Management Review and Audit Data Requirements

T

tomvehoski

#1
We just heard from one of the registrars we use that they are requiring 12 months of audit and management review data prior to registration to 16949: 2002. This is an issue for a couple of our start-up clients that will not have been in business long enough (or running a quality system long enough) to meet the 12 month requirement.

Has anyone else heard of this or run into issues with it? I am also waiting on responses back from some of our other registrars.


Tom
 
Elsmar Forum Sponsor
#2
From the AIAG

Tom this is from "Quality QuickBytes", an AIAG E-publicaiton"


Q: I need clarification the "Rules." What happens if a company does not have 12 previous months of internal auditing or management reviews, but it has at least one round of each prior to the registration week? Does that comply?

A: In situations that the company is a new operation (start-up) and the required 12 months of data is not available, it would be acceptable to review the available data and to process it accordingly. In such situation, it would be necessary to review at least 12 months of data at the first surveillance audit and if the data reflects acceptable performance the company would continue certification. If the data reflects unacceptable performance, the organization will risk loss if its certificate.
This is from Volume 1, Issue 5; dated October 4, 2002. I hope that helps.
 
T

tomvehoski

#3
Thanks for the info. Any idea who actually wrote this? Is it official? The registrar we talked to apparently lost a potential customer because of their stance on this issue. I worry about trying to use AIAG publications as ammunition against an auditor or registrar.

One of my clients had a fire in August 2001 and is just now up and running again. Hope to have them certified in March. The stance I am thinking of taking is that the company has been in business for many years, but did not make anything from 8/01 to 12/02. Our first audit and management review cover the last 12 months. One nonconformance for no previous audit, one for no previous Management Review and one for poor record protection since most everything was lost in the fire. Hopefully this will cover any issues.

Thanks again,

Tom
 
#4
Any idea who actually wrote this?
I have no idea. but....
Is it official?
I would hope so...it came directly from the AIAG, not some website paraphrasing something they read or heard. The information was a direct quote from the AIAG publication. IT was under the title: ISO/TS 16949:2002 Frequently Asked Questions.

I'm sure if someone were to contact the AIAG with the information I presented in my first post, the AIAG could verify whether it came from them or from the IATF. I think that would be the real question. Is this just the interpretation of the AIAG, or is this from the IATF? This I don't know.
 
Y
#5
if i interprete that correctly, you were saying that if a company going for TS certification, it will need to have at least 12 months of management review and internal audit data ?

In that case, TS implementation project will has to be more than a year ? Because, the company will need to get everything in places, and then to prove to registrars that they have 12 months management audit / IQA data ?

Please correct me, if I'm wrong ??
 
S
#6
Tomvehoski,
The requirements for documents to be submitted to the CB is in "Automotive certification scheme for ISO/TS 16949 Rules for achieving IATF recognition". Refer to page 12.
- quality manual for each site to be audited
- Internal audit and management review planning and results from previous 12 months.
- list of qualified internal auditors
- list of customer specific requirements
- customer complaint status
- operational performance trends for the previous 12 months, minimum.

There is also a suggested list in the guidance document.

If you have been ISO/QS certified or if you have a TQM philosiphy this requirement should pose no problem. If not ,IMO you would have to gather data for a year before attempting certification.
 
#7
Sam I agree, with the exception of the start-up operations that I mentioned in the earlier post. YKT, your interpretation is correct provided the company is not just starting up operations. In Tom's situation with the client with the fire, I'm not sure that it fits. Perhaps they could use data from before the fire I'm not sure. Tom, that is a puzzler. Let us know how it unfolds.
 
T

tomvehoski

#8
Unfortunately most all records were lost. The only quality related document they recovered was an old quality manual that was never implemented and a couple forms here and there. Computers went too, so there was no electronic data saved. Off-site backup storage will definately become a new program for them. We started from scratch with a new 16949 and 14001 system.

I think we are going to be back to another situation where each registrar has a different opinion on this one. I will just have to be careful about who we select to conduct the audit.

Tom
 
D

Don Wood - 2011

#9
According to Harold Hodder, Exec. Director of the IAOB, the 12 months of evidence can be from your existing QMS. It does NOT have to date from the complete implementation of a TS2 compliant system.

