Is the up-dated ISO 9004:2009 needed to pass audit?

Q

Qualqueen

#1
We're having our recertification audit on the 26th. I just realized that the Q9004 edition I have (2000) has been superceded by edition (2009). My question is do I need to have the new edition; would this be considered a finding? I have stamped the inside cover obsolete - reference only.
 
Elsmar Forum Sponsor

howste

Thaumaturge
Trusted Information Resource
#2
Re: Is the up-dated Q9004-2009 needed to pass audit?

We're having our recertification audit on the 26th. I just realized that the Q9004 edition I have (2000) has been superceded by edition (2009). My question is do I need to have the new edition; would this be considered a finding? I have stamped the inside cover obsolete - reference only.
Since it's a guidance document, you don't even need to have a copy of it at all. I believe that it's a great resource to use to develop and maintain your system though, and I'm glad to hear that you have it.

As far as the version goes, if you feel that the 2000 version of ISO 9004 is still useful to you, there's no need to "obsolete" it. I'd suggest that you (when you get around to it) get a copy of the new version and use it for guidance in the future.
 

Randy

Super Moderator
#3
Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.
 

howste

Thaumaturge
Trusted Information Resource
#4
Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.
If they reference it in their documentation, it would only need to be updated if they refer to the latest version of it. If they reference the 2000 version, they wouldn't need to update it.
 
Q

Qualqueen

#5
Re: Is the up-dated Q9004-2009 needed to pass audit?

It isn't needed at all unless you have referenced it in your documentation. If you have, yep, you betcha it better be updated.
I have it listed in my Master Document list under external documents!!???

If they reference it in their documentation, it would only need to be updated if they refer to the latest version of it. If they reference the 2000 version, they wouldn't need to update it.
This is how I have it listed on the Master doc. - ISO9004 rev. 2000
 

Randy

Super Moderator
#6
Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid

Why did you reference it to begin with?
 
Q

Qualqueen

#7
Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid

Why did you reference it to begin with?
The consultant we had three years ago asked for all external docs to be listed on the master doc list. I have all 5 listed that we use - ISO 9000, 9001, 9004, 13485 and 14969. Are you saying I can remove them all because they don't need to be listed on the master doc list?
 

Randy

Super Moderator
#8
Where is there a requirement to even have a master document list?

Your consultant is having you do something that isn't necessary. Which isn't that uncommon by the way.
 
Q

Qualqueen

#9
Where is there a requirement to even have a master document list?

Your consultant is having you do something that isn't necessary. Which isn't that uncommon by the way.
We're also ISO13485 and they have a requirement.
 

howste

Thaumaturge
Trusted Information Resource
#10
Re: Is the up-dated Q9004-2009 needed to pass audit?

Either delete all references to it or change it because the one you reference is no longer valid
I disagree. Did the guidance suddenly become invalid simply because there's a new version of the document? Since it's not an externally required document, the document is only valid or invalid if the organization makes that determination.
 
Thread starter Similar threads Forum Replies Date
Q ISO/TS-16949 Semi conductor commodity specification, the latest one dated 1/12/2004 IATF 16949 - Automotive Quality Systems Standard 3
D IEC EN 61326 Dated Standards - Dated standards for test protocols CE Marking (Conformité Européene) / CB Scheme 3
J Revised Honda Supplier Quality Manual dated 5/1/2011 Available Customer and Company Specific Requirements 0
Kales Veggie Ford has issued a new CSR dated August 2008 and CQI 9 / W-HTX checklist Customer and Company Specific Requirements 15
kisxena Issued travelers that have out-dated revision - 21 CFR 820.40 - Document Control Document Control Systems, Procedures, Forms and Templates 10
J Has anyone looked at the new GM Customer Specifics dated 3-31-2006? Customer and Company Specific Requirements 7
C Delphi latest released on CSR dated Nov 22, 2005 and again Feb 1,2006 Customer and Company Specific Requirements 3
M What MUST be signed and dated? FDA QSR requires signatures for specific sections ISO 13485:2016 - Medical Device Quality Management Systems 4
Ed Panek ISO 9001 Cert Scope Adjustment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 9001: Quality Management as a process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
K ISO 2859-5 (single run production) control plan issues FMEA and Control Plans 2
K ISO 17025 Method Validation and Verification for Test Lab ISO 17025 related Discussions 4
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
D ISO 14001 Finding - Missing Safety Data Sheets ISO 14001:2015 Specific Discussions 2
J ISO 17025 Calibration Other Medical Device Related Standards 2
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 81
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L ISO 20417 crucial changes Other Medical Device Related Standards 1
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
LabCat Internal SOP for a validated (ISO) method? ISO 17025 related Discussions 2
L Confusion about ISO 14644 Other Medical Device Related Standards 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom