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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

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.

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

• f 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.

• 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

Key points

The Organization shall

The Organization shall

Key points

• 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.

  

Aquire the standard Review, training Perform gap analysis Define transition action plan including provisions for certification