatory requirements?

13485:2016 Does the organization document the role(s) undertaken by the organization under the applicable regulatory requirements?

13485:2016 4.1.2 Does the organization…

13485:2016 a) determine the processes needed for the quality management system and the application of these processes throughout the organization taking into account the roles undertaken by the organization?

13485:2016 b) apply a risk based approach to the control of the appropriate processes needed for the quality management system?

13485:2016 c) determine the sequence and interaction of these processes?

13485:2016 4.1.3 Does the organization… for each quality management system process?

13485:2016 a) …determine criteria and methods needed to ensure that both the opera-tion and control of these processes are effective…

13485:2016 b) …ensure the availability of resources and information necessary to sup-port the operation and monitoring of these processes…

13485:2016 c) …implement actions necessary to achieve planned results and maintain the effectiveness of these processes…

13485:2016 d) …monitor, measure as appropriate, and analyse these processes…

13485:2016 c) …establish and maintain records needed to demonstrate conformance to this International Standard and compliance with applicable regulatory re-quirements…

13485:2016 4.1.4 The organization shall manage these quality management system proc-esses in accordance with the requirements of this International Standard and applicable regulatory requirements. Are the following changes to these processes made:


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 6 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 4.1.4.1 a) evaluated for their impact on the quality management system?

13485:2016 b) evaluated for their impact on the medical devices produced under this quality management system?

13485:2016 c) controlled in accordance with the requirements of this International Stan-dard and applicable regulatory requirements?

13485:2016 4.1.5 Does the organization monitor and ensure control to any outsourced proc-esses that affects product conformity to requirements?

13485:2016 Does the organization retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for out-sourced processes?

13485:2016 Are the controls proportionate to the risk involved and the ability of the ex-ternal party to meet the requirements in accordance with 7.4?

13485:2016 Do the controls include written quality agreements?

13485:2016 4.1.6 Does the organization document procedures for the validation of the appli-cation of computer software used in the quality management system?

13485:2016 Are such software applications validated prior to initial use and, as appro-priate, after changes to such software or its application?

13485:2016 Are the specific approach and activities associated with software validation and revalidation proportionate to the risk associated with the use of the software?

13485:2016 Are records of such activities maintained (see 4.2.5)?

4.2 Documentation requirements

4.2.1 General

Does the quality manual include…

13485 9001

- a quality manual? - documented procedures as required by the standard? - all other by national or regional regulations required documents and re-

cords?

13485 - documented statements of a quality policy and quality objectives?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 7 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

9001

13485 9001

- documents needed by the organization to ensure the effective planning, operation and control of its processes?

13485 9001

- records as required by the standard?

13485:2016 4.2.1 General

13485:2016 Does the quality management system documentation (see 4.2.4) include:

13485:2016 a) documented statements of a quality policy and quality objectives?

13485:2016 b) a quality manual?

13485:2016 c) documented procedures and records required by this International Standard?

13485:2016 d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes?

13485:2016 e) other documentation specified by applicable regulatory requirements?

4.2.3 Product documentation

13485 Are files available, containing all products specifications and quality assur-ance specifications, or is the location of those documents described ex-actly? ( NB-MED 2.5.1-5) (see also Annex II / V/ VI 93/42/EWG and if necessary DQS-Support check-lists)

13485 Is this information available and comprehensible for each type or each model of the medical device? (if necessary also the information for installa-tion / maintenance)

MDD/MPG Are correct declarations of conformity issued? ( EK-MED 3.9 A4)

MDD/MPG Are the classifications of the Medical Devices traceable to the MDD?

MDD/MPG Are designated harmonized standards, which are applicable to the product / procedures defined and available (Is the adherence systematically en-sured)? If no harmonized standards are available, is there proof, which en-sures the safety and suitability of the products?

MDD/MPG Is it defined and documented for each product how the applicable “Essential Requirements (Annex I)“ are fulfilled and are there proofs to validate the statements made?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 8 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

MDD/MPG

Are there, for all products/product groups, complete risk analyses defined and documented? (copy the risk analysis to the documents for the DQS as example; if necessary apply 370.2.13 Checklist Risk Management)

MDD/MPG Are all the possible safety risks comprehensibly determined? Are the initial risks evaluated? Is the evaluation of the risks comprehensible?

MDD/MPG Do designated suppliers with activities having a substantial influence on the quality identified exist? (EK-MED 3.9 B17) (see 360.1.5 BasicData-Organization)

MDD/MPG Are they listed including their activities and are appropriate certificates of the subcontractors/ suppliers available?

MDD/MPG If no appropriate certificates for subcontractors/suppliers are available, are they appropriately assessed to fulfill the requirements of the suppliers / sub-contractors?

MDD/MPG Are contractual declarations/agreements signed with subcontrac-tors/suppliers with defined activities and responsibilities, if they have a sub-stantial influence on the quality?

MDD/MPG Does the contract with e.g. OEM suppliers contain sufficient descriptions and regulations on notification of the legal authorities and to ensure appro-priate information in case of vigilance?

(EK-MED 3.9 B16)

MDD/MPG Is there a procedure to evaluate the actuality of the subcontrac-tor’s/supplier’s proofs (certificates of analysis, etc.)?

MDD/MPG Has the company established that the purpose is fulfilled? (in accordance with MDD Annex X)

MDD/MPG Are there corresponding pre-clinical product reviews for the products?

MDD/MPG Is there a evaluation of the essential requirements of the Machinery Direc-tive, if this is applicable to the product?

(NB-MED 2.2 Rec. 5)

MDD/MPG If the destination of the products falls below the standards for personal pro-tective equipment, is a notified body involved for this?

4.2.2 Quality manual

Does the quality manual include ...


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 9 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001

- the scope of the QM system, including details of and justifications for any exclusions and / or non-application?

13485 9001

- the documented procedures established for the QM system, or reference to them?

- a description of the interaction between the processes of the QM system?

13485 - an overview of the structure of the used documentation?

13485:2016 Does the organization document a quality manual that includes:

13485:2016 a) the scope of the quality management system, including details of and justification for any exclusion or non-application?

13485:2016 b) the documented procedures for the quality management system, or reference to them?

13485:2016 c) a description of the interaction between the processes of the quality management system?

13485:2016 Does the quality manual shall outline the structure of the documentation used in the quality management system?

4.2.3 Control of documents

13485 9001

Is there a procedure in place for control of documents (including external docu-ments)

4.2.3 Medical device file

13485:2016 Does the organization establish and maintain for each medical device type or medical device family, one or more files either containing or referencing documents generated to demonstrate conformity to the requirement of this International Standard and compliance with applicable regulatory require-ments?

13485:2016 Does the content of the file(s) include (but is not limited to):

13485:2016 a) general description of the medical device, intended use/purpose, and labelling, including any instructions for use?

13485:2016 b) specifications for product?

13485:2016 c) specifications or procedures for manufacturing, packaging, storage, han-dling and distribution?

13485:2016 d) procedures for measuring and monitoring?

13485:2016 e) as appropriate, requirements for installation?

13485:2016 f) as appropriate, procedures for servicing?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 10 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

Has a documented procedure been established to define the controls needed to ...

13485 9001

- approve documents for adequacy prior to issue? Review and update documents as necessary and re-approve documents?

13485 9001

- ensure that changes and the current revision status of documents are identified?

13485 9001

- ensure that relevant versions of documents are available at point of use and that documents remain legible / readily identifiable?

13485 9001

- ensure that documents of external origin are identified and that their dis-tribution is controlled?

13485 9001

- prevent the unintended use of obsolete documents (to apply suitable iden-tification to them, if they are retained for any purpose)?

