Informational "Context of the Organization" in ISO 9001:2015 Clause 4.1

[somashekar]

Re: "Context of the Organization" in 4.1 of ISO 9001:2015

A genuine question - why is it "The Organization shall determine external and internal issues.." and not "The Top Management" ?

So that they are collective issues that are not later disowned or challenged by the organization.

 

[Chennaiite]

Re: "Context of the Organization" in 4.1 of ISO 9001:2015

Here's an innocuous attempt to figure out requirements related to "Context of the Organization" and its close relative "RBT".

The idea is to try and correlate the so-called explicit-turned-implicit concepts of ISO with the retained requirements of older version that we are extremely familiar with. In some sense, this might look like nothing more than graphics of some related requirements put in jig-saw style, without bothering to add any value. Or it might reflect total lack of understanding on my part – totally possible.

Nevertheless, I am putting up here my thought process to welcome all your valuable feedback and, in the process, to cultivate my own understanding. While use of slide-show will get the story going, for the sake of some who have the tendency to get annoyed with animation, there is a PDF version at your disposal.

 

[AprilH]

Re: "Context of the Organization" in 4.1 of ISO 9001

Agree. If a business has been going for 30+ years then apparently they've been doing something right.

 

[Sidney Vianna]

Re: "Context of the Organization" in 4.1 of ISO 9001

Agree. If a business has been going for 30+ years then apparently they've been doing something right.

Sure, but, in many cases, the regulations applicable to products change. Customer expectations change all the time. Market conditions change. Supplier bases change.

Context assessment is a repetitive, never-ending, ongoing, dynamic process.

 

[AprilH]

Re: "Context of the Organization" in 4.1 of ISO 9001

Agree. However, you would be aware of this if you have been in business for 30+ years. That type of longevity is not possible without staying abreast of new technology and customer satisfaction.

 

[Sidney Vianna]

Re: "Context of the Organization" in 4.1 of ISO 9001:2015

That might be the case. But if we go that route, then such longevity and success would mean this organization needs not to bother with ISO 9001 either, isn't it?

 

[DRAMMAN]

Re: "Context of the Organization" in 4.1 of ISO 9001

Longevity and success do not necessarily indicate high quality or satisfied customers. There are plenty crapy companies out there that have been in business for a long time.

The idea behind gaining and maintaining ISO certification is to have a respected external validation that your QMS or operating system is designed to a base level.

The ISO committe (liek them or love them) have determined that in the current state of business, high performing QMS's should include determining the context of the organization. With it, you increase your chances of attaining high quality levels.

 

[DRAMMAN]

Re: "Context of the Organization" in 4.1 of ISO 9001:2015

Chennaiite
You explanation slide does a good job. I may end up borrowing it.

 

[Russ]

Re: "Context of the Organization" in 4.1 of ISO 9001

Then you need to have a conversation with your CB to change your auditor. Be factual when you do that.

Why would you pay for auditing when you feel they are not doing you justice? I have replaced more than one auditor.

 

[Jim Green]

Re: Context of the Organization Warning Vent Alert

IT took me a long time to understand 4.1. I must have read it 100 times and after listening to our CEO's Business Plan a light came one.

I am really getting frustrated. The fact that I to have to read it over and over again is a problem. "Context of the Organization" Really? Could not come up with something a little more cerebrally friendly. It gets harder and harder to sell to Management when ya go in with "Context of the Organization". I have been doing this for 20 years and have been through several revisions. I get the " Well ya know they use general terminology because it is a worldwide standard". The fact that you have to write books titled "In plain English" is a problem... Most of the mid level, and mom and pop shops know exactly what I am talking about. OK, done with venting... Time to go back to reading and time consuming interpretation.