ISO 13485 version 2016 requirements, medical devices, quality management systems

22/08/2017

The "ISO 13485 version 2016 Requirements" quiz will help you understand the main requirements of the standard.

The questions (requirements) included in this quiz are 98 of the 416 in the standard, but don't worry. These 98 requirements are among the most important. So do not hesitate to learn in a fun way!

Do not think you can finish this quiz in less than an hour, or even two hours, unless of course you are a little genius!

News on the medical devices standard ISO 13485 version 2016

The 416 requirements (verb shall) of clauses 4 to 8 of the standard ISO 13485 version 2016 are as follows:

ISO 13485 version 2016 requirements
No	Clause	PDCA cycle	Requirement No	Quantity
4	Quality management system	Plan	1 ÷ 62	62
5	Management responsibility	Plan, Act	63 ÷ 110	48
6	Resource management	Plan	111 ÷ 130	20
7	Product realization	Do	131 ÷ 325	195
8	Measurement, analysis and improvement	Check, Act	326 ÷ 416	91
Total				416

requirements

Requirements, clauses and sub-clauses of the standard ISO 13485 version 2016

pdca

Deming PDCA cycle

Notes:

To facilitate understanding of the requirements the verb shall is replaced by the verb closest to the requirement
Human resources is replaced by people (as in the ISO 9001 version 2015 edition)

ISO 13485 version 2016 - Requirements and comments
No	Clause, sub-clause	Requirement	PDCA cycle, links, comments
	4	Quality management system
	4.1	General requirements
1	4.1.1	Document a quality management system (QMS)	Develop your QMS. Cf. sub-clause 4.2.5
2	4.1.1	Maintain the effectiveness of your QMS	Effectiveness is the capacity to realize planned activities with minimum efforts
3	4.1.1	Establish any requirement, procedure, activity or arrangement	In accordance with ISO 13485 or applicable regulatory requirements
4	4.1.1	Implement any requirement, procedure, activity or arragement	In accordance with ISO 13485 or applicable regulatory requirements
5	4.1.1	Maintain any requirement, procedure, activity or arrangement	In accordance with ISO 13485 or applicable regulatory requirements
6	4.1.1	Document the roles undertaken by the organization under the applicable regulatory requirements	Cf. sub-clause 4.2.5. Identify the roles undertaken by the organization (manufacturer, distributor or representative of the manufacturer)
7	4.1.2 a	Determine the processes needed for the QMS and the application of these processes	Although process mapping is not explicitly required, it is in practice the best response to this requirement
8	4.1.2 b	Apply a risk based approach to control the processes needed for the QMS	Cf. sub-clause 7.1. Identify process risks, their levels, their impact on the safety and performance of the product. Justify the chosen degree of risk control
9	4.1.2 c	Determine the sequence and interaction of these processes	Although process mapping is not explicitly required, it is in practice the best response to this requirement
10	4.1.3 a	Determine criteria and methods to ensure process effectiveness and control	Support each process of your QMS
11	4.1.3 b	Ensure the availability of resources and information needed to support process operation and monitoring	For each process of the QMS
12	4.1.3 c	Implement actions to achieve planned results and process effectiveness	For each process of the QMS
13	4.1.3 d	Monitor, measure and analyze these processes	Measure as appropriate
14	4.1.3 e	Establish and retain records needed to demonstrate conformity with ISO 13485 standard and with applicable regulatory requirements	Cf. sub-clause 4.2.5. For each process of the QMS
15	4.1.4	Manage QMS processes	In accordance with ISO 13485 and applicable regulatory requirements
16	4.1.4 a	Evaluate the impact of changes on the QMS	Describe the management of changes (rules, criteria, follow-up)
17	4.1.4 b	Evaluate the impact of changes on the medical devices produced under this QMS	Cf. sub-clause 7.3.9
18	4.1.4 c	Control the process changes	In accordance with ISO 13485 and applicable regulatory requirements
19	4.1.5	Monitor and control outsourced processes	That may affect compliance with requirements. List of outsourced processes, associated risk levels
20	4.1.5	Retain responsibility of conformity	To the ISO 13485 standard, to customer and applicable regulatory requirements
21	4.1.5	Keep controls proportionate to the risks involved	And the ability of the external party to meet the requirements, cf. sub-clause 7.4
22	4.1.5	Include in the controls written quality arrangements	Supplier quality agreements, especially for outsourced processes with high risk level
23	4.1.6	Document procedures for the validation of software used in the QMS	Cf. sub-clause 4.2.4
24	4.1.6	Validate software applications prior to initial use and after any change	List of validated software used in the QMS
25	4.1.6	Keep validation and revalidation activities proportionate to the risk associated with the use of the software	For each software used, justify the validation approach in relation to the level of risk
26	4.1.6	Retain records of these activities	Cf. sub-clause 4.2.5
	4.2	Documentation requirements
	4.2.1	General
27	4.2.1 a	Document a quality manual and quality objectives	Cf. sub-clauses 4.2.4 and 4.2.5 . Quality policy and objectives are formalized in a relevant and simple document
28	4.2.1 b	Include the quality manual in documented form	If the procedures are not part of the quality manual then there is a reference to them and the location where they can be found (this may be the Intranet system)
29	4.2.1 c	Include documented procedures and records required by the standard ISO 13485	Cf. sub-clause 4.2.4. The requirements of the ISO 13485 v 2016 standard are 416
30	4.2.1 d	Include documents and records, determined by the organization as necessary to ensure the effective planning, operation and control of its processes	Cf. sub-clause 4.2.5
31	4.2.1 e	Include other documentation related to applicable regulatory requirements	Cf. sub-clauses 4.2.4 and 4.2.5. The bare essentials is often the best choice
	4.2.2	Quality manual
32	4.2.2 a	Prepare a quality manual including the scope of the QMS	Cf. sub-clause 4.2.4 Justification of any exclusion or non-application
33	4.2.2 b	Document a quality manual with documented procedures	Cf. sub-clause 4.2.4. Or include a reference to procedures
34	4.2.2 c	Document a quality manual with interaction between processes of the QMS	Cf. sub-clauses 4.2.1 and 4.2.4
35	4.2.2	Outline the structure of the documentation of the QMS	The simplest is the documentary pyramid: quality manual, processes, procedures, documents, records
	4.2.3	Medical device file
36	4.2.3	Establish and maintain a file containing documents to demonstrate conformity to the requirements of the standard ISO 13485 and applicable regulatory requirements	Cf. sub-clause 4.2.5. Link with the CE marking of the medical device
	4.2.3 a	Include in this file a description of the medical device, intended use and labelling	Including instructions for use. More information in ISO 15223 (Medical devices - Symbols for use with labels, labeling and information relating to medical devices - Part 1: General requirements)
38	4.2.3 b	Include in this file product specifications	Cf. sub-clause 7.2.1
39	4.2.3 c	Include in this file manufacturing, packaging, storage, handling and distribution specifications	Cf. sub-clause 7.2.1
40	4.2.3 d	Include in this file measuring and monitoring procedures	Cf. sub-clause 7.6
41	4.2.3 e	Include in this file installation requirements	Cf. sub-clause 7.5.3, as appropriate
42	4.2.3 f	Include in this file servicing procedures	Cf. sub-clause 7.5.4, as appropriate
	4.2.4	Control of documents
43	4.2.4	Control required QMS documents	The procedure defines how before you start using a document, it is approved (verified, validated) by a person with defined responsibilities and authorities
44	4.2.4	Control records	Cf. sub-clause 4.2.5. Records are a particular type of document
45	4.2.4 a	Review and approve documents	For adequacy prior to issue
46	4.2.4 b	Review and re-approve documents	Update if necessary
47	4.2.4 c	Ensure identification of changes and current revision status	Managing changes and revisions (versions) of documents is performed by a person with established responsibilities and authorities
