6 Requirements for an ISO 9001:2015 Transition Audit

Kales Veggie

People: The Vital Few
2. Organizational knowledge:
This I tackled quite easily and although I'll only know if my approach worked after the audit(which I could update you if you like) I sure think it'll work.
What you need to show is explained quite clearly in the ISO clause. What must your people know to get the job done right? Although procedures are no longer mandatory I would suggest you hold on to them.
I made a form identifying the key positions in the organization (grab it from the organization chart which you MUST have) and then determined what procedures and standards (internal and external) are required by a person hired in that position needs to know to get his job done right. It's really easy to make and at the time of the audit this could be used to explain to the auditor how you identify training too!
Hope this helps!

Regards,

Ronel

WRT to 7.1.6, you should also think about attrition and retirement. A company may have high employee turnover due to business fluctuations or labor shortage. Are work instructions as they are sufficient? Quite a few companies have a labor force that is getting ready to retire (i.e. baby boomers). Many of their tasks / activities (e.g. maintenance mechanic knowledge on how to fix machines) may not be documented, but maybe vital for a smooth operation.
 

roneljdsilva

Involved In Discussions
Hello,

I'm sorry I was wrong there. It is not a mandatory document but it is great to have documented nonetheless. I would definitely love to have your feedback on my earlier response however.

Regards,

Ronel
 

roneljdsilva

Involved In Discussions
Oh yes indeed. We are talking about covering the basic requirements and getting that ISO certificate here. This is definitely not the bottom line. It's a head start and then you dig deep into actually understanding and determining every requirement to make it effective.
Correct me if I'm wrong.

Regards,

Ronel
 

Helmut Jilling

Auditor / Consultant
Hello,

I am currently trying to tie up loose ends for our ISO 2015 transition. I am hung up on items such as "Context of the Organization" and "Organizational Knowledge," I am sure that I am over analyzing both clauses. Does anyone have any advice on how to handle these items and any tips on how to get through transition audits.

Context of the Organization - Describe your company, your place in your industry, the inherent risks of your industry, the network of related plants if there is more than one, your history, your general plans and objectives... Think in terms of a one page biography addressing these things. "Context" is a new addition to the standard, so we don't have a lot of experience with it yet. But, what I described should satisfy most auditors.
 

Sidney Vianna

Post Responsibly
Leader
Admin
Let's not forget the multitude of "advice" already offered concerning ISO 9001:2015 by documents made available from the TC 176 like, for example the FAQ document, which mentions

Questions relating to specific clauses in the standard

15. What is meant by the context of the organization?
This is the combination of those internal and external factors that affect an organization's approach to the way in which it provides products and services that are delivered to its customer.
External factors can include, for example, cultural, social, political, legal, regulatory, financial, technological, economic, and competitive environment, at the international, national, regional or local level.
Internal factors typically include the organization’s corporate culture, governance, organizational structure, technologies, information systems, and decision-making processes (both formal and informal).

16. What are the needs and expectations associated with interested parties?
The organization will need to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties, as outlined in clause 4.2. This does not extend past the quality management system requirements and the scope of this International Standard.
As stated in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.


17. What is meant by organizational knowledge?
Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives. Requirements regarding organizational knowledge were introduced for the purpose of safeguarding the organization from loss of knowledge and encouraging the organization to acquire new knowledge as its business context changes.
 
S

soldertraining

The International Standards are based on the quality management principles described in ISO 9000. However, ISO 9001:2015 is going to apply on any organization, regardless of size or industry. This includes not only organizations that are certified to ISO 9001:2008, but also on those organizations who involved in training or certifying others.
 

Paul Simpson

Trusted Information Resource
The International Standards are based on the quality management principles described in ISO 9000. However, ISO 9001:2015 is going to apply on any organization, regardless of size or industry. This includes not only organizations that are certified to ISO 9001:2008, but also on those organizations who involved in training or certifying others.

Absolutely right. Making a requirements standard applicable to all types and sizes of organisation makes it difficult to pitch the requirements so they can be meaningful for larger organisations and the corner shop. There is an article covering the Context section on the CQI site.
 
T

tongxiaozhi

Hello,

I am currently trying to tie up loose ends for our ISO 2015 transition. I am hung up on items such as "Context of the Organization" and "Organizational Knowledge," I am sure that I am over analyzing both clauses. Does anyone have any advice on how to handle these items and any tips on how to get through transition audits.
I use SWOT analysis to understand the context of the organzation.
 
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