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What happens in an ISO 9001:2008 Re-Certification Audit?

TPMB4

Quite Involved in Discussions
#1
Being new to the quality role I have yet to go through a re-cert audit so I am wondering what happens. I have not found a thread that actually spells that out so if I write down what I am guessing happens can you correct me as appropriate?
  • CB contacts you to arrange a re-cert audit and ask for money.
  • CB provides an audit plan.
  • CB visits site and has opening meeting.
  • CB performs the audit over n number of days with a close out meeting at the end.
  • CB writes up report outlining any NCs, OFI, observations, etc.
  • Audited then has a period of time to provide an action plan to correct any NC.
  • NCs are corrected and closed out by audited and checked by CB.
  • CB then provides the certificate to start over the 3 year cycle.
Is this more or less how it happens assuming you have no major NCs that warrant a refusal?

Also, what is the typical CB/audited company relationship like? Is it cooperative? I am a little confused about that. On one level the CB is the supplier of product and services to the company being audited but on the other hand they are checking up on the QMS. Kind of policing the company's QMS and taking money to do it. I guess that is where the CB's integrity and independence is important. That and payment up front!!:D
 
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A

AliPat

#2
Is it a re-certification or annual audit?
I had our 3 year re-certification last year. The auditor concentrated on the actual QMS and documentation relating to the standard rather than process SOPs.

The objective (from the report) was to confirm that the management system had been established and implemented in accordance with the requirements of the audit standard.

Manual & Procedures
Internal Audits & Management Reviews
Customer Satisfaction
Control of Documents
Control of Records
Calibration
Purchasing

On each annual audit report we get a breakdown of what will be covered the following year.

Hope this helps
 

krishkaar

Involved In Discussions
#3
During the re-certification audits, the CB (thro' its auditor(s)) would like to assess the improvements you have achieved thro the implementation of the QMS. (directly pointing to the 7th management principle - Continual Improvement) and the impact to the business.

Moreover, they would also expect improved response of understanding even at the lower level (say, shop floor) and the contribution made by them in achieving the Goals and performance standards.
 

TPMB4

Quite Involved in Discussions
#4
It is probably the company's third red certification, perhaps more I'm not sure but my first. I'm guessing they'll be interested in MR, internal audits and their use as drivers for change and improvement. We have very hands on senior management, too hands on sometimes, but it often feels like daily auditing when they are in the factory. This keeps us on our toes and sets the company ethos, namely doing things right. We all spot things that are b wrong but at our company people just put them right when they see them off their own bat. Management have the attitude of trusting operators to come up with their own ways or solutions to improve what they do. Obviously with support and oversight when needed.

Anyway, Looking forward to getting it over. Even the best managed QMS's will have a worried QM at recertification time I think.
 
E

esqchem

#5
I am not sure where to inquire regarding my dilemma on re-certification. I found this one and I thought maybe anyone here can assist me too.

I am in charge of the QMS in our company. We are supposed to have the ISO 9001:2008 Recertification audit. The thing is, we have restructuring in the organization and I only have 3 weeks to prepare.

What can you suggest regarding the following:
1. Will the external auditor accept that we are undergoing transition but we are still following previous standards set?
2. Do I have to send internal memo just to inform that we remain in status quo and changes in our quality manual and other documents are in process/on going?

I am really confused.
 

Stijloor

Staff member
Super Moderator
#6
I am not sure where to inquire regarding my dilemma on re-certification. I found this one and I thought maybe anyone here can assist me too.

I am in charge of the QMS in our company. We are supposed to have the ISO 9001:2008 Recertification audit. The thing is, we have restructuring in the organization and I only have 3 weeks to prepare.

What can you suggest regarding the following:
1. Will the external auditor accept that we are undergoing transition but we are still following previous standards set?
2. Do I have to send internal memo just to inform that we remain in status quo and changes in our quality manual and other documents are in process/on going?

I am really confused.
You should contact the Registrar directly as soon as possible and inform them of your Organization's situation. It's possible that they agree to reschedule the recertification audit. Also, report any major changes such as changes in the number of personnel because that has an impact on the number of audit days and cost.
 
S

sridharafep

#7
Change management is part of process to make improvements. I suggest you should go for re-certification with out delay and it may give more input for you to align the business process.
 
E

esqchem

#8
I am just preparing. The recertification date was already a rescheduled date. So I guess I'll just have to go through this. I'll prepare all documents and let the auditors check it, I guess.
 

Mikishots

Trusted Information Resource
#9
Being new to the quality role I have yet to go through a re-cert audit so I am wondering what happens. I have not found a thread that actually spells that out so if I write down what I am guessing happens can you correct me as appropriate?
  • CB contacts you to arrange a re-cert audit and ask for money.
  • CB provides an audit plan.
  • CB visits site and has opening meeting.
  • CB performs the audit over n number of days with a close out meeting at the end.
  • CB writes up report outlining any NCs, OFI, observations, etc.
  • Audited then has a period of time to provide an action plan to correct any NC.
  • NCs are corrected and closed out by audited and checked by CB.
  • CB then provides the certificate to start over the 3 year cycle.
Is this more or less how it happens assuming you have no major NCs that warrant a refusal?

Also, what is the typical CB/audited company relationship like? Is it cooperative? I am a little confused about that. On one level the CB is the supplier of product and services to the company being audited but on the other hand they are checking up on the QMS. Kind of policing the company's QMS and taking money to do it. I guess that is where the CB's integrity and independence is important. That and payment up front!!:D
This is essentially what happens, except for the "policing"; best not to think this way, as it misses the whole point of an audit of a QMS.

Flunking a re-cert audit is rare, except in situations where the company has either decided not to pursue continuation of certification or if it's clear that the company does not have the resources or ability to maintain the system. A fair chunk of money is at stake, and it's in the best interest of the registrar to do what they can to ensure continuation of certification (within the bounds of what they are permitted to do).
 
Last edited:

Randy

Super Moderator
#10
This is essentially what happens, except for the "policing"; best not to think this way, as it misses the whole point of an audit of a QMS.

Flunking a re-cert audit is rare, except in situations where the company has either decided not to pursue continuation of certification or if it's clear that the company does not have the resources or ability to maintain the system. A fair chunk of money is at stake, and it's in the best interest of the registrar to do what they can to ensure continuation of certification (within the bounds of what they are permitted to do).
Fair chunk of money? Because of my recent recommendation to not recertify due to multiple majors, a company had to pull out of an IPO and it cost them and their investors tons until the problems were resolved including a large staffing change starting with the plant manager and a couple corporate pukes

It's amazing how many "professionals" think this management system stuff is meaningless Horse-fritters :horse:
 
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