In this situation (data loss) you've definitely got a problem. I'd recommend asking your (or your client's) CB to get an interpretation from the IAOB. In some circumstances the IAOB will allow exceptions. There's not a CB on the face of the Earth that will make that call on their own, unless they truly enjoy having a witness auditor rack them up one side and down the other. Expect to get some grief about contingency planning! :)
Don Wood
 
D

dewie

#10
system on fire

in that fire case
could it be possible to start from requesting the company's QM from th CB, since QM from the last surviellance should be there.
 
Thread starter Similar threads Forum Replies Date
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
J Time frame for Management Review before ISO 14001 precertifcation audit ISO 14001:2015 Specific Discussions 3
T Management Review - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
C How should I present Internal Audit results to Management in Management Review Internal Auditing 18
Celtic Warrior Consolidating results of LPA (Layered Process Audit) for Management Review Process Audits and Layered Process Audits 13
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
D Management Review Analysis of Internal Audit Findings Quality Manager and Management Related Issues 8
O Management Review Inputs and Outputs - AS9100 Registration Audit Requirements Management Review Meetings and related Processes 16
6 Management Review does not highlight Internal Audit Finding - Root Cause Analysis General Auditing Discussions 11
E Management Review - Internal Audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
D TS16949 Audit in Progress - 5.6.2 (b) ?Customer Feedback? not in Management Review IATF 16949 - Automotive Quality Systems Standard 23
G External Audit Finding - Audits of System Management vs. Process Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Is it Compulsory to complete Management Review before Stage 1 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
J Management Review output - privileged or audit fodder? ISO 13485:2016 - Medical Device Quality Management Systems 5
T How do I Audit Management Review? Do I audit my boss? Management Review Meetings and related Processes 30
D ISO 13485:2003 Registration Audit - Management Review of major regulatory standards Management Review Meetings and related Processes 5
I What is the Difference between Management Review and Internal Audit? Management Review Meetings and related Processes 4
R Internal Audit and Management Review before Certification: Is it a required? Management Review Meetings and related Processes 3
Antonio Vieira The importance of some processes... Internal Audit, Management Review, Nonconformance Management Review Meetings and related Processes 3
A Management Review and Internal Audits Before Registration Audit Management Review Meetings and related Processes 2
S Management Review (9.3) - Management Review Minutes/Report ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
O ISO 13485 - Is management review required before stage 1? ISO 13485:2016 - Medical Device Quality Management Systems 6
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
T Management review meeting workflow ISO 13485:2016 - Medical Device Quality Management Systems 9
Casana ISO 9001 - 9.3.1 Management Review - Attendees in a flat organization Management Review Meetings and related Processes 6
C Management Review Agenda Management Review Meetings and related Processes 20
Q Do Management Review records have to be on a controlled form? ISO 13485:2016 - Medical Device Quality Management Systems 30
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 9001 - 9.3.1 Management Review - Content and Frequency Management Review Meetings and related Processes 12
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Q How to run a Management Review Management Review Meetings and related Processes 10
S List of requirements for Management Review in IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
D EMS Management review outputs - Strategic direction of the organization Miscellaneous Environmental Standards and EMS Related Discussions 1
B How to comply with IATF 16949:2016 9.3.2.1k - Management review IATF 16949 - Automotive Quality Systems Standard 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
M FDA News USFDA Final Report – MDUFA IV Independent Assessment of FDA’s Device Review Process Management Medical Device and FDA Regulations and Standards News 0
T Difference between "data analysis" and "management review" ISO 13485:2016 - Medical Device Quality Management Systems 4
J 3 Questions about Management Review - ISO 9001 and IATF 16949 Management Review Meetings and related Processes 4
W Can 2 different sites under different Quality System have a common management review? ISO 13485:2016 - Medical Device Quality Management Systems 4
I Trying to explain some of the Management Review Inputs (AS9100D) Management Review Meetings and related Processes 10
W IATF 16949 Clause 6.1.1 - My first Major NCR (Management Review) IATF 16949 - Automotive Quality Systems Standard 57
H ISO 9001:2015 Cl. 9.3.1 - General Director doesn't participate in Management Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Tagin Management Review - How elaborate should Management Review be? Management Review Meetings and related Processes 14
R University Research Project - Management Review Management Review Meetings and related Processes 17
G ISO 9001:2015 - Management Review 9.3.2 c) 5) - Monitoring and Measurement Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B IATF 16949 Clause 9.3.2.1 - Management Review Inputs IATF 16949 - Automotive Quality Systems Standard 1

Similar threads

Top Bottom