13485 Does the organization ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions?

13485 9001

Is a retention period set for the keeping of at least one copy of outdated documents, especially if these documents contain specifications of how the medical devices were manufactured? Are manufacturing and test docu-ments for the life time of the medical device accessible?

13485 Is the useful life time of the product appropriately determined?

13485 Does period ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements?

4.2.4 Control of records

13485 9001

Has a documented procedure been established to define the controls of records (Identification, storage, protection, retrieval, legibility, retention periods and disposal of records)?

13485 9001

Are records established and maintained to provide evidence of conformity to requirements and of the effective operation of the QM system?

13485 Are the quality records maintained for the life time of the products (at least 2

years after product release / date of shipment) or according to the storage require-ments of the relevant rules (MPG min. 5 years, for implants min. 15 years)


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 11 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

4.2.4 Control of documents

13485:2016 Are documents controlled required by the quality management system?

13485:2016 Records are a special type of document. Are they controlled according to the requirements given in 4.2.5?

13485:2016 Does a documented procedure define the controls needed to:

13485:2016 a) review and approve documents for adequacy prior to issue?

13485:2016 b) review, update as necessary and re-approve documents?

13485:2016 c) ensure that the current revision status of and changes to documents are identified?

13485:2016 d) ensure that relevant versions of applicable documents are available at points of use?

13485:2016 e) ensure that documents remain legible and readily identifiable?

13485:2016 f) ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled?

13485:2016 g) prevent deterioration or loss of documents?

13485:2016 h) prevent the unintended use of obsolete documents and apply suitable identification to them?

5 Management responsibility

5.1 Management commitment

13485:2016 Does top management provide evidence of its commitment to the develop-ment and implementation of the quality management system and mainte-nance of its effectiveness by:

13485:2016 a) communicating to the organization the importance of meeting customer as well as applicable regulatory requirements?

13485:2016 b) establishing the quality policy?

13485:2016 c) ensuring that quality objectives are established?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 12 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 d) conducting management reviews?

13485:2016 e) ensuring the availability of resources?

13485 9001

Communicating to the organization the importance of meeting customer, as well as statutory and regulatory requirements?

9001 Does top management provide evidence of its commitment to the continues improvement of the quality system? Is the availability of necessary re-sources ensured?

5.2 Customer focus

13485 9001

Does top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction gets attended?

13485:2016 Does top management ensure that customer requirements and applicable regulatory requirements are determined and met?

5.3 Quality policy

13485 9001

Is the quality policy appropriate to the purpose of the organization and does it provide a framework for establishing and reviewing quality objectives?

13485 9001

Does the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the QM system?

13485 9001

Is the quality policy communicated and understood within the organization?

Is the quality policy reviewed for continuing suitability?

13485:2016 Does top management ensure that the quality policy:

13485:2016 a) is applicable to the purpose of the organization?

13485:2016 b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system?

13485:2016 c) provides a framework for establishing and reviewing quality objectives?

13485:2016 d) is communicated and understood within the organization?

13485:2016 e) is reviewed for continuing suitability?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 13 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

5.4 Planing

5.4.1 Quality objectives

13485 9001

Are quality objectives (preferably measurable) established at relevant func-tions and levels within the organization? Are the quality objectives measur-able and consistent with the quality policy?

13485 9001

Are there objectives needed to meet the requirements for products?

13485:2016 Does top management shall ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within the organiza-tion?

13485:2016 Does the quality objectives shall be measurable and consistent with the quality policy?

5.4.2 Quality management system planning

13485 9001

Does top management ensure that the planning of the QM system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?

13485 9001

Is it ensured that the integrity of the quality management system is main-tained when changes to the quality management system are planned and implemented?

13485:2016 Does top management ensure that:

13485:2016 a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?

13485:2016 b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

13485 9001 13485:2016

Does the top management ensure that the responsibilities and authorities are defined, communicated and documented within the organization?

13485 Does the top management establish the interrelation of all personnel who manage, perform and verify work affecting quality?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 14 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 Is the necessary independence and authority to perform these tasks en-sured and is particular attention paid to the nomination of specific persons responsible for activities related to product monitoring from the post-production stage and reporting adverse events?

13485:2016 Does top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the in-dependence and authority necessary to perform these tasks?

5.5.2 Management representative

13485:2016 Has the top management appointed a member of the organization's management, who irrespective of other responsibilities, has responsi-bility and authority that includes ...

13485 9001

- ensuring that processes needed for the QM system are established, im-plemented and maintained?

13485 9001

- reporting to top management on the performance of the QM system and any need for improvement?

13485 9001

- ensuring the promotion of awareness of customer requirements through-out the organization?

13485:2016 a) ensuring that processes needed for the quality management system are documented?

13485:2016 b) reporting to top management on the effectiveness of the quality man-agement system and any need for improvement?

13485:2016 c) ensuring the promotion of awareness of applicable regulatory require-ments and quality management system requirements throughout the or-ganization?

MDD/MPG Who is appointed (and trained) as Medical Device Safety Representative? Is the expertise provided sufficiently?

(§ 30 MPG; Statement in the report)

MDD/MPG Are the Medical Device Safety Representative’s responsibilities and compe-tencies defined and documented and was the Medical Device Safety Rep-resentative notified to the legal authorities?

5.5.3 Internal communication

13485 9001

Does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QM system?

13485:2016 Does top management shall ensure that appropriate communication proc-esses are established within the organization and that communication takes place regarding the effe tiveness of the quality management system?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 15 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

5.6 Management review

5.6.1 General

13485 9001

Does top management review the organization’s QM system at planned intervals, to ensure its continuing suitability, adequacy and effectiveness?

13485 9001

Does this review include assessing opportunities for improvement and the need for changes of the QM system, including the quality policy and quality objectives?

13485 9001

Are records from management reviews maintained?

13485:2016 Does the organization document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness?

13485:2016 Does the review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives?

13485:2016 Are records from management reviews maintained (see 4.2.5)?

5.6.2 Review input

Does the input to management review include information on ...

13485 9001

- results of audits? - customer feedback?

13485 9001

- process performance and product conformity? - status of preventive and corrective actions?

13485 9001

- follow-up actions from previous management reviews? - changes that could affect the QM system?

13485 9001

- recommendations for improvement? - new or revised regulatory requirements?

13485:2016 Does the input to management review shall include, but is not limited to, information arising from:

13485:2016 a) feedback?

13485:2016 b) complaint handling?

13485:2016 c) reporting to regulatory authorities?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 16 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 d) audits?

13485:2016 e) monitoring and measurement of processes?

13485:2016 f) monitoring and measurement of product?

13485:2016 g) corrective action?

13485:2016 h) preventive action?

13485:2016 i) follow-up actions from previous management reviews?

13485:2016 j) changes that could affect the quality management system?

13485:2016 k) recommendations for improvement?

13485:2016 l) applicable new or revised regulatory requirements?

5.6.3 Review output

Does the output of the management review include any decisions and actions related to ...

9001 - improvement of the effectiveness of the QM system and its processes?

13485 - improvements needed to maintain the effectiveness of the quality man-agement system and related to customer requirements?

13485 9001

- resource needs?

13485:2016 Does the output from management review be recorded (see 4.2.5) and in-clude the input reviewed and any decisions and actions related to:

13485:2016 a) improvement needed to maintain the suitability, adequacy, and effec-tiveness of the quality management system and its processes?

13485:2016 b) improvement of product related to customer requirements?

13485:2016 c) changes needed to respond to applicable new or revised regulatory re-quirements?

13485:2016 d) resource needs?

