Do I have too many ISO 9001 procedures?

M

Mike Smith

#21
Sorry for the mistake guys. I was reading the TS standard.

Ingeniero,
We are a supplier of instrument clusters and various other electronic components for the automotive industry. We are the best remanufacturer too. :) I was just curious since you supply the automotive industry, is your customer requiring you to be TS16949 certified?
 
Elsmar Forum Sponsor
G

Greg B

#22
ddhartma said:
Greg B,
Additionally, there is NO real requirement for the three/four tier documentation system. I have worked with small businesses that had approximately twenty 1-2 page documents that addressed Who, What, When, Where and How (and this was to comply with ISO 9002:1994 and QS-9000).
Dave,
I totally agree.

ISO GUY said:
Greg that is why I said JMHO (just my humble opinion). We have WI's that not only say how but who, what where and when. It all depends on what type of product/service you are providing. Remember WI's and Procedure definitions are not one size fits all. Again JMHO.
ISO, Sorry If I came across a bit grumpy, I should have read your post better. :eek:

Greg B
 
I

Ingeniero1

#23
There is no question that we WILL have procedures to control critical processes. I would not dream of 'pretending' to control a process without the properly documented procedure(s). If anything, I know that I tend to fault in the too-many-procedures and too-detailed instructions. Though with age, I have learned to temper this tendency.

My question does not relate to determining the need for a procedure - I know we will do that correctly. My question is how many of the procedures we have (or will have), which may well be more than explicitly or implicitly required by the Standard, do we have to make, or should make available to the auditor? Will the 'extra procedures' serve to show how well (hopefully) we control our operation? Will the auditor pick apart a procedure that perhaps I didn’t even have to ‘produce’ for the auditor’s perusal?

When the auditor comes, I want to show him/her that we fully meet the requirements of the Standard and are worthy of the certificate. I am not interested, however, in showing the auditor how great we are or how meticulously we document everything if such is not required. If I can meet the requirements and be certified by having the auditor spend X-hours auditing, why add anymore that would just result in the auditor spending 2X-hours if the result will be the same? Sort of the KISS principle, if you get my drift.

Alex
 
#24
ISO GUY said:
Greg that is why I said JMHO (just my humble opinion). We have WI's that not only say how but who, what where and when. It all depends on what type of product/service you are providing. Remember WI's and Procedure definitions are not one size fits all. Again JMHO. :bigwave:
I don't get too wrapped up in this stuff. I've seen places where their "procedures" are very detailed work instructions (this seems to be most prevalent in the aerospace industry). I’ve also seen work instructions so vague they are actually procedures. To me, it might not be important to argue with a company on whether something is actually one thing or another, but to make sure the information contained in the document is correct, and the document is controlled. :agree:
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#25
Ingeniero1 said:
When the auditor comes, I want to show him/her that we fully meet the requirements of the Standard and are worthy of the certificate. I am not interested, however, in showing the auditor how great we are or how meticulously we document everything if such is not required. If I can meet the requirements and be certified by having the auditor spend X-hours auditing, why add anymore that would just result in the auditor spending 2X-hours if the result will be the same? Sort of the KISS principle, if you get my drift.

Alex
When the external auditor shows up, s/he should be performing an audit following the PROCESS APPROACH. S/HE should ask you questions such as:

How do you control your purchasing process? You (or the process owner) should then proceed to explain it. The auditor should then be taking good notes

If you have elected NOT to develop a procedure to explain/control your purchasing process, then the external auditor will start to collect objective evidence (by observations, interviews and records review) to verify that the purchasing process is being performed according to the process that you (or the process owner explained. Lack of a documented procedure could be challenged by the auditor if s/he finds inconsistent ways of performing the tasks/activities associated with that process.

For more on this, go to http://isotc176sc2.elysium-ltd.net/APG-MinDocumentation.doc

Now, if you are concerned about procedures that have nothing to do with the QMS processes, such as payroll, accounting, environmental compliance, etc . . ., the auditor should not be involved with those, since they are outside of the scope of the audit you contracted them for.
 
