ISO 13485 VERSION 2016 REQUIREMENTS

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

Requirement
No Clause PDCA cycle Quantity
No
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, clauses and sub-clauses of the standard ISO 13485 version 2016

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 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 version 2015 edition)

ISO 13485 version 2016 - Requirements and comments

Clause,
No sub- Requirement PDCA cycle, links, comments
clause
4 Quality management system
4.1 General requirements
1 4.1.1 Document a quality management system Develop your QMS. Cf. sub-clause 4.2.5
(QMS)
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, In accordance with ISO 13485 or applicable
activity or arrangement regulatory requirements
4 4.1.1 Implement any requirement, procedure, In accordance with ISO 13485 or applicable
activity or arragement regulatory requirements
5 4.1.1 Maintain any requirement, procedure, In accordance with ISO 13485 or applicable
activity or arrangement regulatory requirements
6 4.1.1 Document the roles undertaken by the Cf. sub-clause 4.2.5. Identify the roles
organization under the applicable undertaken by the organization
regulatory requirements (manufacturer, distributor or representative
of the manufacturer)
7 4.1.2 a Determine the processes needed for the Although process mapping is not explicitly
QMS and the application of these required, it is in practice the best response to
processes this requirement
8 4.1.2 b Apply a risk based approach to control the Cf. sub-clause 7.1. Identify process risks,
processes needed for the QMS 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 Although process mapping is not explicitly
of these processes required, it is in practice the best response to
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 this requirement
10 4.1.3 a Determine criteria and methods to ensure Support each process of your QMS
process effectiveness and control
11 4.1.3 b Ensure the availability of resources and For each process of the QMS
information needed to support process
operation and monitoring
12 4.1.3 c Implement actions to achieve planned For each process of the QMS
results and process effectiveness
13 4.1.3 d Monitor, measure and analyze these Measure as appropriate
processes
14 4.1.3 e Establish and retain records needed to Cf. sub-clause 4.2.5. For each process of the
demonstrate conformity with ISO 13485 QMS
standard and with applicable regulatory
requirements
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 Describe the management of changes (rules,
QMS criteria, follow-up)
17 4.1.4 b Evaluate the impact of changes on the Cf. sub-clause 7.3.9
medical devices produced under this QMS
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 And the ability of the external party to meet
involved the requirements, cf. sub-clause 7.4
22 4.1.5 Include in the controls written quality Supplier quality agreements, especially for
arrangements outsourced processes with high risk level
23 4.1.6 Document procedures for the validation of Cf. sub-clause 4.2.4
software used in the QMS
24 4.1.6 Validate software applications prior to List of validated software used in the QMS
initial use and after any change
25 4.1.6 Keep validation and revalidation activities For each software used, justify the validation
proportionate to the risk associated with approach in relation to the level of risk
the use of the software
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 Cf. sub-clauses 4.2.4 and 4.2.5 . Quality
objectives policy and objectives are formalized in a
relevant and simple document
28 4.2.1 b Include the quality manual in documented If the procedures are not part of the quality
form 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 Cf. sub-clause 4.2.4. The requirements of
records required by the standard ISO the ISO 13485 v 2016 standard are 416
13485
30 4.2.1 d Include documents and records, Cf. sub-clause 4.2.5
determined by the organization as
necessary to ensure the effective
planning, operation and control of its
processes
31 4.2.1 e Include other documentation related to Cf. sub-clauses 4.2.4 and 4.2.5. The bare
applicable regulatory requirements essentials is often the best choice
4.2.2 Quality manual
32 4.2.2 a Prepare a quality manual including the Cf. sub-clause 4.2.4 Justification of any
scope of the QMS exclusion or non-application
33 4.2.2 b Document a quality manual with Cf. sub-clause 4.2.4. Or include a reference
documented procedures to procedures
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34 4.2.2 c Document a quality manual with Cf. sub-clauses 4.2.1 and 4.2.4
interaction between processes of the QMS
35 4.2.2 Outline the structure of the The simplest is the documentary pyramid:
documentation of the QMS quality manual, processes, procedures,
documents, records
4.2.3 Medical device file
36 4.2.3 Establish and maintain a file containing Cf. sub-clause 4.2.5. Link with the CE
documents to demonstrate conformity to marking of the medical device
the requirements of the standard ISO
13485 and applicable regulatory
requirements
4.2.3 a Include in this file a description of the Including instructions for use. More
medical device, intended use and labelling 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, Cf. sub-clause 7.2.1
packaging, storage, handling and
distribution specifications
40 4.2.3 d Include in this file measuring and Cf. sub-clause 7.6
monitoring procedures
41 4.2.3 e Include in this file installation Cf. sub-clause 7.5.3, as appropriate
requirements
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 Managing changes and revisions (versions)
current revision status of documents is performed by a person with
established responsibilities and authorities
48 4.2.4 d Ensure availability at points of use of "The right document, in the right place,
relevant versions of applicable documents at the right time" and with the right
version
49 4.2.4 e Ensure legible and readily identifiable Each document is clear, simple to
documents understand, easy to categorize including
electronic files
50 4.2.4 f Ensure that documents of external origin External documents determined by the
are identified and their distribution company as necessary for the planning and
controlled 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 Outdated (obsolete) documents are
documents identified, stored, archived, locked or
destroyed so that they cannot be used
normally
53 4.2.4 Ensure that changes to documents are Either by the original approving function or
reviewed and approved by authorised by a person with pertinent information
persons
54 4.2.4 Define the period for which obsolete Cf. sub-clause 4.2.5
documents will be retained
55 4.2.4 Ensure a period for which documents will List of mandatory documented procedures:
be retained at least equal to the lifetime Validation of software applications (sub-
of the medical device, but no less than clauses 4.1.6, 7.5.6 and 7.6)
the retention period as specified by Control of documents (sub-clause 4 2 4)
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 applicable regulatory requirements 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 "Words fly away, writings remain". Latin
requirements 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 By retaining records
the QMS
58 4.2.5 Document the procedure for control of Cf. sub-clause 4.2.4. The procedure for
records 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 In accordance with the applicable regulatory
confidential health information requirements
60 4.2.5 Keep records legible, readily identifiable Each record is clear, easy to understand,
and retrievable 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 In accordance with the requirements of the
the lifetime of the medical device 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
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 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
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 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 "When you sweep the stairs, you start
commitment to the development, at the top". Romanian proverb
implementation and maintenance of the
effectiveness of the QMS
64 5.1 a Communicate the importance of meeting And applicable regulatory requirements
customer 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 Quantify in each department quality
established 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 And applicable regulatory requirements. Cf.
requirements 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 quality policy is consistent with customer
the organization satisfaction and continual improvement of
the QMS
71 5.3 b Include the commitment to comply with Unambiguous commitment from top
requirements and to maintain the management
effectiveness of the QMS
72 5.3 c Provide a framework for establishing And review quality objectives. Cf. sub-
quality objectives clause 5.6. The management review is the
framework par excellence for this
requirement
73 5.3 d Communicate and explain the quality Cf. sub-clause 5.5.3
policy
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 Including those needed to meet applicable
functions within the organization 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 are quantified, translated
quality objectives (declined) into indicators and monitored
regularly (dashboards). A measurability
criterion can be "Yes / No"
5.4.2 Quality management system planning
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78 5.4.2 a Respect the process approach when And the quality objectives. Cf. sub-