6 Resource management

6.1 Provision of resources

Does the organization determine and provide the resources needed to…

9001 - to implement and maintain the quality management system, to continually improve its effectiveness and enhance customer satisfaction by meeting customer requirements?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 17 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 - to implement and maintain the quality management system, to continually improve its effectiveness and to meet regulatory and customer require-ments?

13485:2016 a) implement the quality management system and to maintain its effec-tiveness?

13485:2016 b) meet applicable regulatory and customer requirements?

6.2 Human Resources

13485:2016 Does personnel performing work affecting product quality be competent on the basis of appropriate education, training, skills and experience?

13485:2016 Does the organization document the process(es) for establishing compe-tence, providing needed training, and ensuring awareness of personnel?

13485:2016 Does the organization:

13485:2016 a) determine the necessary competence for personnel performing work affecting product quality?

13485:2016 b) provide training or take other actions to achieve or maintain the neces-sary competence?

13485:2016 c) evaluate the effectiveness of the actions taken?

13485:2016 d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?

13485:2016 e) maintain appropriate records of education, training, skills and experience (see 4.2.5)?

6.2.1 General

13485 9001

Is personnel competent on the basis of appropriate education, training, skills and experience if they perform work affecting conformity to product requirements?

MDD/MPG Is the training of new medical device representatives and sales personnel planned, executed and recorded?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 18 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

6.2.2 Competence, training and awareness

Does the organization….

13485 9001

determinate the necessary competence of personnel performing work af-fecting conformity to product requirements?

13485 9001

provide training or take other actions to achieve the necessary compe-tence?

13485 9001

evaluate the effectiveness of the actions taken?

13485 9001

ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objec-tives?

13485 9001

maintain appropriate records of education, training, skills and experience?

6.3 Infrastructure

13485 9001

Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?

13485 9001

Does that include, as applicable, buildings, workspace and associated utili-ties, process equipment (both hardware and software) and supporting ser-vices (such as transport, communication or information system)?

13485

Are the documented requirements for maintenance activities, including their frequency established, when such activities or lack thereof can affect prod-uct quality?

13485

Are records of such maintenance getting maintained?

13485:2016 Does the organization document the requirements for the infrastructure needed to achieve conformity to product requirements, prevent product mix-up and ensure orderly handling of product?

Infrastructure includes, as appropriate:

a) buildings, workspace and associated utilities;

b) process equipment (both hardware and software);

c) supporting services (such as transport, communication, or information systems).


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 19 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Does the organization document requirements for the maintenance activi-ties, including the interval of performing the maintenance activities, when such maintenance activities, or lack thereof, can affect product quality?

13485:2016 Does as appropriate, the requirements apply to equipment used in produc-tion, the control of the work environment and monitoring and measurement?

13485:2016 Are records of such maintenance maintained (see 4.2.5)?

6.4 Work environment

13485 9001

6.4.1 Does the organization determine and manage the work environment needed to achieve conformity to product requirements?

13485

6.4.2 Has the organization established documented requirements for health, cleanliness and clothing of personnel, if contact between such personnel and the product or work environment could adversely affect the quality of the product?

If work environment conditions can have an adverse effect on product quality:

13485

6.4.3 Does the organization establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions?

13485

6.4.4 Does the organization ensure that all personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained person?

13485

6.4.5 If necessary: are special arrangements established and documented for the control of contaminated or potentially contaminated product in order to pre-vent contamination of other product, the work environment or personnel?

6.4 Work environment and contamination control

13485:2016 6.4.1 Work environment

13485:2016 Does the organization document the requirements for the work environment needed to achieve conformity to product requirements?

13485:2016 If the conditions for the work environment can have an adverse effect on product quality, does the organization document the requirements for the work environment and the procedures to monitor and control the work envi-ronment?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 20 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Does the organization:

13485:2016 a) document requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could affect medical device safety or performance?

13485:2016 b) ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are compe-tent or supervised by a competent person?

13485:2016 6.4.2 Contamination control

13485:2016 Does, as appropriate, the organization plan and document arrangements for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product?

13485:2016 Does the organization document for sterile medical devices, requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes?

7 Product realization

7.1 Planning of product realization

13485 9001 13485:2016

Does the organization plan and develop the processes needed for product realization? Is the planning of product realization consistent with the re-quirements of the other processes of the QM system?

13485:2016 Does the organization document one or more processes for risk manage-ment in product realization?

13485:2016 Are records of risk management activities maintained (see 4.2.5)?

Does the organization determine the following, as appropriate, in planning product realization ...

13485 9001 13485:2016

- quality objectives and requirements for the product?

13485 9001 13485:2016

- the need to establish processes and documents(see 4.2.4), and to pro-vide resources specific to the product including infrastructure and work environment?

13485 9001 13485:2016

- required verification, validation, monitoring, measurement, inspection and test activities storage, distribution and traceability specific to the product together with the and the criteria for product acceptance?

13485 9001

- records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.5)?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 21 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016

13485 9001 13485:2016

Is the output of this planning in a suitable form for the organization’s method of operations documented?

13485

Has the organization established the documented requirements for risk management throughout product realization?

13485

Are records arising from risk management including the results getting maintained? (throughout the entire lifecycle of products, see for example EN ISO 14971)

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

9001 Are procedures and competencies for contract reviews defined?

Does the organization determine ...

13485 9001 13485:2016

- requirements specified by the customer, including the requirements for delivery and post-delivery activities?

13485 9001 13485:2016

- requirements not stated by the customer but necessary for specified or intended use, where known?

13485 9001

- statutory and regulatory requirements applicable to the product and any additional requirements considered necessary by the organization?

13485:2016 - applicable regulatory requirements related to the product?

13485:2016 - any user training needed to ensure specified performance and safe use of the medical device?

13485:2016 - any additional requirements determined by the organization?

7.2.2 Review of requirements related to the product

13485 9001 13485:2016

Does the organization review the requirements related to the product? Is this review conducted prior to the organization’s commitment to supply a product to the customer (for exemple: Submission of tenders, acceptance of contracts or orders, acceptance of a contract or orders, acceptance of changes to contracts or orders)

Does this review ensure that ...

13485 9001 13485:2016

a) product requirements are defined and the organization has (the ability to meet the) defined requirements?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 22 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001 13485:2016

b) contract or order requirements differing from those previously expressed are resolved?

13485:2016 c) applicable regulatory requirements are met?

13485:2016 d) any user training identified in accordance with 7.2.1 is available or planned to be available?

13485:2016 e) the organization has the ability to meet the defined requirements?

13485 9001 13485:2016

Are the records of the results of the review and actions arising from the review maintained and stored (see 4.2.5)?

13485 9001 13485:2016

Does the organization confirm the customer requirements before accep-tance, where the customer provides no documented statement of require-ment?

13485 9001 13485:2016

Does the organization ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements?

7.2.3 Customer communication

13485 9001

1 Has the organization determined and implemented effective arrangements for communication with customers in relation to: product information, enquir-ies, contracts or order handling, including amendments and customer feed-back, including customer complaints and advisory notices (see 8.5.1)?

7.2.3 Communication

13485:2016 The organization shall plan and document arrangements for communicating with customers in relation to:

13485:2016 a) product information?

13485:2016 b) enquiries, contracts or order handling, including amendments?

13485:2016 c) customer feedback, including complaints?

13485:2016 d) advisory notices?

13485:2016 Does the organization communicate with regulatory authorities in accor-dance with applicable regulatory requirements?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 23 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

7.3 Design and development

7.3.1 General

13485:2016 Does the organization document procedures for design and development?

7.3.1 Design and development planning

13485 Are documented procedures and the responsibilities and authorities for the design and development determined?

Does the organization determine during the design and development planning ......

13485 9001

- the design and development stages, the review, verification and validation that are appropriate to each design and development stage?

