What to audit against clause 6.4 of ISO 9001:2000

E

energy

#21
You Go Girl!

Originally posted by SteelMaiden
According to our registrar, they will be considering all the things that energy talked about....But
All right Steel....Those nay sayers can tell energy to pack sand, but a registrar.....:eek: :vfunny: We're half way there!:bonk: :ko: :smokin:
 
Elsmar Forum Sponsor
E

energy

#22
I stand dejected!

Originally posted by M Greenaway
Energy, isnt ISO9004:2000 guidelines for performance improvement, or excellence or something like that. i.e. things you can do to go beyond the requirements of ISO9001:2000.
I stand corrected. ""The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards which have been designed to compliment each other, but can be used independently.

Further on: ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractural purposes."

As these were released at the same time, as well as 9000-2000 Fundamentals and Vocabularly, I will continue to use them as intended. To compliment one another. If you feel that employee health and safety issues are exempt, make sure that the livestock pen shows good housekeeping and that the employees in there are not without the proper protective equipment!:ko: :smokin: :vfunny:
 
Last edited by a moderator:

SteelMaiden

Super Moderator
Super Moderator
#23
energy,
Scary isn't it?:biglaugh: :eek:

Just remember the operative phrase was considering....

In my experience, the auditors (registrar's) are all in all a pretty good bunch to work with. I made it my policy early on in the game to use their experience and audits to my advantage. I've never looked at an audit as anything other than an opportunity to improve the system. I have, on ocassion, "stood my ground and faced 'em down", but over-all not all that often. I really don't think they (ISO auditors) are as bad as you fear. I bet you have nightmares of the Grim Reaper with a clipboard, don't you?:biglaugh:


I've gone through over a dozen surveillance audits, and 2 certification audits, one for ISO '94 version, one for QS, and probably 100 customer specific (before we were ISO) certifications. Believe me, the customer audits were by far the worst. They all want you to do business how they want you to do business. The auditors are often untrained, unobjective, and outright opinionated. At least the registrars I have worked with seem to have auditors that basically think the same.

Of course, as one of my co-workers once said, "who in their right mind, would even try to argue with you, unless he had a death wish?" Keep on keepin' on. It ain't so bad!
 
M

mcenyll

#24
Now I'm confused since I've read somewhere else that ISO9001 has these main aspects excluded:
- health and safety
- environmental considerations
- finance
- people issues...

Then why are we talking about employee health and safety? I know it's relevant and somehow affects product conformity but is this auditable against clause 6.4?
 

harry

Super Moderator
#25
Welcome Mcenyll,

What you read represents the line of thought at that change-over period in 2002.

The current interpretation about ISO 9001 vs health and safety is clearer as seen in this recent thread. I'll leave it to others to respond to your post.

Also look at this thread.
 
Last edited:
Q

qualitychic

#26
Re: What to audit against clause 6.4 of ISO9001:2000

The work environment requirement on this standard is relevant only in the context of product conformity. To identify nonconformance against this clause, auditors may need to obtain objective evidence that working conditions are detrimental to achieving product conformity.

This requirement is auditable only in situations where working conditions are obviously inappropriate and in situations where there are actual specified requirements for working environments. Auditors may look at work methods, ambient conditions, and other aspects of the work environment and may ask if there are any specified limits on conditions that could impact product quality.

Strictly speaking, as long as conformity of product is not compromised, auditors may not be able to write a nonconformance.
 
Thread starter Similar threads Forum Replies Date
dubrizo Audit Findings: Writing against Internal an ISO Clause Internal Auditing 10
K How do you audit past verbal approvals against ISO 9001 Clause 4.2.3a? Internal Auditing 69
D Customer Audit Finding against ?where appropriate? of ISO 9001, Clause 7.4.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Evaluation of Service Supplier - Third party audit NC against clause 7.4.1 General Auditing Discussions 6
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
Manix Should a 3rd Party Auditor Audit against IATF rules and not just the ISO standard? General Auditing Discussions 4
G Audit Finding against ISO/TS 16949 6.2.2 Competence, Training and Awareness IATF 16949 - Automotive Quality Systems Standard 3
D ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope IATF 16949 - Automotive Quality Systems Standard 8
S Process Audit against different jobs (but part of the same process) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D PPAP Audit Checklist to Audit our PPAP?s against the Current Process APQP and PPAP 8
L Root Cause - Analysis and Defining - A/R against 8.2.2 Internal Audit Problem Solving, Root Cause Fault and Failure Analysis 12
B Purchasing Element Audit Checklist to audit against ISO 9001 Document Control Systems, Procedures, Forms and Templates 6
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Supplier audit Medical Device and FDA Regulations and Standards News 2
M Go Live With New ERP System before Recertification Audit General Auditing Discussions 6
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 7
B Remote IATF 16949 audit preparation General Auditing Discussions 10
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
I Do I need to sign off my annual audit calendar? Internal Auditing 2
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Nice and simple invitation email to an audit kickoff meeting Internal Auditing 1
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
Q IATF audit - Root Cause Analysis results IATF 16949 - Automotive Quality Systems Standard 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
xfngrs NIOSH Audit for N95 respirators US Food and Drug Administration (FDA) 1
Sidney Vianna IATF 16949 News Risked Based Audit Day Calculation IATF 16949 - Automotive Quality Systems Standard 2
T AS9100 audit due to facility move AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B SAP Audit trail Periodic Review EU Medical Device Regulations 1
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
salaheddine96 Internal audit planning Internal Auditing 2
A MDSAP Audit Questionnaire Medical Device and FDA Regulations and Standards News 7
H Obligations as a contract manufacturer during an MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna IATF 16949 News Update on the IATF CARA Project (“Common Audit Report Application”) - 12/2020 IATF 16949 - Automotive Quality Systems Standard 1
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
Z Rapid audit template for plastic parts manufacturing process Manufacturing and Related Processes 12
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S Quality Audit Training Activities Quality Manager and Management Related Issues 2

Similar threads

Top Bottom