ISO9001:2015 Process Matrix with clauses

Audit Coordinator

Involved In Discussions
#1
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!
 
Last edited:
Elsmar Forum Sponsor

Big Jim

Super Moderator
#2
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

Quite Involved in Discussions
#3
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
 

Big Jim

Super Moderator
#6
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

Involved In Discussions
#7
Jim, that was a big help!
:thanx:
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 :thanks:
 

Attachments

Kronos147

Trusted Information Resource
#8
(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

Involved In Discussions
#9
(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!
:thanx:
 
Thread starter Similar threads Forum Replies Date
C Process Map Transition from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Informational ISO9001:2015 Process Interactions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 71
S Are there ISO9001:2015 Requirements for Preventive Maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO9001:2015 Clause 9.1 - What the external auditor will look at? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
I ISO9001:2015 9.1.2 - Customer Satisfaction Feedback ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Is writing out the ISO9001:2015 standard full name a requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
E Interesting Discussion Was this the fastest ever stage 2 ISO9001:2015 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
ScottK Question for Auditors on 7.1.4 in the ISO9001:2015 revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod ISO9001:2015 Cl. 9.1.1 and 9.1.3 evidenced with only improvement actions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 2
S ISO9001:2015 Cl. 4.4.1 - What Processes Do I Need Documented ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q ISO9001:2015 Cl. 6.1 - What evidences of risk addressing is needed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B Bare Bones/Under the Radar ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Is ISO9001:2015 required for AS9100:2016 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Icy Mountain ISO9001:2015 & IATF 16949:2016 Gap Analysis Tool IATF 16949 - Automotive Quality Systems Standard 7
D Internal Audit During the Transition Period from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Does ISO9001:2015 require any specific "processes"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N ISO9001:2015 clause 7.1.5 "Resources" (Formerly "Equipment") ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Icy Mountain ISO9001:2015 Upgrade Diary ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A ISO9001:2015 Auditor Training Materials Training - Internal, External, Online and Distance Learning 2
M ISO9001:2015 Clause 8.4 Control of External Processes and Purchased Goods & Materials ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Corporate Manual - Global Multi-Site ISO9001:2015 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A ISO9001:2015 comparison with AS9100:2016 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Auditing Clause 5 - Leadership in ISO9001:2015 Internal Auditing 4
S ISO9001:2015 Section 4.4.1 - Support Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Risks involved in requesting Cert to ISO9001:2015 right when released ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Changes in ISO9001:2015 to the requirements for a management representative ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Customer Waiver in ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Lean in the ISO9001:2015 World Lean in Manufacturing and Service Industries 1
A Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
Pau Calvo Quality Management process is mandatory in ISO9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I Form templates for software (iso9001) Document Control Systems, Procedures, Forms and Templates 0
T COVID, Furlough and ISO9001 Surveillance Audit Coffee Break and Water Cooler Discussions 2
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S What's meant by ISO9001 clause 8.7 non conforming output? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Calibration: Conforming to ISO9001 Requirements General Measurement Device and Calibration Topics 6
H Communication plan according to ISO9001 - Pharmaceutical field Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
N Is consultant prohibited in ISO9001 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
R ISO13485/ISO9001 Convenient Document Management System Document Control Systems, Procedures, Forms and Templates 3
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
a_bardi Excluding ISO9001 Cl. 8.4 - Supplier Selection and Evaluation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Can Six sigma support ISO9001? If yes, in what ways? Lean in Manufacturing and Service Industries 5
C Checklist comparison between ISO9001:2008 and ISO 3834 Quality Management System (QMS) Manuals 1

Similar threads

Top Bottom