13485 - design and development transfer activities? If the design and develop-ment results to the manufacturing process proved to be suitable?

13485 9001

Are the interfaces between different groups involved in design and devel-opment managed? Are effective communication and clear assignment of responsibilities ensured?

9001 If the output of planning is updated, as the design and development pro-gresses?

MDD/MPG If in the design planning, the legal requirements, especially in regard to the licensing and reporting requirements are intent?

13485:2016 Does the organization plan and control the design and development of product?

13485:2016 As appropriate, Are design and development planning documents main-tained and updated as the design and development progresses?

13485:2016 During design and development planning, does the organization document:

13485:2016 a) the design and development stages?

13485:2016 b) the review(s) needed at each design and development stage?

13485:2016 c) the verification, validation, and design transfer activities that are appro-priate at each design and development stage?

13485:2016 d) the responsibilities and authorities for design and development?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 24 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 e) the methods to ensure traceability of design and development outputs to design and development inputs?

13485:2016 f) the resources needed, including necessary competence of personnel?

7.3.2 7.3.3

Design and development inputs

13485 9001 13485:2016

Are inputs related to product requirements determined and records main-tained (see 4.2.5)?

Do these inputs include ...

13485 9001 13485:2016

- functional, performance usability and safety requirements according to the intended use?

13485 9001 13485:2016

- applicable (statutory and) regulatory requirements(, as well as the results from the risk management) and standards?

13485 9001

- where applicable, information derived from previous similar designs and other requirements essential for design and development?

13485:2016 - applicable output(s) of risk management?

13485:2016 - as appropriate, information derived from previous similar designs?

13485:2016 - other requirements essential for design and development of the product and processes?

13485 9001 13485:2016

Are these inputs reviewed for adequacy and approved?

13485 9001

Are these requirements complete, unambiguous, able to be verified or vali-dated and not in conflict with each other?

MDD/MPG Has the applicable harmonized standards for safety requirements for medi-cal devices systematically identified?

MDD/MPG If no harmonized standards were applied: Has the safety requirements completely identified (systematically)?

13485:2016 Is the requirement related to the management of the interfaces between different groups involved in design and development eliminated?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 25 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

7.3.3 7.3.4

Design and development outputs

13485 9001 13485:2016

Are the outputs of the design and development in a form suitable for verifi-cation against the design and development input and are approved prior to release?

13485 9001

Are the outputs of the design and development approved prior to release? Do the design and development outputs contain or reference product ac-ceptance criteria?

13485 9001

Do the design and development outputs provide appropriate information for purchasing, production and for service provision?

13485 9001

Do the design and development outputs specify the characteristics of the product that are essential for its safe and proper use?

13485:2016 Do Design and development outputs …:

13485:2016 a) meet the input requirements for design and development?

13485:2016 b) provide appropriate information for purchasing, production and service provision?

13485:2016 c) contain or reference product acceptance criteria?

13485:2016 d) specify the characteristics of the product that are essential for its safe and proper use?

13485:2016 Are Records of the design and development outputs maintained (see 4.2.5)?

7.3.4 7.3.5

Design and development review

13485 9001

Are systematic reviews of design and development performed at suitable stages to evaluate the ability of the results of design and development to meet requirements and to identify any problems and propose necessary actions?

13485 9001

Do the participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed? Is specialist personnel included, where necessary?

13485 9001

Are records of the results of the reviews and any necessary actions main-tained?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 26 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 At suitable stages, are systematic reviews of design and development per-formed in accordance with planned and documented arrangements to:

13485:2016 a) evaluate the ability of the results of design and development to meet requirements?

13485:2016 b) identify and propose necessary actions?

13485:2016 Do participants in such reviews include representatives of functions con-cerned with the design and development stage being reviewed, as well as other specialist personnel?

13485:2016 Are Records of the results of the reviews and any necessary actions main-tained and include the identification of the design under review, the partici-pants involved and the date of the review (see 4.2.5)?

7.3.5 7.3.6

Design and development verification

13485 9001

Is verification performed and recorded to ensure that design and develop-ment outputs have met the design and development input requirements?

13485:2016 Are design and development verification performed in accordance with planned and documented arrangements to ensure that the design and de-velopment outputs have met the design and development input require-ments?

13485:2016 Does the organization document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size?

13485:2016 If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), does verification include confirmation that the design outputs meet design inputs when so connected or interfaced?

13485:2016 Are records of the results and conclusions of the verification and necessary actions maintained (see 4.2.4 and 4.2.5)?

7.3.6 7.3.7

Design and development validation

13485 9001

Is the design and development validation performed to ensure that the re-sulting product is capable of meeting the requirements for the specified application or intended use?

13485 Is validation completed prior to the delivery or implementation of the product


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 27 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

9001 or completed until the product has been formally transferred to the cus-tomer?

13485 9001

Are records of the results of validation and any necessary actions main-tained?

13485 MDD/MPG

Are sufficient clinical data provided, to prove that the product fulfills the per-formance, design characteristics and intended purpose of the device as stated in MDD 93/42/EEC Annex I (clinical evaluation or if necessary clinical investigation)?

13485:2016 Are design and development validation performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or in-tended use?

13485:2016 Does the organization document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size?

13485:2016 Are design validation conducted on representative product? Representative product includes initial production units, batches or their equivalents.

13485:2016 Is the rationale for the choice of product used for validation recorded (see 4.2.5)?

13485:2016 As part of design and development validation, does the organization per-form clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements? A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.

13485:2016 If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), does validation include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced?

13485:2016 Are validation completed prior to release for use of the product to the cus-tomer?

13485:2016 Are records of the results and conclusion of validation and necessary ac-tions maintained (see 4.2.4 and 4.2.5)?

7.3.8 Design and development transfer

13485:2016 Does the organization shall document procedures for transfer of design and development outputs to manufacturing?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 28 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Are these procedures ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product require-ments?

13485:2016 Are results and conclusions of the transfer shall be recorded (see 4.2.5)?

7.3.7 7.3.9

Control of design and development changes

13485:2016 Does the organization shall document procedures to control design and development changes?

13485:2016 Does the organization determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use?

13485 9001 13485:2016

Are design and development changes identified and records maintained and reviewed, verified and validated, as appropriate? Are design and de-velopment changes approved before implementation?

13485 9001 13485:2016

Does the review of design and development changes include evaluation of the effect of the changes on constituent parts and product in process or already delivered or outputs of risk management and product realization processes?

13485 9001 13485:2016

Are records of the results of the review of changes and any necessary ac-tions maintained? (see 4.2.5).

MDD/MPG Which procedures guarantee that the DQS is informed when substantial modifications are done to the products?

7.3.10 Design and development files

13485:2016 Does the organization shall maintain a design and development file for each medical device type or medical device family?

13485:2016 Does this file include or reference records generated to demonstrate con-formity to the requirements for design and development and records for design and development changes?

7.4 Purchasing

7.4.1 Purchasing process

13485 Have documented procedures been established to ensure that the pur-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 29 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

9001

chased products conforms to specified purchase requirements?

13485 9001

Does the organization evaluate and select suppliers to ensure that products are delivered in accordance with the requirements of the organization?

13485 9001

Are the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subse-quent product realization or the final product?

13485 9001

Are criteria established for selection, evaluation and reevaluation? Are records maintained of the results of evaluations and any necessary actions?

13485:2016 Does the organization document procedures (see 4.2.4) to ensure that pur-chased product conforms to specified purchasing information?

13485:2016 Does the organization establish criteria for the evaluation and selection of suppliers? Are the criteria:

13485:2016 a) based on the supplier’s ability to provide product that meets the organiza-tion’s requirements?

