Checklist for the assessment based on the standards · way, please remember your audit training. The checklist must be used for the documentation of the assessment. The checklist

Checklist for Assessment

ISO 13485 & MDD

Ref: xxxxxx

410_09e_Checkliste_for_Assessment_13485_MDD.docx

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

If 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

Audit date 4. Year

Auditor:

Name

Signature

Audit date 5. Year

Auditor:

Name

Signature


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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 EN ISO 13485:2016 + AC : 2016, MDD 93/42/EEC, Annex II/V/VI and if applicable the German Medical Device Act (MPG).

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

13485:2016 Requirement of the EN ISO 13485:2016 + AC:2016

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 13485 is 3 years.

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

In the 2nd to the 3rd year the audit will be performed on a statistical basis, but in summary within these 2 years all requirements must be assessed.

The requirements regarding Management responsibility, Internal Audits, Human resources, Production 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

EN ISO 13485:2016 + AC:2016 allows exclusions in clauses 6, 7 and 8. To claim compliance with MDD only certain exclusions in clause 7 are possible, see below.

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)].

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)].


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

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0 General

0.1 1.1 General questions for the certification

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

0.2 1.2 Additional requirements of the 93/42/EEC to es-

tablish the procedure

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

MDD/MPG Was the company completely informed about the previous and present (today’s) activities of the auditor(s)? Is the declaration “ Audi-tors’/Experts’ Independence and Objectivity “ countersigned?

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

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

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

13485:2016 Does the organization ensure the control of any outsourced processes, which affect product conformity with requirements and is the control of such outsourced processes identifiable within the QM system?


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13485:2016 Does the organization document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements?

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

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

13485:2016 Does the organization…

13485:2016 a) determine the processes needed for the quality management sys-tem 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 proc-esses needed for the quality management system?

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

13485:2016 Does the organization…

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

13485:2016 b) …ensure the availability of resources and information necessary to support 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 confor-mance to this International Standard and compliance with applicable regulatory requirements…

…for each quality management system process?

13485:2016 The organization manages these quality management system proc-esses in accordance with the requirements of this International Stan-dard and applicable regulatory requirements. Are the following


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changes to these processes made:

13485:2016 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 Standard and applicable regulatory requirements?

13485:2016 Does the organization monitor and ensure control to any outsourced processes that affects product conformity to requirements?

13485:2016 Does the organization retain responsibility of conformity to this Interna-tional Standard and to customer and applicable regulatory require-ments for outsourced processes?

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

13485:2016 Do the controls include written quality agreements?

13485:2016 Does the organization document procedures for the validation of the application of computer software used in the quality management sys-tem?

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

13485:2016 Are the specific approach and activities associated with software vali-dation 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

13485:2016 Does the quality management system documentation (see 4.2.4) in-clude:

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


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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 require-ments?

4.2.3 Product documentation

13485:2016 Are files available, containing all products specifications and quality assurance specifications, or is the location of those documents de-scribed exactly? ( NB-MED 2.5.1-5) (see also Annex II / V/ VI 93/42/EWG and if necessary DQS-Support checklists)

13485:2016 Is this information available and comprehensible for each type or each model of the medical device? (if necessary also the information for installation / 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 system-atically ensured)? If no harmonized standards are available, is there proof, which ensures the safety and suitability of the products?

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

MDD/MPG

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

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)


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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 sup-pliers / subcontractors?

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

MDD/MPG Does the contract with e.g. OEM suppliers contain sufficient descrip-tions and regulations on notification of the legal authorities and to en-sure appropriate 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 Directive, 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 protective equipment, is a notified body involved for this?

4.2.2 Quality manual

Does the quality manual include ...

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 qual-ity management system?

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


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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 appli-cable regulatory requirements?

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, handling 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?

4.2.4 Control of documents

13485:2016 Are documents controlled required by the quality management sys-tem?

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?


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13485:2016 f) ensure that documents of external origin, determined by the organi-zation 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 suit-able identification to them?

4.2.5 Control of records

13485:2016 Are records maintained to provide evidence of conformity to require-ments and of the effective operation of the quality management sys-tem?

13485:2016 Does the organization documents procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records?

13485:2016 Does the organization defines and implements methods for protecting confidential health information contained in records in accordance with the applicable regulatory requirements.

