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ISO 9001:2015 QMS | Interactive Training

Training course designed and delivered by our expert dedicated to the Transition to the new ISO 9001:2015 Standard

Picto ISO 9001 certification training courseWith 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

PROGRAM

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

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

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Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager