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4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015 - Page 2


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context of the organization, interested parties, iso 9001:2015
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  Post Number #9  
Old 13th December 2016, 01:48 AM
tony s's Avatar
tony s

 
 
Total Posts: 123
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

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 as specified in last paragraph of Annex 6, which says:
Quote:
Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.
Thank You to tony s for your informative Post and/or Attachment!

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  Post Number #10  
Old 15th December 2016, 05:17 PM
ogghall

 
 
Total Posts: 18
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Working on the same issue. What you have to consider is the most practical way you can provide evidence of the activity. For example if you are a relatively self-contained operation/single site type of an organization you could provide the evidence by the top level manager(s) explaining who the interested parties are, what their requirements are and how they are reviewed. If your organization is more global/multi-site and management is not entirely located at a single site my opinion would be to list in a registry the Interested Parties, what their requirements are and which function is responsible for reviewing the requirements of the particular interested party. This also helps sites in providing evidence when audited.

I think it always comes down to what is the best way for you to show the particular evidence that is needed. Evidence is not always a document. Evidence can be what is said to the auditor. So long as the response is provided in way that indicates there is a level of knowledge and understanding by the auditee.
Thank You to ogghall for your informative Post and/or Attachment!
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  Post Number #11  
Old 15th December 2016, 06:17 PM
BoardGuy

 
 
Total Posts: 113
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Quote:
In Reply to Parent Post by tony s View Post

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.
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.
Thank You to BoardGuy for your informative Post and/or Attachment!
  Post Number #12  
Old 20th December 2016, 06:58 AM
BatteryHen

 
 
Total Posts: 7
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... Interested Party Group Report.pdf

Interested Party Report.pdf

Interested Party Analysis.docx

QCP1.11R0 - Interested Parties.docx
Thank You to BatteryHen for your informative Post and/or Attachment!
  Post Number #13  
Old 20th December 2016, 11:18 AM
LUV-d-4UM

 
 
Total Posts: 726
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.
  Post Number #14  
Old 20th December 2016, 11:39 AM
BatteryHen

 
 
Total Posts: 7
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!
  Post Number #15  
Old 9th January 2017, 05:22 PM
ahirons

 
 
Total Posts: 4
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.
Thank You to ahirons for your informative Post and/or Attachment!
  Post Number #16  
Old 30th January 2017, 12:55 PM
dsanabria

 
 
Total Posts: 1,070
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Quote:
In Reply to Parent Post by ahirons View Post

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.
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.
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