13485:2016 Are records remain legible, readily identifiable and retrievable? Are changes to a record remain identifiable?

13485:2016 Does the organization retain the records for at least the lifetime of the medical device as defined by the organization, or as specified by appli-cable regulatory requirements, but not less than two years from the medical device release by the organization.

MDD/MPG Does the manufacturer keep the records for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured.

5 Management responsibility

5.1 Management commitment

13485:2016 Does top management provides evidence of its commitment to the development and implementation of the quality management system and maintenance of its effectiveness by:

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

13485:2016 b) establishing the quality policy?


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

13485:2016 d) conducting management reviews?

13485:2016 e) ensuring the availability of resources?

5.2 Customer focus

13485:2016 Does top management ensures that customer requirements and appli-cable regulatory requirements are determined and met?

5.3 Quality policy

13485:2016 Does top management ensures 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 objec-tives?

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

13485:2016 e) is reviewed for continuing suitability?

5.4 Planing

5.4.1 Quality objectives

13485

Are quality objectives (preferably measurable) established at relevant functions and levels within the organization? Are the quality objectives measurable and consistent with the quality policy?

13485

Are there objectives needed to meet the requirements for products?

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


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13485:2016 Are the quality objectives measurable and consistent with the quality policy?

5.4.2 Quality management system planning

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 ob-jectives?

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

5.5 Responsibility, authority and communication

5.5.1 Responsibility and authority

13485:2016 Does the top management ensures that the responsibilities and au-thorities are defined, communicated and documented within the or-ganization?

13485:2016 Is the necessary independence and authority to perform these tasks ensured 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 documents the interrelation of all personnel who manage, perform and verify work affecting quality and ensures the independence 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 respon-sibility and authority that includes ...

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

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

13485:2016 c) ensuring the promotion of awareness of applicable regulatory re-quirements and quality management system requirements throughout the organization?

MDD/MPG Who is appointed (and trained) as Medical Device Safety Representa-


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tive? Is the expertise provided sufficiently?

(§ 30 MPG; Statement in the report)

MDD/MPG Are the Medical Device Safety Representative’s responsibilities and competencies defined and documented and was the Medical Device Safety Representative notified to the legal authorities?

5.5.3 Internal communication

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

5.6 Management review

5.6.1 General

13485:2016 Does the organization document procedures for management review. Top management reviews the organization’s quality management sys-tem at documented planned intervals to ensure its continuing suitabil-ity, 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, but is not limited to, information arising from:

13485:2016 a) feedback?

13485:2016 b) complaint handling?

13485:2016 c) reporting to regulatory authorities?

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?


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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

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

13485:2016 a) improvement needed to maintain the suitability, adequacy, and ef-fectiveness 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 regula-tory requirements?

13485:2016 d) resource needs?

6 Resource management

6.1 Provision of resources

Does the organization determine and provide the resources needed to…

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


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

6.2 Human Resources

13485:2016 Does personnel performing work affecting product quality be compe-tent on the basis of appropriate education, training, skills and experi-ence?

13485:2016 Does the organization document the process(es) for establishing com-petence, providing needed training, and ensuring awareness of per-sonnel?

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 nec-essary 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 ex-perience (see 4.2.5)?

6.3 Infrastructure

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 informa-tion systems).

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


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product quality?

13485:2016 Does as appropriate, the requirements apply to equipment used in production, 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 and contamination control

13485:2016 6.4.1 Work environment

13485:2016 Does the organization document the requirements for the work envi-ronment 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 environment?

13485:2016 Does the organization:

13485:2016 a) document requirements for health, cleanliness and clothing of per-sonnel if contact between such personnel and the product or work en-vironment 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 competent or supervised by a competent person?

13485:2016 6.4.2 Contamination control

13485:2016 Does, as appropriate, the organization plan and document arrange-ments 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, require-ments for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or pack-aging processes?

7 Product realization

7.1 Planning of product realization


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13485:2016 Does the organization plan and develop the processes needed for product realization? Is the planning of product realization consistent with the requirements of the other processes of the QM system?

13485:2016 Does the organization document one or more processes for risk man-agement 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 ...

13485:2016 - quality objectives and requirements for the product?

13485:2016 - the need to establish processes and documents(see 4.2.4), and to provide resources specific to the product including infrastructure and work environment?

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?

