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Integrated approach of ISO 13485 and ISO 9001

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Guest user Created:   Aug 04, 2020 Last commented:   Aug 19, 2020

Integrated approach of ISO 13485 and ISO 9001

1.An Integrated approach of ISO 13485 and ISO9001 What should be focused on considering these 2 standards (These will be audited separately). For integrated approach, I am following Anenxure B of ISO 13485

2. How to pass ISO 9001 stage 1 and stage 2 audit?

3. A Regulatory procedure and form is required that will meet both the standards requirements

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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 Aug 19, 2020
1.An Integrated approach of ISO 13485 and ISO9001 What should be focused on considering these 2 standards (These will be audited separately). For integrated approach, I am following Anenxure B of ISO 13485

Yes, for integrated part you can follow Annex B of the ISO 13485:2016 standard. Be focused on the following:

To strictly defined and state in Quality manual which requirements from ISO 13485:2016 are not applicable for your process and medical device. For example, if your medical device is not sterile, then requirements 7.5.5 Particular requirements for sterile medical devices and requirement 7.5.7 Particular requirement for validation of processes for sterilization and sterile barrier systems are not applicable for you.

There are certain requirements in the ISO 13485 that need to have documented procedures, while there are no such strict requirements in the ISO 9001:2015. For example, you need to make a documented procedure for purchasing (requirement 7.4.1), the procedure for validation (7.5.6), the procedure for identification, and traceability (7.5.8 and 7.5.9).  

For more information what ISO 13485 is, please see the article on the following link:

For more information about Similarities and differences between ISO 9001:2015 and ISO 13485:2016, please see the article on the following link: https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

2. How to pass ISO 9001 stage 1 and stage 2 audit?

To pass ISO 9001 stage 1 and stage 2 audit, your organization must have a quality management system designed according to ISO 9001:2015 requirements and must be implemented and followed.

3. A Regulatory procedure and form is required that will meet both the standards requirements

You can add in your Quality manual cross-reference table for your Quality management system between ISO 9001:2015 and ISO 13485:2016.

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Aug 04, 2020

Aug 19, 2020