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ISO 13485 version 2016 requirements

Requirements ISO 13485 v 2016

You want to familiarize yourself with the structure of the standard, identify and understand the requirements of ISO 13485 v 2016, then it's up to you to play!

Start

The "ISO 13485 v 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!

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

ISO 13485 v 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 v 2016

 

pdca

Deming PDCA cycle

Notes:

  1. To facilitate understanding of the requirements the verb shall is replaced by the verb closest to the requirement
  2. Human resources is replaced by people (as in the ISO 9001 v 2015 edition)
ISO 13485 v 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
up
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
up
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
up
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
up
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
up
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
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 7.27.5 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
up
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
up
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
up
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
up
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
up
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
up
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
up
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
up
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
up
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
up
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
up
 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
up
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 4.2.44.2.5 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
up
 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
up
 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
up
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
up
 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
up
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
up
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
up
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
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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
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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
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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
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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
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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
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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
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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
 
 
 
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