planning the QMS clause 4.1
79 5.4.2 b Maintain the integrity of the QMS when Cf. sub-clause 7.3.9. Pay special attention to
planning and implementing changes the control of the changes and their
consequences on the performance of the
QMS
Responsibility, authorities and
5.5
communication
5.5.1 Responsibility and authority beginning
80 5.5.1 Define, document and communicate Cf. sub-clause 4.2.5. "Responsibility
responsibilities and authorities 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 It is a commitment that top management
personnel who manage, perform and validates if it is not defined by top
verify work affecting quality management
82 5.5.1 Ensure the independence and authority to Cf. sub-clause 8.2.1
manage, perform and verify work
affecting quality
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 By the management representative. Cf. sub-
QMS clauses 7.2, 7.5 and 4.2.4
85 5.5.2 b Report to top management on the By the management representative. And any
effectiveness of the QMS need for improvement, cf. sub-clause 8.5
86 5.2.2 c Ensure the promotion of awareness of By the management representative. Include
applicable regulatory and QMS in the job description of the management
requirements 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 Pay special attention to the feedback of the
processes staff (surveys, suggestion box)
88 5.5.3 Communicate on the effectiveness of the It is a top management commitment
QMS
5.6 Management review
5.6.1 General
89 5.6.1 Document the procedure management Cf. sub-clause 4.2.4. "No system is
review 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 "Love your customers more than
handling products". All customer satisfaction and
non-satisfaction data is an important source
of information for finding opportunities to
improve the QMS
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96 5.6.2 c Include information from reporting to Cf. sub-clause 8.2.3
regulatory authorities
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 Results of the achievement of the quality
monitoring and measurement objectives and analysis of the data related to
the defects (nonconformities) of the
processes
99 5.6.2 f Include information from Results and trends
product monitoring and measurement
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 Results of actions, their follow-up,
action improvements obtained
102 5.6.2 i Include information from follow-up actions Results of decisions taken during the last
from previous management reviews management review and their follow-up
103 5.6.2 j Include information from changes that Consider, evaluate and analyze any changes
could affect the QMS that may impact the QMS (new products and
processes, new customers, new functions
and responsibilities)
104 5.6.2 k Include information from improvement Suggestions, opinions, proposals from all
recommendations staff or external interested parties
105 5.6.2 l Include information from new or revised Legal watch (changes in applicable
applicable regulatory requirements 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 To maintain the suitability, adequacy and
improvement effectiveness of the QMS
108 5.6.3 b Decide actions related to product Related to customer requirements
improvement
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 Identify and ensure current and future
needed to implement and maintain the resource needs:
effectiveness of the QMS staff (competencies)
infrastructure (buildings, workspaces,
facilities)
process equipment (software, hardware)
support services (logistics,
communication)
112 6.1 b Determine and provide the resources "The right person, at the right place, at the
needed to meet applicable regulatory and right moment"
customer requirements
6.2 People
113 6.2 Ensure competent people performing work Skills are based on initial and professional
affecting product quality training, know-how and experience
114 6.2 Document the process needed for Cf. sub-clause 4.2.4. "Quality is
establishing competence, provide training everyone's business". Raise awareness of
and ensuring awareness of personnel 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
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 conformity of medical devices)
118 6.2 d Ensure that personnel are aware of the And how they contribute to the achievement
relevance and the importance of their of the quality objectives
activities
119 6.2 e Retain records of education, training, Cf. sub-clause 4.2.5
skills and experience
6.3 Infrastructure
120 6.3 Document the requirements for the Cf. sub-clause 4.2.4. To satisfy product
necessary infrastructure requirements, prevent product mix-up and
ensure orderly handling of product
121 6.3 Document the requirements for the Cf. sub-clause 4.2.4. Especially when these
maintenance activities and its frequency activities or their absence can affect the
quality of the product
122 6.3 Apply these requirements to maintenance Equipment used in production, the control of
equipment 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 Cf. sub-clause 4.2.4. Anything that can have
necessary work environment an impact on product conformity (motivation,
work organization, workplace ergonomics,
lighting, hygiene, temperature, safety)
125 6.4.1 Document the requirements for the work Cf. sub-clause 4.2.4. Especially if the work
environment and the procedures to environment can negatively affect the quality
monitor and control it of the product. Cf. sub-clause 7.5.1
126 6.4.1 a Document requirements for health, Cf. sub-clause 4.2.4. In the case of contact
cleanliness and clothing of personnel 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 Or supervised by a competent person. Cf.
temporary under special environmental sub-clause 6.2. More information into ISO
conditions are competent 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 Cf. sub-clause 4.2.4. In order to prevent
control of contaminated or potentially contamination of the work environment,
contaminated product personnel or product. Cf. sub-clause 7.5.5
129 6.4.2 Document requirements for control of Cf. sub-clause 4.2.4. For sterile medical
contamination (with microorganisms or devices
particulate matter)
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 Cf. sub-clause 4.2.5. These are all processes
realization 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 Take into account infrastructure and the work
realization environment, cf. sub-clauses 6.3 and 6.4
133 7.1 Plan product realization consistent with Cf. sub-clause 4.1. Take prevention into
the requirements of other processes of account as much as possible
the QMS
134 7.1 Document the risk management Cf. sub-clause 4.2.4. More information in
processes throughout product realization ISO 14971 (Medical devices - Application of
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 risk management to medical devices)
135 7.1 Retain records of risk management Cf. sub-clause 4.2.5
activities
136 7.1 a Determine quality objectives and product Establish and implement processes and
requirements documentation for each product
137 7.1 b Determine the need to establish processes Cf. sub-clause 4.2.4
and documents
138 7.1 b Determine how to provide resources Including infrastructure and work
specific to the product environment
139 7.1 c Determine the verification, validation, And traceability activities specific to the
monitoring, measurement, inspection and product
test, handling, storage and distribution
activities
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 Cf. sub-clause 4.2.5. Paper or electronic,
suitable form easily readable and identifiable
7.2 Customer-related products
Determination of requirements
7.2.1 related to product
144 7.2.1 a Determine requirements specified by the "The only measure of quality is
customer, including those for delivery and customer satisfaction". Identify and apply
post-delivery activities 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 Identify all applicable requirements related
requirements to the product (including recycling and
disposition) and implement a legal watch
147 7.2.1 d Determine any user training to ensure And safe use of the medical device
specified performance
148 7.2.1 e Determine any additional internal Such as constraints, internal rules,
requirements confidentiality, occupational health and
safety, hygiene
Review of requirements related to
7.2.2 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 Review tenders, amendments, acceptance of
product to customer contracts, changes
151 7.2.2 a Ensure that product requirements are Cf. sub-clause 4.2.4
defined and documented
152 7.2.2 b Ensure that the gaps between the Before accepting the contract or the order
requirements of a contract or order and
those previously expressed are resolved
153 7.2.2 c Ensure that applicable regulatory Requirements are defined and approved
requirements are met
154 7.2.2 d Ensure that any user training is available Cf. sub-clause 7.2.1
or planned to be available
155 7.2.2 e Ensure that the organization has the Requirements are defined and approved
ability to meet the defined requirements
156 7.2.2 Retain records of the results of the review Cf. sub-clause 4.2.5
and actions taken
157 7.2.2 When customer requirements are not By sending them to the customer with
documented, confirm them before acknowledgment of receipt (by mail or
acceptance email)
158 7.2.2 When product requirements are changed, And relevant personnel is informed
ensure that relevant documents are
amended