13485:2016 b) based on the performance of the supplier?

13485:2016 c) based on the effect of the purchased product on the quality of the medi-cal device

13485:2016 d) proportionate to the risk associated with the medical device?

13485:2016 Does the organization plan the monitoring and re-evaluation of suppliers?

13485:2016 Does supplier performance in meeting requirements for the purchased product be monitored?

13485:2016 Does the results of the monitoring provide an input into the supplier re-evaluation process?

13485:2016 Are Non-fulfilment of purchasing requirements addressed with the supplier proportionate to the risk associated with the purchased product and compli-ance with applicable regulatory requirements?

13485:2016 Are records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities maintained (see 4.2.5)?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 30 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

7.4.2 Purchasing information

13485 9001 13485:2016

Does the purchasing information describe the product to be purchased? Does the information include, where appropriate ...

13485:2016 a) product specifications?

13485 9001 13485:2016

a) requirements for (approval of) product acceptance, procedures, proc-esses and equipment?

13485 9001

b) requirements for qualification of personnel?

13485:2016 d) quality management system requirements?

13485 9001 13485:2016

Is the adequacy of specified purchase requirements ensured, prior to their communication to the supplier?

13485 Maintains the organization copies of the relevant purchasing information, i.e. documents and records to the extent required for traceability?

13485:2016 Does purchasing information include, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the pur-chased product to meet specified purchase requirements?

13485:2016 To the extent required for traceability given in 7.5.9, does the organization maintain relevant purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5)?

7.4.3 Verification of purchased product

13485 9001 13485:2016

Does the organization establish and implement the inspection or other ac-tivities necessary for ensuring that purchased product meets specified pur-chase requirements?

13485:2016 Is the extent of verification activities based on the supplier evaluation results and proportionate to the risks associated with the purchased product?

13485:2016 When the organization becomes aware of any changes to the purchased product, does the organization determine whether these changes affect the product realization process or the medical device?

13485 9001 13485:2016

Where the organization or its customer intends to perform verification at the supplier’s premises: are the intended verification activities (arrangements)


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 31 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

and method of product release stated in the purchasing information?

13485:2016 Are records of the verification maintained (see 4.2.5)?

7.5 Production and service provision

7.5.1 Control of production and service provision

13485:2016 Are production and service provision planned, carried out, monitored and controlled to ensure that product conforms to specification?

13485:2016 As appropriate, does production controls include but are not limited to:

13485:2016 a) documentation of procedures and methods for the control of production (see 4.2.4)?

13485:2016 b) qualification of infrastructure?

13485:2016 c) implementation of monitoring and measurement of process parameters and product characteristics?

13485:2016 d) availability and use of monitoring and measuring equipment?

13485:2016 e) implementation of defined operations for labelling and packaging?

13485:2016 f) implementation of product release, delivery and post-delivery activities?

13485:2016 Does the organization establish and maintain a record (see 4.2.5) for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution?

13485:2016 Is the record verified and approved?

General Requirements

13485 9001

Does the organization plan and carry out production and service provision under controlled conditions?

Do these controlled conditions include, as applicable ...

13485 9001

- the availability of information that describes the characteristics of the product?

- and the availability of work instructions?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 32 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001

- the use of suitable equipment and the availability? - the use of monitoring and measuring devices?

13485 9001

- the implementation of monitoring and measurement? - as well as the implementation of defined operations for labeling and

packaging?

13485 9001

- the implementation of release, delivery and post-delivery activities?

13485 Does the organization establish and maintain a record for each batch of medical devices that provides traceability to the extent specified in 7.5.3?

Specific requirements

Cleanliness of product and contamination control

13485 The organization shall establish documented requirements for cleanliness of product if,

- the product is cleaned by the organization prior to sterilization and/or its use or, - the product is supplied non-sterile to be subjected to a cleaning process prior to sterilization

and/or its use or, - the product is supplied to be used non-sterile and its cleanliness is of significance in use or, - process agents are to be removed from product during manufacture.

Installation activities (if applicable)

13485 Has the organization established documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device?

13485 If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent, has the organization pro-vided documented requirements for installation and verification?

13485 Are records of installation and verification performed by the organization or its authorized agent maintained (see 4.2.4)?

Servicing activities (if applicable)

13485 Has the organization established documented procedures, work instructions and reference materials and reference measurement procedures, as nec-essary, for performing servicing activities and verifying that they meet the specified requirements?

13485 Are those records of servicing activities carried out by the organization maintained?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 33 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

Particular requirements for sterile medical devices

13485 Steril

Does the organization maintain records of the process parameters for the sterilization process which was used for each sterilization batch, and are these sterilization records traceable to each production batch of medical devices (see 7.5.1.1)?

13485:2016 7.5.2 Cleanliness of product

13485:2016 Does the organization document requirements for cleanliness of product or contamination control of product if:

13485:2016 a) product is cleaned by the organization prior to sterilization or its use?

13485:2016 b) product is supplied non-sterile and is to be subjected to a cleaning proc-ess prior to sterilization or its use?

13485:2016 c) product cannot be cleaned prior to sterilization or its use, and its cleanli-ness is of significance in use?

13485:2016 d) product is supplied to be used non-sterile, and its cleanliness is of signifi-cance in use?

13485:2016 e) process agents are to be removed from product during manufacture?

13485:2016 Was the product cleaned in accordance with a) or b) above? (The require-ments contained in 6.4.1 do not apply prior to the cleaning process)

7.5.2 Validation of processes for production and service provision

General requirements

13485 9001

Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent moni-toring or measurement? ( EK-MED 3.9 B18)

13485 9001

Does this include any processes where, as consequence, deficiencies be-come apparent only after the product is in use or the service has been de-livered?

13485 9001

Does the validation demonstrate the ability of these processes to achieve planned results?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 34 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001

Has the organization established arrangements for these processes including, as applicable ...

13485 9001

- defined criteria for review and approval of the processes? - approval of equipment and qualification of personnel?

13485 9001

- use of specific methods and procedures? - requirements for records (see 4.2.4.)?

13485 9001

- revalidation?

If software is used within the production process and in service delivery and this has a influence to the product quality/specification:

13485 Are documented procedures for the validation of the application of computer software (and changes and / or its application) for production and service provision that affect the ability of the product to conform to specified re-quirements established?

13485 Are such software applications validated prior to initial use?

Are records of validation maintained?

Particular requirements for sterile medical devices

13485 Steril

Has the organization established documented procedures for the validation of sterilization processes?

13485 Steril

Are sterilization processes validated prior to initial use?

Are records of validation of each sterilization process maintained?

13485 Steril

Where such records of the production process stored (including steriliza-tion) to demonstrate that the products were manufactured according to the validated process?

Are the results recorder of each batch release?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 35 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

7.5.3 Identification and traceability

13485:2016 7.5.3 Installation activities

13485:2016 Does the organization document requirements for medical device installa-tion and acceptance criteria for verification of installation, as appropriate?

13485:2016 If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organization or its sup-plier, does the organization provide documented requirements for medical device installation and verification of installation?

13485:2016 Are records of medical device installation and verification of installation performed by the organization or its supplier maintained (see 4.2.5)?

Identification

13485 9001

Does the organization identify the products by suitable means throughout product realization according to a documented procedure?

13485 Are documented procedures established to ensure that medical devices returned to the organization are identified and distinguished from conform-ing product?

Traceability

General

13485 Are documented procedures for traceability established?

Is the extent of product traceability defined and are the records required for traceability defined (see 4.2.4, 8.3 and 8.5)?

