ISO 9001:2015 threads in the standard

[Kronos147]

[FONT=&quot]Good day to all of my fellow Cove People,

One of the things I witnessed as an auditor in the field was that organizations often fail to realize the threads in the standard and approach the same concept from different directions.

While I was qualifying to conduct ISO 9001:2015 assessments, and now as I try to implement systemic changes prior to transition, I felt that I should share some of these concepts with the masses to make sure we all keep it as simple as possible and don't overthink anything.

Please be aware of the following threads in [/FONT][FONT=&quot]ISO 9001:2015.[/FONT]

[FONT=&quot]Risks and Opportunities[/FONT][FONT=&quot]:[/FONT]
[FONT=&quot]0.3.3[/FONT]
[FONT=&quot]Risk-based Thinking[/FONT]
[FONT=&quot]0.1[/FONT]
[FONT=&quot]General[/FONT]
[FONT=&quot]4.4.1 (f)[/FONT]
[FONT=&quot]QMS and its Processes[/FONT]
[FONT=&quot]5.1.2 (b)[/FONT]
[FONT=&quot]Customer Focus[/FONT]
[FONT=&quot]6.1.1, 6.1.2[/FONT]
[FONT=&quot]Planning: Actions to Address Risks and Opportunities[/FONT]
[FONT=&quot]8.3.3 (e)[/FONT]
[FONT=&quot]Design and Development Inputs[/FONT]
[FONT=&quot]8.3.6 (d)[/FONT]
[FONT=&quot]Design and Development Changes[/FONT]
[FONT=&quot]8.4.2[/FONT]
[FONT=&quot]Type and Extent of Control[/FONT]
[FONT=&quot]9.3.1 (e)[/FONT]
[FONT=&quot]Management Review: General[/FONT]
[FONT=&quot]10.2.1[/FONT]
[FONT=&quot]Nonconformity and Corrective Action[/FONT]
[FONT=&quot]A.4[/FONT]
[FONT=&quot]Risk-based Thinking[/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]Change Management[/FONT][FONT=&quot]:[/FONT]
[FONT=&quot]4.4.1 (g)[/FONT]
[FONT=&quot]QMS and its Processes[/FONT]
[FONT=&quot]5.3 (e)[/FONT]
[FONT=&quot]Organizational Roles, Responsibilities and Authorities[/FONT]
[FONT=&quot]6.3[/FONT]
[FONT=&quot]Planning of Changes[/FONT]
[FONT=&quot]7.5.3.2 (c)[/FONT]
[FONT=&quot]Control of Documented Information[/FONT]
[FONT=&quot]8.1[/FONT]
[FONT=&quot]Operational Planning and Control[/FONT]
[FONT=&quot]8.2.4[/FONT]
[FONT=&quot]Changes to the Requirements of Products and Services[/FONT]
[FONT=&quot]8.3.6[/FONT]
[FONT=&quot]Design and Development Changes[/FONT]
[FONT=&quot]8.5.6[/FONT]
[FONT=&quot]Control of Changes[/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]Process Approach[/FONT][FONT=&quot]:[/FONT]
[FONT=&quot]0.1[/FONT]
[FONT=&quot]General[/FONT]
[FONT=&quot]0.2[/FONT]
[FONT=&quot]Quality Management Principles[/FONT]
[FONT=&quot]0.3.1[/FONT]
[FONT=&quot]Process Approach: General[/FONT]
[FONT=&quot]4.4.1[/FONT]
[FONT=&quot]QMS and its Processes[/FONT]
[FONT=&quot]5.1.1[/FONT]
[FONT=&quot]Leadership and Commitment: General[/FONT]
[FONT=&quot]5.3[/FONT]
[FONT=&quot]Organizational Roles, Responsibilities and Authorities[/FONT]
[FONT=&quot]6.1.2[/FONT]
[FONT=&quot]Planning: Actions to Address Risks and Opportunities[/FONT]
[FONT=&quot]8.1[/FONT]
[FONT=&quot]Operational Planning and Control[/FONT]
[FONT=&quot]9.2.2[/FONT]
[FONT=&quot]Internal Audit[/FONT]
[FONT=&quot]9.3.2[/FONT]
[FONT=&quot]Management Review: Inputs[/FONT]
[FONT=&quot] [/FONT]
I may have missed a clause here or there, so always keep an open mind and think about continual improvement!