48	4.2.4 d	Ensure availability at points of use of relevant versions of applicable documents	"The right document, in the right place, at the right time" and with the right version
49	4.2.4 e	Ensure legible and readily identifiable documents	Each document is clear, simple to understand, easy to categorize including electronic files
50	4.2.4 f	Ensure that documents of external origin are identified and their distribution controlled	External documents determined by the company as necessary for the planning and operation of the QMS (standards, requirements, specifications) are identified and controlled (list, location, version). Method of coding documents
51	4.2.4 g	Prevent deterioration or loss of documents	Including electronic files (regular backups)
52	4.2.4 h	Prevent the unintended use of obsolete documents	Outdated (obsolete) documents are identified, stored, archived, locked or destroyed so that they cannot be used normally
53	4.2.4	Ensure that changes to documents are reviewed and approved by authorised persons	Either by the original approving function or by a person with pertinent information
54	4.2.4	Define the period for which obsolete documents will be retained	Cf. sub-clause 4.2.5
55	4.2.4	Ensure a period for which documents will be retained at least equal to the lifetime of the medical device, but no less than the retention period as specified by applicable regulatory requirements	List of mandatory documented procedures: Validation of software applications (sub-clauses 4.1.6, 7.5.6 and 7.6) Control of documents (sub-clause 4.2.4) Control of records (sub-clause 4.2.5) Management review (sub-clause 5.6.1) Control of the working environment (sub-clause 6.4.1) Design and development (sub-clause 7.3) Design and development transfer (sub-clause 7.3.8) Control of design and development changes (Sub-Clause 7.3.9) Purchasing (sub-clause 7.4) Control of production (sub-clause 7.5) Process validation (sub-clauses 7.5.6 and 7.5.7) Identification and traceability (subclauses 7.5.8 and 7.5.9) Product preservation (sub-clause 7.5.11) Control of monitoring and measuring equipment (sub-clause 7.6) Feedback (sub-clause 8.2.1) Claims handling (sub-clause 8.2.2) Reporting to regulatory authorities (sub-clause 8.2.3) Internal audit (sub-clause 8.2.4) Control of nonconforming product (sub-clause 8.3.1) Advisory notices (sub-clause 8.3.3) Rework (sub-clause 8.3.4) Data analysis (sub-clause 8.4) Corrective action (sub-clause 8.5.2) Preventive action (sub-clause 8.5.3)
	4.2.5	Control of records
56	4.2.5	Retain records as evidence of meeting requirements	"Words fly away, writings remain". Latin proverb. The records are entered daily (without delay). Without them it is difficult (if not impossible) to demonstrate compliance with the requirements of the QMS
57	4.2.5	Provide evidence of the effectiveness of the QMS	By retaining records
58	4.2.5	Document the procedure for control of records	Cf. sub-clause 4.2.4. The procedure for records answers questions who, when, how, under what conditions identify, store, implement measures for security and integrity, retrieve, retain and delete records
59	4.2.5	Define and apply methods for protecting confidential health information	In accordance with the applicable regulatory requirements
60	4.2.5	Keep records legible, readily identifiable and retrievable	Each record is clear, easy to understand, easy to categorize including electronic files
61	4.2.5	Keep changes to records identifiable	Rules to apply (e.g. name, signature, date, justification)
62	4.2.5	Retain records at least at least equal to the lifetime of the medical device	In accordance with the requirements of the company or applicable regulatory requirements but more than 2 years after the distribution of the medical device. List of mandatory records: Role of the organization (sub-clause 4.1.1) Process control (subclauses 4.1.3 e and 4.2.1 d) Validation of software applications (sub-clause 4.1.6) General QMS documentation (sub-clause 4.2.1) Regulatory requirements (sub-clause 4.2.1 e) Medical device file (sub-clause 4.2.3) Control of records (sub-clause 4.2.4) Responsibilities, authorities and independence (5.5.1) Management review (sub-clauses 5.6.1 and 5.6.3) Competence of staff (sub-clause 6.2 e) Maintenance of infrastructure (sub-clause 6.3) Working environment (sub-clause 6.4.1) Control of contamination (sub-clause 6.4.2) Risk management (sub-clause 7.1) Production planning (sub-clause 7.1) Compliance of processes and product (sub-clause 7.1 d) Review of product requirements (sub-clause 7.2.2) Communication with the customer (sub-clause 7.2.3) Design and development inputs (sub-clause 7.3.3) Design and development outputs (sub-clause 7.3.4) Design and development review (sub-clause 7.3.5) Design and development verification (sub-clause 7.3.6) Design and development validation (sub-clause 7.3.7) Design and development transfer (sub-clause 7.3.8) Design and development changes (sub-clause 7.3.9) Design and development files (sub-clause 7.3.10) Control of suppliers (sub-clause 7.4.1) Purchasing information (sub-clause 7.4.2) Verification of the purchased product (sub-clause 7.4.3) Verification and approval of medical devices before release (sub-clause 7.5.1) Cleanliness of the product (sub-clause 7.5.2) Installation and verification of medical devices (sub-clause 7.5.3) Servicing activities (sub-clause 7.5.4) Batch sterilization parameters (sub-clause 7.5.5) Process validation (sub-clause 7.5.6) Validation of sterilization processes (sub-clause 7.5.7) Unique identification (sub-clause 7.5.8) Traceability (sub-clause 7.5.9.1) Consignee of the package (sub-clause 7.5.9.2) Customer property concern (sub-clause 7.5.10) Preservation of product (sub-clause 7.5.11) Calibration and verification of measuring equipment (sub-clause 7.6) Validation results of monitoring and measuring software (sub-clause 7.6) Feedback (sub-clause 8.2.1) Complaint handling (sub-clause 8.2.2) Reporting to regulatory authorities (sub-clause 8.2.3) Internal audits (sub-clause 8.2.4) Monitoring and measurement of the product (sub-clause 8.2.6) Nonconformities (sub-clause 8.3.1) Authorization of concession (sub-clause 8.3.2) Advisory notices (sub-clause 8.3.3) Rework (sub-clause 8.3.4) Analysis of data (sub-clause 8.4) Corrective action undertaken (sub-clause 8.5.2) Preventive action undertaken (sub-clause 8.5.3)
	5	Management responsibility	Planifier (Plan), Agir (Act)
	5.1	Management commitment
63	5.1	Provide evidence of top management's commitment to the development, implementation and maintenance of the effectiveness of the QMS	"When you sweep the stairs, you start at the top". Romanian proverb
64	5.1 a	Communicate the importance of meeting customer requirements	And applicable regulatory requirements
65	5.1 b	Establish the quality policy	Defining the quality policy is an essential, direct and documented involvement of top management in developing and maintaining the effectiveness of the QMS
66	5.1 c	Ensure that quality objectives are established	Quantify in each department quality objectives consistent with the quality policy and customer requirements
67	5.1 d	Conduct management reviews	Cf. sub-clause 5.6. Keep records of management reviews as evidence that the QMS is relevant, effective and continuously improving
68	5.1 e	Ensure the availability of resources	Cf. sub-clause 6.1. Top management provides the necessary resources to carry out the quality policy and achieve the objectives set
	5.2	Customer focus
69	5.2	Determine and meet customer requirements	And applicable regulatory requirements. Cf. sub-clauses 7.2.1 and 8.2.1
	5.3	Quality policy
70	5.3 a	Adapt the quality policy to the purpose of the organization	The quality policy is consistent with customer satisfaction and continual improvement of the QMS
71	5.3 b	Include the commitment to comply with requirements and to maintain the effectiveness of the QMS	Unambiguous commitment from top management
72	5.3 c	Provide a framework for establishing quality objectives	And review quality objectives. Cf. sub-clause 5.6. The management review is the framework par excellence for this requirement
73	5.3 d	Communicate and explain the quality policy	Cf. sub-clause 5.5.3
