How to approach ISO 9001:2015 Clause 7.1.6 when 3rd Party Auditing

armani

Involved In Discussions
#1
I am asking for an opinion: how to approach 7.1.6 when 3rd party auditing?
Asking questions about determination / updating the necessary knowledge for every specific process, when auditing the respective process?? Or discussing about determination etc. of necessary OK with top mgm? Or both?? ...or....any other combination u can imagine....please share!
 
Last edited:

LUV-d-4UM

Quite Involved in Discussions
#2
I am asking for an opinion: how to approach 7.1.6 whan 3rd party auditing?
Asking questions about determination / updating the necessary knowledge for every specific process, when auditing the respective process??Or discussing about determination etc. of necessary OK with top mgm? Or both?? ...or....any other combination u can imagine....please share!
Do you have any succession planning program in your company? Discuss the process and perhaps show some matrices
 

BoardGuy

Quite Involved in Discussions
#3
The organization must determine and maintain “the knowledge necessary for the operation of its processes and to achieve conformity.” The organization is the one who determines what knowledge is necessary and I suggest you review the Organizational Knowledge Annex A.7 to ISO 9001:2015.

Also the ISO/IAF Auditing Practices Group Guidance on Organizational Knowledge makes reference to the following:

1) Knowledge is a resource needed for the organization to support the quality management system processes, quality activities, and to ensure conformity of products and services.

2) Organizational Knowledge is the specific knowledge of the organization, coming either from its collective experience or form the individual experience of its persons.

3) Organizational knowledge in the persons of the organization may be recorded in documented information, imbedded in the processes, products and services of the organization, etc. Examples include documented information regarding a process, product or service specifications, and work instructions.

4) Knowledge and knowledge management vary considerably according to an organization’s context, the sector it operates in, the competitiveness of its markets, etc.

5) Organizations should consider internal and external sources, such as

- Learning form failures, near miss situations and successes;
- Gathering knowledge from customers, suppliers and partners;
- Capturing knowledge that exists within the organization;
- Benchmarking against competitors;
- Sharing organizational knowledge with relevant interested parties
- Updating the necessary organizational knowledge based on the results of improvements
- Knowledge coming from conferences, attending to fairs, networking seminars, or other external events.

Remember your organization is the one who will determine what knowledge is necessary and not the 3rd party auditor. When you start to address auditors question on this your answer should (my recommendation) start with “based on the context of the organization…” this limits the scope of the question and informs the auditor that it is based on the organizational context determined in Section 4 of ISO 9001.
 

LUV-d-4UM

Quite Involved in Discussions
#4
The organization must determine and maintain “the knowledge necessary for the operation of its processes and to achieve conformity.” The organization is the one who determines what knowledge is necessary and I suggest you review the Organizational Knowledge Annex A.7 to ISO 9001:2015.

Also the ISO/IAF Auditing Practices Group Guidance on Organizational Knowledge makes reference to the following:

1) Knowledge is a resource needed for the organization to support the quality management system processes, quality activities, and to ensure conformity of products and services.

2) Organizational Knowledge is the specific knowledge of the organization, coming either from its collective experience or form the individual experience of its persons.

3) Organizational knowledge in the persons of the organization may be recorded in documented information, imbedded in the processes, products and services of the organization, etc. Examples include documented information regarding a process, product or service specifications, and work instructions.

4) Knowledge and knowledge management vary considerably according to an organization’s context, the sector it operates in, the competitiveness of its markets, etc.

5) Organizations should consider internal and external sources, such as

- Learning form failures, near miss situations and successes;
- Gathering knowledge from customers, suppliers and partners;
- Capturing knowledge that exists within the organization;
- Benchmarking against competitors;
- Sharing organizational knowledge with relevant interested parties
- Updating the necessary organizational knowledge based on the results of improvements
- Knowledge coming from conferences, attending to fairs, networking seminars, or other external events.

Remember your organization is the one who will determine what knowledge is necessary and not the 3rd party auditor. When you start to address auditors question on this your answer should (my recommendation) start with “based on the context of the organization…” this limits the scope of the question and informs the auditor that it is based on the organizational context determined in Section 4 of ISO 9001.
SHOULD CONSIDER- not to do all of it. We now are undergoing training for succession planning and Individual Development Plan. That has never been an issue in the past and now the auditor has already started asking questions along the line of 7.1.6 and our objective evidence ia OK for him to make a decision that the process is meeting the intent of the standard.:deadhorse:
 

Sidney Vianna

Post Responsibly
Staff member
Super Moderator
#5
I am asking for an opinion: how to approach 7.1.6 whan 3rd party auditing?
Asking questions about determination / updating the necessary knowledge for every specific process, when auditing the respective process??Or discussing about determination etc. of necessary OK with top mgm? Or both?? ...or....any other combination u can imagine....please share!
There has been such a lengthy debate on this, in this thread. Look, specifically to post #2 of that thread. The back and forth points can be used for implementation and assessment perspectives.

A search is a terrible thing to waste.
 

armani

Involved In Discussions
#7
There has been such a lengthy debate on this, in this thread. Look, specifically to post #2 of that thread. The back and forth points can be used for implementation and assessment perspectives.

A search is a terrible thing to waste.
Thanks, Sidney. Of course I read the thread u are pointing to....but this is not my original question.
Maybe I didn't make myself clear - I want an advice (let's say, advice for a 3rd party auditor) about how to approach this clause - discussion with top mgm., discussion when auditing every process, a combination of both or other approach??
 

dsanabria

Quite Involved in Discussions
#8
Thanks, Sidney. Of course I read the thread u are pointing to....but this is not my original question.
Maybe I didn't make myself clear - I want an advice (let's say, advice for a 3rd party auditor) about how to approach this clause - discussion with top mgm., discussion when auditing every process, a combination of both or other approach??
Simple:

1. How do you define Knowledge

2. Objective evidence that is documented and maintained.
 
Top