8.2.2 Internal Audit - Determination of Effective Implementation

[morteza]

Hi all
In clause 8.2.2 ISO/TS states:
The organization shall conduct internal audits at planned intervals to determine whether the quality management system:
b) is effectively implemented and maintained

May someone describe me the meaning of effectively implemented? How can I satisfy this requirement during internal audit?

Overview:
I think this requirement asks the organization to evaluate the effectiveness of its QMS during internal audit. If the intent of the above requirement is this, it would be logical and better that the standard would write the requirement in this way:
b) is effective and maintain effectively
So, I think effectively implementation and effectiveness of QMS should be 2 different things.

Is it right?
Thanks all

[amit_rd]

Congratulations for bringing such interesting topic:

To understand 8.2.2 completely, I suggest that you study 7.1 (ISO/TS16949:2009), Clause 8.3.3 from ISO 9004:2009 and also refer to ISO 19011 for further insights on auditing.

I am sure that you will be clear on the fact the effectively implementing the QMS is the key to QMS effectiveness

Hence what clause specifies is correct!

Note: We must remember that ISO 9001 and ISO/TS16949 are not designed in isolation, and all references to them are to be carefully studied for better interpretations.

[kgott]

In Reply to Parent Post by morteza

Hi all
In clause 8.2.2 ISO/TS states:
The organization shall conduct internal audits at planned intervals to determine whether the quality management system:
b) is effectively implemented and maintained

May someone describe me the meaning of effectively implemented? How can I satisfy this requirement during internal audit??
Thanks all

Perhaps if you looked at 5.1 e- objectives and 5.4.1 - Objectives. While I can't find it, (I'm a bit short on time) I know there is a phrase ' in accordance with planned arrangements."

I think you will find insight in these areas to the question you have, which by the way is a good question.

To some extent "effectively implemented' may also mean whatever management is happy with.

hope this helps.

[Colin]

A couple of things to to my mind regarding this aspect of the internal auditing clause.

In terms of the implementation aspect of this clause, I have known many situations where a procedure defines a process very well but it is simply not being followed, It is often the case that people find new, easier ways of doing the job but the procedure gets 'left behind' - so it lacks maintenance.

Or:

You could be conducting an audit where a procedure defines that the sequence of activities is A, B then C. When you check this you find that they are following this sequence but the output from the process is not what the organisation wants it to be. As kgott rightly states, we should be checking that the output satisfies the quality objectives. In this situation you could not raise an NC for not complying with the procedure, but you should raise it because it is not effective in meeting the organisation's needs.

[mortby]

To me, effectiveness is simply - does it work?

I use a 3 level model to help prioritise improvement activities:

Compliance - does it meet the basic requirements of the standard(s) or procedure(s)?
Effectiveness - does it work? does it do the job intended? does it achieve the goal?
Efficiency - does it work well? is it quick and easy to use? does it minimise the time and resource required to achieve the goal?

We must maintain compliance, effectiveness is important (but survivable short term) and efficiency is nice to have (but wins you lots of credit with people in your business)