74	5.3 e	Review the quality policy	Cf. sub-clause 5.6. The quality policy is constantly evolving. This is one of the goals of the management review
	5.4	Planning
	5.4.1	Quality objectives
75	5.4.1	Establish quality objectives at relevant functions within the organization	Including those needed to meet applicable regulatory and product requirements. Cf. sub-clause 7.1
76	5.4.1	Ensure measurable quality objectives	Cf. sub-clause 7.1
77	5.4.1	Ensure consistent with the quality policy quality objectives	Quality objectives are quantified, translated (declined) into indicators and monitored regularly (dashboards). A measurability criterion can be "Yes / No"
	5.4.2	Quality management system planning
78	5.4.2 a	Respect the process approach when planning the QMS	And the quality objectives. Cf. sub-clause 4.1
79	5.4.2 b	Maintain the integrity of the QMS when planning and implementing changes	Cf. sub-clause 7.3.9. Pay special attention to the control of the changes and their consequences on the performance of the QMS
	5.5	Responsibility, authorities and communication
	5.5.1	Responsibility and authority	beginning
80	5.5.1	Define, document and communicate responsibilities and authorities	Cf. sub-clause 4.2.5. "Responsibility cannot be shared". Robert Heilein. Clear and internally available job descriptions (also organization chart, competency matrix)
81	5.5.1	Document the interrelation of all personnel who manage, perform and verify work affecting quality	It is a commitment that top management validates if it is not defined by top management
82	5.5.1	Ensure the independence and authority to manage, perform and verify work affecting quality	Cf. sub-clause 8.2.1
	5.5.2	Management representative
83	5.5.2	Appoint management representative	He is a member of the management and he is not necessarily part of the quality department
84	5.5.2 a	Document the processes needed for the QMS	By the management representative. Cf. sub-clauses 7.2, 7.5 and 4.2.4
85	5.5.2 b	Report to top management on the effectiveness of the QMS	By the management representative. And any need for improvement, cf. sub-clause 8.5
86	5.2.2 c	Ensure the promotion of awareness of applicable regulatory and QMS requirements	By the management representative. Include in the job description of the management representative the tasks related to the awareness of the personnel to the different requirements
	5.5.3	Internal communication
87	5.5.3	Establish appropriate communication processes	Pay special attention to the feedback of the staff (surveys, suggestion box)
88	5.5.3	Communicate on the effectiveness of the QMS	It is a top management commitment
	5.6	Management review
	5.6.1	General
89	5.6.1	Document the procedure management review	Cf. sub-clause 4.2.4. "No system is perfect". Usually once or twice a year, review the entire QMS to verify the achievement of quality objectives
90	5.6.1	Review the QMS at planned intervals	To ensure its continuing suitability, adequacy and effectiveness. Review opportunities (conditions, possibilities, circumstances) for continual improvement of the QMS
91	5.6.1	Evaluate improvement opportunities	Review opportunities (conditions, possibilities, circumstances) for continual improvement of the QMS
92	5.6.1	Evaluate the need for changes to the QMS	Including the quality policy and quality objectives. Review opportunities (conditions, possibilities, circumstances) for continual improvement of the QMS
93	5.6.1	Retain records of the management review	Cf. sub-clause 4.2.5
	5.6.2	Review input
94	5.6.2 a	Include information from feedback	If it is the first element, it is often the most important
95	5.6.2 b	Include information from complaint handling	"Love your customers more than products". All customer satisfaction and non-satisfaction data is an important source of information for finding opportunities to improve the QMS
96	5.6.2 c	Include information from reporting to regulatory authorities	Cf. sub-clause 8.2.3
97	5.6.2 d	Include information from audits	Internal audit reports and their proposals are an important source of information for finding opportunities to improve the QMS
98	5.6.2 e	Include information from process monitoring and measurement	Results of the achievement of the quality objectives and analysis of the data related to the defects (nonconformities) of the processes
99	5.6.2 f	Include information from product monitoring and measurement	Results and trends
100	5.6.2 g	Include information from corrective action	Results of actions, their follow-up, improvements obtained
101	5.6.2 h	Include information from preventive action	Results of actions, their follow-up, improvements obtained
102	5.6.2 i	Include information from follow-up actions from previous management reviews	Results of decisions taken during the last management review and their follow-up
103	5.6.2 j	Include information from changes that could affect the QMS	Consider, evaluate and analyze any changes that may impact the QMS (new products and processes, new customers, new functions and responsibilities)
104	5.6.2 k	Include information from improvement recommendations	Suggestions, opinions, proposals from all staff or external interested parties
105	5.6.2 l	Include information from new or revised applicable regulatory requirements	Legal watch (changes in applicable regulatory requirements)
	5.6.3	Review output
106	5.6.3	Record management review output	Cf. sub-clause 4.2.5. After analysis and review of all inputs, formalize decisions
107	5.6.3 a	Decide actions related to QMS improvement	To maintain the suitability, adequacy and effectiveness of the QMS
108	5.6.3 b	Decide actions related to product improvement	Related to customer requirements
109	5.6.3 c	Decide actions related to needed changes	To respond to applicable new or revised regulatory requirements
110	5.6.3 d	Decide actions related to resource needs	In order to meet the needs of staff and material resources
	6	Resource management	Planifier (Plan)
	6.1	Provision of resources
111	6.1 a	Determine and provide the resources needed to implement and maintain the effectiveness of the QMS	Identify and ensure current and future resource needs: staff (competencies) infrastructure (buildings, workspaces, facilities) process equipment (software, hardware) support services (logistics, communication)
112	6.1 b	Determine and provide the resources needed to meet applicable regulatory and customer requirements	"The right person, at the right place, at the right moment"
	6.2	People
113	6.2	Ensure competent people performing work affecting product quality	Skills are based on initial and professional training, know-how and experience
114	6.2	Document the process needed for establishing competence, provide training and ensuring awareness of personnel	Cf. sub-clause 4.2.4. "Quality is everyone's business". Raise awareness of staff of the link between training and individual responsibility to achieve quality objectives
115	6.2 a	Determine the necessary competence	For personnel performing work affecting product quality
116	6.2 b	Provide training	Or take other actions to achieve or maintain the necessary competence
117	6.2 c	Evaluate the effectiveness of the training	The method is proportionate to the risk associated (Impacts on safety and regulatory conformity of medical devices)
118	6.2 d	Ensure that personnel are aware of the relevance and the importance of their activities	And how they contribute to the achievement of the quality objectives
119	6.2 e	Retain records of education, training, skills and experience	Cf. sub-clause 4.2.5
	6.3	Infrastructure
120	6.3	Document the requirements for the necessary infrastructure	Cf. sub-clause 4.2.4. To satisfy product requirements, prevent product mix-up and ensure orderly handling of product
121	6.3	Document the requirements for the maintenance activities and its frequency	Cf. sub-clause 4.2.4. Especially when these activities or their absence can affect the quality of the product
122	6.3	Apply these requirements to maintenance equipment	Equipment used in production, the control of the work environment and monitoring and measurement
123	6.3	Retain records on maintenance activities	Cf. sub-clause 4.2.5
	6.4	Work environment and contamination control
	6.4.1	Work environment
