FDAnews Announces — New Management Report — ISO 9001:2015 — What Devicemakers Need to Know

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The ISO has completely restructured its quality management system standard for manufacturers. The ISO 9001:2015 management report, based on a presentation by one of the world’s top ISO authorities, explains how the recent revision totally restructures the standard, and breaks it down section by section to point out new requirements devicemakers should follow.

ISO 9001:2015
What Devicemakers Need to Know
**An FDAnews Management Report**
http://info.fdanews.com/iso-90012015-pr

The ISO has completely restructured its quality management system standard for manufacturers. If devicemakers have or want to get certification for their devices under ISO 9001:2015, they’ll need to restructure their QMS to fit.

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 manufacturers 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 manufacturers be ready when they do?

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

  • Analyzing an organization’s operations and needs
  • 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

ISO 9001:2015 — What Devicemakers Need to Know includes a timetable for transitioning to the new certification. Don’t get left behind in securing certification. Order ISO 9001:2015 today.

Who Will Benefit:

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

FDAnews Management Report Details:
ISO 9001:2015
What Devicemakers Need to Know
Price: $397
http://info.fdanews.com/iso-90012015-pr

Easy Ways to Order:
Online: http://info.fdanews.com/iso-90012015-pr        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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