API Q1 Preventive Action/ ISO 9001: Risk-based Thinking

donhan

Starting to get Involved
Dear Guys,

API Q1 requires a documented procedure to determine and implement preventive actions. We are certified for ISO 9001:2015 and actually, our QMS does not have the preventive action procedure as ISO 9001:2015 does not have the preventive actions clauses. The concept of preventive action is expressed through the use of risk-based thinking. We have another Procedure for Risk Assesment and Management.
Do we need to develop a procedure for preventive action?

Thank you.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Hello donahan,

ISO 9001:2015 does not any longer require a procedure for preventive action, however it does require consideration of your customers' and interested parties' requirements. If they require API Q1 conformance (Customer requirements documents? Contracts?), then that is what you must do.
 

jmech

Trusted Information Resource
If you want to conform to API Q1 9th Edition, then one of your procedures must address preventive action per 6.4.3. Note that per 4.4.2 Note 1, "A single document can address the requirements of one or more procedures", so preventive actions could be address in your "Procedure for Risk Assesment and Management" or your procedure that addresses corrective actions or another procedure (it does not have to be its own new procedure).

API Q1 10th Edition was recently published and removed the preventive action requirements. Per the transition notification on the API website below, starting January 1, 2024, organizations may request to be audited to API Q1 10th Edition. For new applicants, conformance to API Q1 10th Edition will be mandatory starting March 1, 2024. So depending on your situation, you may want to move directly to API Q1 10th Edition (which would remove the need for a procedure that addresses preventive action).

 

donhan

Starting to get Involved
Hello donahan,

ISO 9001:2015 does not any longer require a procedure for preventive action, however it does require consideration of your customers' and interested parties' requirements. If they require API Q1 conformance (Customer requirements documents? Contracts?), then that is what you must do.
Thank you, Jen.
 

donhan

Starting to get Involved
If you want to conform to API Q1 9th Edition, then one of your procedures must address preventive action per 6.4.3. Note that per 4.4.2 Note 1, "A single document can address the requirements of one or more procedures", so preventive actions could be address in your "Procedure for Risk Assesment and Management" or your procedure that addresses corrective actions or another procedure (it does not have to be its own new procedure).

API Q1 10th Edition was recently published and removed the preventive action requirements. Per the transition notification on the API website below, starting January 1, 2024, organizations may request to be audited to API Q1 10th Edition. For new applicants, conformance to API Q1 10th Edition will be mandatory starting March 1, 2024. So depending on your situation, you may want to move directly to API Q1 10th Edition (which would remove the need for a procedure that addresses preventive action).

That's very valuable information for me. Thank you for your reply.
 
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