124	6.4.1	Document the requirements for the necessary work environment	Cf. sub-clause 4.2.4. Anything that can have an impact on product conformity (motivation, work organization, workplace ergonomics, lighting, hygiene, temperature, safety)
125	6.4.1	Document the requirements for the work environment and the procedures to monitor and control it	Cf. sub-clause 4.2.4. Especially if the work environment can negatively affect the quality of the product. Cf. sub-clause 7.5.1
126	6.4.1 a	Document requirements for health, cleanliness and clothing of personnel	Cf. sub-clause 4.2.4. In the case of contact between personnel or work environment and the product. Cf. sub-clause 7.5.2
127	6.4.1 b	Ensure that all personnel who work temporary under special environmental conditions are competent	Or supervised by a competent person. Cf. sub-clause 6.2. More information into ISO 14644 (Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration) and ISO 14698 (Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods)
	6.4.2	Contamination control
128	6.4.2	Plan and document arrangements for the control of contaminated or potentially contaminated product	Cf. sub-clause 4.2.4. In order to prevent contamination of the work environment, personnel or product. Cf. sub-clause 7.5.5
129	6.4.2	Document requirements for control of contamination (with microorganisms or particulate matter)	Cf. sub-clause 4.2.4. For sterile medical devices
130	6.4.2	Maintain the required cleanliness	During assembly or packaging processes. For sterile medical devices list the necessary measures implemented
	7	Product realization	Dérouler (Do)
	7.1	Planning of product realization
131	7.1	Plan the processes needed for product realization	Cf. sub-clause 4.2.5. These are all processes that meet customer needs and expectations (from quote request to after-sales service). A process mapping can clarify the overall image of product realization
132	7.1	Develop the processes needed for product realization	Take into account infrastructure and the work environment, cf. sub-clauses 6.3 and 6.4
133	7.1	Plan product realization consistent with the requirements of other processes of the QMS	Cf. sub-clause 4.1. Take prevention into account as much as possible
134	7.1	Document the risk management processes throughout product realization	Cf. sub-clause 4.2.4. More information in ISO 14971 (Medical devices - Application of risk management to medical devices)
135	7.1	Retain records of risk management activities	Cf. sub-clause 4.2.5
136	7.1 a	Determine quality objectives and product requirements	Establish and implement processes and documentation for each product
137	7.1 b	Determine the need to establish processes and documents	Cf. sub-clause 4.2.4
138	7.1 b	Determine how to provide resources specific to the product	Including infrastructure and work environment
139	7.1 c	Determine the verification, validation, monitoring, measurement, inspection and test, handling, storage and distribution activities	And traceability activities specific to the product
140	7.1 c	Determine product acceptance criteria	And implement them without exception
141	7.1 d	Determine specific process records	Cf. sub-clause 4.2.5. In order to provide evidence of meeting requirements
142	7.1 d	Determine specific product records	Cf. sub-clause 4.2.5. In order to provide evidence of meeting requirements
143	7.1	Ensure that planning output is in a suitable form	Cf. sub-clause 4.2.5. Paper or electronic, easily readable and identifiable
	7.2	Customer-related products
	7.2.1	Determination of requirements related to product
144	7.2.1 a	Determine requirements specified by the customer, including those for delivery and post-delivery activities	"The only measure of quality is customer satisfaction". Identify and apply customer needs and expectations to internal product requirements (realization, delivery and post-delivery)
145	7.2.1 b	Determine requirements for intended use	Identify and apply implicit client needs and expectations (lifetime warranty, exemplary reliability, simple maintenance)
146	7.2.1 c	Determine applicable regulatory requirements	Identify all applicable requirements related to the product (including recycling and disposition) and implement a legal watch
147	7.2.1 d	Determine any user training to ensure specified performance	And safe use of the medical device
148	7.2.1 e	Determine any additional internal requirements	Such as constraints, internal rules, confidentiality, occupational health and safety, hygiene
	7.2.2	Review of requirements related to product
149	7.2.2	Review product requirements	Upstream review of product requirements (feasibility, cost effectiveness)
150	7.2.2	Conduct review prior committing to supply product to customer	Review tenders, amendments, acceptance of contracts, changes
151	7.2.2 a	Ensure that product requirements are defined and documented	Cf. sub-clause 4.2.4
152	7.2.2 b	Ensure that the gaps between the requirements of a contract or order and those previously expressed are resolved	Before accepting the contract or the order
153	7.2.2 c	Ensure that applicable regulatory requirements are met	Requirements are defined and approved
154	7.2.2 d	Ensure that any user training is available or planned to be available	Cf. sub-clause 7.2.1
155	7.2.2 e	Ensure that the organization has the ability to meet the defined requirements	Requirements are defined and approved
156	7.2.2	Retain records of the results of the review and actions taken	Cf. sub-clause 4.2.5
157	7.2.2	When customer requirements are not documented, confirm them before acceptance	By sending them to the customer with acknowledgment of receipt (by mail or email)
158	7.2.2	When product requirements are changed, ensure that relevant documents are amended	And relevant personnel is informed
	7.2.3	Communication
159	7.2.3 a	Plan and document arrangements for communicating with customers in relation to product information	Cf. sub-clause 4.2.5. "Good news walks, bad news runs". Swedish proverb
160	7.2.3 b	Plan and document arrangements for communicating with customers in relation to enquiries, contracts, order handling and amendments	Cf. sub-clause 4.2.5. Establish effective communication methods with the customer
161	7.2.3 c	Plan and document arrangements for communicating with customers in relation to customer feedback	Cf. sub-clause 4.2.5. Including complaints. Cf. sub-clause 8.2.1
162	7.2.3 d	Plan and document arrangements for communicating with customers in relation to advisory notices	Cf. sub-clauses 8.3.3 and 4.2.4
163	7.2.3	Communicate with regulatory authorities in accordance with applicable regulatory requirements	Cf. sub-clause 8.2.3
	7.3	Design and development
	7.3.1	General
164	7.3.1	Prepare procedures for design and development	Cf. sub-clause 4.2.4. "I have not failed. I've just found 10,000 ways that don't work". Thomas Edison
	7.3.2	Design and development planning
165	7.3.2	Plan and control product design and development	Identify and formalize relationships between all stakeholders in product design and development (meetings and reviews at key milestones)
166	7.3.2	Retain and maintain, as appropriate, planning documents	During the course of design and development
167	7.3.2 a	Document the design and development stages	Cf. sub-clause 4.2.4
168	7.3.2 b	Document the reviews needed at each design and development stage	Cf. sub-clause 4.2.4
169	7.3.2 c	Document the verification, validation and design transfer activities at each design and development stage	Cf. sub-clause 4.2.4
170	7.3.2 d	Document the responsibilities and authorities for design and development	Cf. sub-clause 4.2.4
171	7.3.2 e	Document the methods to ensure traceability of outputs	Cf. sub-clause 4.2.4. Related to design and development inputs
172	7.3.2 f	Document the needed resources	Cf. sub-clause 4.2.4. Including competence of personnel
	7.3.3	Design and development inputs
173	7.3.3	Determine inputs relating to product requirements	Product characteristics and technical specifications (packaging and others)
174	7.3.3	Retain records of inputs	Cf. sub-clause 4.2.5
175	7.3.3 a	Include usability requirements	Functional, performance and safety characteristics
176	7.3.3 b	Include applicable regulatory requirements	And specific standards
177	7.3.3 c	Include outputs of risk management	Cf. sub-clause 7.1
178	7.3.3 d	Include information from previous similar designs	Why re-invent the wheel?
