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

#21
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
thank you so much BoardGuy, these are so helpful but please how do we monitor and review information about these interested parties and their relevant requirements in last paragraph of 4.2
 

Haddad9921

Starting to get Involved
#22
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Hi,
For 4.1 all what you need is a SWOT analysis.
for 4.2, you need to state the following,
Interested party, requirements, QMS Processes

Example:
Interested party: Customers
Requirements: Orders accurately taken, Product arrive on time, All product specifications met.
QMS process: Sales and customer service process, shipping and logistics process, Inspection process.
 

LUV-d-4UM

Quite Involved in Discussions
#23
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Just a comment from my own transition to the new standard: What is the relevance of the 4.1 SWOT and PESTLE analysis to 4.2 Interested parties. :bigwave:
 

tony s

Information Seeker
Trusted
#24
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Since 4.2 should be considered "when planning for the QMS..." (6.1.1) and outputs of QMS planning will include Quality Objectives (6.2), it is expected that "internal and external issues" (4.1) are considered or analyzed (thru SWOT, PESTLE, etc.) since these issues will affect the "approach in developing and achieving quality objectives" (definition of Context of the Organization) that are relevant to "needs and expectations" of interested parties.
 
#25
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

from my firms POV this is encompassed in the company business plan - this is reviewed annually and has context of the org within it
 

QChas

Involved - Posts
#26
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Working at a small company (50 employees) with the owners being hands on every day our approach is to keep it simple. The following statement will be included in our Management Review minutes:

The management team reviewed the system elements of ISO 9001:2015 and concluded that the requirements are being met.

The owners understand the requirements and can explain to the auditor when asked. I do not see a need to document any further than this.
 
#27
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

thank you so much BoardGuy, these are so helpful but please how do we monitor and review information about these interested parties and their relevant requirements in last paragraph of 4.2
What about making it a topic of discussion during management review. If no changes, make a note "no changes".

KISS
 

armani

Involved In Discussions
#28
Re: Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1

Still don't get it...why it would be better to approach 4.2 before 4.1?
 
Last edited:

dhakadmilind

Starting to get Involved
#29
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Dear sir ,
Our company is also in transition phase for ISO9001 2008 to 2016.My view for auditor question is that there is no requirements for documentation for context of organization .So against your business plan ,if auditor is able to convince you that you have missed some interested parties then he will note it as a observation or minor NC .So finally it is just demonstration and convincing to auditor or audittee will play the important role in it.
 

sunnycosta

Starting to get Involved
#30
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

I am the QM of a CNC machine shop. I am looking for a template (form) to do a SWOT analysis and PESTLE analysis. During the Gap audit, the auditor was looking whether we had these.
 
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