Does the system audit have to be done to remain in compliance?

J

Judy Deja

#1
In management review, it is stated that you review the entire quality system once per year. If you cover all the elements in your internal audits, does the system audit have to be done (in addition) to remain in compliance?
 
Elsmar Forum Sponsor

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#2
Judy,

No, you do not have to, provided Internal Quality Audits cover all elements in the standard (over a defined period).

However, there are advantages to doing a complete Quality System audit. A system is made up of several activities, each dependent in some form or manner to the others. By doing section audits, you tend to look at the system 'parts' as being independent, which they are not (correlations may be weak or strong and not always obvious).

My suggestion: do a Quality System audit first. Identify areas of weakness and schedule follow-up section audits to help improve and reinforce standard practices.

Regards,

Kevin
 
#3
IMO, yes. The audit serves the purpose of providing evidence of your compliance with the requirements.
The review required in 4.1.3 is for continuing suitability and effectiveness; apples and oranges.
Now, if you want to be creative you can include in your audit checklist questions that relate to S&E. I tried this approach at a previous employer and it was accepted by the auditor, but not without question, i.e., how is S$E accomplished effectively without a team review.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#4
....more for the mix.

Marc answered a post a couple of days back about registered organizations having to have all ISO elements present for ISO registration. Marc stated that the elements (and points within each) had to be satisfied prior to registration. With this I agree entirely!! How is this accomplished?

Here are some of my observations:

I have seen it where all elements had to be present within the Quality Program and the Quality System, and both had to pass Suitability, Compliance, and effectiveness for Registration. This was with what I consider to be a reputable Registrar.

I have seen it where all elements had to be present within the Quality Program and mostly deployed within the Quality System, and where not, a plan for deployment would suffice. Effectiveness was of little consideration, but Suitability and Compliance were reviewed (as applicable). This was done by what I would consider a less-than-reputable registrar.

In both situations, both organizations were registered. Needless to say, the registration of the organization without complete compliance surprised the heck out of me. It happens often enough, I'm sure, but should not.

Also as an observation, the Surveillence Audits of Registrars have been less than a complete Quality System audit. They hit core elements (what they consider core) and a few additional elements when performing the surveillence. The goal of the Registrar is to see all elements over the three year registration period (sometimes duplicating the core elements, sometimes not). This I akin to the Internal Quality Audits, performed in areas or for documents rather than the complete system audit. It seems to be common practice both from my experience as an observer and from information I have read (here and elsewhere).

With this stated, my position is this: A system is not the sum of its parts. The parts are not separate, and as such, should not be audited separately. However, the practice of Registrars (beyond the initial registration audit) and the other auditing programs I have seen and used successfully, suggest to me otherwise. I guess I am a bit of a hypocrit, but I can change.

Regards,

Kevin
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Originally posted by Kevin Mader:

Marc answered a post a couple of days back about registered organizations having to have all ISO elements present for ISO registration. Marc stated that the elements (and points within each) had to be satisfied prior to registration.
Just to clarify: All elements have to be addressed as opposed to present. Most elements have to be present - such as you cannot opt out of the Internal Audits requirement but some companies may not do design (and as such can exclude design from their registration scope and they need not have a defined design system).

The 9001:2000 is actually addressing this plainly with 1.2 Permissible Exclusions.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Originally posted by Kevin Mader:

....where not, a plan for deployment would suffice...
For registration, this is not supposed to be allowed in so far as ISO requirements are concerned. You either have a functioning system with evidence that it is functioning or you do not. A plan is not sufficient.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
Marc,

Agreed! I was totally stupified. When the Management Rep called me to tell me they had passed, I was totally amazed. They hadn't done one corrective action, no internal audits were performed, and document control was in shambles. If I had placed a bet, I would have lost heavy! Additionally, the registration audit only covered 6 elements (the rest to do on subsequent surveillence audits)! 6! What a joke! This certainly does not promote confidence, not for me anyway.

