ISO9001:2015 Cl. 9.1.1 and 9.1.3 evidenced with only improvement actions?

qualprod

Trusted Information Resource
#1
Hello everybody

In auditing a QMS.

If the purpose of 9.1.1 and 9.1.3, is to have data analyzed in order to carry out improvements and tunning of the QMS.

If we are not complying fully with these clauses, will it deserve a NC?

Because in order to prove improvements, I can show improvement projects
which were outputs for the MR meetings or isolated opportunities for improvements.

But I'm not collecting data nor doing analysis.

I guess This is also audited in 9.3.2 c) 5) (monitoring and measurement results)

Please share your comments

Thanks
 
Elsmar Forum Sponsor
#2
Hello everybody

In auditing a QMS.

If the purpose of 9.1.1 and 9.1.3, is to have data analyzed in order to carry out improvements and tunning of the QMS.

If we are not complying fully with these clauses, will it deserve a NC?

Because in order to prove improvements, I can show improvement projects
which were outputs for the MR meetings or isolated opportunities for improvements.

But I'm not collecting data nor doing analysis.

I guess This is also audited in 9.3.2 c) 5) (monitoring and measurement results)

Please share your comments

Thanks
How do you really pick an improvement project.
a) Just because someone feels something has to be improved somehow .. ?
OR
b) You know where you are, and you know where you desire to be, and then you pick it as an improvement project.
The outputs of the MR meetings has to be on a basis like b) and not a decision without any substance like a) ....
So just look for such simple data and its analysis to decide what to improve and make a mention in the MR meetings.
As the note in 9.1.3 tells, statistical techniques is just one method. There are many methods, but all have data.
 

qualprod

Trusted Information Resource
#3
Thanks Somashekar

So, if I do it in this way, clearly it deserves to raise a NC.

are you agree?

I have noticed in several audits, that auditors dont audit deeply this clause.
What is your opinion?

Thanks
 

AMIT BALLAL

Super Moderator
#4
qualprod, I don't think auditors don't deeply audit these clauses.

9.1.3 and 9.1.1 relates to clause 8.4- analysis of data of earlier standard ISO9001:2008.

Purpose of the clause is to use the data and information you have for improving your QMS.

Examples:
suggestions received in customer satisfaction survey, in training feedback form should be used to take necessary actions for improvement.

Trends in KPIs should be analyzed and necessary actions to be taken accordingly.
 

John Broomfield

Leader
Super Moderator
#5
Hello everybody

In auditing a QMS.

If the purpose of 9.1.1 and 9.1.3, is to have data analyzed in order to carry out improvements and tunning of the QMS.

If we are not complying fully with these clauses, will it deserve a NC?

Because in order to prove improvements, I can show improvement projects
which were outputs for the MR meetings or isolated opportunities for improvements.

But I'm not collecting data nor doing analysis.

I guess This is also audited in 9.3.2 c) 5) (monitoring and measurement results)

Please share your comments

Thanks
qualprod,

Audit the actual system, it’s processes and their interactions including the inherent tasks of monitoring, supervising, managing and leading.

Don’t allow the documents and their clauses to blind you.

Ask the workers, supervisors and managers what they monitor to be certain that their processes fulfill the requirements of the resulting services and products. Higher management may focus more on the upstream processes (where nonconformity may originate) and on the system as a whole.

Their monitoring may rely on the results of measuring key characteristics especially if, for example, processes are not effectively mistake-proofed.

The need for measurement, in other words, is largely driven by uncertainty (aka risk).

Quality planning was once a greatly valued skilled in determining what verifications (usually of output) were required before our systems designed and ran our processes to prevent nonconformity.

An effective system comprising the interactions of mistake-proofed processes may not need much monitoring or measurement. Improvements may focus on reducing the cost of mistake-proofing and on designing new tools to prevent mistakes.

Leaders celebrate the successes and require managers either to monitor and measure weaknesses more closely or, better still, eliminate the weaknesses from their system.

As auditor you objectively show top management the sources of success and failure in their system.

John
 

dsanabria

Quite Involved in Discussions
#6
Hello everybody

In auditing a QMS.

If the purpose of 9.1.1 and 9.1.3, is to have data analyzed in order to carry out improvements and tunning of the QMS.

If we are not complying fully with these clauses, will it deserve a NC?

Because in order to prove improvements, I can show improvement projects
which were outputs for the MR meetings or isolated opportunities for improvements.

But I'm not collecting data nor doing analysis.

I guess This is also audited in 9.3.2 c) 5) (monitoring and measurement results)

Please share your comments

Thanks
Maybe this will help you:

4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;

b) determine the sequence and interaction of these processes;

c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d) determine the resources needed for these processes and ensure their availability;

e) assign the responsibilities and authorities for these processes;

f) address the risks and opportunities as determined in accordance with the requirements of 6.1;

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
 
Thread starter Similar threads Forum Replies Date
K ISO9001:2015 clause 8 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Legal & Reg. Requirements - ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
H Exclusions to ISO9001:2015 Manufacturing and Related Processes 9
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Are there ISO9001:2015 Requirements for Preventive Maintenance? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
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 12
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
G Effect of ISO9001 2015 transition on ISO IEC 80079-34 Other ISO and International Standards and European Regulations 3
A ISO9001:2015 Process Matrix with clauses General Auditing Discussions 13
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 10
C Process Map Transition from ISO9001:2008 to ISO9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
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 6
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 Informational ISO9001:2015 Process Interactions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
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
D Deltas ISO9001 to TL 9000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ISO9001 Major for repeat issue. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Management Review Inputs ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO9001 QMS: Quality Manual Examples & Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
K AS9100 and ISO9001 together AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
T Transition from ISO9001 to AS9100D: O&G to Aerospace AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
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

Similar threads

Top Bottom