13485 Does the documented and established traceability facilitate the necessary corrective actions? (Note: e.g. simulate a product recall; time needed until the necessary

data and records are collected should be less than 1 day)

Particular requirements for active implant able medical devices and implant able medical devices

13485 Impl.

In defining the records required for traceability, are all components, materi-als and work environmental conditions included, if these could cause the medical device does not fulfill its specified requirements?

13485 Impl.

Does the organization require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and are such re-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 36 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

cords are available for inspection?

13485 Impl.

Is ensured that the name and address of the shipping package consignee is recorded (see 4.2.4)?

Status identification

13485 9001

Is the identification of product status maintained and recorded to ensure the monitoring and measurement requirements throughout production, storage, installation and servicing of the product?

13485:2016 7.5.4 Servicing activities

13485:2016 If servicing of the medical device is a specified requirement, does the or-ganization document servicing procedures, reference materials, and refer-ence measurements, as necessary, for performing servicing activities and verifying that product requirements are met?

13485:2016 Does the organization analyse records of servicing activities carried out by the organization or its supplier:

13485:2016 a) to determine if the information is to be handled as a complaint?

13485:2016 b) as appropriate, for input to the improvement process?

13485:2016 Are Records of servicing activities carried out by the organization or its sup-plier maintained (see 4.2.5)?

7.5.4 Customer property

13485 9001

Does the organization exercise care with customer property while it is under the organization’s control or being used by the organization?

13485 9001

Does the organization identify, verify, protect and safeguard customer prop-erty provided for use or incorporation into the product?

13485 9001

Does the organization report to the customer and maintain records if any customer property is lost, damaged or otherwise found to be unsuitable for use?

13485:2016 7.5.5 Particular requirements for sterile medical devices

13485:2016 Does the organization maintain records of the sterilization process parame-ters used for each sterilization batch (see 4.2.5)?

13485:2016 Are sterilization records traceable to each production batch of medical de-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 37 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

vices?

7.5.5 Preservation of product

13485 Are documented procedures established for preserving the conformity of product during internal processing and delivery to the intended destination?

13485 9001

Does this preservation include identification, handling, packaging, storage and protection?

13485 9001

Does this preservation also apply to the constituent parts of a product?

13485 Are documented procedures or documented work instructions established for the control of product with a limited shelf-life or requiring special storage conditions?

13485 Are such special storage conditions controlled and recorded?

13485:2016 7.5.6 Validation of processes for production and service provision

13485:2016 Does the organization validate any processes for production and service provision where the resulting output cannot be or is not verified by subse-quent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered?

13485:2016 Does validation demonstrate the ability of these processes to achieve planned results consistently?

13485:2016 Does the organization document procedures for validation of processes, including:

13485:2016 a) defined criteria for review and approval of the processes?

13485:2016 b) equipment qualification and qualification of personnel?

13485:2016 c) use of specific methods, procedures and acceptance criteria?

13485:2016 d) as appropriate, statistical techniques with rationale for sample sizes?

13485:2016 e) requirements for records (see 4.2.5)?

13485:2016 f) revalidation, including criteria for revalidation?

13485:2016 g) approval of changes to the processes?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 38 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Does the organization document procedures for the validation of the appli-cation of computer software used in production and service provision?


13485:2016 Are the specific approach and activities associated with software validation and revalidation proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications?

13485:2016 Are records of the results and conclusion of validation and necessary ac-tions from the validation maintained (see 4.2.4 and 4.2.5)?

13485:2016 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems

13485:2016 Does the organization shall document procedures (see 4.2.4) for the valida-tion of processes for sterilization and sterile barrier systems?

13485:2016 Are processes for sterilization and sterile barrier systems validated prior to implementation and following product or process changes, as appropriate?

13485:2016 Are records of the results and, conclusion of validation and necessary ac-tions from the validation maintained (see 4.2.4 and 4.2.5)?

13485:2016 7.5.8 Identification

13485:2016 Does the organization document procedures for product identification and identify product by suitable means throughout product realization?

13485:2016 Does the organization identify product status with respect to monitoring and measurement requirements throughout product realization?

13485:2016 Is identification of product status maintained throughout production, storage, installation and servicing of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used or installed?

13485:2016 If required by applicable regulatory requirements, does the organization document a system to assign unique device identification to the medical device?

13485:2016 Does the organization document procedures to ensure that medical devices returned to the organization are identified and distinguished from conform-ing product?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 39 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 7.5.9 Traceability

13485:2016 7.5.9.1 General

13485:2016 Does the organization document procedures for traceability?

13485:2016 Do these procedures define the extent of traceability in accordance with applicable regulatory requirements and the records to be maintained (see 4.2.5)?

13485:2016 7.5.9.2 Particular requirements for implantable medical devices

13485:2016 Do the records required for traceability include records of components, ma-terials, and conditions for the work environment used, if these could cause the medical device not to satisfy its specified safety and performance re-quirements?

13485:2016 Does the organization require that suppliers of distribution services or dis-tributors maintain records of the distribution of medical devices to allow traceability and that these records are available for inspection?

13485:2016 Are records of the name and address of the shipping package consignee maintained (see 4.2.5)?

13485:2016 7.5.10 Customer property

13485:2016 Does the organization identify, verify, protect, and safeguard customer property provided for use or incorporation into the product while it is under the organization’s control or being used by the organization?

13485:2016 If any customer property is lost, damaged or otherwise found to be unsuit-able for use, does the organization report this to the customer and maintain records (see 4.2.5)?

13485:2016 7.5.11 Preservation of product

13485:2016 Does the organization document procedures for preserving the conformity of product to requirements during processing, storage, handling, and distri-bution?

13485:2016 Does Preservation apply to the constituent parts of a medical device?

13485:2016 Does the organization protect product from alteration, contamination or damage when exposed to expected conditions and hazards during process-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 40 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

ing, storage, handling, and distribution by:

13485:2016 a) designing and constructing suitable packaging and shipping containers?

13485:2016 b) documenting requirements for special conditions needed if packaging alone cannot provide preservation?

13485:2016 If special conditions are required, are they controlled and recorded (see 4.2.5)?

7.6 Control and monitoring of measuring equipment

13485 7.6.1 Are documented procedures established for the control of monitoring and measuring equipment?

13485 9001

7.6.2 Does the organization determine the monitoring and measurement to be taken and is the required monitoring and measuring equipment determined?

13485:2016 Does the organization determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to pro-vide evidence of conformity of product to determined requirements?

13485:2016 Does the organization shall document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements?

Is the measuring equipment, where necessary to ensure valid results, ...

13485 9001 13485:2016

7.6.3 - be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards?

13485 9001 13485:2016

7.6.4 - is the basis used for calibration or verification recorded, where no such standards exist?

13485 9001

7.6.5 - have identification in order to determine its calibration status, (be safe-guarded from adjustments that would invalidate the measurement result and adjusted or re-adjusted, as necessary)?

13485:2016 - be safeguarded from adjustments that would invalidate the measurement result?

13485 9001 13485:2016

7.6.6 - be protected from damage and deterioration during handling, mainte-nance and storage?

13485:2016 Does the organization perform calibration or verification in accordance with documented procedures?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 41 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 9001 13485:2016

7.6.7 Is the validity of previous measuring results assessed and recorded, when the measuring equipment is found not to conform to requirements? Does the organization take appropriate action on the measuring equipment and any product affected?

13485 9001 13485:2016

7.6.8 Are records of the results of calibration and verification maintained (see 4.2.5).?

13485 9001

7.6.9 Is the ability of computer software to satisfy the intended application con-firmed, when used in the monitoring and measurement of specified re-quirements?