Regards,

Kevin

p.s. As a point of clarification, IMO, before calling a registrar in for your registration audit, all elements must be audited internally. Otherwise, how can you assure that all elements have been addressed (as appropriate) and you are compliant with the program? My comment to Judy is in regard the fashion the elements are audited, as I take it from her post. Should a complete System Audit be performed, or can you break it into smaller 'element' audits, or, do you have to do both? My thoughts on that are above. Regards

[This message has been edited by Kevin Mader (edited 22 March 2000).]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#8
It no longer surprises me what registrars let companies get away with - which, of course, denigrates the whole process and the 'meaning' (such as it is) of ISO9001 registration.

Anything for a buck.

I will also admit that the same is true of 'consultants' any more. There's thousands of inept 'newbies' out there. (Of course, I'm not one of them!
)
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
Marc,

I believe it would be rather difficult to sink to that level. You'd have to be in a walking coma.

The pursuit of the 'almighty dollar' drives a lot of good ideas down the tubes. That's really too bad!

Kevin
 
Thread starter Similar threads Forum Replies Date
W AS9100C registration - How long does the system have to run before initial audit? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
J Supplier Quality Management System (QMS) Audit - Formal Documented QMS does not exist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J What does "effective implementation of quality management system" mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Where does the QMS (Quality Management System) fit in your organization? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S Does anyone use a FRACAS system to track lab equipment issues? Calibration and Metrology Software and Hardware 1
S Does anyone have an AS9100 System Training Datum? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
C I asked myself a question 'What does a Management System Manage?' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
R What does the Programmable Electrical Medical System really mean? IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R How does my firm implement hybrid system? ISO 13485:2016 - Medical Device Quality Management Systems 5
N Does the KFDA need our distributor to have a copy of our Quality System ? Other Medical Device Regulations World-Wide 11
D Does the Ford Q1 system/accreditation, etc still exist? Customer and Company Specific Requirements 10
Q Ford 'PCF' - Does anyone have any information regarding a Ford 'PCF' System Customer and Company Specific Requirements 2
T Does anyone have an effective training management and tracking system in place? Training - Internal, External, Online and Distance Learning 1
Q Does Anyone Know About Apriso's FlexNet System Software? Misc. Quality Assurance and Business Systems Related Topics 8
P Does QSE integrated Management System need only one representative? Quality Manager and Management Related Issues 7
M Does FDA allow you to withdraw a CAR once it is in your system Nonconformance and Corrective Action 3
E Quality System Software with TS 16949, Does it good? IATF 16949 - Automotive Quality Systems Standard 1
J Change Management System - Does ISO 9001 specify you need a process flow? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
H Does The Company We Rent Space To Fall Under Our Quality System? Misc. Quality Assurance and Business Systems Related Topics 7
H Where does the 16949 number in TS16949 come from? ISO Numbering System IATF 16949 - Automotive Quality Systems Standard 1
C Does auditing improve a Quality or Business System? Internal Auditing 7
M Aftermarket and Big Three Supplier - How does this affect the quality system? IATF 16949 - Automotive Quality Systems Standard 3
F Does anyone use a palm with their Gagetrak v.4 system Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M When is a system not a single device? Does anybody know of a guidance document? ISO 13485:2016 - Medical Device Quality Management Systems 11
D Does the health of the employees reflect the health of the Quality Management System? Misc. Quality Assurance and Business Systems Related Topics 17
V Quality Module - Does anyone here use the IQMS Quality Module in your ERP system? Quality Assurance and Compliance Software Tools and Solutions 10
M Does the Microsoft (MBS) Company have any certified quality system? Quality Assurance and Compliance Software Tools and Solutions 4
Q Definition BOS - Business Operating System - Does BOS have any relation to Ford's QOS? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
WALLACE FPS (Ford production system) - Does anybody have any interesting comments? Customer and Company Specific Requirements 8
E SOP or system Work Instruction? Controlled Document - Where does one draw the line? Document Control Systems, Procedures, Forms and Templates 5
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 29
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 1
N Small Company - Internal audit process - Who does the audit? Internal Auditing 4
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 21
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
Similar threads


















































Top Bottom