10 replies to this topic

[lakmal]

Hi,

 

Do you have any examples / templates for Context of the Organization under Clause 4 of ISO 9001: 2015?

 

Thanks

[millie]

Here is an example of clause 4.1. I hope this helps:

 

4.1       Understanding the organization and its context

We have determine external and internal issues that are relevant the strategic direction of the company and there effect on our ability to achieve the intended results of our quality management system. We regularly monitor and review the information about these external and internal issues.

[beautiophile]

It could be disguised as a description of your company written in Quality Manual: who you are; your products & their categories, processes, production pattern (e.g. seasonal), materials used, customers, location (country, city), market, competitors, suppliers, shareholders, employees, culture, knowledge, organisation structures, mission, vision, policies, etc. and maybe more that I couldnt point out.

[Saad Baig]

 quality-manual-example shah promoters.pdf   5.93MB   794 downloads

Check if this serve you

[Charles.C]

Hi,

 

Do you have any examples / templates for Context of the Organization under Clause 4 of ISO 9001: 2015?

 

Thanks

 

Sounds like typical ISO waffle. I doubt that an auditor will look at it.

 

Also didn't realise that iso9001 was related to food safety. ?

[lakmal]

We drew up a reasonably extensive procedure analyzing the situation with PESTLE and SWOT analysis. Yet the Auditor raised a minor non-conformance. Since then we have reviewed the procedure to ensure that it is current as this requirement is a dynamic requirement.

 

Thanks for all those to commented on this post.

[jdpaul]

The context of the organization is critical to the PDCA cycle; Planning is first and as stated the 'context of org' means you have gone through the planning stages to understand/map out your growth as a company (what you want to achieve and how you will get there; strategic directive which encompasses any internal weakness, internal/external opportunities, external threats, and internal strengths) that will help make reaching your growth easier or harder. Like you mentioned SWOT with risk mitigation/opportunistic action plans

 

This clause will protect company's from failing if done correctly and with serious top management

Edited by jdpaul, 24 October 2018 - 12:38 AM.

[Charles.C]

Hi jdpaul,

 

I appreciate that ISO's 9000 Quality series is regarded as a profound QA Management tool and I admire your expousal of PDCA logic etc but as a traditionally practical QA person, I have determinedly avoided almost all versions of ISO9001 after the switch (ca 1970) to the "Process" approach. Far too many words, but not enough food action.

 

I realise many famous Food Organisations love ISO/FSSC-22000, particularly for its Managerial content but IMO the  introduction of the OPRP tool ws surely one of the most unfortunate FS events of last decade and a bit. I shudder to think how many hours have been wasted by people trying to understand what it means and how it should be implemented. And eventually giving up.

 

End of Dinosaur Rant !

[jdpaul]

Hi jdpaul,

 

I appreciate that ISO's 9000 Quality series is regarded as a profound QA Management tool and I admire your expousal of PDCA logic etc but as a traditionally practical QA person, I have determinedly avoided almost all versions of ISO9001 after the switch (ca 1970) to the "Process" approach. Far too many words, but not enough food action.

 

I realise many famous Food Organisations love ISO/FSSC-22000, particularly for its Managerial content but IMO the  introduction of the OPRP tool ws surely one of the most unfortunate FS events of last decade and a bit. I shudder to think how many hours have been wasted by people trying to understand what it means and how it should be implemented. And eventually giving up.

 

End of Dinosaur Rant !

 

 

I agree with you in regards to the implementation of the oPRP; I think there was some added redundancy by introducing that terminology. 

[Juliethomas]

Can someone explain how the Context of the Organisation be clearly defined.

[Charles.C]

Can someone explain how the Context of the Organisation be clearly defined.

 

Hi Julie,

 

I thought this was the intention of the previous posts ?

 

also -

 

https://www.ifsqn.co...on/#entry156020