13485 9001

7.6.10 Is this undertaken prior to initial use and reconfirmed, as necessary?

13485:2016 Does the organization document procedures for the validation of the appli-cation of computer software used for the monitoring and measurement of requirements?


13485:2016 Are the specific approach and activities associated with software validation and revalidation proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications?

13485:2016 Are records of the results and conclusion of validation and necessary ac-tions from the validation maintained (see 4.2.4 and 4.2.5)?

8 Measurement, analysis and improvement

8.1 General

Does the organization plan and implement the monitoring, measurement, analysis and improvement processes needed to ...

13485 9001 13485:2016

8.1.1 - demonstrate conformity of the product?

13485 9001 13485:2016

8.1.2 - ensure conformity of the QM-System and to maintain the effectiveness of the QM-System?

13485 9001 13485:2016

8.1.3 - continually improve the effectiveness of the QM-System?

13485 8.1.4 Does this include determination of applicable methods, including statistical


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 42 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

9001 13485:2016

techniques, and the extent of their use?

8.2 Monitoring and measurement

8.2.1 Customer satisfaction

13485 9001

Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements?

9001 Is this information, as one of the measurements of the performance of the QM-System used and are the methods determined for obtaining and using this information determined?

13485

Is a documented procedure for a feedback system established? Is this feedback system used for early warning of quality problems and for input into the corrective and preventive action processes?

13485:2016 8.2.1 Feedback

13485:2016 As one of the measurements of the effectiveness of the quality manage-ment system, does the organization gather and monitor information relating to whether the organization has met customer requirements?

13485:2016 Are the methods for obtaining and using this information documented?

13485:2016 Does the organization document procedures for the feedback process?

13485:2016 Does this feedback process include provisions to gather data from produc-tion as well as post-production activities?

13485:2016 Does the information gathered in the feedback process serve as potential input into risk management for monitoring and maintaining the product re-quirements as well as the product realization or improvement processes?

13485:2016 If applicable regulatory requirements require the organization to gain spe-cific experience from postproduction activities, does the review of this ex-perience form part of the feedback process?

8.2.2 Internal audit

13485 9001

Is there a documented process for planning / conducting internal audits? (Responsibilities, planning, execution, reporting, record keeping, corrective actions)

13485 9001

Are internal audits at planned intervals conducted to determine whether or not the QM-System conforms to the requirements of this International stan-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 43 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

dard and to the QM-System requirements established by the organization and is effectively implemented and maintained?

13485 9001

Is the audit programme planned taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits?

(Audit criteria, scope, frequency, methods)

13485 9001

Does the selection of auditors ensure objectivity and impartiality of the audit process?

(Auditors shall not audit their own work).

13485 9001

Does the management responsible for the area being audited ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes?

13485 9001

Do follow-up activities include the verification of the actions taken and the reporting of verification results?

8.2.2 Complaint handling

13485:2016 Does the organization document procedures for timely complaint handling in accordance with applicable regulatory requirements?

13485:2016 Do these procedures include at a minimum requirements and responsibili-ties for:

13485:2016 a) receiving and recording information?

13485:2016 b) evaluating information to determine if the feedback constitutes a com-plaint?

13485:2016 c) investigating complaints?

13485:2016 d) determining the need to report the information to the appropriate regula-tory authorities?

13485:2016 e) handling of complaint-related product?

13485:2016 f) determining the need to initiate corrections or corrective actions?

13485:2016 If any complaint is not investigated, is justification documented?

13485:2016 Is any correction or corrective action resulting from the complaint handling process documented?

13485:2016 If an investigation determines activities outside the organization contributed


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 44 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

to the complaint, are relevant information exchanged between the organiza-tion and the external party involved?

13485:2016 Are complaint handling records shall be maintained (see 4.2.5)?

8.2.3 Monitoring and measurement of processes

13485 9001

Does the organization apply suitable methods for monitoring and, where applicable, measurement of the QM-Systems processes?

13485 9001

Do these methods demonstrate the ability of the processes to achieve planned results?

13485 9001

Are correction and corrective action taken to ensure conformity of the prod-uct, as appropriate, when planned results are not achieved?

13485:2016 8.2.3 Reporting to regulatory authorities

13485:2016 If applicable regulatory requirements require notification of complaints that meet specified reporting criteria of adverse events or issuance of advisory notices, does the organization document procedures for providing notifica-tion to the appropriate regulatory authorities?

13485:2016 Are records of reporting to regulatory authorities maintained (see 4.2.5)?

8.2.4 Monitoring and measurement of product

13485 9001

Does the organization monitor and measure the characteristics of the prod-uct to verify that product requirements have been met?

13485 9001

Is this carried out at appropriate stages of the product realization process in accordance with the planned arrangements and documented procedures?

13485 9001

Is evidence of conformity with the acceptance criteria maintained and do the records indicate the person(s) authorizing release of product?

13485

Does product release and delivery of service not proceed until the planned arrangements have been satisfactorily completed?

13485 Impl.

Is the identity of personal recorded, which performs any inspection or test-ing?

8.2.4 Internal audit

13485:2016 Does the organization conduct internal audits at planned intervals to deter-


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 45 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

mine whether the quality management system:

13485:2016 a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements es-tablished by the organization, and applicable regulatory requirements?

13485:2016 b) is effectively implemented and maintained?

13485:2016 Does the organization document a procedure to describe the responsibili-ties and requirements for planning and conducting audits and recording and reporting audit results?

13485:2016 Is an audit program planned, taking into consideration the status and impor-tance of the processes and area to be audited, as well as the results of previous audits?

13485:2016 Are the audit criteria, scope, interval and methods defined and recorded (see 4.2.5)?

13485:2016 Does the selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process?

13485:2016 Do Auditors not audit their own work?

13485:2016 Are records of the audits and their results, including identification of the processes and areas audited and the conclusions, maintained (see 4.2.5)?

13485:2016 Does the management responsible for the area being audited ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes?

13485:2016 Do follow-up activities include the verification of the actions taken and the reporting of verification results?

8.2.5 Monitoring and measurement of processes

13485:2016 Does the organization apply suitable methods for monitoring and, as appro-priate, measurement of the quality management system processes?

13485:2016 Do these methods demonstrate the ability of the processes to achieve planned results?

13485:2016 When planned results are not achieved, are correction and corrective action taken, as appropriate?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 46 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 8.2.6 Monitoring and measurement of product

13485:2016 Does the organization monitor and measure the characteristics of the prod-uct to verify that product requirements have been met?

13485:2016 Is this carried out at applicable stages of the product realization process in accordance with the planned and documented arrangements and docu-mented procedures?

13485:2016 Is Evidence of conformity to the acceptance criteria maintained?

13485:2016 Is the identity of the person authorizing release of product recorded (see 4.2.5)?

13485:2016 As appropriate, do records identify the test equipment used to perform measurement activities?

13485:2016 Does product release and service delivery not proceed until the planned and documented arrangements have been satisfactorily completed?

13485:2016 For implantable medical devices, does the organization record the identity of personnel performing any inspection or testing?

8.3 Control of nonconforming product

13485 9001 13485:2016

8.3.1 Does the organization ensure that product which does not conform to prod-uct requirements is identified and controlled to prevent is unintended use or delivery?

13485 9001 13485:2016

8.3.2 Is there a documented procedure established to define the controls and related responsibilities and authorities for dealing with nonconforming prod-uct?

Does the organization deal with nonconforming product by one or more of the following ways ...

13485 9001

8.3.3 - by taking action to eliminate the detected nonconformity or by taking ac-tion to preclude is original intended use or application?

13485 9001

8.3.4 - by authorizing its use, release or acceptance under concession?

13485:2016 Does the evaluation of nonconformity include a determination of the need for an investigation and notification of any external party responsible for the nonconformity?

