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Integration with other management system standards
4. Context of the organization
4.1 Understanding of the organization and its context
4.2 Understanding the organization and its context
4.3 Determining the scope of the quality management system 4.4 QMS and its processes
5. Leadership 5.1 Leadership and commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes
7. Support 7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
10. Improvement 10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
In bold: HLS Structure common sections
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Merged in
Process
Approach
4. Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5. Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organizational roles, responsibilities and authorities
6. Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes
7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information
8. Operations 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of non conforming outputs
Inclusion of the context of the organisation and interested parties
Reinforcement of the requirements related to the processes
Management responsibility accentuated
Suppression of the requirement related to the
management representative
Preventive actions replaced and extented to actions
taken to address risks and opportunities
Reinforcement of the requirements on planning of
changes
Integration of organizational knowledge
Reinforcement of requirements related to awareness and
communication
Reduction of the documentation (absence of requirement related to
quality manual and mandatory procedures)
Reinforcement of the requirements related to the
control of operational activities (external providers,
post delivery activities, modifications…)
10. Improvement 10.1 General 10.2 Non conformity and corrective action 10.3 Continual improvement
9. Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review
Reinforcement of the requirements related to monitoring,
measurement, analysis and evaluation
Removal of the words « preventive actions ». Those actions
are considered in the actions to face risks identified in
chapter 6.
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15 months before
the end of the
transition period
From June 2017 :
- Initial certification audits will be
exclusively conducted
according to version 2015,
- Renewal audits will be
mandatorily transition audits.
Expiration of the
certificates
ISO 9001:2008
2015
Sept
2018
Sept
Publication of
the standards
Version 2015
Beginning of the
conduction of
audits of
transition* in
version 2015
End of the transition
period Beginning of the
transition period
2018
May
From May 2018 :
all audits will be
exclusively
conducted
according to
version 2015 (end
of transition audits)
4 months before
the end of the
transition period
* Transition audit : audit conducted against the requirements of the version 2015 which can be :
- With a joint audit of surveillance or renewal ISO9001:2008
- Independent.
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• The Standard expects that the Organization:
identifies its role(s) under applicable regulatory
requirements;
identifies the regulatory requirements that apply to its
activities under these roles;
incorporates these applicable regulatory requirements
within its quality management system.
• (4.1.1) Roles undertaken by the Organization can include:
manufacturer,
authorized representative,
Importer
distributor
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Key points
The Organization shall
The Organization shall
Key points
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ISO Transition Planning Guidance for ISO 13485:2016 (position paper ISO/TC 21 0/WG
1 N 233) – Nov 2015: 4.2 Co-existence period
12 months prior to
the end of the
transition period
From this date:
- Initiale certification
audits will only be
performed according to
the 2016 revision,
- Renewal audit will be
transition audits
End of validity of
certificates
ISO 13485:2003
NF EN ISO 13485:2012
2016
03r/01
2019
02/28
2016 version
was published
Beginning of
transition
audits* against
2016 version
End of the
transition period Transition period
starts
* Transition audit: audit against the requirements of the 2016 revision that can be:
- Joint audit with surveillance or renewal audit ISO 13485:2003
- Independant.
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Aquire the standard
Review, training
Perform gap analysis
Define transition action plan including provisions for certification
