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Answer:
If you are starting your ISO 9001:2015 QMS implementation project I would choose one or two potential certification bodies and ask them their opinion about a scope statement for that particular case. It can be about pharmaceuticals distribution for certain specialties, for certain geographical markets, and for those 5 hubs listed in the certificate.
The following material will provide you information about scope:
- ISO 9001 – How to define the scope of the QMS according to ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-define-the-scope-of-the-qms-according-to-iso-90012015/
- Certifying different legal entities under one certification scope in ISO 9001 - https://advisera.com/9001academy/blog/2018/03/27/certifying-different-legal-entities-under-one-certification-scope-in-iso-9001/
- Free course – ISO 9001:2015 Internal Auditor Course - https: //advisera.com/training/iso-9001-internal-auditor-course/
· - book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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May 15, 2019