13485:2016 records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.5)?

13485:2016 Is the output of this planning in a suitable form for the organization’s method of operations documented?

13485:2016 Has the organization established the documented requirements for risk management throughout product realization?

13485:2016 Are records arising from risk management including the results getting maintained? (see for example EN ISO 14971)

7.2 Customer-related processes

7.2.1 Determination of requirements related to the product

- Does the organization determine ...

13485:2016

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

13485:2016

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

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


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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

13485:2016

Does the organization review the requirements related to the product? Is this review conducted prior to the organization’s commitment to sup-ply 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 con-tracts or orders)

Does this review ensure that ...

13485:2016

a) product requirements are defined and the organization has (the abil-ity to meet the) defined requirements?

13485:2016

b) contract or order requirements differing from those previously ex-pressed 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?

13485:2016

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

13485:2016 Does the organization confirm the customer requirements before ac-ceptance, where the customer provides no documented statement of requirement?

13485:2016

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

7.2.3 Communication

13485:2016 The organization 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?


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13485:2016 c) customer feedback, including complaints?

13485:2016 d) advisory notices?

13485:2016 Does the organization communicate with regulatory authorities in ac-cordance with applicable regulatory requirements?

7.3 Design and development

7.3.1 General

13485:2016 Does the organization document procedures for design and develop-ment?

7.3.1 Design and development planning

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 maintained 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 appropriate at each design and development stage?

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

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

13485:2016 f) the resources needed, including necessary competence of person-nel?

7.3.3 Design and development inputs


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13485:2016 Are inputs related to product requirements determined and records maintained (see 4.2.5)?

- Do these inputs include ...

13485:2016 - functional, performance usability and safety requirements according to the intended use?

13485:2016 - applicable (statutory and) regulatory requirements(, as well as the results from the risk management) and standards?

13485 - 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 prod-uct and processes?

13485:2016 Are these inputs reviewed for adequacy and approved?

13485:2016 Are these requirements complete, unambiguous, able to be verified or validated and not in conflict with each other?

MDD/MPG Has the applicable harmonized standards for safety requirements for medical 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 be-tween different groups involved in design and development eliminated?

7.3.4 Design and development outputs

13485:2016 Are the outputs of the design and development in a form suitable for verification against the design and development input and are ap-proved prior to release?

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 ser-vice provision?

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


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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)?

7.3.5 Design and development review

13485:2016 At suitable stages, are systematic reviews of design and development performed 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 concerned 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 maintained and include the identification of the design under review, the participants involved and the date of the review (see 4.2.5)?

7.3.6 Design and development verification

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

13485:2016 Does the organization document verification plans that include meth-ods, 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 in-clude confirmation that the design outputs meet design inputs when so connected or interfaced?


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

7.3.7 Design and development validation

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 appli-cation or intended use?

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

13485:2016 Are design validation conducted on representative product? Represen-tative product includes initial production units, batches or their equiva-lents.

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 perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements? A medi-cal 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 in-tended use have been met when so connected or interfaced?

13485:2016 Are validation completed prior to release for use of the product to the customer?

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

7.3.8 Design and development transfer

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

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?


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

7.3.9 Control of design and development changes

13485:2016 Does the organization 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 re-quirements for the medical device and its intended use?

13485:2016 Are design and development changes identified and records main-tained and reviewed, verified and validated, as appropriate? Are design and development changes approved before implementation?

13485:2016 Does the review of design and development changes include evalua-tion of the effect of the changes on constituent parts and product in process or already delivered or outputs of risk management and prod-uct realization processes?

13485:2016 Are records of the results of the review of changes and any necessary actions maintained? (see 4.2.5).

MDD/MPG Which procedures guarantees that the DQS is informed when substan-tial modifications are done to the products?

7.3.10 Design and development files

13485:2016 Does the organization 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 conformity to the requirements for design and development and re-cords for design and development changes?

7.4 Purchasing

7.4.1 Purchasing process

13485:2016 Does the organization document procedures (see 4.2.4) to ensure that purchased 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


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organization’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 medical 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 suppli-ers?

13485:2016 Is supplier performance in meeting requirements for the purchased product 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 sup-plier proportionate to the risk associated with the purchased product and compliance 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)?

7.4.2 Purchasing information

13485:2016 Does the purchasing information describe the product to be purchased? Does the information include, where appropriate ...

