SBS - The best value in QMS software

Additional Quality Systems

K

Karla Chaparro

#1
#1
My company has an additional quality system (Divisional) from qs-9000, and we have the additional requirements documented in the Qs-9000 procedures. Now my question is: Does the external qs-9000 auditor has the right to audit those extra requirements since they are written in our procedures?
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
M

matthew evans - 2002

#2
#2
I think the first question to ask is do the additional requirements to your system come under the scope of your registration. If they do then I think the auditor has the right to audit the additional elements as you have included them in your procedures. If they fall outside the scope then you could argue that he cannot audit a system that is not covered in your scope of registration.
Hope this helps a little.
 
D

Don Reid

#3
#3
I tend to agree with Matthew. We have several additional non QA procedures wrapped up in one procedures manaul and I would not want an assessor/auditor to evaluate them.
 
B

barb butrym

Quite Involved in Discussions
#4
#4
if they link to the system its auditable..no auditor will go off looking for additions, but if he is lead there by procedures...he goes
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
#5
If you write that you do something, it is auditable whether it has anything to do with any spec or not. If you have a procedure which, in part, reads: "...Receive material and then stick your finger up your butt for 15 seconds..." it is auditable ("Show me...." comes to mind right now from an auditor's perspective...). If you say: "...Test to ANSI 1234546..." you better have a current copy of it and test to it.

You say you do it - it's auditable. If it's written in your QS9000 procedures, then it's auditable.

Got an example for us to consider?

[This message has been edited by Marc Smith (edited 16 May 2000).]
 
J

James Gutherson

#6
#6
Don, why don't you want procedures in a procedures manual looked at? Do you actually do these procedures, or are they simply words to fill a gap? This scares me a lot.
 
M

matthew evans - 2002

#7
#7
In addition to my original answer consider a company that has ISO9000, QS9000 and ISO14001 (Environmental Management System) and uses one procedure manual to cover all three standards. When an auditor comes to audit say ISO,QS9000 he will only cover those two standards and not the ISO14001 because this is the scope of his audit, and your registration, and not to cover ISO14001.

See what you think about that.
 
L

Laura M

#8
#8
I wouldn't think the audit trail using the QSA(for QS9000) would lead them there. We had an auditor "stumble" on a procedure that was relavant to the company, but didn't fulfill any QS9000 requirements and he basically said "no, I don't care about that."
Can't even remember what it was, but if the auditor "sticks" to the QSA the other company procedures shouldn't come up. I'm thinking it was something like a Greivance procedure and how to handle the paperwork being that it was a UAW shop.
 
Marc

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
#9
Originally posted by Laura M:

I'm thinking it was something like a Greivance procedure and how to handle the paperwork being that it was a UAW shop.
Click to expand...
If does not affect the quality of the product it's none of the auditor's business. A grievance procedure is not auditable. That's why financials are not looked at.

However, that said, almost all systems can be argued to affect quality.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Q Additional KPI to Top Management beside Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Restructuring and Additional Responsibilities - Need New Quality Title Quality Manager and Management Related Issues 15
L Impact on 510(k) to use an additional manufacture US Food and Drug Administration (FDA) 0
I Additional National requirements for placing MD in the EU countries EU Medical Device Regulations 7
B GM GP-12 Exit Criteria - Additional Safe Launch Inspection - (Also see GM1927-28 ) Customer and Company Specific Requirements 2
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
J CE Certificate and additional processing EU Medical Device Regulations 4
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
V Additional Controls for processing the raw data on different computers (processing system) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
K Letter to file vs Special 510 for additional accessory in orthopaedic kit Other US Medical Device Regulations 1
W FAIR to AS9102 additional documentation Document Control Systems, Procedures, Forms and Templates 5
C Additional Training for CCT (Certified Calibration Technician) Recertification Training - Internal, External, Online and Distance Learning 5
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
Q Risk Management - Additional Process in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Changes in MDSAP regarding to CMDCAS - Are there any new additional requirements? Canada Medical Device Regulations 1
L How document an additional software of my main device software?? IEC 62304 - Medical Device Software Life Cycle Processes 3
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
A Special Characteristics -> Any specific additional requirements to be met? IATF 16949 - Automotive Quality Systems Standard 7
J Example of additional Audits of Remote Supporting Functions IATF 16949 - Automotive Quality Systems Standard 2
F Additional Isolation Required? Doppler Probe Desktop Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B Airbus & Boeing Standard and Additional Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Z Getting Charged for AS9104/1 Additional Audit Time General Auditing Discussions 6
C AS 9102 Form 0 "Additional Information for High Risk Characteristics" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Additional Procedures required for QA Department Document Control Systems, Procedures, Forms and Templates 10
P Does a 'recommended' additional Audit need to be conducted? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A Additional Control Measures for Outsourced Processes under ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P ISO13485 Clause 7.2.1 (d) Additional Requirements - Need advise ISO 13485:2016 - Medical Device Quality Management Systems 2
G MDLA - Extensions allowed for 60 day Request for Additional Information? Canada Medical Device Regulations 4
G Additional Intended Use Predicate 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
T Shipping Additional Product ("Bundle") with a Class 2 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B CMDCAS versus ISO 13485 - What are the additional requirements Canada Medical Device Regulations 21
A TS 16949 5.6.2.1 - Input to Management Review - Additional Management Review Meetings and related Processes 7
B Additional Handset added to System - Additional 510(k) Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Adding an additional site to our current TS 16949 registration scope IATF 16949 - Automotive Quality Systems Standard 5
M Refurbishing a Medical Device - Any additional information needed 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P CMDCAS Checklist with the additional requirements for Health Canada Canada Medical Device Regulations 4
B Additional site to be included in TS Cert. (Common owners & some functions) IATF 16949 - Automotive Quality Systems Standard 5
C Allowance for Slip Fit - Additional Allowance applied to GO NO GO Plug Gage General Measurement Device and Calibration Topics 26
Govind Additional discount on certification fee Professional Certifications and Degrees 4
S EC Official Journal Harmonized Standards - Additional requirements? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Number of copies for an FDA additional information request? ISO 13485:2016 - Medical Device Quality Management Systems 3
J RoHS Compliance - Steel - Customer wants additional samples tested RoHS, REACH, ELV, IMDS and Restricted Substances 32
G Sample Report to justify additional Document Control workforce Document Control Systems, Procedures, Forms and Templates 3
W Additional Regulatory Requirements for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
K Lead Internal Auditor Training - Does the lead auditor require additional training? Internal Auditing 6
H Additional sources for ASQ CQT exam sample questions Professional Certifications and Degrees 6
A EN 9100 - interpretation of additional requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
P Unreasonable FMEA request? Customer requests additional Steps in our FMEA FMEA and Control Plans 5
Y New Japanese EMC/electrical safety standards - Additional product testing required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

Similar threads

Top Bottom