ISO 9k2k 8.2.3

G

GARY MOORE - 2009

#1
Are initiatives such as, through put yield, sampling plans IAW ANSI/ASQC Z1.4, and auditing, cover this clause and the need for statistics without performing SPC on every lot of products?

We also perform lean black belt programs at our facility.
 
Elsmar Forum Sponsor
#2
Process monitoring

Gary, first of all welcome to the Cove!:bigwave:

8.2.3 does not specify the "how" or "how much" to monitor or measure your processes. That is up to you. If the methods you choose demonstrates the ability to achieve planned results then they should be good enough.

SPC is NOT required. Now, if you are looking at TS, the rules are different.
 
M

M Greenaway

#4
Gary

As db has stated SPC is not mandated by the ISO9001 standard, which is one of the worst crimes commited by the writers of this document.

My humble opinion for what its worth is that in order to understand the performance of your processes you MUST analyse them using proven statistical techniques. ISO9001 harps on about the importance of process management, yet fails to highlight the crucial part of process management, i.e. the understanding of variance, and need for statistical analysis of process performance.
 
M

M Greenaway

#5
Jim

Yes the standards do hint at the use of such techniques - I really think they should have driven the message home by making it into real requirements of the standard. But again I guess this is beyond the remit of ISO9001, as it doesnt actually tell us HOW to do anything.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#6
Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?
 
M

M Greenaway

#7
Mike

If mom and pop are going for ISO9001 certification then they must have quantifiable quality objectives and they must monitor, measure and analyse their processes. Now whatever it is they are measuring I would say it must be done statistically. Your measurement of capability can be done against your quality objectives.
 
E

energy

#8
I hear you

Mike S. said:

Martin and Jim,

I agree that, properly used, statistical techniques can be amazingly powerful and useful tools. I'm curious -- where would you have Mom and Pop's Cake Shop implement statistical techniques, and what techniques would you recommend?
Mike S.

They do not have full blown complicated industry sanctioned statistical techniques employed. It can be real simple. Like this:

# of complaints vs number of orders....Goal 3%
# of complaining customers vs total customer base....Goal 2%
Average order filling time....Goal 2 minutes
stale returns vs total number of orders...Goal 2

Nothing fancy...use a Pie Chart :biglaugh: :ko: :smokin:
 
#9
KISS

From energy (welcome back!)

Nothing fancy...
Many times we tend to put more focus on the tool than we do the analysis. I agree w/energy use the KISS (keep is simple stupid, or political correct...keep is short and simple). Don't confuse statistical techniques with SPC.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#10
I was kinda thinkin' along the same lines as db and Energy. IMO, Mom and Pop don't need to calculate their CpK or have a bunch of x-bar/R charts hanging around. But it was sounding to me like Martin and Jim were sanctioning formal SPC as the only way to go in every circumstance (maybe I misunderstood), so I wanted to see what their actual ideas were. I'm still kinda unsure what exactly they would use for Mom and Pop. Can you be more specific Martin and Jim?

Maybe part of the confusion is what, exactly, represents a "statistical technique"? Is a pie chart a statistical technique? Is calculating an average of orders per month a statistical technique simply because "average" is a statistical term?
 
Thread starter Similar threads Forum Replies Date
J Engineering having a hard time defining Objectives - ISO 9k2k 5.4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Management Representative Requirements - ISO 9k2k Clause 5.5.2a interpretation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
N ISO 9K2K documentation (records) for small scale tool rooms or job shops Document Control Systems, Procedures, Forms and Templates 1
P Process Audit Worksheets for ISO 9k2k - Marketing Analysis Process Audits and Layered Process Audits 2
W Re: Training for ISO 9K2K General Auditing Discussions 15
D Is ISO 9001:2000 (9k2k) HARDER than the 1994 Version? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R QS Shop upgrading to ISO 9K2K QS-9000 - American Automotive Manufacturers Standard 1
K TS 16949 & ISO 9K2K BENEFITS QS-9000 - American Automotive Manufacturers Standard 1
John C. Abnet ISO 45001:2018 (5.4 - Consultation and participation of workers) Occupational Health & Safety Management Standards 1
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
S ISO 15223-1:2020 Symbols Other Medical Device Related Standards 1
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
J Can signed agreements over-ride review of every "contract" under ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 3
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 5
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9

Similar threads

Top Bottom