Informational Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

tony s said:

There is also no requirement to have a list/register to document the needs and expectations of the interested parties. The requirements in 4.2, including in 4.1, were specified to guide organizations in establishing the appropriate scope of their QMS (4.3) and for planning for the QMS (6.1.1) i.e. objectives are set consistent with the needs and expectations of the interested parties.

The organization has the prerogative whether to keep documented information concerning the requirements of 4.1 and 4.2.

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True the standard does not directly state that the context of the organization must be documented or a record of it must be retained but you are required to:

(1) Monitor and review information about external and internal issues (4.1)
(2) Monitor and review information about these interested parties and their relevant requirements (4.2)
(3) Determine the scope of the QMS by considering the external and internal issues referenced in 4.1 and requirements of relevant interested parties referred to in 4.2 (4.3 a & b)
(4) The established quality policy and objectives must be compatible with the context and strategic direction of the organization (5.1.1 b)
(5) The quality policy must be appropriate to the purpose and context of the organization (5.2.1 a)

Without some form of documenting the context of the organization, interested parties and the strategic direction of the origination this information could be forgotten and that is why Standard requires:

(A) The organization to determine what documented information is necessary to show the QMS is effective (7.5.1 b)
(B) The Documented information to be review and approval for suitability and adequacy before use (7.5.2 c)
(C) The control and preservation of this information (7.5.3.2)

As noted in my earlier post this is why my colleague recommended development of a procedure and the use of a register of interested parties.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I have been looking at Interested Parties and how they are managed and controlled - having just got our 14001:2015 cert and now have a year to ensure compliance to 9001 / IATF.

I found a document that stated that simply listing Interested parties wouldn't meet the clause which i found really useful - google NQA and interested parties and it comes up. But when you start looking at Interested Parties, especially in Context to the Organisation, it can get very complicated as stated earlier in the thread - there are End Users, whose requirements are known and therefore can affect either decisions or actions, End Users where their requirements are not known, down to sub suppliers and how their actions or decisions affect the organisation.... I got a headache just thinking about it

However, I do not know if the solution I have stumbled across would be of use to anyone else out there, or indeed if it would pass muster in an audit! The whole idea is based on the FMEA style approach and gives a score that can be put into the Management review as guidance to those Interested Parties that would affect Management Decisions or Activities - or other risks or opportunities...
I have broken down all the Interested Parties into generic groups - End User, Manufacturing Cell, General Supplier, Raw Material Supplier, Sub Contractor, Sub-Supplier, Waste Management, Contract Services, Certification Boards, Utilities / Emergency Services, Legal and Local Authorities. These were then broken down into more relevant groups - I ended up with 64 in total but that is because of the company is not just Automotive but ASME 'U' Industrial as well! Against each group you can then list the Needs and Expectations, and how it might affect the decision or activity of the organisation. This can then be ranked or scored...

Each Person / Organisation / Interested Party can then be listed against a particular group or even groups - for example a Customer may also be a Supplier - but each Group has a different Need and Expectation. But against each Interested Party you can then list how, when, who and what is communicated.. sales orders, purchase orders, works orders, pay slips, etc. etc. I know this all sounds complicated but hopefully the attached might give a better hint? The Group Report is one based on an Automotive Customer and can be applied to all Automotive Customers. The other report is a specific one for a Customer who is also a supplier of General parts - but this report then lists what is communicated, when, how , by whom etc.

I've done it all as a database cos that's what I do - but I do also have a Word doc version too - if anyone finds that useful... The Procedure (edited of course!) is also attached - for reference if it helps... View attachment Interested Party Group Report.pdf

View attachment Interested Party Report.pdf

View attachment Interested Party Analysis.docx

View attachment QCP1.11R0 - Interested Parties.docx

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I agree with you that the whole idea of your contest might be based on the FMEA approach. However, the deployment of the business plan should be the basis for identifying the ISO certified company's strength and weakness to carry on a strategic planning to meet the business plan. Once you do the SWOT analysis then you can proceed to identify all the interested parties external/internal and their requirements. You feed these information into the scope of your QMS justifying at least one exclusion - Product design. The scope should be inputed to your processes - manufacturing and non-manufacturing and do a risk based thinking. We did all these things and even if the auditor perhaps had other ideas on how we should approach the RBT, he realized that there was a flow of information where one leads to another that met the intent of the ISO9001:2015 and he moved on to audit the whole manufacturing process. We had findings but not in 4.0.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I must admit that the whole process was started as we moved to the :2015 versions of the standards from the previous versions. It was the 14001 we moved to first and that auditor was interested in how 'Interested Parties' were considered for environmental reasons - local residents, Local authorities, waste handlers etc - had we considered how far raw materials traveled or how far our product had to go to reach our customer? Looking forward to ISO9001 / IATF (if one can look forward to such things! ) I was trying to find a way that showed how our company had reviewed our customers and supply base etc in line with the Business Plan and company goals. As an aside - our ASME auditor is not interested in ISO or IATF and so he ignores it - but from an ISO point of view we can have an NC raised against us if we have not taken ASME requirements into consideration as part of the Context of the Org... I found this was a way of showing we had considered them from the business point of view... But i really appreciate the feed back tho!

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I think we are making this much harder than it needs to be. Add this to your MRM agenda, so where interested parties/stakeholders and considered.

This new standard is suppose to help the same business, not kill us with papers.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

ahirons said:

I think we are making this much harder than it needs to be. Add this to your MRM agenda, so where interested parties/stakeholders and considered.

This new standard is suppose to help the same business, not kill us with papers.

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Thank You - Keep it simple.....

On your Management minutes /template / presentation...

add your scope of the QMS

add Internal Issues - Goal -(values, culture, knowledge and performances) Risk and management observation / notes.

add External Issues (i.e. legal, Technological, competition, market, cultural, social and environmental) Risks and management observations

Add Interested parties relevant to the QMS and observations.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I think "keep it simple" is a relative term depending on how "simple" your organization is. Organizations that are single locations and a single business so to speak can make it simple because of their business and organizational structure.

Having a larger global organization with different business segments is a completely different animal. The management reviews may not be a nice neat "template" to include how the review of interested parties and issues occurs. I appreciated the posting by Batteryhen.

And while the standard doesn't specifically state these items require to be documented an organization has to decide what is the best way to provide evidence of the activity. Organizations where "top management" is not in a single location I think is better positioned to avoid NC when there is the type of paper trails provided. (Even though not simple) Additionally it helps communicate how that process works for locations and lets them be better able to show auditors.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I have made several QMS using 9001:2015, and I still haven't any advantage in this new requirement for any Organization.

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Are you doing any Continuous Improvement Initiative or is your QMS just the status quo?

Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Has anyone obtained a copy of ISO 9000:2015