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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2
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Context of the Organization & Interested Parties Evidence - ISO 9001:2015 Cl. 4.1/4.2 - Page 3


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context of the organization, evidence, interested parties, iso 9001:2015, records (evidence) and records control, scope (general term)
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  Post Number #17  
Old 30th January 2017, 05:27 PM
ogghall

 
 
Total Posts: 18
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.

Last edited by ogghall; 30th January 2017 at 05:43 PM.
Thanks to ogghall for your informative Post and/or Attachment!

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  Post Number #18  
Old 16th February 2017, 09:28 AM
Antonio Vieira's Avatar
Antonio Vieira

 
 
Total Posts: 463
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.
Thank You to Antonio Vieira for your informative Post and/or Attachment!
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  Post Number #19  
Old 16th February 2017, 09:31 AM
LUV-d-4UM

 
 
Total Posts: 753
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?
  Post Number #20  
Old 21st February 2017, 09:07 PM
John Martinez's Avatar
John Martinez

 
 
Total Posts: 309
Re: 4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015

Has anyone obtained a copy of ISO 9000:2015
Quality management systems — Fundamentals and vocabulary?

While some may be vague, some are quite definitive.

Keep in mind. From the third party accredited certification view. "Organization" The name(s) and address(es) that are listed on the certificate.

A single site's definition of "interested parties", "top management", and "context of the organization" will be different based upon that definition of "organization" in the third party certification process.

In my humble opinion, leave out employees no matter how that "organization" is defined, and the "organization" gets it wrong.
ISO 9000:2015 - 3.2.3 interested party - "stakeholder person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity".

Note that "organization" in ISO 9000:2015 is different than described above; however, from a third party accredited certification perspective, it is accurate...unless you want your CB auditor talking to the "C" level when all they are auditing is a site with a plant manager as "top management".

Last edited by John Martinez; 21st February 2017 at 09:08 PM. Reason: ISO 9000:2015
Thanks to John Martinez for your informative Post and/or Attachment!
  Post Number #21  
Old 1st June 2017, 08:48 AM
Nneka Chima

 
 
Total Posts: 1
Re: 4.1 & 4.2 Context and Interested Parties, ISO 9001:2015

Quote:
In Reply to Parent Post by BoardGuy View Post

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
  Post Number #22  
Old 1st June 2017, 03:21 PM
Haddad9921

 
 
Total Posts: 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.
Thanks to Haddad9921 for your informative Post and/or Attachment!
  Post Number #23  
Old 1st June 2017, 11:48 PM
LUV-d-4UM

 
 
Total Posts: 753
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.
  Post Number #24  
Old 2nd June 2017, 01:12 AM
tony s's Avatar
tony s

 
 
Total Posts: 129
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.
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