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 7.2.3 Communication
159 7.2.3 a Plan and document arrangements for Cf. sub-clause 4.2.5. "Good news walks,
communicating with customers in relation bad news runs". Swedish proverb
to product information
160 7.2.3 b Plan and document arrangements for Cf. sub-clause 4.2.5. Establish effective
communicating with customers in relation communication methods with the customer
to enquiries, contracts, order handling
and amendments
161 7.2.3 c Plan and document arrangements for Cf. sub-clause 4.2.5. Including complaints.
communicating with customers in relation Cf. sub-clause 8.2.1
to customer feedback
162 7.2.3 d Plan and document arrangements for Cf. sub-clauses 8.3.3 and 4.2.4
communicating with customers in relation
to advisory notices
163 7.2.3 Communicate with regulatory authorities Cf. sub-clause 8.2.3
in accordance with applicable regulatory
requirements
7.3 Design and development
7.3.1 General
164 7.3.1 Prepare procedures for design and Cf. sub-clause 4.2.4. "I have not failed.
development 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 Identify and formalize relationships between
development all stakeholders in product design and
development (meetings and reviews at key
milestones)
166 7.3.2 Retain and maintain, as appropriate, During the course of design and
planning documents development
167 7.3.2 a Document the design and development Cf. sub-clause 4.2.4
stages
168 7.3.2 b Document the reviews needed at each Cf. sub-clause 4.2.4
design and development stage
169 7.3.2 c Document the verification, validation and Cf. sub-clause 4.2.4
design transfer activities at each design
and development stage
170 7.3.2 d Document the responsibilities and Cf. sub-clause 4.2.4
authorities for design and development
171 7.3.2 e Document the methods to ensure Cf. sub-clause 4.2.4. Related to design and
traceability of outputs 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 Product characteristics and technical
requirements 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 And specific standards
requirements
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 Why re-invent the wheel?
designs
179 7.3.3 e Include other requirements essential for Benchmarking, market research
process and product design and
development
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, More information in IEC 62366-1 (Medical
unambiguous, able to be verified or devices - Part 1: Application of usability
12/24
 validated and not in conflict with each engineering to medical devices)
other
7.3.4 Design and development outputs
183 7.3.4 a Ensure that design and development If this is not the case, repeat some steps
outputs meet input requirements
184 7.3.4 b Ensure that design and development The accuracy of this information is essential
outputs provide appropriate information
for purchasing, production and service
provision
185 7.3.4 c Ensure that design and development Requirements (restrictions or
outputs contain or reference product recommendations) related to transport,
acceptance criteria packaging, labels, instructions for use,
expiration date, traceability, components
used
186 7.3.4 d Ensure that design and development The results of design reviews of similar old
outputs specify the characteristics of the products (tests, reliability, feasibility) and
product that are essential for its safe and feedback from users (after-sales service,
proper use recommendations, suggestions)
187 7.3.4 Ensure that design and development Requirement included in the procedure
outputs are in a form suitable for design and development, cf. sub-
verification against inputs clause 7.3.1
188 7.3.4 Ensure that design and development Requirement included in the procedure
outputs approved prior to release design and development, cf. sub-
clause 7.3.1
189 7.3.4 Retain records of the design and Cf.sub-clause 4.2.5
development outputs
7.3.5 Design and development review
190 7.3.5 Perform systematic reviews of design and In accordance with planned and documented
development at suitable stages arrangements
191 7.3.5 a Evaluate the ability of the results to meet Cf. sub-clause 7.3.3
requirements
192 7.3.5 b Propose necessary actions After problems are identified
193 7.3.5 Ensure that representatives of functions And other specialist personnel
concerned with the stages being reviewed
are participating in these reviews
194 7.3.5 Retain records of the results of the Cf. sub-clause 4.2.5. These records include
reviews and necessary actions 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 To ensure that the design and development
verification in accordance with planned outputs have met the input requirements
and documented arrangements
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 If the intended use requires that the medical
that the design outputs meet design device be connected to, or have an interface
outputs when connected or interfaced with, other medical devices
198 7.3.6 Retain records of the results and Cf. sub-clauses 4.2.4 and 4.2.5
conclusions of the verification and
necessary actions
7.3.7 Design and development validation
199 7.3.7 Perform design and development To ensure that the resulting product is
validation in accordance with planned and capable of meeting the requirements for the
documented arrangements 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 The representative product includes initials
representative product production units, batches or their equivalents
202 737 Record the rationale for the choice of Cf sub-clause 4 2 5
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 product used for validation
203 7.3.7 Perform clinical evaluations or Clinical evaluation or performance evaluation
performance evaluations of the medical of a medical device is not considered to be
device as part of design and development released for use to the customer
validation in accordance with applicable
regulatory requirements
204 7.3.7 Include in the validation confirmation that When the intended use requires that the
the requirements for the specified medical device be connected to or have
application or intended use have been interface with other medical devices
met when so connected or interfaced
205 7.3.7 Complete validation prior to release for Cf. sub-clauses 7.5.6 and 7.5.7
use of the product to the customer
206 7.3.7 Retain records of the results and Cf. sub-clauses 4.2.4 and 4.2.5
conclusion of validation and necessary
actions
7.3.8 Design and development transfer
207 7.3.8 Document procedures for transfer of Cf. sub-clause 4.2.4. Identify, formalize and
design and development outputs to retain the information needed to initiate
manufacturing product design and development
208 7.3.8 Ensure that design and development Before becoming final production
outputs are verified as suitable for specifications
manufacturing
209 7.3.8 Ensure that production capability can Cf. sub-clause 7.2.1
meet product requirements
210 7.3.8 Record results and conclusions of the Cf. sub-clause 4.2.5
transfer
Control of design and development
7.3.9
changes
211 7.3.9 Document procedures to control design Cf. sub-clause 4.2.4. Identify and formalize
and development changes 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 On components of the product, on product
development changes, evaluation of the being delivered or already delivered, on
effect of the changes inputs or outputs of risk management and on
product realization processes
219 7.3.9 Retain records of changes, their review Cf. sub-clause 4.2.5
and necessary changes
7.3.10 Design and development files
220 7.3.10 Maintain a design and development filefor Cf. sub-clause 4.2.4
each medical device type or family
221 7.3.10 Include or reference in this file records Cf. sub-clauses 4.2.5 and 7.3.4
generated to demonstrate satisfaction to
design and development requirements
222 7.3.10 Include or reference in this file records for Cf. sub-clauses 4.2.5 and 7.3.9
design and development changes
7.4 Purchasing
7.4.1 Purchasing process
223 7.4.1 Document procedures to ensure that Cf. sub-clause 4.2.4. Information is internal
purchased product conforms to specified requirements
purchasing information
224 7.4.1 Establish criteria for the evaluation and The purchasing process includes the criteria

