Training course designed and delivered by our expert dedicated to the Transition to the new ISO 9001:2015 Standard
With over one million certified companies over the world, the international quality management systems standard ISO 9001 is among the most commonly used today.
Since the first publication in 1987, several revisions have taken place aligning those standards to the evolution of the market needs. The latest edition of ISO 9001 standard for the medical device industry was officially made available on September 2015.
Manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
Objectives of the training
- Understand the new concepts and definitions introduced by ISO 9001:2015
- Identify the new revised High Level Structure (HLS) for ISO 9001:2015
- Comprehend the new regulatory requirements and purpose for ISO 9001:2015
- Cross referencing between the old and new versions for a smooth transition
ISO 9001:2015 Quality Management Standard
- What’s new? Definitions & Terminology
- The new ISO Management Systems High Level Structure (HLS)
- The changes and the new requirements impacting:
- Clause 4: Context of the Organization
- Clause 5: Leadership and commitment
- Clause 6: Planning
- Clause 7: Support
- Clause 8: Operations
- Clause 9: Performance & Evaluation
- Clause 10: Improvement processes
- Workshop session
- Transition planning