13485:2016 a) product specifications?

13485:2016 a) requirements for (approval of) product acceptance, procedures, processes and equipment?

13485:2016 b) requirements for qualification of personnel?

13485:2016 d) quality management system requirements?

13485:2016 Is the adequacy of specified purchase requirements ensured, prior to their communication to the supplier?

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


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ments?

13485:2016 To the extent required for traceability given in 7.5.9, does the organiza-tion 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

13485:2016 Does the organization establish and implement the inspection or other activities necessary for ensuring that purchased product meets speci-fied purchase 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 pur-chased product, does the organization determine whether these changes affect the product realization process or the medical device?

13485:2016 Where the organization or its customer intends to perform verification at the supplier’s premises: are the intended verification activities (ar-rangements) and method of product release stated in the purchasing information?


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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 produc-tion (see 4.2.4)?

13485:2016 b) qualification of infrastructure?

13485:2016 c) implementation of monitoring and measurement of process parame-ters 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 activi-ties?

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 trace-ability to the extent specified in 7.5.9 and identifies the amount manu-factured and amount approved for distribution?

13485:2016 Is the record verified and approved?

13485:2016 7.5.2 Cleanliness of product

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

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


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

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

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

13485:2016 e) process agents are to be removed from product during manufac-ture?

13485:2016 Was the product cleaned in accordance with a) or b) above? (The re-quirements contained in 6.4.1 do not apply prior to the cleaning proc-ess)

13485:2016 7.5.3 Installation activities

13485:2016 Does the organization document requirements for medical device in-stallation and acceptance criteria for verification of installation, as ap-propriate?

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 supplier, 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)?

13485:2016 7.5.4 Servicing activities

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

13485:2016 Does the organization analyses 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


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supplier maintained (see 4.2.5)?

13485:2016 7.5.5 Particular requirements for sterile medical devices

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

13485:2016 Are sterilization records traceable to each production batch of medical devices?

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

13485:2016 Does the organization validate any processes for production and ser-vice provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, defi-ciencies become apparent only after the product is in use or the ser-vice 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 proc-esses, 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?

13485:2016 Does the organization document procedures for the validation of the application of computer software used in production and service provi-sion?



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13485:2016 Are the specific approach and activities associated with software vali-dation and revalidation proportionate to the risk associated with the use of the software, including the effect on the ability of the product to con-form to specifications?

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

13485:2016 7.5.7 Particular requirements for validation of processes for steriliza-tion and sterile barrier systems

13485:2016 Does the organization 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 actions 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 prod-uct 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 organiza-tion 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 conforming products?

13485:2016 7.5.9 Traceability

13485:2016 7.5.9.1 General


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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 main-tained (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, materials, and conditions for the work environment used, if these could cause the medical device not to satisfy its specified safety and per-formance requirements?

13485:2016 Does the organization require that suppliers of distribution services or distributors 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 con-signee 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 unsuitable 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 con-formity of product to requirements during processing, storage, han-dling, and distribution?

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 processing, storage, handling, and distribution by:

13485:2016 a) designing and constructing suitable packaging and shipping con-tainers?


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13485:2016 b) documenting requirements for special conditions needed if packag-ing 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

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

13485:2016 Does the organization 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, ...

13485:2016 - be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards?

13485:2016 - is the basis used for calibration or verification recorded, where no such standards exist?

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

13485:2016 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?

13485:2016 Is the validity of previous measuring results assessed and recorded, when the measuring equipment is found not to conform to require-ments? Does the organization take appropriate action on the measur-ing equipment and any product affected?

13485:2016 Are records of the results of calibration and verification maintained (see 4.2.5).?

13485:2016 Does the organization document procedures for the validation of the application of computer software used for the monitoring and meas-urement of requirements?



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13485:2016 Are the specific approach and activities associated with software vali-dation and revalidation proportionate to the risk associated with the use of the software, including the effect on the ability of the product to con-form to specifications?

13485:2016 Are records of the results and conclusion of validation and necessary actions 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, measure-ment, analysis and improvement processes needed to ...

13485:2016 - demonstrate conformity of the product?

13485:2016 - ensure conformity of the QM-System and to maintain the effective-ness of the QM-System?

13485:2016 continually improve the effectiveness of the QM-System?