179	7.3.3 e	Include other requirements essential for process and product design and development	Benchmarking, market research
180	7.3.3	Review inputs for adequacy	Compared to intended use
181	7.3.3	Approve inputs	By a person with established responsibilities and authorities. Cf. sub-clause 5.5.1
182	7.3.3	Ensure that requirements are complete, unambiguous, able to be verified or validated and not in conflict with each other	More information in IEC 62366-1 (Medical devices - Part 1: Application of usability engineering to medical devices)
	7.3.4	Design and development outputs
183	7.3.4 a	Ensure that design and development outputs meet input requirements	If this is not the case, repeat some steps
184	7.3.4 b	Ensure that design and development outputs provide appropriate information for purchasing, production and service provision	The accuracy of this information is essential
185	7.3.4 c	Ensure that design and development outputs contain or reference product acceptance criteria	Requirements (restrictions or recommendations) related to transport, packaging, labels, instructions for use, expiration date, traceability, components used
186	7.3.4 d	Ensure that design and development outputs specify the characteristics of the product that are essential for its safe and proper use	The results of design reviews of similar old products (tests, reliability, feasibility) and feedback from users (after-sales service, recommendations, suggestions)
187	7.3.4	Ensure that design and development outputs are in a form suitable for verification against inputs	Requirement included in the procedure design and development, cf. sub-clause 7.3.1
188	7.3.4	Ensure that design and development outputs approved prior to release	Requirement included in the procedure design and development, cf. sub-clause 7.3.1
189	7.3.4	Retain records of the design and development outputs	Cf.sub-clause 4.2.5
	7.3.5	Design and development review
190	7.3.5	Perform systematic reviews of design and development at suitable stages	In accordance with planned and documented arrangements
191	7.3.5 a	Evaluate the ability of the results to meet requirements	Cf. sub-clause 7.3.3
192	7.3.5 b	Propose necessary actions	After problems are identified
193	7.3.5	Ensure that representatives of functions concerned with the stages being reviewed are participating in these reviews	And other specialist personnel
194	7.3.5	Retain records of the results of the reviews and necessary actions	Cf. sub-clause 4.2.5. These records include the identification of the design review subject, the participants and the date of the review. Requirement included in the procedure design and development, cf. sub-clause 7.3.1
	7.3.6	Design and development verification
195	7.3.6	Perform design and development verification in accordance with planned and documented arrangements	To ensure that the design and development outputs have met the input requirements
196	7.3.6	Document verification plans	Cf. sub-clause 4.2.4. These plans include methods, acceptance criteria, statistical techniques with rationale for sample size
197	7.3.6	Include in the verification the confirmation that the design outputs meet design outputs when connected or interfaced	If the intended use requires that the medical device be connected to, or have an interface with, other medical devices
198	7.3.6	Retain records of the results and conclusions of the verification and necessary actions	Cf. sub-clauses 4.2.4 and 4.2.5
	7.3.7	Design and development validation
199	7.3.7	Perform design and development validation in accordance with planned and documented arrangements	To ensure that the resulting product is capable of meeting the requirements for the spcified application or intended use
200	7.3.7	Document validation plans	Cf. sub-clause 4.2.4. These plans include methods, acceptance criteria, statistical techniques with rationale for sample size
201	7.3.7	Conduct design validation on representative product	The representative product includes initials production units, batches or their equivalents
202	7.3.7	Record the rationale for the choice of product used for validation	Cf. sub-clause 4.2.5
203	7.3.7	Perform clinical evaluations or performance evaluations of the medical device as part of design and development validation in accordance with applicable regulatory requirements	Clinical evaluation or performance evaluation of a medical device is not considered to be released for use to the customer
204	7.3.7	Include in the validation confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced	When the intended use requires that the medical device be connected to or have interface with other medical devices
205	7.3.7	Complete validation prior to release for use of the product to the customer	Cf. sub-clauses 7.5.6 and 7.5.7
206	7.3.7	Retain records of the results and conclusion of validation and necessary actions	Cf. sub-clauses 4.2.4 and 4.2.5
	7.3.8	Design and development transfer
207	7.3.8	Document procedures for transfer of design and development outputs to manufacturing	Cf. sub-clause 4.2.4. Identify, formalize and retain the information needed to initiate product design and development
208	7.3.8	Ensure that design and development outputs are verified as suitable for manufacturing	Before becoming final production specifications
209	7.3.8	Ensure that production capability can meet product requirements	Cf. sub-clause 7.2.1
210	7.3.8	Record results and conclusions of the transfer	Cf. sub-clause 4.2.5
	7.3.9	Control of design and development changes
211	7.3.9	Document procedures to control design and development changes	Cf. sub-clause 4.2.4. Identify and formalize relationships between all stakeholders in product design and development (meetings and reviews at key milestones)
212	7.3.9	Determine the significance of the change	To the function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use
213	7.3.9	Identify design and development changes	With rules (document version) and methods (red ink, signature, date)
214	7.3.9 a	Review the changes	Before implementation
215	7.3.9 b	Verify the changes	Before implementation
216	7.3.9 c	Validate the changes, as appropriate	Before implementation
217	7.3.9	Approve the changes	Before implementation
218	7.3.9	Include, during the review of design and development changes, evaluation of the effect of the changes	On components of the product, on product being delivered or already delivered, on inputs or outputs of risk management and on product realization processes
219	7.3.9	Retain records of changes, their review and necessary changes	Cf. sub-clause 4.2.5
	7.3.10	Design and development files
220	7.3.10	Maintain a design and development filefor each medical device type or family	Cf. sub-clause 4.2.4
221	7.3.10	Include or reference in this file records generated to demonstrate satisfaction to design and development requirements	Cf. sub-clauses 4.2.5 and 7.3.4
222	7.3.10	Include or reference in this file records for design and development changes	Cf. sub-clauses 4.2.5 and 7.3.9
	7.4	Purchasing
	7.4.1	Purchasing process
223	7.4.1	Document procedures to ensure that purchased product conforms to specified purchasing information	Cf. sub-clause 4.2.4. Information is internal requirements
224	7.4.1	Establish criteria for the evaluation and selection of suppliers	The purchasing process includes the criteria for on-going (monthly or quarterly) evaluation of suppliers (% of purchased nonconforming products detected in reception, production and post-production inspection)
225	7.4.1 a	Ensure that the criteria are based on the supplier's ability to provide product that meets the requirements of the organization	Cf. sub-clause 7.2.1
226	7.4.1 b	Ensure that the criteria are based on the performance of the supplier	Conforming product, respect of cost and deadlines
227	7.4.1 c	Ensure that the criteria are based on the effect of the purchased product on the quality of the medical device	"If you buy quality, you cry only once. English proverb"
228	7.4.1 d	Ensure that the criteria are proportionate to the risk associated with the medical device	Cf. sub-clause 7.1
229	7.4.1	Plan the monitoring and re-evaluation of suppliers	Include in the list of suppliers the evaluation history
230	7.4.1	Monitor supplier performance	Meeting requirements for the product purchased. Monitoring activities are described in the purchasing procedure
231	7.4.1	Provide, as input into the supplier re-evaluation process, the results of the monitoring	Use records of verification of deliveries
232	7.4.1	Address reactions with the supplier, in case of non-fulfillment of purchasing requirements, proportionate to the risk associated with the purchased product	And compliance with applicable regulatory requirements. Cf. sub-clause 7.1
233	7.4.1	Retain records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance	And any necessary acions taken. Cf. sub-clause 4.2.5
	7.4.2	Purchasing information
234	7.4.2	Describe or reference the product to be purchased	All the data of the purchased product (specifications, transport, packaging, reception, test, storage and other conditions) are taken into account
235	7.4.2 a	Describe product specifications	Cf. sub-clause 7.2.1
236	7.4.2 b	Describe requirements for product acceptance, procedures, processes and equipment	Relating to the product to be purchased
237	7.4.2 c	Describe requirements for qualification of supplier personnel	For specific cases, staff receive appropriate training (new product, machine or equipment not used until then)