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 selection of suppliers 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 Cf. sub-clause 7.2.1
supplier's ability to provide product that
meets the requirements of the
organization
226 7.4.1 b Ensure that the criteria are based on the Conforming product, respect of cost and
performance of the supplier deadlines
227 7.4.1 c Ensure that the criteria are based on the "If you buy quality, you cry only once.
effect of the purchased product on the English proverb"
quality of the medical device
228 7.4.1 d Ensure that the criteria are proportionate Cf. sub-clause 7.1
to the risk associated with the medical
device
229 7.4.1 Plan the monitoring and re-evaluation of Include in the list of suppliers the evaluation
suppliers 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- Use records of verification of deliveries
evaluation process, the results of the
monitoring
232 7.4.1 Address reactions with the supplier, in And compliance with applicable regulatory
case of non-fulfillment of purchasing requirements. Cf. sub-clause 7.1
requirements, proportionate to the risk
associated with the purchased product
233 7.4.1 Retain records of the results of evaluation, And any necessary acions taken. Cf. sub-
selection, monitoring and re-evaluation of clause 4.2.5
supplier capability or performance
7.4.2 Purchasing information
234 7.4.2 Describe or reference the product to be All the data of the purchased product
purchased (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 Relating to the product to be purchased
acceptance, procedures, processes and
equipment
237 7.4.2 c Describe requirements for qualification of For specific cases, staff receive appropriate
supplier personnel 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 Before communicating them to the supplier
purchasing requirements
240 7.4.2 Include, as applicable, a written Prior to implementation of any changes that
agreement that the supplier notify the could affect the purchased product to meet
organization of changes in the purchased spcified purchase requirements
product
241 7.4.2 Retain relevant purchasing information in To the extend required for traceability. Cf.
the form of documents and records 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 To ensure that purchased product meets
activities 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 The activities are proportionate to the risk
on the supplier evaluation results associated with the purchased product. Cf.
sub-clause 7.1. Link between verification
15/24
 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 Cf. sub-clause 7.3.9