13485:2016 Does this include determination of applicable methods, including statis-tical techniques, and the extent of their use?

8.2 Monitoring and measurement

13485:2016 8.2.1 Feedback

13485:2016 As one of the measurements of the effectiveness of the quality man-agement 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 production as well as post-production activities?

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


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

8.2.2 Complaint handling

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

13485:2016 Do these procedures include at a minimum requirements and respon-sibilities for:

13485:2016 a) receiving and recording information?

13485:2016 b) evaluating information to determine if the feedback constitutes a complaint?

13485:2016 c) investigating complaints?

13485:2016 d) determining the need to report the information to the appropriate regulatory 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 han-dling process documented?

13485:2016 If an investigation determines activities outside the organization con-tributed to the complaint, are relevant information exchanged between the organization and the external party involved?

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

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 pro-viding notification to the appropriate regulatory authorities?

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


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8.2.4 Internal audit

13485:2016 Does the organization conduct internal audits at planned intervals to determine whether the quality management system:

13485:2016 a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system require-ments established by the organization, and applicable regulatory re-quirements?

13485:2016 b) is effectively implemented and maintained?

13485:2016 Does the organization document a procedure to describe the responsi-bilities and requirements for planning and conducting audits and re-cording and reporting audit results?

13485:2016 Is an audit program planned, taking into consideration the status and importance 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 re-corded (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 appropriate, measurement of the quality management system proc-esses?


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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?

13485:2016 8.2.6 Monitoring and measurement of product

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

13485:2016 Is this carried out at applicable stages of the product realization proc-ess in accordance with the planned and documented arrangements and documented 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 com-pleted?

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

13485:2016 Does the organization ensure that products which does not conform to product requirements are identified and controlled to prevent is unin-tended use or delivery?

13485:2016 Is there a documented procedure established to define the controls and related responsibilities and authorities for dealing with noncon-forming product?

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

13485:2016 Are records of the nature of nonconformities and any subsequent ac-tions taken, including the evaluation, any investigation and the ration-ale for decisions concessions obtained maintained? (see 4.2.5)


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13485:2016 8.3.2 Actions in response to nonconforming product detected before delivery

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 products are detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity. Are records of actions taken maintained (see 4.2.5)?

13485:2016 Does the organization document procedures for issuing advisory no-tices in 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 maintained (see 4.2.5)?

13485:2016 8.3.4 Rework

13485:2016 Does the organization perform rework in accordance with documented procedures 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?


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

8.4 Analysis of data

13485:2016 Does the organization determine, collect and analyses appropriate data to demonstrate the suitability and effectiveness of the QM system (and to assess 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, in-cluding statistical techniques and the extent of their use?

13485:2016 Does the analysis of data include data generated as a result of moni-toring and measurement and from other relevant sources and include, at a minimum, input from:

13485:2016 a) feedback?

13485:2016 b) conformity to product requirements?

13485:2016 c) characteristics and trends of processes and product, including op-portunities 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

13485:2016 Does the organization identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effec-tiveness of the quality management system as well as medical device safety and performance with the use of the quality policy, quality objec-tives, audit results, postmarket surveillance, analysis of data, corrective actions, preventive actions and management review?


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

8.5.2 Corrective action

13485:2016 Does the organization take action to eliminate the causes of noncon-formities in order to prevent recurrence?

13485:2016 Are corrective actions appropriate to the effects of the nonconformities encountered?

- Is a documented procedure established to define requirements

for ...

13485:2016 - reviewing nonconformities (including customer complaints)? - determining the causes of nonconformity?

13485:2016 - evaluating the need for action to ensure that nonconformities do not recur?

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 abil-ity to meet applicable regulatory requirements or the safety and per-formance of the medical device?

13485:2016

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

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

13485:2016 Does the organization determine action to eliminate the causes of po-tential nonconformities in order to prevent their occurrence?

Are preventive actions appropriate to the effects of the potential prob-lems?

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

13485:2016 - determining potential nonconformities and their causes? - evaluating the need for action to prevent occurrence of nonconform-

ities?

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


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Eva-lua-tion5.

Year

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

13485:2016 reviewing the effectiveness of the preventive action taken, as appro-priate?

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

Documents

Checklist for the assessment based on the standards · way, please remember your audit training. The checklist must be used for the documentation of the assessment. The checklist