Medical Devices

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ISO 13485:2016 has been revised. It has not adopted the Annexe SL format common to other international standards. It follows the format of the former standard ISO 9001:2008. We have developed a one day course that focuses on the changes and the significant differences with ISO 9001:2015. We look at the implications for audit practice and use your own ISO 13485 process documents to illustrate the audit process. This course can be delivered on a stand alone basis or as a ...

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New standards – New challenge

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This revision to the standards ISO 9001:2015 and ISO 14001:2015 adopts the new common format
and vocabulary of Annex SL. All new standards will have the same format. And that includes the revisions to BS OHSAS 18001 due next year when it becomes ISO 45001:2016.

The new requirements include a statement of business context, stakeholder needs and expectations and a risk based approach to establishing and implementing system controls. The changes to requirements are focused on making improvement the core purpose ...

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