purchased product affect the product

realization process or the medical device
245 7.4.3 State the intended verification activities When the organization or its customer
and method of product release in the intends to perform verification at the
purchasing information 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
Control of production and service
7.5.1 provision
247 7.5.1 Plan, carry out, monitor and control To ensure that product conforms to
medical device production and service requirements
provision
248 7.5.1 a Include in production controls Cf. sub-clause 4.2.4
documentation of procedures and
methods for the control of production
249 7.5.1 b Include in production controls qualification Cf. sub-clause 6.3
of infrastructure
250 7.5.1 c Include in production controls Maintenance of equipment is regular
implementation of monitoring and
measurement of process parameters and
product characteristics
251 7.5.1 d Include in production controls availability Monitoring and measuring equipment is
and use of monitoring and measuring maintained in good condition and staff is
equipment trained in its use
252 7.5.1 e Include in production controls According to product requirements, cf. sub-
implementation of defined operations for clause 7.2.1. More information in ISO 15223
labelling and packaging (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 Monitoring and measuring equipment are
implementation of product release, regularly used
delivery and post-delivery activities
254 7.5.1 Establish and retain a record for each Cf. sub-clause 4.2.5. To provide specified
medical device of batch of medical devices traceability. Cf. sub-clause 7.5.9
255 7.5.1 Establish and retain a record that Cf. sub-clause 4.2.5
identifies the amount manufactured and
the amount approved for distribution
256 7.5.1 Verify and approve each record Cf.sub-clause 4.2.5
Cleanliness of product
7.5.2
257 7.5.2 a Document requirements for cleanliness of Prior to sterilization or its use. Cf. sub-
product or contamination control of clause 4.2.4
product when product is cleaned by the
organization
258 7.5.2 b Document requirements for cleanliness of Prior to sterilization or its use. And the
product or contamination control of product is subjected to a cleaning process
product when product is supplied non- before its sterilization or its use. Cf. sub-
sterile and is to be subjected to a cleaning clause 4.2.5
process
259 7.5.2 c Document requirements for cleanliness of Prior to sterilization or its use. And its
product or contamination control of cleanliness is of significance in use. Cf. sub-
product when product cannot be cleaned clause 4.2.4
260 7.5.2 d Document requirements for cleanliness of And its cleanliness is of significance in
product or contamination control of use. Cf. sub-clause 4.2.4
product when product is supplied to be
used non-sterile
261 7.5.2 e Document requirements for cleanliness of Cf. sub-clause 4.2.4
product or contamination control of

16/24
 product when process agents are to be
removed from product during
manufacture
262 7.5.2 Do not apply requirements prior to the Cf. sub-clause 6.4.1
cleaning process if product is cleaned in
accordance with a) or b) above
Installation activities
7.5.3
263 7.5.3 Document requirements for medical Cf. sub-clause 4.2.4
device installation and acceptance criteria
for verification of installation, as
appropriate
264 7.5.3 Provide documented requirements for If the agreed customer requirements allow
medical device installation and verification installation by an external party outside the
of installation company or its supplier
265 7.5.3 Retain records of medical device Performed by the organization or its supplier.
installation and verification of installation Cf. sub-clause 4.2.5
Servicing activities
7.5.4
266 7.5.4 Document servicing procedures, reference For performing servicing activities and
materials and reference measurements 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 By the organization or its supplier. Cf. sub-
carried out clause 4.2.5
Particular requirements for sterile
7.5.5 medical devices
270 7.5.5 Retain records of the sterilization process
Cf. sub-clause 4.2.5
parameters used for each sterilization
batch
271 7.5.5 Ensure the traceability of each production
With sterilization records. Cf. sub-
batch of medical devices
clause 7.5.9
Validation of processes for production
7.5.6 and service provision
272 7.5.6 Validate any processes for production and
service provision where the resulting This includes all processes for which
output cannot be or is not verified by deficiencies occur only after the product is in
subsequent monitoring or measurement use or the service has been delivered
273 7.5.6 Demonstrate by validation the ability of
these processes to achieve planned Validation is realized after review and
results consistently verification of processes
274 7.5.6 a Document procedures for validation of
processes including defined criteria for Cf. sub-clause 4.2.4
review and approval of processes
275 7.5.6 b Document procedures for validation of
processes including equipment And qualification of personnel. Cf. sub-
qualification clause 4.2.4
276 7.5.6 c Document procedures for validation of
processes including use of specific Cf. sub-clause 4.2.4
methods, procedures and acceptance
criteria
277 7.5.6 d Document procedures for validation of
processes including statistical techniques As appropriate. Cf. sub-clause 4.2.4
with rationale for sample sizes
278 7.5.6 e Document procedures for validation of
processes including requirements for Cf. sub-clauses 4.2.4 and 4.2.5
records
279 7.5.6 f Document procedures for validation of
processes including revalidation Including criteria for revalidation. Cf. sub-
280 7.5.6 g Document procedures for validation of clause 4.2.4. Including revalidation criteria
processes including approval of changes Cf. sub-clause 4.2.4

