ISO 9001:2015: What Devicemakers Need to Know

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ISO 9001:2015
What Devicemakers Need to Know

It’s time to start getting ready for the new ISO 9001:15 certification requirements.

Devicemakers must be ready to comply with the new ISO 9001:2015 standards starting in September 2017 — for firms seeking first-time certification — and September 2018 for firms with current certification.

Even devicemakers subject to the ISO 13485 standard can learn from the 9001 changes — where do the two standards overlap; where do they differ; and what can the new 9001 teach you about ISO’s priorities and future direction?

And ISO plans to review 13485 again in three years. Will they revise it to follow the 9001 model? Will you be ready when they do?

This report, based on a presentation by one of the world’s top ISO 9001 authorities, explains how the recent revision totally restructures the standard, and breaks it down section by section to point out new requirements devicemakers must follow to maintain their certification, including:

  • Requirements for products and services
  • Design and development of products and services
  • Control of externally provided processes, products and services
  • Internal auditing and management review
  • Comprehensive opportunities for improvement
  • Dealing with nonconformities and corrective action

With this report you gain an understanding of why 9001 was revised and the key themes the new standard presents including:

  • Leadership involvement in the management system
  • Risk-based decisionmaking
  • Common QMS structure
  • Alignment of the quality management system with the organization’s strategy

ISO 9001:2015 includes a timetable for transitioning to the new certification. Don’t get left behind in securing your certification.


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Who Will Benefit

  • Senior management
  • Quality systems management
  • Regulatory/compliance department
  • Design engineers
  • Production managers

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