ISO9001:2015 Process Matrix with clauses

[Audit Coordinator]

I'm in need of developing a matrix between our processes and the new ISO9001:2015 clauses. I have begun but wondered if any of you have done the same and would be willing to share it. Obviously, everyone's process are different but would like to try to not reinvent the wheel.
Thanks!

 

[Big Jim]

Post your processes and I'll show you how the elements of the standard probably line up. I say probably because of idiosyncrasies that differ from one organization to another.

If you don't want to post them, send me a PM.

 

[dsanabria]

I'm in need of developing a matrix between our processes and the new ISO9001:2015 clauses. I have begun but wondered if any of you have done the same and would be willing to share it. Obviously, everyone's process are different but would like to try to not reinvent the wheel.
Thanks!

For addd\additional cross reference information go to the IAQG website

IAQG: Requirements

 

[Audit Coordinator]

Hello Big Jim,
See below post - just figured out how to make the attachment....lol.

 

[Audit Coordinator]

Ah ha! Just figured it out - haven't been here a long time to be familiar with this site, sorry

Attached is the matrix I've come up with so far (Revised - See post 7 in this discussion).

 

[Big Jim]

That's not a bad start.

I have run out of time this morning but let me quickly make some comments.

Most often when I see this sort of matrix it is only done to the first decimal (8.4, not 8.4.1, 8.4.2, 8.4.3). You can do it however you want though.

7.1.3, 7.1.4 probably should also be a topic for Production.

7.1.5 isn't what many think it is at first blush. It is calibration. I doubt that you need to worry about calibration for every process. I'm guessing Production, Shipping / Receiving, nonconforming Product, and wherever you handle inspection.

7.2 remove from Production or add to all.

7.4 only Management Responsibility or add to all.

8.1, planning for production - I question all. More likely Production and then whatever process is responsible for work order creation.

8.2 add Quotation. You can't quote unless you have gathered all the requirements.

8.4 add Receiving and whatever process is responsible for approving suppliers.

I've run out of time. Maybe others can comment before I can get back to this.

 

[Audit Coordinator]

Jim, that was a big help!

It just seemed a daunting task that was easier with the previous standard. I feel the the revised standard is just a bit more ambiguous than before - not so cut and dried, which can be an advantage for sure during a CB audit. More wiggle room.
You provided me some insight and I liked your suggestions! So, I made some changes and I've attached the revised copy for anyone to see; nothing proprietary here....lol.
Thank you

 

[Kronos147]

(FYI - Our organization is AS9100)

Our organization has 5 processes:

1) Management
2) CRP’s (Customer Related Processes)
3) Production
4) Purchasing
5) I&C - Inspection and Compliance
​

Management Process Requirements:

4.1 Understanding the Organization and Context
4.2 Understanding the Needs and Expectations of Interested Parties
4.3 Determining the Scope of the QMS
4.4 QMS and its Processes

5.1 Leadership and Commitment

6.2 Quality Objective and Planning to Achieve Them

7.1 Resources

8.1 Operational Planning and Control

9.1 Monitoring, Measurement, Analysis and Evaluation
9.1.2 Customer Satisfaction
9.3 Management Review

10. Improvement
​

CRP’s (Customer Related Processes) Requirements:

8.2.1 Customer Communications
8.2.2 Determining the Requirements for Products and Services
8.5.3 Property belonging to Customer or External Service Providers

9.1.2 Customer Satisfaction
​

Production Process Requirements:

8.1 Operational Planning and Control
8.1.1 Operational Risk Management
8.1.2 Configuration Management
8.1.3 Product Safety
8.2.4 Changes to Requirements for Products and Services
8.3 Design and Development for Products and Services
8.4.3 Information for External Providers
8.5.1 Control of Production and Service Provision
8.5.2 Identification and Traceability
8.5.4 Preservation,
8.5.5 Post-Delivery Activities​

Purchasing Process Requirements:

8.1.4 Prevention of Counterfeit Parts
8.4 Control of Externally Provided Processes, Products and Services
8.4.2 Type and Extent of Control
8.4.3 Information for External Providers​

I&C - Inspection and Compliance Process:

7.1.5 Monitoring and Measuring Resources
7.5 Control of Documented Information

8.2.3 Review of Requirements for Products and Services
8.6 Release of Products and Services

9.2 Internal Audit

10.2 Nonconformity and Corrective Action​

All processes have these requirements:

0.1 General
0.3 Process Approach
0.3.1 General
0.3.2 Plan-Do-Check-Act

4. Context of the Organization

5.1.2 Customer Focus
5.2 Policy
5.3 Organizational Roles and Responsibility

7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the Operation of Processes
7.1.6 Organizational Knowledge
7.4 Communication
7.5 Documented Information

8.7 Control of Nonconforming Outputs

10.3 Continual Improvement​

Threaded Requirements:

Risks and Opportunities:

0.3.3 Risk-based Thinking
0.1 General

4.4.1 (f) QMS and its Processes

5.1.2 (b) Customer Focus

6.1.1, 6.1.2 Planning: Actions to Address Risks and Opportunities

8.3.3 (e) Design and Development Inputs
8.3.6 (d) Design and Development Changes
8.4.2 Type and Extent of Control

9.3.1 (e) Management Review: General

10.2.1 Nonconformity and Corrective Action

A.4 Risk-based Thinking​

Process Approach:

0.1 General
0.2 Quality Management Principles
0.3.1 Process Approach: General

4.4.1 QMS and its Processes

5.1.1 Leadership and Commitment: General
5.3 Organizational Roles, Responsibilities and Authorities

6.1.2 Planning: Actions to Address Risks and Opportunities

7.1.4 Environment for the Operation of Processes

8.1 Operational Planning and Control

9.2.2 Internal Audit
9.3.2 Management Review: Inputs​

Change Management:

4.4.1 (g) QMS and its Processes

5.3 (e) Organizational Roles, Responsibilities and Authorities

6.3 Planning of Changes

7.5.3.2 (c) Control of Documented Information

8.1 Operational Planning and Control
8.2.4 Changes to the Requirements of Products and Services
8.3.6 Design and Development Changes
8.5.6 Control of Changes​

 

[Audit Coordinator]

(FYI - Our organization is AS9100)

Our organization has 5 processes:

1) Management
2) CRP’s (Customer Related Processes)
3) Production
4) Purchasing
5) I&C - Inspection and Compliance
​

<snip>

Kronos,
You really went the extra mile today sir! Thank you for your time consuming input here!

We are AS9100 certified as well. About two months ago, we had our AS9100 CB audit and the auditor told me that she would like to see the respective clause to each question in our audit checklists therefore showing which clauses we have touched on in our internal audits. I determined the best way to do this was to create this matrix first, then it would be easier to refer to it for the checklists.

Yes, we still use checklist as we have a high turnover rate of auditors and they are not always as intelligent as one would like. That way, it assures us that they will cover the important points with the liberty to add additional questions, if they feel so moved down a path.

Again, you took more time than I deserve, being I'm rather new, and I surely do appreciate it as our goal in quality is to do the best job we can do!

 

[Stijloor]

Here is a link to a thread in which I posted a matrix and linkages to requirements (clauses). See post #3 and its attachments. It is an old version, but if you look at the last two columns, you'll see how this can be accomplished.

https://elsmar.com/Forums/fileslist.php?mode=allfiles&sortby=date&pageamt=1&criteria=Process+Matrix

Hope this helps a little.