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 to the processes
281 7.5.6 Document procedures for the validation of Used in production and service provision. Cf.
the application of computer software sub-clause 4.2.4
282 7.5.6 Validate software applications prior to And also after changes to such software or
initial use its application
283 7.5.6 Establish an approach proportionate to Including the effect on the ability of the
the risk associated with the use of the product to conform to specifications. Cf. sub-
software clause 7.1
284 7.5.6 Retain records of the results and Cf. sub-clauses 4.2.4 and 4.2.5
conclusion of the validation and necessary
actions undertaken
Particular requirements for validation
7.5.7 of processes for sterilization and
sterile barrier systems
285 7.5.7 Document procedures for the validation of Cf. sub-clause 4.2.4
processes for sterilization and sterile
barrier systems
286 7.5.7 Validate processes for sterilization and And after product or process changes, as
sterile barrier systems prior to appropriate
implementation
287 7.5.7 Retain records of the results and Cf. sub-clauses 4.2.4 and 4.2.5. More
conclusion of validation and necessary information in ISO 11607-1 (Packaging for
actions undertaken 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 Cf. sub-clause 4.2.4
identification
289 7.5.8 Identify product by suitable means Throughout product realization
290 7.5.8 Identify product status with respect to Throughout product realization
monitoring and measurement
requirements
291 7.5.8 Maintain product identification throughout To ensure that only product that has passed
production, storage, installation and the required inspections and tests or
servicing of product released under an authorized concession is
dispatched, used or installed
292 7.5.8 Document a system to assign unique Cf. sub-clause 4.2.5. If required by
device identification to the medical device applicable regulatory requirements
293 7.5.8 Document procedures to ensure that Cf. sub-clause 4.2.4.
medical devices returned to the
organization are identified and
distinguished from conforming product
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
Particular requirements for
7.5.9.2
implantable medical devices
297 7.5.9.2 Include in the records required for When these parameters may result in the
traceability records of components, medical device not meeting the specified
materials and conditions for the work safety and performance requirements
environment used
298 7.5.9.2 Require that suppliers of distribution To allow traceability and that these records
services or distributors retain records of are available for inspection
the distribution of medical devices

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299 7.5.9.2 Retain records of the shipping package Name and address. Cf. sub-clause 4.2.5
consignee
7.5.10 Customer property
300 7.5.10 Identify, verify, protect and saveguard When customer property is under the control
customer property provided for use or of the organization or being used
incorporation into the product
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 Cf. sub-clause 4.2.4. Product preservation
conformity of product during processing, includes all stages of the product's life cycle
storage, handling and distribution (receiving, producing, handling, storing,
delivering)
304 7.5.11 Apply preservation to constituent parts of Including packaging
the medical device
305 7.5.11 a Protect product from alteration, Through the design and construction of
contamination or damage when exposed suitable packaging and shipping containers
to expected conditions and hazards during
processing, storage, handling and
distribution
306 7.5.11 b Protect product from alteration, By documenting requirements for special
contamination or damage when exposed conditions needed, if packaging alone cannot
to expected conditions and hazards during provide preservation
processing, storage, handling and
distribution
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 Monitoring and measurement processes are
measurement activities implemented to provide evidence of product
conformity. Cf. sub-clause 7.2.1
310 7.6 Determine the monitoring and Maintain a list of equipment
measurement equipment
311 7.6 Document procedures to ensure that Cf. sub-clause 4.2.4. Consistent with the
monitoring and measurement can be monitoring and measurement requirements
carried out and are carried out in a
consistent manner
312 7.6 a Ensure valid results with measuring Against measurement standards traceable to
equipment that is calibrated or verified at international or national measurement
specified intervals or prior to use 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 The measuring equipment is regularly
equipment that is adjusted or re-adjusted adjusted
as necessary
314 7.6 b Record the adjustments realized Cf. sub-clause 4.2.5
315 7.6 c Ensure valid results with measuring In order to determine its calibration status
equipment that is identified
316 7.6 d Ensure valid results with measuring Effective protection not only during use
equipment that is safeguarded from (displacement, maintenance, storage)
adjustments that would invalidate the
measurement result
317 7.6 e Ensure valid results with measuring This concerns potentially nonconforming
equipment that is protected from damage products
and deterioration during handling,
maintenance and storage
318 7.6 Perform calibration or verification in The equipment is calibrated and verified.
accordance with documented procedures Products are inspected, validated (with or
without concession) or identified as
nonconforming
319 7.6 Assess and record the validity of the When the equipment is found not meeting