13485 9001 13485:2016

8.3.5 Are records of the nature of nonconformities and any subsequent actions taken, including the evaluation, any investigation and the rationale for deci-sions concessions obtained maintained? (see 4.2.5)


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 47 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 8.3.6 Is it ensured that nonconforming product is accepted by concession only if regulatory requirements are met?

13485 8.3.7 Is the identity of the person(s) maintained who authorizes the concession?

13485 8.3.8 When nonconforming product is corrected; is it subject to re-verification to demonstrate conformity to the requirements?

13485 8.3.9 Does the organization take action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?

13485 8.3.10 If product needs to be reworked, does the organization document the re-work process in a work instruction, which undergone the same authorization and approval procedure as original work instruction?

13485 8.3.11 Prior to authorization and approval of the work instruction, is it assured that a determination of any adverse effect of the rework upon product is made and documented?

13485:2016 8.3.2 Actions in response to nonconforming product detected before deliv-ery

13485:2016 Does the organization deal with nonconforming product by one or more of the following ways:

13485:2016 a) taking action to eliminate the detected nonconformity?

13485:2016 b) taking action to preclude its original intended use or application?

13485:2016 c) authorizing its use, release or acceptance under concession?

13485:2016 Does the organization ensure that nonconforming product is accepted by concession only if the justification is provided, approval is obtained and applicable regulatory requirements are met?

13485:2016 Are records of the acceptance by concession and the identity of the person authorizing the concession maintained (see 4.2.5)?

13485:2016 8.3.3 Actions in response to nonconforming product detected after delivery

13485:2016 When nonconforming product is detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity. Records of actions taken shall be maintained (see 4.2.5)?

13485:2016 Does the organization document procedures for issuing advisory notices in


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 48 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

accordance with applicable regulatory requirements?

13485:2016 Are these procedures capable of being put into effect at any time?

13485:2016 Are records of actions relating to the issuance of advisory notices main-tained (see 4.2.5)?

13485:2016 8.3.4 Rework

13485:2016 Does the organization perform rework in accordance with documented pro-cedures that takes into account the potential adverse effect of the rework on the product?

13485:2016 Do these procedures undergo the same review and approval as the original procedure?

13485:2016 After the completion of rework, is product verified to ensure that it meets applicable acceptance criteria and regulatory requirements?

13485:2016 Are records of rework maintained (see 4.2.5)?

8.4 Analysis of data

13485 13485:2016

8.4.1 Does the organization determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the QM system (and to as-sess and evaluate where improvement of the effectiveness of the quality management system can be made)?

13485:2016 Do the procedures include determination of appropriate methods, including statistical techniques and the extent of their use?

13485 9001

8.4.2 Does this include data generated as a result of monitoring and measure-ment and from other relevant sources?

Does the analysis provide information relating to ...

9001 8.4.3 - customer satisfaction?

13485 9001

- customer feedback? - conformity to product requirements?

MDD/MPG 8.4.4 - monitoring the market about incidents with their own or similar products?

13485 9001

8.4.5 - characteristics and trends of procedures, processes and products includ-ing opportunities for preventive action and suppliers?

13485 8.4.6 Are records of the results of the analysis of data be maintained?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 49 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Does the analysis of data include data generated as a result of monitoring and measurement and from other relevant sources and include, at a mini-mum, input from:

13485:2016 a) feedback?

13485:2016 b) conformity to product requirements?

13485:2016 c) characteristics and trends of processes and product, including opportuni-ties for improvement?

13485:2016 d) suppliers?

13485:2016 e) audits?

13485:2016 f) service reports, as appropriate

13485:2016 If the analysis of data shows that the quality management system is not suitable, adequate or effective, does the organization use this analysis as input for improvement as required in 8.5?

13485:2016 Are records of the results of analyses maintained (see 4.2.5)?

8.5 Improvement

8.5.1 General

9001 Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objec-tives, audit results, analysis of data, corrective and preventive actions and management review?

13485 13485:2016

Does the organization identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use of the quality policy, quality objectives, audit results, postmarket surveillance, analysis of data, corrective actions, pre-ventive actions and management review?

13485 Are thereby used: the quality policy, quality objectives, audit results, analy-sis of data, corrective and preventive actions and management review?

13485 Are documented procedures established for the issue and implementation of advisory notices?

13485 Are these procedures capable of being implemented at any time?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 50 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485 Are records of all customer complaint investigations maintained?

13485 If investigation determines that activities outside the organization contrib-uted to customer complaints, is there relevant information between the or-ganizations involved exchanged (see 4.1.)?

13485 If any customer complaint is not followed by corrective and/or preventive action, is the reason authorized and recorded?

MDD/MPG Is a procedure defined and documented for notify the regulatory authorities and the DQS of those adverse events which meet the reporting criteria? (DIMDI-Data base for incidents, or rather initial and final reporting of incidents forms) (MED-DEV 2.12/1)

8.5.2 Corrective action

13485 9001 13485:2016

Does the organization take action to eliminate the causes of nonconform-ities in order to prevent recurrence?

13485 9001 13485:2016

Are corrective actions appropriate to the effects of the nonconformities en-countered?

Is a documented procedure established to define requirements for ...

13485 9001 13485:2016

- reviewing nonconformities (including customer complaints)? - determining the causes of nonconformity?

13485 9001 13485:2016

- evaluating the need for action to ensure that nonconformities do not re-cur?

13485 13485:2016

- (determining and implementing) planning and documenting action needed, including, if appropriate, updating documentation (see 4.2)?

13485:2016 - verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device?

13485 13485:2016

- recording of the results of any investigation and of action taken? - reviewing the corrective action taken and its effectiveness?

13485

- Are the results of recent risk evaluation included? - Do the reflected results flow back to the risk management and are they

covered by the risk management documents?

13485 - Is it also checked in the analysis whether the error can occur for compa-rable products/processes?


ISO 13485 & MDD & 9001

Ref: xxxxxx


Version: 1.0 51 / 51

Dieses D

oku

men

t wird

bei A

usd

ruck

en o

der A

blag

e an ein

em an

deren

als dem

ursp

rün

glich

en S

peich

erort u

ng

ültig

.

Jeder N

utzer ist d

afür vera

ntw

ortlich

, aussch

ließlich

mit d

em

jew

eils gü

ltigen

Au

sgab

estan

d d

es D

oku

me

nts zu

arbe

iten!

Eva-lua-tion1.

Year

Eva-lua-tion2.

Year

Eva-lua-tion3.

Year

13485:2016 Are records of the results of any investigation and of action taken main-tained (see 4.2.5)?

8.5.3 Preventive action

13485 9001 13485:2016

Does the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence?

Are preventive actions appropriate to the effects of the potential problems?

Is a documented procedure established to define requirements for ...

13485 9001 13485:2016

- determining potential nonconformities and their causes? - evaluating the need for action to prevent occurrence of nonconformities?

13485 9001

- determining and implementing action needed? - recording of the results of any investigations and of action taken?

13485 9001

- reviewing preventive action taken?

13485:2016 - planning and documenting action needed and implementing such action, including, as appropriate, updating documentation?

13485:2016 - verifying that the action does not adversely affect the ability to meet appli-cable regulatory requirements or the safety and performance of the medi-cal device?

13485:2016 - reviewing the effectiveness of the preventive action taken, as appropri-ate?

13485:2016 Are records of the results of any investigations and of action taken main-tained (see 4.2.5)?

Documents

Checklist for Assessment ISO 13485 & MDD & 9001 Ref: …€¦ · 9001 Requirement of the DIN EN ISO 9001:2008 ... way, please remember your audit training. The Checklist must be used