238	7.4.2 d	Describe requirements of the QMS	All that concerns the control of nonconformities related to the purchased product and the actions, the responsible and deadlines to be implemented
239	7.4.2	Ensure the adequacy of specified purchasing requirements	Before communicating them to the supplier
240	7.4.2	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 could affect the purchased product to meet spcified purchase requirements
241	7.4.2	Retain relevant purchasing information in the form of documents and records	To the extend required for traceability. Cf. sub-clauses 4.2.4, 4.2.5 and 7.5.9
	7.4.3	Verification of purchased product
242	7.4.3	Establish and implement inspection activities	To ensure that purchased product meets specified purchasing requirements. The purchasing process includes the identification and implementation of both reception and in-process inspections
243	7.4.3	Base the extent of verification activities on the supplier evaluation results	The activities are proportionate to the risk associated with the purchased product. Cf. sub-clause 7.1. Link between verification activities and the results of the supplier evaluation and also the level of risk associated with the purchased product
244	7.4.3	Determine whether any changes to the purchased product affect the product realization process or the medical device	Cf. sub-clause 7.3.9
245	7.4.3	State the intended verification activities and method of product release in the purchasing information	When the organization or its customer intends to perform verification at the supplier's premises. Without written acceptance by the supplier, any request may be refused
246	7.4.3	Retain records of the verification	Cf. sub-clause 4.2.5
	7.5	Production and service provision
	7.5.1	Control of production and service provision
247	7.5.1	Plan, carry out, monitor and control medical device production and service provision	To ensure that product conforms to requirements
248	7.5.1 a	Include in production controls documentation of procedures and methods for the control of production	Cf. sub-clause 4.2.4
249	7.5.1 b	Include in production controls qualification of infrastructure	Cf. sub-clause 6.3
250	7.5.1 c	Include in production controls implementation of monitoring and measurement of process parameters and product characteristics	Maintenance of equipment is regular
251	7.5.1 d	Include in production controls availability and use of monitoring and measuring equipment	Monitoring and measuring equipment is maintained in good condition and staff is trained in its use
252	7.5.1 e	Include in production controls implementation of defined operations for labelling and packaging	According to product requirements, cf. sub-clause 7.2.1. More information in ISO 15223 (Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements)
253	7.5.1 f	Include in production controls implementation of product release, delivery and post-delivery activities	Monitoring and measuring equipment are regularly used
254	7.5.1	Establish and retain a record for each medical device of batch of medical devices	Cf. sub-clause 4.2.5. To provide specified traceability. Cf. sub-clause 7.5.9
255	7.5.1	Establish and retain a record that identifies the amount manufactured and the amount approved for distribution	Cf. sub-clause 4.2.5
256	7.5.1	Verify and approve each record	Cf.sub-clause 4.2.5
	7.5.2	Cleanliness of product
257	7.5.2 a	Document requirements for cleanliness of product or contamination control of product when product is cleaned by the organization	Prior to sterilization or its use. Cf. sub-clause 4.2.4
258	7.5.2 b	Document requirements for cleanliness of product or contamination control of product when product is supplied non-sterile and is to be subjected to a cleaning process	Prior to sterilization or its use. And the product is subjected to a cleaning process before its sterilization or its use. Cf. sub-clause 4.2.5
259	7.5.2 c	Document requirements for cleanliness of product or contamination control of product when product cannot be cleaned	Prior to sterilization or its use. And its cleanliness is of significance in use. Cf. sub-clause 4.2.4
260	7.5.2 d	Document requirements for cleanliness of product or contamination control of product when product is supplied to be used non-sterile	And its cleanliness is of significance in use. Cf. sub-clause 4.2.4
261	7.5.2 e	Document requirements for cleanliness of product or contamination control of product when process agents are to be removed from product during manufacture	Cf. sub-clause 4.2.4
262	7.5.2	Do not apply requirements prior to the cleaning process if product is cleaned in accordance with a) or b) above	Cf. sub-clause 6.4.1
	7.5.3	Installation activities
263	7.5.3	Document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate	Cf. sub-clause 4.2.4
264	7.5.3	Provide documented requirements for medical device installation and verification of installation	If the agreed customer requirements allow installation by an external party outside the company or its supplier
265	7.5.3	Retain records of medical device installation and verification of installation	Performed by the organization or its supplier. Cf. sub-clause 4.2.5
	7.5.4	Servicing activities
266	7.5.4	Document servicing procedures, reference materials and reference measurements	For performing servicing activities and verifying that product requirements are met. Cf. sub-clause 4.2.4. If the servicing activities of the medical device constitute a specified requirement (such as maintenance)
267	7.5.4 a	Analyse records of servicing activities	To determine if the information is to be handled as a complaint
268	7.5.4 b	Analyse records of servicing activities	To use this information for input to the improvement process
269	7.5.4	Retain records of servicing activities carried out	By the organization or its supplier. Cf. sub-clause 4.2.5
	7.5.5	Particular requirements for sterile medical devices
270	7.5.5	Retain records of the sterilization process parameters used for each sterilization batch	Cf. sub-clause 4.2.5
271	7.5.5	Ensure the traceability of each production batch of medical devices	With sterilization records. Cf. sub-clause 7.5.9
	7.5.6	Validation of processes for production and service provision
272	7.5.6	Validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement	This includes all processes for which deficiencies occur only after the product is in use or the service has been delivered
273	7.5.6	Demonstrate by validation the ability of these processes to achieve planned results consistently	Validation is realized after review and verification of processes
274	7.5.6 a	Document procedures for validation of processes including defined criteria for review and approval of processes	Cf. sub-clause 4.2.4
275	7.5.6 b	Document procedures for validation of processes including equipment qualification	And qualification of personnel. Cf. sub-clause 4.2.4
276	7.5.6 c	Document procedures for validation of processes including use of specific methods, procedures and acceptance criteria	Cf. sub-clause 4.2.4
277	7.5.6 d	Document procedures for validation of processes including statistical techniques with rationale for sample sizes	As appropriate. Cf. sub-clause 4.2.4
278	7.5.6 e	Document procedures for validation of processes including requirements for records	Cf. sub-clauses 4.2.4 and 4.2.5
279	7.5.6 f	Document procedures for validation of processes including revalidation	Including criteria for revalidation. Cf. sub-clause 4.2.4. Including revalidation criteria
280	7.5.6 g	Document procedures for validation of processes including approval of changes to the processes	Cf. sub-clause 4.2.4
281	7.5.6	Document procedures for the validation of the application of computer software	Used in production and service provision. Cf. sub-clause 4.2.4
282	7.5.6	Validate software applications prior to initial use	And also after changes to such software or its application
283	7.5.6	Establish an approach proportionate to the risk associated with the use of the software	Including the effect on the ability of the product to conform to specifications. Cf. sub-clause 7.1
284	7.5.6	Retain records of the results and conclusion of the validation and necessary actions undertaken	Cf. sub-clauses 4.2.4 and 4.2.5
	7.5.7	Particular requirements for validation of processes for sterilization and sterile barrier systems
285	7.5.7	Document procedures for the validation of processes for sterilization and sterile barrier systems	Cf. sub-clause 4.2.4
286	7.5.7	Validate processes for sterilization and sterile barrier systems prior to implementation	And after product or process changes, as appropriate
287	7.5.7	Retain records of the results and conclusion of validation and necessary actions undertaken	Cf. sub-clauses 4.2.4 and 4.2.5. More information in ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) and ISO 11607-2 (Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes)
	7.5.8	Identification
288	7.5.8	Document procedures for product identification	Cf. sub-clause 4.2.4
289	7.5.8	Identify product by suitable means	Throughout product realization
290	7.5.8	Identify product status with respect to monitoring and measurement requirements	Throughout product realization
291	7.5.8	Maintain product identification 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
292	7.5.8	Document a system to assign unique device identification to the medical device	Cf. sub-clause 4.2.5. If required by applicable regulatory requirements
293	7.5.8	Document procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product	Cf. sub-clause 4.2.4.
	7.5.9	Traceability
	7.5.9.1	General
294	7.5.9.1	Document procedures for traceability	Cf. sub-clause 4.2.4. Product preservation includes all stages of the product's life cycle (receiving, producing, handling, storing, delivering)
295	7.5.9.1	Define the extent of product traceability	According to applicable regulatory requirements
296	7.5.9.1	Retain traceability records	Cf. sub-clause 4.2.5
	7.5.9.2	Particular requirements for implantable medical devices
297	7.5.9.2	Include in the records required for traceability records of components, materials and conditions for the work environment used	When these parameters may result in the medical device not meeting the specified safety and performance requirements
298	7.5.9.2	Require that suppliers of distribution services or distributors retain records of the distribution of medical devices	To allow traceability and that these records are available for inspection
299	7.5.9.2	Retain records of the shipping package consignee	Name and address. Cf. sub-clause 4.2.5
	7.5.10	Customer property
300	7.5.10	Identify, verify, protect and saveguard customer property provided for use or incorporation into the product	When customer property is under the control of the organization or being used
301	7.5.10	Report to the customer	If customer property is lost, damaged or otherwise found to be unsuitable for use
302	7.5.10	Retain records of reports	Cf. sub-clause 4.2.5
	7.5.11	Preservation of product
303	7.5.11	Document procedures for preserving the conformity of product during processing, storage, handling and distribution	Cf. sub-clause 4.2.4. Product preservation includes all stages of the product's life cycle (receiving, producing, handling, storing, delivering)
304	7.5.11	Apply preservation to constituent parts of the medical device	Including packaging
305	7.5.11 a	Protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling and distribution	Through the design and construction of suitable packaging and shipping containers
306	7.5.11 b	Protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling and distribution	By documenting requirements for special conditions needed, if packaging alone cannot provide preservation
307	7.5.11	Control the required special conditions	As a limited shelf life and specific storage conditions
308	7.5.11	Record the required special conditions	Cf. sub-clause 4.2.5
	7.6	Control of monitoring and measuring equipment
309	7.6	Determine the monitoring and measurement activities	Monitoring and measurement processes are implemented to provide evidence of product conformity. Cf. sub-clause 7.2.1
310	7.6	Determine the monitoring and measurement equipment	Maintain a list of equipment
311	7.6	Document procedures to ensure that monitoring and measurement can be carried out and are carried out in a consistent manner	Cf. sub-clause 4.2.4. Consistent with the monitoring and measurement requirements
312	7.6 a	Ensure valid results with measuring equipment that is calibrated or verified at specified intervals or prior to use	Against measurement standards traceable to international or national measurement standards. When these standards do not exist, the basis used for calibration or verification is recorded. Cf. sub-clause 4.2.5
313	7.6 b	Ensure valid results with measuring equipment that is adjusted or re-adjusted as necessary	The measuring equipment is regularly adjusted
314	7.6 b	Record the adjustments realized	Cf. sub-clause 4.2.5
315	7.6 c	Ensure valid results with measuring equipment that is identified	In order to determine its calibration status
316	7.6 d	Ensure valid results with measuring equipment that is safeguarded from adjustments that would invalidate the measurement result	Effective protection not only during use (displacement, maintenance, storage)
317	7.6 e	Ensure valid results with measuring equipment that is protected from damage and deterioration during handling, maintenance and storage	This concerns potentially nonconforming products
318	7.6	Perform calibration or verification in accordance with documented procedures	The equipment is calibrated and verified. Products are inspected, validated (with or without concession) or identified as nonconforming
319	7.6	Assess and record the validity of the previous measuring results	When the equipment is found not meeting requirements
320	7.6	Take appropriate action in regard to the equipment and any product affected	Monitoring and measuring software are validated before use
321	7.6	Retain records of the results of calibration and verification	Cf. sub-clause 4.2.5
322	7.6	Document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements	Cf. sub-clause 4.2.4. Perform a second validation if the first one is not satisfactory
323	7.6	Validate software application prior to initial use and after changes to software or its application	Perform a second validation if the first one is not satisfactory
324	7.6	Define the specific approach and activities associated with software validation and revalidation that are proportionate to the risk associated with the use of the software	Including the effect on the ability of the product to conform to specifications. Cf. sub-clause 7.1
325	7.6	Retain records of the results and conclusion and necessary action from the validation	Cf. sub-clauses 4.2.4 and 4.2.5. More information in ISO 10012 (Measurement management systems - Requirements for measurement processes and measuring equipment)
	8	Measurement, analysis and improvement	Constater (Check), Agir (Act)
	8.1	General
326	8.1 a	Plan and implement the needed monitoring, measurement, analysis and improvement processes	To demonstrate conformity of product. Control of product conformity is demonstrated through inspection processes throughout the production stages
327	8.1 b	Ensure conformity of the QMS	"If you can't measure it, you can't manage it. Peter Drucker"
328	8.1 c	Maintain the effectiveness of the QMS	Controlling QMS conformity is achieved through management processes (strategy, audit, continuous improvement, self-evaluation)
329	8.1	Include determination of appropriate methods	Including statistical techniques and the extent of their use
	8.2	Monitoring and measurement
	8.2.1	Feedback
330	8.2.1	Gather and monitor information relating to whether the organization has met customer requirements	As one of the measures of QMS performance
331	8.2.1	Document the methods for obtaining and using this information	Cf. sub-clause 4.2.5
332	8.2.1	Document procedures for the feedback process	Cf. sub-clauses 4.2.4 and 7.2.3
333	8.2.1	Include in the feedback process provisions to gather data from production activities	And post-production activities
334	8.2.1	Use the information gathered in the feedback process as potential input into risk management	For monitoring and maintaining the product requirements, the product realization and process improvements. Cf. sub-clause 7.1
335	8.2.1	Include in the feedback process the review of the experience from post-production activities	If it is required by applicable regulatory requirements
	8.2.2	Complaint handling
336	8.2.2	Document procedures for complaint handling	Cf. sub-clause 4.2.4. Within appropriate time limits in accordance with applicable regulatory requirements
337	8.2.2 a	Include requirements and responsibilities for receiving and recording information	Who, when, how
338	8.2.2 b	Include requirements and responsibilities for evaluating information	To determine if the feedback constitutes a complaint. By the person in charge and his team
339	8.2.2 c	Include requirements and responsibilities for investigating complaints	The 8 D method is judicious to meet this requirement
340	8.2.2 d	Include requirements and responsibilities for determining the need to report the information	To the appropriate regulatory authorities. Cf. sub-clause 8.2.3
341	8.2.2 e	Include requirements and responsibilities for handling of complaint-related product	Verify the extent of the claim
342	8.2.2 f	Include requirements and responsibilities for determining the need to initiate corrections or corrective actions	And undertake the necessary actions
343	8.2.2	Document a justification if the complaint is not investigated	Cf. sub-clause 4.2.4
344	8.2.2	Document any correction or corrective action following a complaint	Cf. sub-clause 4.2.4
345	8.2.2	Exchange relevant information between the organization and the external party involved	When the investigation determines that activities outside the company have contributed to the complaint
346	8.2.2	Retain complaint handling records	Cf. sub-clause 4.2.5
	8.2.3	Reporting to regulatory authorities
347	8.2.3	Document procedures for providing notification to the appropriate regulatory authorities about complaints that meet specified reporting critéria of adverse events or issuance of advisory notices	Cf. sub-clause 4.2.4. If applicable regulatory requirements require it
348	8.2.3	Retain records of reporting to regulatory authorities	Cf. sub-clause 4.2.5
	8.2.4	Internal audit
349	8.2.4 a	Conduct internal audits at planned intervals	To determine whether the QMS conforms to planned and documented arrangements, to requirements of ISO 13485 standard, to QMS requirements and to applicable regulatory requirements
350	8.2.4 b	Determine whether the QMS is effectively implemented and maintained	Cf. sub-clause 7.1
351	8.2.4	Document a procedure to describe the responsibilities and requirements	Cf. sub-clause 4.2.4. For planning and conducting audits and recording and reporting audit results
352	8.2.4	Plan an audit program taking into consideration the status and importance of the process and area to be audited	As well as the results of previous audits
353	8.2.4	Define and record the audit criteria, scope, interval and methods	Cf. sub-clause 4.2.5
