How to Audit the Quality Department (Internal Audit)

Hi everyone

I am requested from one of our sister company to conduct internal audit for the quality department. So I wanna know exactly

which clauses from the standard (ISO 9001) I have to consider.
What are the processes or the procedures I have to audit?
What are the documents I have to ask before going to conduct the audit?
What are the documents I have to check in the audit?
What are the records I have to check?

If any one have any material which can help me (checklists- questionnaire , ..) whaich can help me pls let me know. I wanna something specific to audit the quality dept only

Thanks for your help

Regards
Ahmed

ahmed_hasan said:

Hi everyone

I am requested from one of our sister company to conduct internal audit for the quality department. So I wanna know exactly

which clauses from the standard (ISO 9001) I have to consider.
What are the processes or the procedures I have to audit?
What are the documents I have to ask before going to conduct the audit?
What are the documents I have to check in the audit?
What are the records I have to check?

If any one have any material which can help me (checklists- questionnaire , ..) whaich can help me pls let me know. I wanna something specific to audit the quality dept only

Thanks for your help

Regards
Ahmed

Click to expand...

If you mean QMS, you should assess clause 8.2.2 , verifying audit plan and criteria to assess processes , closure of non conformities ( internal and external audit) and related effectiveness , internal audit procedure ( one of mandatory ones of QMS) , records for audits ( 4.2.4 ), competence of internal auditors ( 6.2) and so on.
It is also important to assess if the results of the audits ( internal/external) are taken as one of the inputs of management review (5.6.2).
It could be usefull to understand how the process of internal audit be monitored and measured as well and how Mgmt representative communication the results and the data coming from audits
Hop e this helps.

I would want to know what their responsibilities were before deciding.

In some organisations the QA department have a very broad scope of activities such as internal audit, management review, document control, record control,, inspection, calibration, objectives, nonconforming product, analysis of data, continual improvement, corrective action, preventive action, etc.

In others, it may be limited to just audits and management review.

qusys said:

If you mean QMS, you should assess clause 8.2.2 , verifying audit plan and criteria to assess processes , closure of non conformities ( internal and external audit) and related effectiveness , internal audit procedure ( one of mandatory ones of QMS) , records for audits ( 4.2.4 ), competence of internal auditors ( 6.2) and so on.
It is also important to assess if the results of the audits ( internal/external) are taken as one of the inputs of management review (5.6.2).
It could be usefull to understand how the process of internal audit be monitored and measured as well and how Mgmt representative communication the results and the data coming from audits
Hop e this helps.

Click to expand...

No, no, no! Internal audits aren't performed against clauses of any external standard!! We've been trying to get away from this type of thing here for nearly 10 years (or more)! We should be auditing to the organization's own criteria

Internal audits - of the Quality Department - should be performed against the organization's own qms for whatever the Quality Department does - the processes and procedures etc. that Colpart indicated - for example. And he's correct, to give guidance we must know more about the responsibilities of this department.

Colpart said:

I would want to know what their responsibilities were before deciding.

In some organisations the QA department have a very broad scope of activities such as internal audit, management review, document control, record control,, inspection, calibration, objectives, nonconforming product, analysis of data, continual improvement, corrective action, preventive action, etc.

In others, it may be limited to just audits and management review.

Click to expand...

Clearly I agree with Colpart, very precise.

You should define the scope of the audit and the extent.
In my response I make assumption to audit only Quality system mgmt process.
QRA is very very large and it changes form organization to organization , but the basic responsibilities are the ones that Colpart said in his response

In responding to the question I have intended that he should perform an internal audit from Corporate point of view, auditing the QMS of another site he belongs to.
From my working experience, it usually happened to verufy the status of health of a QSM different from yours ( seen as an external eye, I mean ) and part of the audit was related to 8.2.2 , interviewing the personnel ( collegues) with responsibility of Quality Systems and auditing.
Some questions concerned with the local audit planning, the reporting of result to managament, monitoring of effectiveness of non conformities and so on,

As I said before, the collegue should define to scope of his assessment, identifying the process to be audited

AndyN said:

No, no, no! Internal audits aren't performed against clauses of any external standard!! We've been trying to get away from this type of thing here for nearly 10 years (or more)! We should be auditing to the organization's own criteria

Internal audits - of the Quality Department - should be performed against the organization's own qms for whatever the Quality Department does - the processes and procedures etc. that Colpart indicated - for example. And he's correct, to give guidance we must know more about the responsibilities of this department.

Click to expand...

qusys said:

In responding to the question I have intended that he should perform an internal audit from Corporate point of view, auditing the QMS of another site he belongs to.
From my working experience, it usually happened to verufy the status of health of a QSM different from yours ( seen as an external eye, I mean ) and part of the audit was related to 8.2.2 , interviewing the personnel ( collegues) with responsibility of Quality Systems and auditing.
Some questions concerned with the local audit planning, the reporting of result to managament, monitoring of effectiveness of non conformities and so on,

As I said before, the collegue should define to scope of his assessment, identifying the process to be audited

Click to expand...

Doesn't really matter what point of view you take it from 'corporate' or anything else. It's an internal audit, done by someone who isn't 'auditing their own work'. We still don't know what the function is responsible for, so until we know what Ahmed has in mind, we can't say, except for generalizations, and he asked for specifics........

Ahmed,

Are you ISO registered? If so how was the previous audit conducted?

Thank you very much for your corporation. The quality department in this company is only responsible for the management of the quality system. They dealt with the consultant until the company certified, they are responsible of the internal auditing, establishing policies, manual, procedure.

I mean they are responsible of implementing the QMS within the organization and to ensure that all the reqs. Of iso 9001 are met. They have nothing technical to do

as you all requested from me to know exactly what this dept. is doing, what else shall I ask (info. and documents) them to provided me with?

I believe the question to be answered is what is the audit criteria.

I don't understand Andy's problem with Qusys posting. I see no problem with auditing to the requirements of an external standard, assuming there is an external standard that applies. I would also consider any customer requirments if there are any (as related to internal auditing.)

If an external standard applies, why not verify if the internal audit program meets the criteria if the standard's requirements?

I would definitely include external standards as part of the audit criteria. In addition, I would include any "planned arrangements" which are internal criteria for auditing like an Internal Audit Procedure and/or a Quality Manual.

ISO 9000:2005
3.9.1
internal audit
systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled


ISO 14001:
3.16
internal audit
systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the environmental management system audit criteria set by the organization are fulfilled