(DIS)ISO 9001:2015 — What to expect from the latest version As The latest revisions to ISO 9000 are likely to be published during the fall of this year — medical device companies should take notice, since corresponding changes to ISO 13485 are sure to follow after this.
ISO 9001:2015 will represent the most significant change since 2000, when the standard moved from a checklist approach to a process management approach it took into account all the critical areas of an organization and its interactions.
with the introduction of ISO 9001:2015 while the structure of the standards will change the scope of ISO 9000 will remain same.
The technical committee has put great effort into making the standard more user friendly, regardless of whether you are a manufacturer or a service provider.
• adoption of the HLS as set out in Annex SL of ISO Directives Part One,
• an explicit requirement for risk-based thinking to
support and improve the understanding and application of the process
• fewer prescribed requirements,
• less emphasis on documents,
• improved applicability for services,
• a requirement to define the boundaries of the QMS,
• increased emphasis on organizational context,
• increased leadership requirements,
• greater emphasis on achieving desired outcomes to
improve customer satisfaction.
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