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Surveillance audit for a new facility

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Guest user Created:   Oct 22, 2019 Last commented:   Oct 22, 2019

Surveillance audit for a new facility

We added a new facility this year. Our surveillance audit is this coming January. Do we need to do anything now or address it to the auditor in the next audit

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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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Carlos Pereira da Cruz Oct 22, 2019

Is this new facility within the scope of your quality management system? If the answer is no, your organization does not need to do anything

If the answer is yes, your organization should communicate that change to the certification body, together with a plan for the integration of that new facility in the quality management system.

For example, when an organization acquires another facility, ISO 9001:2015 clause 6.3 is used, some of the things that need to done can be: training people in the new practices and procedures; introducing the new procedures; creating/changing quality control plans; integrating infrastructure in the system, calibrating monitoring resources, … 

As an auditor I would like to see an integration planning and evidences of implementation and effectiveness verification. For example, everything can start with determining risks and opportunities coming from that new facility added into the quality management system. 

You can get much more detailed information in the following links:

- Article - QMS Change Management in 7 steps – https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/
- Article - 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/
- Enroll for free - 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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Oct 22, 2019

Oct 22, 2019