Thread starter Similar threads Forum Replies Date
G Too many customer complaints Customer Complaints 16
D IATF 16949: Do we have too many processes? Are they all the same? Registrars and Notified Bodies 7
C How to Write Procedures without too many Details ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
L How to deal with too many CARs (Corrective Action Requests), PARs (Preventive Action) Nonconformance and Corrective Action 25
C ARGH Too Many Internal Audits Internal Auditing 22
Q Issuance of Corrective Action - Too many related to safety ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Sidney Vianna Too many competing schemes for "approval of responsible recyclers"? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
J How to know how many procedures are too many? Document Control Systems, Procedures, Forms and Templates 7
P Too Many purchasing/supplier procedures How do I fix them? Document Control Systems, Procedures, Forms and Templates 6
M Do we have too many operational procedures and are they too long? ISO 13485:2016 - Medical Device Quality Management Systems 7
J Documentation to Flow Chart - Too many documents Document Control Systems, Procedures, Forms and Templates 6
S Too many different types of audit!!! General Auditing Discussions 4
C CMM Granite too hard General Measurement Device and Calibration Topics 4
M Do I Expect Too Much of Job Candidates? Career and Occupation Discussions 33
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Informational FDA Panel: Too early to pull textured breast implants over cancer risk, need more data Medical Device and FDA Regulations and Standards News 0
F Looking for a Japan MAH recommendation that is not too expensive Japan Medical Device Regulations 6
S FDA Inspections and Pest Control - Pallets too close to walls 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
L Nonconformity's risk is too low, so don't report it? General Auditing Discussions 25
O Is the Quality Objective for Company-wide Training as >90% too high? Training - Internal, External, Online and Distance Learning 4
J Thread Gauge Calibration Failure for Pitch Diameter being too large General Measurement Device and Calibration Topics 3
K Too Simple an Internal Audit Check Sheet? Internal Auditing 10
GStough Rejecting a Supplier's Corrective Action Plan When It's Too Weak Supplier Quality Assurance and other Supplier Issues 22
B Is the ISO 13485 auditor being too picky concerning CMDCAS? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Sourcing a Sterile Product - Asking for supplier for too much regulatory stuff? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Reduced Device License Fee was rejected for being sent in too early Canada Medical Device Regulations 2
N Calibration Lab unable to issue Accredited Certificate when error is too high? General Measurement Device and Calibration Topics 3
H "Too little" variation in gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J ISO13485 File-Index getting too large Document Control Systems, Procedures, Forms and Templates 2
N Boss is too hard on me.... Career and Occupation Discussions 48
Sidney Vianna The frequent flyers that flew too much... Unlimited AAirpass Coffee Break and Water Cooler Discussions 11
B Management Review Meetings too Long - How to Shorten and Improve Effectiveness Management Review Meetings and related Processes 7
B NAFTA Requirements - Finished Product or Materials/Parts from Suppliers, too? RoHS, REACH, ELV, IMDS and Restricted Substances 2
A When a Company is Too Big for Quality Service Industry Specific Topics 20
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
G Histogram Interpretation when a process is "running too high" or "running too low"? Quality Tools, Improvement and Analysis 4
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
B Can the Variation on Data be too small in a Variables Data Gage R&R Study Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Customer SQE - Within Specification but too much Variance Customer Complaints 7
A What to do when customer requirements are too much? Quality Manager and Management Related Issues 29
A Are Risk Analysis Studies required only for devices, or other processes too? ISO 13485:2016 - Medical Device Quality Management Systems 11
R MSDS Sheets for Products - How much is too much - Or is there ever too much? Occupational Health & Safety Management Standards 12
BradM Definitely too old to Trick or Treat Funny Stuff - Jokes and Humour 0
Jim Wynne Is this ISO 9001 Registration Scope Statement Too Vague? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Late CA (Corrective Action) excuse or I'm too important or no response Nonconformance and Corrective Action 19
4 Change Control Systems - How much is too much? Document Control Systems, Procedures, Forms and Templates 10
Q How much detail in DHR (Device History Record) is too much? US Food and Drug Administration (FDA) 3
J The Dude abides, and this weekend Hub ?Lebowski? fans will, too Coffee Break and Water Cooler Discussions 2
R Audit N/C - Quality Policy too generic? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Jim Wynne Another way to tell that you've got too much money Coffee Break and Water Cooler Discussions 16

Similar threads

Top Bottom