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Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards

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Guest user Created:   Jul 13, 2020 Last commented:   Jul 14, 2020

Cross-mapping ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards

I am trying to cross map ISO 13485, ISO 15189 and other accreditation and regulatory Canadian standards that apply to medical testing labs that develop IVTs. In development of a QMS that will satisfy all of them. Any advice?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 14, 2020

It is really hard work, but I think it is doable. Since both standards are similar to ISO 9001:2008, maybe that is the starting point.

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Jul 13, 2020

Jul 14, 2020