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Implementing ISO 9001 in hospitals

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

Implementing ISO 9001 in hospitals

We're on the phase of preparation for implementing ISO 9001:2015 in our hospital. How can I apply the followed procedures in a healthcare field not industrial field:
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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 Apr 19, 2016

- organizational context

The requirements for determining context of the organization do not differ much from the industry to industry. You need to determine all internal and external issues relevant to our hospital and its ability to achieve its objectives. The best way to do it is to involve key people in the hospital and discuss and issues relevant to the quality of your service and satisfaction of your customers. For more information, see: How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

- resources management

This shouldn't be too difficult because it existed even without QMS. You need to determine all necessary resources for your hospital, this includes human resources, infrastructure, equipment, etc. However, you don't have to document the process of providing resources but you will need to keep records about competence of your employees and records about calibration of measuring equipment.

- design and development

This clause can be excluded if your hospital does not design new practices for patient treatment.

- control of nonconforming output

Nonconforming output in the case of hospitals is when some procedures are not followed. The nonconforming product can be out dated or corrupted medicines or improper disposal of medical waste.

In addition, Will I have to contain the clinical units in our QMS, if yes, How?

It depend on how you defined the scope of your QMS, if you decided to include all your clinical units in the scope then you need to define them in the document Scope of QMS. For more information, see: How to define the scope of the QMS according to ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/
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Apr 19, 2016

Apr 19, 2016

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