J
joburum
Created a COTO log for our organization and it appears to have wrapped up most of what this clause requires.
Informational "Context of the Organization" in ISO 9001:2015 Clause 4.1
- Thread starter Mike S.
- Start date
charanjit singh
Involved In Discussions
"Context of Organisation"
One typical example of a manufacturing company:
"To run a profitable business by supplying our products to customers' satisfaction"
And it met with the CB's satisfaction also during up-gradation of certification to ISO 9001:2015
One typical example of a manufacturing company:
"To run a profitable business by supplying our products to customers' satisfaction"
And it met with the CB's satisfaction also during up-gradation of certification to ISO 9001:2015
S
Swagman
Fancy sharing it?, I need some inspiration in the next 6 months as we move to 2015!
Re: Context of the Organization Warning Vent Alert
The Technical Committee isn't here to defend themselves for their choice of terminology, but I can offer their choice of terms seems to have been deliberate. It may have something to do with this being a global standard.
The Context clauses seem foreign because QA managers have been left out of the business planning for so long. The requirements are subjects taken straight from business planning templates/software, every version of which I have seen asks the same things but uses different terms.
Who are your internal customers?
Who are your external customers?
What laws/regulations must you follow?
What challenges does your organization face?
What are your strengths?
I often advise my people to not overthink this.
The Technical Committee isn't here to defend themselves for their choice of terminology, but I can offer their choice of terms seems to have been deliberate. It may have something to do with this being a global standard.
The Context clauses seem foreign because QA managers have been left out of the business planning for so long. The requirements are subjects taken straight from business planning templates/software, every version of which I have seen asks the same things but uses different terms.
Who are your internal customers?
Who are your external customers?
What laws/regulations must you follow?
What challenges does your organization face?
What are your strengths?
I often advise my people to not overthink this.
I am updating my QMS risk-based planner and will direct you to it soon, hopefully later today. I added a series of adapted SWOT pages in case people want to use them for their system and process planning. I'm updating the Instructions page now but must step out for awhile.
R
ReworkIT
We have taken a different approach in that, as Jennifer has advised, it's just like bring out whats in the business plan. The context doesn't change so much over the course of a business planning cycle, so would a "log" be beneficial? The ISO requirements seem to want the quality management system to be aligned with the prganization's business and usually logs aren't created, are they?
The challenge is how Top Management will review the (9.3.2 b) changes in internal and external issues that are relevant to the QMS. It might be hard to do that if there is no document.
Okay here it is.
I have updated my Risk Based Planner to include a section for defining Context, as well as sheets to document SWOTs for departments/processes if the organization decides it is worthwhile to do so.
The Risk-Based Planner is meant to be a living document, suitable for top managers to define and review/update the management system Context, and process owners to define and address process risks.
Re: "Context of the Organization" in 4.1 of ISO 9001
If someone has changed many Auditors within a CB then maybe it is time to change CBs.
Having someone review your system, in that snapshot in time, can not hurt the organization (in my opinion). Having the outside of the box review, as long as it is objective and not subjective, can only help an organization achieve their desired results. But, if Upper Management does not support the 3rd Party review then there is a Catch 22. You need the flow down from the top. Without that, it is highly probable that the system will fail, and it may cost existing and potential customers.
Just my opinion.
Why would you pay for auditing when you feel they are not doing you justice? I have replaced more than one auditor.
If someone has changed many Auditors within a CB then maybe it is time to change CBs.
Having someone review your system, in that snapshot in time, can not hurt the organization (in my opinion). Having the outside of the box review, as long as it is objective and not subjective, can only help an organization achieve their desired results. But, if Upper Management does not support the 3rd Party review then there is a Catch 22. You need the flow down from the top. Without that, it is highly probable that the system will fail, and it may cost existing and potential customers.
Just my opinion.
Kronos147
Trusted Information Resource
For a smaller company, I think incorporating this into the management review meeting minutes makes sense.
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