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ISO 9001:2015 and health care organization

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Guest user Created:   Dec 19, 2016 Last commented:   Dec 19, 2016

ISO 9001:2015 and health care organization

I work as Quality Manager for a Home healthcare Organization in India and would appreciate some clarity on the following:
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Dec 19, 2016

1. Do we need to identify and define risks in all the core and support processes?

The organization must identify and address risks and opportunities not only in the core processes but also all risks and opportunities emerging from context of the organization. For more information, see: How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/

2. Does the documentation for ISO require TIER system like Manuals,policies,procedures,record ?

The standard explicitly requires only documents such as Quality Policy and Quality Objectives, other than that it basically requires only records. But besides the mandatory document there should be other documents that company determines as necessary for running its QMS. For more information, see: List of mandatory documents required by ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/

3. For a Home Healthcare Company like Ours,the core processes would be mostly clinical in nature, so do we need to write SOP s for all the clinical protocols could we have generic documents on common processes?

No, there is no requirement to document every process and every activity, you should document only those where is a chance of nonconformities. For more information, see: Deciding Which Procedures to Document in QMS https://advisera.com/9001academy/blog/2013/11/26/deciding-procedures-document-qms/
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Dec 19, 2016

Dec 19, 2016

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