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

[AMIT BALLAL]

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.

Please find attached form for Internal and external issues (Context of the Organization).


Thanks,
Amit

 

[sunnycosta]

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

Thank you Amit Ballal.
Do you have a template for Interested Parties. I will be ever so thankful.
Cheers!

 

[Antonio Vieira]

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

I'm pretty sure that if on ISO 9001:1987 there were these requirements (4.1 & 4.2), instead of the 1.000.000 certificates that we have today, we would have no more that 10.000, if ISO 9001 would still exits...

 

[Sidney Vianna]

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

Antonio, I know what you mean, but, in the case of ISO 9001, the reason for the early surge and successful market penetration of the standard has less to do with the actual requirements and much more with the intended goal of creating a cost-effective confidence-building scheme for the global supply chain.

Now, 30 years after the original release of ISO 9001 and 25 years of history of the accredited management system certification sector, we know two things:

1. ISO 9001 has been hijacked from the original intent of providing assurance to customers of certified organization and conflated with quality management amorphous, subjective, unverifiable stuff.

2. Using the words of Dr. Simon Feary, the (vanilla) accredited certification system has leaked credibility, due to market pressures. So much so that, high risk industries, such as Aerospace, Automotive, Telecommunication, Medical Devices, etc... had to significantly enhance/augment their respective accredited certification schemes, in order to bring confidence back to stakeholders.

The ISO 9001 number of certified organizations has plateaued a few years ago. In some specific markets, it has significantly declined, despite the lack of reliable data in the ISO Survey.

To me, the most concerning thing is the fact that people who are supposed to lead this, continually mis-diagnose the problem and prescribe ineffective solutions.

E la nave va....

 

[Joe.cmspin]

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

Forgot to add quote in reply.
Do you think this will hold true for IATF?

 

[charanjit singh]

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

Since IATF 16949 is to be used in conjunction with ISO 9001:2015, I think the clarifications given in Annexure A to ISO 9001:2015 should apply in this case also.

 

[MrPhish]

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

I created a simple spreadsheet matrix. Listed all of the IPs down the left (9 total), and all of the clause requirements (i.e. 4.1, 4.2, 4.3, and 4.4) across the top. For each IP, I provided the objective evidence (OE) that would show compliance for each clause number. For example under 4.2.c), I listed the methods used to monitor/review information about each IP listed. Kept the matrix SIMPLE (not too many OE items per IP). Collected all of the OE cited for each IP and hyperlinked the document, e-mail, picture, etc. to each clause requirement, so I could quickly show the auditor how each IP was compliant and being tracked. Registrar passed me on my Transition Audit, so this is my method moving forward. Turns out to be a great training aid for employees too, so they understand the concept of IPs.

 

[Marc]

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

Sounds good. Care to share with us?

 

[MrPhish]

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

Not a problem to share. Just let me clean up some of the "Company specific" text and I'll post a file.

 

[qualprod]

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

Hi mrphish
Could you share the spreadsheet matrix for context?
Thanks