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

[qualprod]

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

 

[somashekar]

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]

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]

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]

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]

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;