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Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
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Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit
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audit plans and audit frequency, internal audits, iso 9001 - quality management systems
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  Post Number #25  
Old 6th August 2007, 10:37 AM
DaMann

 
 
Total Posts: 13
Re: Internal Auditing to ISO 9001:2000 - How to schedule/plan and perform an ISO audi

Quote:
In Reply to Parent Post by Randy View Post

Please don't take me wrong but I'm pretty blunt and an old Grunt and cop so when I say things they are taken in a wrong way.

Based upon your statement above why are you even doing this? On the evidence of you own admission you have no business being involved in any audit process because you do not possess the "compentency" required.

You last question causes me to want to say "DUH!!!"

How about taking an auditing course from a "recognized" training provider? Internal, Lead Auditor, whatever. These things aren't new and the providers aren't kept on some secret list in a vault. The right hand side of this very website provides you answers to the training, books and other blah, blah, blah you asked about.

I have to agree with this post as we were hit with a minor non-conformance
due to the fact there was no justified way to show my "compentency" and ability to preform an Internal Audit. Our Corrective action was to send me to a 3 day course for internal auditor training. I actually learned a few things i did not know.

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  Post Number #26  
Old 1st November 2007, 10:51 AM
qualityboi's Avatar
qualityboi

 
 
Total Posts: 359
Using standard clauses titles to name processes

Quote:
In Reply to Parent Post by Jeff Frost View Post

I may be in error but I believe that QS 9000 was based on ISO 9001:1994 (20 elements). The ISO 9001:2000 is based on process flow method where each clause is linked directly through a reference or through an implied link to each other.

The standard really is made up of 4 main or master process comprised of management processes, realization processes, specific (special) realization process and documentation requirements (not a real process but still must be audited).

Each of these 4 processes can be broken down into sub-processes that can be audited requiring just 11 internal audits (usually more). An example of one of these sub-processes is the audit Clause 5.5.3 and 7.2.3 which relates to the organizations communication process.

Here is a list of the main and sub-processes of the standard:

Management Process
• QMS Implementation & Maintenance Process
• Management Review Process
• Communication Process
• Internal Auditing Process
• CAPA Process

Realization Processes
• Design & Development Process
• Requirements - Determination & Review Process
• Purchasing Process
• Facilities & Equipment Management Process

Specific Realization Process (old ISO 9001:1994 special processes)
• Dye Penetrant Process
• NDT Process
• Material Testing Process
• Other ????

Documentation Requirements (requirements)
• Documentation requirements
• Quality Manual requirements
After 12 yrs of auditing and ending up with a huge audit schedule comprised of about 80 processes (all of which are critical to the product and customer satisfaction). I decided to take the approach above mainly because our company (and the majority of American companies) do not manage by process, but manage by personnel in charge of functional (often siloed) departments or areas. This has cut our internal schedule to less than half 30-33 audits.
The ISO clauses however, are structured to a process audit. I see no problem in making the design, manufacturing and facility departments part of a larger product realization process on an audit schedule. This approach I believe is the best one, especially for siloed organizations where you have great difficulty process mapping because you may have many departments with different methods for what should be systemic processes, eg, corrective action, document control, training etc.
Sure I know 3rd party auditors could be writing us up for not having systemic processes but where in the standard does it state you must be systemic? It's only implicity implied and I am not about to argue with our CEO to change the org structure. When external auditors even try to go there each individual department manager just states that they have their own way of meeting requirement because of their specific needs...Is this wildly inefficient...in some cases it is, and some cases it is actually true. One still has to get out an audit plan that will align to the company structure, meet ISO requirements, and still be somewhat effective and feasible.

Last edited by qualityboi; 1st November 2007 at 10:52 AM. Reason: Added how many audits we are doing now
Thanks to qualityboi for your informative Post and/or Attachment!
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  Post Number #27  
Old 1st November 2007, 07:33 PM
PVieira

 
 
Total Posts: 14
Re: Internal Auditing to ISO 9001:2000 - How to schedule/plan and perform an ISO audi

wweng7

Here is the example you asked for..... I hope it helps.

If you have any questions feel free to contact me and I will monitor this thread for the next few days as well.


Good Luck,
P Vieira
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf MFG006 Process Control.pdf (42.6 KB, 898 views)
Thanks to PVieira for your informative Post and/or Attachment!
  Post Number #28  
Old 2nd November 2007, 07:22 AM
Helmut Jilling

 
 
Total Posts: 4,366
Re: Using standard clauses titles to name processes

Quote:
In Reply to Parent Post by qualityboi View Post

After 12 yrs of auditing and ending up with a huge audit schedule comprised of about 80 processes (all of which are critical to the product and customer satisfaction). I decided to take the approach above mainly because our company (and the majority of American companies) do not manage by process, but manage by personnel in charge of functional (often siloed) departments or areas. This has cut our internal schedule to less than half 30-33 audits.
I agree that 80 processes would be way too many. I would assume many of those were actually sub-processes, and the system was broken down into too many smaller pieces. The averages I see range from 15-20 processes.


Quote:

The ISO clauses however, are structured to a process audit. I see no problem in making the design, manufacturing and facility departments part of a larger product realization process on an audit schedule.

......When external auditors even try to go there each individual department manager just states that they have their own way of meeting requirement because of their specific needs...Is this wildly inefficient...

I would argue it is wildly ineffective. That one "Super Process" is probably 75% of your organization's core activities. If you audit that as one processes, you hide the whole point of seeing how the processes (and depts.) interact. This is the very silo thing that the process approach is designed to audit through.

Most companies are not changing their departmental structure, but that's OK. But the system has to be designed to view it as a process approach. Over time the metrics and audits can be designed to measure the effectiveness between these processes. The two are compatible with each other, if done well.


Quote:
One still has to get out an audit plan that will align to the company structure, meet ISO requirements, and still be somewhat effective and feasible.
Agree on that point, but I don't think your Super-Process would meet that intent.
Thanks to Helmut Jilling for your informative Post and/or Attachment!
  Post Number #29  
Old 25th April 2013, 03:09 PM
YoYoW

 
 
Total Posts: 7
Re: Internal Auditing to ISO 9001:2000 - How to schedule/plan and perform an ISO audi

Here my old ISO/ TS audit schedule. Let me know if this helps you at all.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf 2010 Audit Schedule.pdf (15.0 KB, 730 views)
  Post Number #30  
Old 14th July 2017, 11:47 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,021
Re: Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit

This is an old thread but I want to add to it anyway.

I made an Audit Program Manager tool for integrated ISO 9001:2015 and ISO 14001:2015 systems. The contents are not specifically required by the standards, but are designed to help plan, perform, track results of and maintain follow up for internal audits.

I will follow up with a 9001 only version - today I added the tabs for the report and corrective action templates.

I hope this helps!
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: xls Audit Program Manager 9k, 14k - risk based(14Jul2017).xls (1.73 MB, 128 views)
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #31  
Old 15th July 2017, 02:42 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,940
Re: Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit

Very much appreciated!
  Post Number #32  
Old 15th July 2017, 09:16 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,073
Re: Internal Auditing to ISO 9001 - How to schedule/plan and perform an ISO audit

Thanks Jen
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