Regards,
Kronos

 

[Kronos147]

Re: ISO 9001:2015 threads

My transition is for an AS9100 AQMS (Aerospace Quality Management System), which the users of this forum may or may not be acquainted. It is the advise of the industry that us aerospace shops not wait for the release of AS9100 Rev. D (based on the changes of ISO 9001:2015) to start our transition.

In my current system I had the following procedures:
SOP Title
SOP-4.2.3&4 Control of Documents and Records
SOP-5 Management Responsibility
SOP-6 Resource Management
SOP-7.2 Planning of Product Realization
SOP-7.2 Customer-Related Processes (CRP's)
SOP-7.4 Control of Purchasing
SOP-7.5.1 Control of Production and Service Provision
SOP-7.6 Control of Measuring and Monitoring Equipment
SOP-8.2 Monitoring and Measurement
SOP-8.2.2 Internal Audit
SOP-8.3 Control of Nonconforming Product
SOP-8.4 Analysis of Data
SOP-8.5 Improvement (including Corrective and Preventive Action)

As you can see, they were all rooted in the clauses.

I am proposing the following replacements for our shop:
SOP-01 Management Responsibility
(including Management Review, Analysis of Data, and Monitoring & Measurement)
SOP-02 Resource Management
(including Competence, Awareness, & Organizational Knowledge)
SOP-03 Control of Documented Information
SOP-04 Control of Production and Service Provision
(including Planning of Product Realization)
SOP-05 Customer-Related Processes (CRP's)
SOP-06 Control of Purchasing
SOP-07 Control of Measuring and Monitoring Equipment
SOP-08 Control of Nonconforming Outputs
SOP-09 Internal Audit
SOP-10 Improvement (including Corrective Action)

In planning these changes, I recognized what I need and what I have:
New SOP Use references
SOP-01 SOP-5, SOP-8.4, SOP-8.2
SOP-02 SOP-6
SOP-03 SOP-4.2.3&4
SOP-04 SOP-7.1, SOP-7.5.1
SOP-05 SOP-7.2
SOP-06 SOP-7.4
SOP-07 SOP-7.6
SOP-08 SOP-8.3
SOP-09 SOP-8.2.2
SOP-10 SOP-8.5

Finally, I started a new Quality Manual (in Microsoft Word). I took the ISO 9001:2015 standard, and started typing all of the clauses as section headers. I took all of the section headers, and copied them, then then pasted as a hyperlink into a table of contents at the beginning. Now, I can click to any spot in the document.

We are spending a lot of time on the context of the organization. We are using this as an opportunity to really make sure that the Quality Manual is a road map to the AQMS. The objectives for our AQMS development is to have a system that one of my fellow Cove People would be able to step in, read the manual, and be productive.

We are keeping our references to our procedures in the manual. In the different sections, where the procedure is more specific, I discuss the requirements and reference the procedure as our method of adherence.

I wanted to share this with you as the Cove has been a great wealth of information over the years for me, and so that all of us approach this transition from a logical, easy perspective ("work smarter, not harder"). To iterate, I have a unique perspective of having been an auditor, and also being the Quality Manager for different companies that were certified to different registrars.

Cheers,
Kronos

 

[LUV-d-4UM]

Thank you for sharing this information. I am happy to share with all the covers that my has passed the upgrade to ISO9001:2015 after a rather bumpy journey. We were not sure of this and that prior to the audit but we have taken our QMS into a different space as foundation to our other Continuous Improvement projects. The bottom line is this: there has not been any customer complaint coming from this pilot facility since we embarked on our CI project. Special thanks to all of you especially to BIG JIM for steering me in the right direction.

 

[Kronos147]

...has passed the upgrade to ISO9001:2015...

Congrats!!!!

 

[oldmanian]

great news we are still months away at present and as we have re certification audit next week we hope ours goes as well as yours did.
well done LUV-d-4UM

 

[Marc]

can any one help me to gain sop for iso9001-2015 in risks related to validation of method of analysis and stability studies of pharmaceutical product

This discussion is related to ISO 9001 and isn't specific to pharmaceuticals.

There is a forum here focused on pharmaceuticals: Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and other related Regulations) - You might want to start a new discussion thread there and ask.