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

QAnalyst1

Starting to get Involved
#1
I was hoping to get some ideas/feedback from those seeking certification to ISO 9001:2015 as to how they are/plan to demonstrate evidence of determining interested parties and their requirements, since there is no explicit requirement to "maintain as documented information" in clause 4.1 and 4.2. I take it we don't have to have a list of the relevant, interested parties we considered, or their requirements.

Since 4.3 Determining the Scope requires that you consider the results of determining 4.1 context of the organization, and 4.2 needs and expectations of interested parties, and that the Scope "shall be available and be maintained as documented information" would a simple statement of the fact that the relevant interested parties and their requirements were considered by top management suffice, and then have the Scope signed by top management and included in the QAM?
 
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dubrizo

Involved In Discussions
#2
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

would a simple statement of the fact that the relevant interested parties and their requirements were considered by top management suffice, and then have the Scope signed by top management and included in the QAM?
Sure, but be ready to SHOW how you "monitor and review the information about these interested parties and their relevant requirements."

I'm personally including this as an agenda item during Management Review meetings. This way the intent of the clause can be met and I've got meeting minutes showing the review (inputs/outputs, action items, etc.) took place.
 

BoardGuy

Quite Involved in Discussions
#3
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

I stumbled about within this section of the standard until a professional colleague pointed out that Section 4 is not written as a process and is not in the proper order for implementation of the requirements. My colleague suggested the below order, the addition of requirements from 6.1 and also the need to for development of strategic direction of the organization information.

Colleagues recommended order:

4.2 Understanding the Needs and Expectations of Interested Parties

4.1 Understanding the Organization and Its Context

4.4 Quality Management System and Its Processes

4.3 Determining the Scope of the Quality Management System

6.1 Actions to Address Risks and Opportunities

Determining the Strategic Direction of the Organization based on following clause references:

- 0.3.1 (Process Approach) General: The Quality Management System process should satisfy the Strategic Direction of the Organization

- 4.1 Understanding the Organization and Its Context: The organization shall determine… issues relevant to… its strategic direction…

- 5.1.1.b (Leadership and Commitment) General: Top management shall… ensure that the quality policy and objectives… are compatible (aligned) with the… strategic direction of the organization.

- 5.2.1.a Establishing the Quality Policy: Top management shall establish, implement, and maintain a quality policy that is appropriate… and supports (the organizations)… strategic direction.

- 9.3.1 (Management Review) General: During management review the entire QMS must be assessed against the strategic direction.

My colleague also recommended that a procedure be developed and a register of interested parties be used to show evidence that the organization determined it interested party and then developed it QMS scope, process and risk mitigation to address Section 4. As dubrizo mentions you then review this information during the management review meeting and update the register as needed.
 

weakness

Starting to get Involved
#4
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

Im working on clause 4.1 &4.2&4.3 with our consultant.He given an example to me.

Im preparing a list about expectation third parties.

An example is below
Third parties:Supplier
Expectation:Regular Order
influencing factors:Order frequency is not suitable
Risk:Suplier could be delay .
Control Metod:Supplier Delivery Performance
If anybody has another example please share us.
 

BoardGuy

Quite Involved in Discussions
#5
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

Here are a few more examples for you:

Certification Body: Level of compliance to ISO 9001.
Direct Customer: Expect high quality products and flows down their QMS requirements into our system
Distributors: Product quality, price, on-time delivery of products and after sale service.
Employee / Staff: Good work environment, fair compensation and appropriate training
Local Community: Wants our company to hire and retain local workers
Owner/shareholder/Investors: Must assure profitability, return on investment and growth in market value of organization
Public: Maintain good community relationships
Regulatory Bodies: Must comply with all regulations and statutes applicable to product/organization
Supplier: Expect to be paid promptly and need for company to clearly defined product/service requirements in P.O.
Top Management: Company must remain financially healthy, concerned with growth of company and QMS processes must be efficient
 

charanjit singh

Involved In Discussions
#7
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

While we are at it, it is helpful to re-read Annex A3 to the standard, particularly para 2 that clearly states "There is no requirement in this International Standard for the organisation to consider interested parties WHERE IT HAS DECIDED (emphasis is mine) that those parties are not relevant to its quality management system.IT IS FOR THE ORGANISATION TO DECIDE (again emphasis is mine) if a particular requirement of a relevant interested party is relevant to its quality management system.

In effect it means that the organisation can, in its own wisdom decide the issue and that decision cannot be questioned by a CB auditor or be a subject of non-conformity
 

LUV-d-4UM

Quite Involved in Discussions
#8
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

That's why Context if the Organization will depend on your Business Plan. The auditor cannot question that if you have considered the relevant interested parties that can affect the accomplishment of your quality objectives.
 

tony s

Information Seeker
Trusted Information Resource
#9
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:
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.
 

ogghall

Starting to get Involved
#10
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.
 
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