354	8.2.4	Ensure objectivity and impartiality of the audit process	By selection of auditors and conduct of audits
355	8.2.4	Ensure that auditors do not audit their own work
356	8.2.4	Retain records of the audits and their results	Cf. sub-clause 4.2.5. Including process identification, areas audited and the conclusions
357	8.2.4	Ensure that the management responsible for the area being audited takes without undue delay any necessary corrections and corrective actions	To eliminate detected nonconformities and their causes
358	8.2.4	Include in the follow-up activities the verification of the actions taken and the reporting of verification results	More information in ISO 19011 (Guidelines for auditing management systems)
	8.2.5	Monitoring and measurement of processes
359	8.2.5	Apply suitable methods for monitoring	And, as appropriate, measurement of the QMS processes
360	8.2.5	Demonstrate the ability of the processes to achieve planned results	Cf. sub-clause 7.1
361	8.2.5	Take correction and corrective action, as appropriate, when planned results are not achieved	Cf. sub-clause 8.5.2
	8.2.6	Monitoring and measurement of product
362	8.2.6	Monitor and measure medical device characteristics	To verify that product requirements have been met
363	8.2.6	Carry out this at applicable stages of the product realization process	In accordance with the planned arrangements and documented procedures
364	8.2.6	Retain evidence of conformity to the acceptance criteria	Cf. sub-clause 4.2.5
365	8.2.6	Record the identity of the person authorizing release of product	Cf. sub-clause 4.2.5
366	8.2.6	Identify, as appropriate, in records, the test equipment used to perform measurement activities	Cf. sub-clause 4.2.5
367	8.2.6	Do not proceed with product release and service delivery until the planned and documented arrangements have been satisfactorily completed	Cf. sub-clause 7.1
368	8.2.6	Record the identity of personnel performing any inspection or testing of implantable medical devices	Cf. sub-clause 4.2.5
	8.3	Control of nonconforming product
	8.3.1	General
369	8.3.1	Ensure that nonconforming product is identified and controlled	To prevent its unintended use or delivery
370	8.3.1	Document a procedure to define the controls of nonconforming product	Cf. sub-clause 4.2.4. Determine the related responsibilities and authorities, identification, documentation, segregation, evaluation and disposition of nonconforming product
371	8.3.1	Include in the evaluation of nonconformity a determination of the need for an investigation	And notification of any external party responsible for the nonconformity
372	8.3.1	Retain records of the nature of the nonconformities and any subsequent action taken	Cf. sub-clause 4.2.5. Including the evaluation, any investigation and the rationale for decisions
	8.3.2	Actions in response to nonconforming product detected before delivery
373	8.3.2 a	Take action to eliminate the detected nonconformity	To deal with the nonconforming product
374	8.3.2 b	Take action to preclude its original intended use or application	To deal with the nonconforming product
375	8.3.2 c	Authorize its use, release or acceptance under concession	To deal with the nonconforming product
376	8.3.2	Ensure that nonconforming product is accepted by concession only if the justification is provided	And approval is obtained and applicable regulatory requirements are met
377	8.3.2	Retain records of the acceptance by concession	And the identity of the person authorizing the concession. Cf. sub-clause 4.2.5
	8.3.3	Actions in response to nonconforming product detected after delivery
378	8.3.3	Take action appropriate to the effects, or potential effects, of the nonconformity	In order to treat the nonconforming product detected after delivery or after its use has started
379	8.3.3	Retain records of actions taken	Cf. sub-clause 4.2.5
380	8.3.3	Document procedures for issuing advisory notices	In accordance with applicable regulatory requirements. Cf. sub-clause 4.2.4
381	8.3.3	Be capable to put these procedures at any time	In order to issue advisory notices without delay
382	8.3.3	Retain records of actions relating to the issuance of advisory notices	Cf. sub-clause 4.2.5
	8.3.4	Rework
383	8.3.4	Perform rework in accordance with documented procedures	Cf. sub-clause 4.2.4. Take into account the potential adverse effect of the rework on the product
384	8.3.4	Undergo theses procedures the same review and approval as the original procedure	Put again in the normal flow
385	8.3.4	Verify the reworked product	To ensure that it meets applicable criteria and regulatory requirements
386	8.3.4	Retain records of rework	Cf. sub-clause 4.2.5
	8.4	Analysis of data
387	8.4	Document procedures to determine, collect and analyse appropriate data	Cf. sub-clause 4.2.4. To demonstrate the suitability, adequacy and effectiveness of the QMS
388	8.4	Include in the procedures determination of appropriate methods	Including statistical techniques and the extent of their use
389	8.4	Include in the analysis of data information generated as a result of monitoring and measurement	And from other relevant sources
390	8.4 a	Include input from feedback	Cf. sub-clause 8.2.1
391	8.4 b	Include input from product conformity	Cf. sub-clause 7.2.1
392	8.4 c	Include input from characteristics and trends of processes and product	Including improvement opportunities
393	8.4 d	Include input from suppliers	Cf. sub-clause 7.4.1
394	8.4 e	Include input from audits	Cf. sub-clause 8.2.4
395	8.4 f	Include input from service reports, as appropriate	Cf. sub-clause 7.5.4
396	8.4	Use this analysis as input for improvement	If the analysis of data shows that the QMS is not suitable, adequate or effective. Cf. sub-clause 8.5
397	8.4	Retain records of the results of analyses	Cf. sub-clause 4.2.5
	8.5	Improvement
	8.5.1	General
398	8.5.1	Identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the QMS as well as medical device safety and performance	Through the use of the quality policy, quality objectives, audit results, post-market surveillance, data analysis, corrective and preventive actions and management review
	8.5.2	Corrective action
399	8.5.2	Take action to eliminate the causes of nonconformities	In order to prevent recurrence
400	8.5.2	Take any necessary corrective actions without any undue delay	Do not wait is fundamental
401	8.5.2	Adapt corrective actions proportionate to the effects of the nonconformities encountered	The procedure for corrective actions answers questions about who, when, how, under what conditions, with what resources to identify and treat nonconformities, determine and eliminate the causes, evaluate the need for corrective actions, implement corrective actions and review actions
402	8.5.2 a	Document a procedure to define requirements for reviewing nonconformities	Cf. sub-clause 4.2.4. Include in the procedure the method of finding the causes of nonconformities (diagramme of Ishikawa, statistical process control)
403	8.5.2 b	Document a procedure to define requirements for determining the causes of nonconformities	Use 5 W (why) method
404	8.5.2 c	Document a procedure to define requirements for evaluating the need for action	To ensure that nonconformities do not recur
405	8.5.2 d	Document a procedure to define requirements for planning and documenting action needed and implementing such action	Cf. sub-clause 4.2.4. Including, as appropriate, documentation update
406	8.5.2 e	Document a procedure to define requirements for verifying that corrective action has no adversely effect	The ability to meet applicable regulatory requirements or the safety and performance of the medical device
407	8.5.2 f	Document a procedure to define requirements for reviewing the effectiveness of corrective action taken	To ensure that nonconformities do not recur
408	8.5.2	Retain records of the results of any investigation and of action taken	Cf. sub-clause 4.2.5
	8.5.3	Preventive action
409	8.5.3	Determine action to eliminate the causes of potential nonconformities	In order to prevent their occurrence. Analysis and eradication of potential causes of process or QMS nonconformities
410	8.5.3	Adapt preventive actions proportionate to the effects of the potential problems	Do what is necessary in relation to the potential effects (remain within available resources)
411	8.5.3 a	Document a procedure to describe requirements for determining potential nonconformities and their causes	Cf. sub-clause 4.2.4. The procedure for preventive actions answers the questions who, when, how, under what conditions, with what resources to identify potential nonconformities, determine their causes, evaluate the need for preventive actions, implement preventive actions and review actions
412	8.5.3 b	Document a procedure to describe requirements for evaluating the need for action to prevent occurence of nonconformities	To ensure that nonconformities do not occur. Will the occurrence be avoided? Are the necessary resources available?
413	8.5.3 c	Document a procedure to describe requirements for planning and documenting action needed and implementing such action	Cf. sub-clause 4.2.4. Including, as appropriate, documentation update
414	8.5.3 d	Document a procedure to describe requirements for verifying that the preventive action does not have adversely effect	The ability to meet applicable regulatory requirements or the safety and performance of the medical device
415	8.5.3 e	Document a procedure to describe requirements for reviewing the effectiveness of the preventive action taken	"Prevention is always cheaper"
416	8.5.3	Retain records of the results of any investigations and of action taken	Cf. sub-clause 4.2.5