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 previous measuring results requirements
320 7.6 Take appropriate action in regard to the Monitoring and measuring software are
equipment and any product affected validated before use
321 7.6 Retain records of the results of calibration Cf. sub-clause 4.2.5

and verification
322 7.6 Document procedures for the validation of Cf. sub-clause 4.2.4. Perform a second
the application of computer software used validation if the first one is not satisfactory
for the monitoring and measurement of
requirements
323 7.6 Validate software application prior to Perform a second validation if the first one is
initial use and after changes to software not satisfactory
or its application
324 7.6 Define the specific approach and activities Including the effect on the ability of the
associated with software validation and product to conform to specifications. Cf. sub-
revalidation that are proportionate to the clause 7.1
risk associated with the use of the
software
325 7.6 Retain records of the results and Cf. sub-clauses 4.2.4 and 4.2.5. More
conclusion and necessary action from the information in ISO 10012 (Measurement
validation management systems - Requirements for
measurement processes and measuring
equipment)

8 Measurement, analysis and Constater (Check), Agir (Act)

improvement
8.1 General
326 8.1 a Plan and implement the needed To demonstrate conformity of
monitoring, measurement, analysis and product. Control of product conformity is
improvement processes 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 Including statistical techniques and the
methods extent of their use
8.2 Monitoring and measurement
8.2.1 Feedback
330 8.2.1 Gather and monitor information relating As one of the measures of QMS performance
to whether the organization has met
customer requirements
331 8.2.1 Document the methods for obtaining and Cf. sub-clause 4.2.5
using this information
332 8.2.1 Document procedures for the feedback Cf. sub-clauses 4.2.4 and 7.2.3
process
333 8.2.1 Include in the feedback process provisions And post-production activities
to gather data from production activities
334 8.2.1 Use the information gathered in the For monitoring and maintaining the product
feedback process as potential input into requirements, the product realization and
risk management process improvements. Cf. sub-clause 7.1
335 8.2.1 Include in the feedback process the If it is required by applicable regulatory
review of the experience from post- requirements
production activities
8.2.2 Complaint handling
336 8.2.2 Document procedures for complaint Cf. sub-clause 4.2.4. Within appropriate time
handling limits in accordance with applicable
regulatory requirements
337 8.2.2 a Include requirements and responsibilities Who, when, how
for receiving and recording information
338 8.2.2 b Include requirements and responsibilities To determine if the feedback constitutes a
for evaluating information complaint. By the person in charge and his
team
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339 8.2.2 c Include requirements and responsibilities The 8 D method is judicious to meet this
for investigating complaints requirement
340 8.2.2 d Include requirements and responsibilities To the appropriate regulatory authorities. Cf.
for determining the need to report the sub-clause 8.2.3
information
341 8.2.2 e Include requirements and responsibilities Verify the extent of the claim
for handling of complaint-related product
342 8.2.2 f Include requirements and responsibilities And undertake the necessary actions
for determining the need to initiate
corrections or corrective actions
343 8.2.2 Document a justification if the complaint Cf. sub-clause 4.2.4
is not investigated
344 8.2.2 Document any correction or corrective Cf. sub-clause 4.2.4
action following a complaint
345 8.2.2 Exchange relevant information between When the investigation determines that
the organization and the external party activities outside the company have
involved 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 Cf. sub-clause 4.2.4. If applicable regulatory
notification to the appropriate regulatory requirements require it
authorities about complaints that meet
specified reporting critéria of adverse
events or issuance of advisory notices
348 8.2.3 Retain records of reporting to regulatory Cf. sub-clause 4.2.5
authorities
8.2.4 Internal audit
349 8.2.4 a Conduct internal audits at planned To determine whether the QMS conforms to
intervals 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 Cf. sub-clause 7.1
implemented and maintained
351 8.2.4 Document a procedure to describe the Cf. sub-clause 4.2.4. For planning and
responsibilities and requirements conducting audits and recording and
reporting audit results
352 8.2.4 Plan an audit program taking into As well as the results of previous audits
consideration the status and importance
of the process and area to be audited
353 8.2.4 Define and record the audit criteria, Cf. sub-clause 4.2.5
scope, interval and methods
354 8.2.4 Ensure objectivity and impartiality of the By selection of auditors and conduct of
audit process 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 Cf. sub-clause 4.2.5. Including process
results identification, areas audited and the
conclusions
357 8.2.4 Ensure that the management responsible To eliminate detected nonconformities and
for the area being audited takes without their causes
undue delay any necessary corrections
and corrective actions
358 8.2.4 Include in the follow-up activities the More information in ISO 19011 (Guidelines
verification of the actions taken and the for auditing management systems)
reporting of verification results
Monitoring and measurement of
8.2.5
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 Cf. sub-clause 7.1
to achieve planned results
361 8.2.5 Take correction and corrective action, as Cf. sub-clause 8.5.2
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 appropriate, when planned results are not
achieved
Monitoring and measurement of
8.2.6
product

