What regulations apply to certification?
- Transitional phase for QMS from September 2015 to September 2018 (3 years).
- All certificates based on ISO 9001:2008 will expire in late September 2018.
- With effect from March 2017 (18 months after publication of the new standard) all initial certifications
- must be carried out according to the ISO 9001:2015 standard.
The approach outlined below is recommended to organisations that hold certificates according to ISO 9001:2008:
- Identify the areas of your QMS that need re-adjustment to be in conformity with the new requirements. In this context, give particular consideration to the following subjects: the context of the organisation, risk-based thinking, process approach as defined in the new standard, expanded understanding of leadership responsibility, and understanding of your organisation.
- The additional expenses for the transition will be lower in a re-certification audit than in a surveillance audit.
- Prepare an implementation plan and decide on the best time for certification according to the new standard.
- Provide appropriate training for all target groups in your organisation affected by the new standard.
- Update your existing QMS to ensure conformity with the changed requirements in both content and practice. Contact your certification body and/or your auditor for a transition agreement, where appropriate.
- Clarify whether you need a pre-audit or delta analysis for transition to the new standard.
- Track the development of the FDIS and the final standard and take into account that minor changes in content may still be possible.