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Home » Store » Books » 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.
PDF Edition
Available Format
PDF Edition — $397
Who Will Benefit
Senior management
Quality systems management
Regulatory/compliance department
Design engineers
Production managers
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