362 8.2.6 Monitor and measure medical device To verify that product requirements have
characteristics been met
363 8.2.6 Carry out this at applicable stages of the In accordance with the planned
product realization process arrangements and documented procedures
364 8.2.6 Retain evidence of conformity to the Cf. sub-clause 4.2.5
acceptance criteria
365 8.2.6 Record the identity of the person Cf. sub-clause 4.2.5
authorizing release of product
366 8.2.6 Identify, as appropriate, in records, the Cf. sub-clause 4.2.5
test equipment used to perform
measurement activities
367 8.2.6 Do not proceed with product release and Cf. sub-clause 7.1
service delivery until the planned and
documented arrangements have been
satisfactorily completed
368 8.2.6 Record the identity of personnel Cf. sub-clause 4.2.5
performing any inspection or testing of
implantable medical devices
8.3 Control of nonconforming product
8.3.1 General
369 8.3.1 Ensure that nonconforming product is To prevent its unintended use or delivery
identified and controlled
370 8.3.1 Document a procedure to define the Cf. sub-clause 4.2.4. Determine the related
controls of nonconforming product responsibilities and authorities, identification,
documentation, segregation, evaluation and
disposition of nonconforming product
371 8.3.1 Include in the evaluation of nonconformity And notification of any external party
a determination of the need for an responsible for the nonconformity
investigation
372 8.3.1 Retain records of the nature of the Cf. sub-clause 4.2.5. Including the
nonconformities and any subsequent evaluation, any investigation and the
action taken rationale for decisions
Actions in response to nonconforming
8.3.2
product detected before delivery
373 8.3.2 a Take action to eliminate the detected To deal with the nonconforming product
nonconformity
374 8.3.2 b Take action to preclude its original To deal with the nonconforming product
intended use or application
375 8.3.2 c Authorize its use, release or acceptance To deal with the nonconforming product
under concession
376 8.3.2 Ensure that nonconforming product is And approval is obtained and applicable
accepted by concession only if the regulatory requirements are met
justification is provided
377 8.3.2 Retain records of the acceptance by And the identity of the person authorizing
concession the concession. Cf. sub-clause 4.2.5
Actions in response to nonconforming
8.3.3
product detected after delivery
378 8.3.3 Take action appropriate to the effects, orIn order to treat the nonconforming product
potential effects, of the nonconformity 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 In accordance with applicable regulatory
notices requirements. Cf. sub-clause 4.2.4
381 8.3.3 Be capable to put these procedures at any In order to issue advisory notices without
time delay
382 8.3.3 Retain records of actions relating to the Cf. sub-clause 4.2.5
issuance of advisory notices
8.3.4 Rework
383 834 Perform rework in accordance with Cf sub-clause 4.2.4 Take into account the
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 documented procedures potential adverse effect of the rework on the
product
384 8.3.4 Undergo theses procedures the same Put again in the normal flow
review and approval as the original
procedure
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, Cf. sub-clause 4.2.4. To demonstrate the
collect and analyse appropriate data suitability, adequacy and effectiveness of the
QMS
388 8.4 Include in the procedures determination Including statistical techniques and the
of appropriate methods extent of their use
389 8.4 Include in the analysis of data information And from other relevant sources
generated as a result of monitoring and
measurement
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 Including improvement opportunities
trends of processes and product
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 Cf. sub-clause 7.5.4
appropriate
396 8.4 Use this analysis as input for If the analysis of data shows that the QMS is
improvement 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 Through the use of the quality policy, quality
necessary to ensure and maintain the objectives, audit results, post-market
continued suitability, adequacy and surveillance, data analysis, corrective and
effectiveness of the QMS as well as preventive actions and management review
medical device safety and performance
8.5.2 Corrective action
399 8.5.2 Take action to eliminate the causes of In order to prevent recurrence
nonconformities
400 8.5.2 Take any necessary corrective actions Do not wait is fundamental
without any undue delay
401 8.5.2 Adapt corrective actions proportionate to The procedure for corrective actions answers
the effects of the nonconformities questions about who, when, how, under what
encountered 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 Cf. sub-clause 4.2.4. Include in the
requirements for reviewing procedure the method of finding the causes
nonconformities of nonconformities (diagramme of Ishikawa,
statistical process control)
403 8.5.2 b Document a procedure to define Use 5 W (why) method
requirements for determining the causes
of nonconformities
404 8.5.2 c Document a procedure to define To ensure that nonconformities do not recur
requirements for evaluating the need for
action
405 8.5.2 d Document a procedure to define Cf. sub-clause 4.2.4. Including, as
requirements for planning and appropriate, documentation update
documenting action needed and
implementing such action

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406 8.5.2 e Document a procedure to define
requirements for verifying that corrective
action has no adversely effect
407 8.5.2 f Document a procedure to define
requirements for reviewing the
effectiveness of corrective action taken
408 8.5.2 Retain records of the results of any
investigation and of action taken
8.5.3 Preventive action
409 8.5.3 Determine action to eliminate the causes
of potential nonconformities
410 8.5.3 Adapt preventive actions proportionate to
the effects of the potential problems
411 8.5.3 a Document a procedure to describe
requirements for determining potential
nonconformities and their causes
412 8.5.3 b Document a procedure to describe
requirements for evaluating the need for
action to prevent occurence of
nonconformities
413 8.5.3 c Document a procedure to describe
requirements for planning and
documenting action needed and
implementing such action
414 8.5.3 d Document a procedure to describe The ability to meet applicable regulatory
requirements for verifying that the requirements or the safety and performance
preventive action does not have adversely of the medical device
effect
415 8.5.3 e Document a procedure to describe
requirements for reviewing the
effectiveness of the preventive action
taken
416 8.5.3 Retain records of the results of any
investigations and of action taken
The ability to meet applicable regulatory
requirements or the safety and performance
of the medical device
To ensure that nonconformities do not recur
Cf. sub-clause 4.2.5
In order to prevent their occurrence. Analysis
and eradication of potential causes of
process or QMS nonconformities
Do what is necessary in relation to the
potential effects (remain within available
resources)
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
To ensure that nonconformities do not occur.
Will the occurrence be avoided? Are the
necessary resources available?
Cf. sub-clause 4.2.4. Including, as
appropriate, documentation update
"Prevention is always cheaper"
Cf. sub-clause 4.2.5
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