SBS - The best value in QMS software

Hard cut off date for certificates to be issued against ISO 9001:2008?

D

DWilliamA

#11
I facilitated a registration in house some years back - ISO 1987 with a heavy dose of Malcolm Baldrige. I basically took an ISO void of everything it stands for today and turned it into everything it stands for today, and did so through a team effort. Right now the company is very na?ve. 50% of the time when we have 'quality' meetings scheduled they get cancelled because someone can't (read won't) make it. Recently replaced a CEO that asserted that corrective actions are only for RMA and preventive actions are only for in-process related activities, black and white. The mindset still centers on QA inspector centric processes, the opposite of Demings 3rd of 14 points, ceasing the dependence on inspection based systems. My initial attempts to train ended up going to the ... just throw it together and make it happen. The last meeting we discussed "objective evidence" and the push back was 'been doing this for 27 years, that should be good enough' .... so there are some up hill battles here, we are truly working on (in need of) revamping the culture of the company from the top down.

I agree, the core work should take about 6 months... It might appear that this company is not ready for this... it thinks it is, but there is some serious support and buy in issues, its just getting off to a rocky start and my plan allows for an appropriate amount of time to get through this stage.
 
Elsmar Forum Sponsor
R

Reg Morrison

#12
Re: hard cut off date for 2008?

so my questions morphs into - what concerns might an early adopter have creating a fresh QMS?
One of the concerns for the early registrants is the fact that the 2015 Edition of ISO 9001 has a significant amount of requirements that are non-traditional. Things like defining the context of the organization, risk based thinking, mandatory process approach, latitude on documentation development, etc...

Many external auditors will struggle on how to audit systems against the new set of requirements, despite whatever classroom training their employers mandate. So, for many of the early registrants, they will be like guinea pigs validating if the auditors can adequately assess systems against a radically different set of requirements.

In my opinion, the certified organizations will behave exactly like the last time we had a significant change in the standard (year 2000) and delay the transition as much as possible to learn from the lessons of the early adopters.
 
D

DWilliamA

#13
I considered the 'delay' game, or hassles associated with everything being new. I am hoping we do it right and are worthy of certification, and can find a registrar that will play - and maybe we have a slightly easier time of it being an early adopter. Or it turns into sour grapes and we would have been better off with 2008 ???

Probably need to start investigating where the registrars are likely to land on this topic.
 
#14
I considered the 'delay' game, or hassles associated with everything being new. I am hoping we do it right and are worthy of certification, and can find a registrar that will play - and maybe we have a slightly easier time of it being an early adopter. Or it turns into sour grapes and we would have been better off with 2008 ???

Probably need to start investigating where the registrars are likely to land on this topic.
Compared to the 1994/2000 transition, CBs are now required to have a plan on how to address the differences, auditor training etc. It would be worthwhile considering how a prospective CB would handle that. I've already heard that some auditors have dismissed the changes as minimal, so their CB clearly hasn't effectively communicated a position to their staff...
 
Last edited:

Helmut Jilling

Auditor / Consultant
#15
Re: hard cut off date for 2008?

So we have some time to work with 2008 if we wanted, conventional wisdom seems to indicate that if we are going to build a fresh QMS might as well jump straight to 2015.... besides, it would annoy me personally to have to craft something and turn right around revamp it.

so my questions morphs into - what concerns might an early adopter have creating a fresh QMS? Doesn't seem all that complicated to start now with DIS with a reasonable expectation that the FDIS and final release will fall in line without too much hassle.
You ask a very valid question. I would suggest that if your management team personnel has some degree of familiarity of ISO 9001:2008 from past experience, past companies...then it may be an easier implementation to go with the familiar first, and gradually build in the new.


However, if there is no past familiarity, then I would go with the new. I will agree that I would take a full year to build it into the company, do it in stages, modules, and roll it out slowly and smoothly with planning, training, implementing and checking each phase as you go.


I agree with my friend AndyN that it CAN be done more quickly, but I disagree that quicker is better. In. Small company, it is frequently disruptive and incomplete if you rush it faster. That is why I favor the modular approach I discussed. Less disruptive...easier to get the buy in.


The use of a good consultant to start the process and help define the modules and path for your company might be a good initial investment. They can also provide some much needed training.


I would not be concerned about the registrars. Pick a good one, make sure they don't assign a new rookie auditor, and you should be good to go. AndyN, Sidney Vianna and I all represent good registrars, and that gives you 3 good ones to interview....
 
D

DWilliamA

#16
Re: hard cut off date for 2008?

Just talked with TUV (they called me because I visited their web risk webinar thing) and they confirmed that they would be ready to go with auditing to 2015 shortly after release, and probably be able to offer on-site audit activities in advance of the release as well. didn't seem too concerned with transition, being that they have to have a transition plan in place too, in advance of offering transition services - little convoluted, all good.

After reading through the DIS, I can see how it shouldn't be too difficult to audit. Fact is, I am completely excited with the way the structure is modeled after PDAC with Risk Management up front and integrated throughout.... it makes it so much easier to visualize the process approach with integrated risk management, as one big preventive action process, which helps with training.... Frankly, I was is pain trying to bring sense to the 2008 model with the provisions and the realizations, and no formal configuration management (like AS9100) etc. and no clear concept on how to connect quality policies and objectives to make it all go.....

I really like 2015 so far.
 
#17
I can confirm NQA, USA will be in the same position. In fact, as part of the development team, I'm currently involved in the internal training for our people...
 
M

Michael Drechsel

#18
Just for information: IAF published its Transition Planning Guidance on January 12 as an official document. IAF ID 9:2015. The 18 months period become not Part of the document. In theory it Would br possible to use the old Standard and to get a certificate (of course wit a erstritten validity period)) During the whole 3 years Transition period.
 
Thread starter Similar threads Forum Replies Date
C CMM Granite too hard General Measurement Device and Calibration Topics 4
J Argentina Asked for FSC Hard-Copy Edition Only Other Medical Device Regulations World-Wide 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod Non conformity, do nothing? Employee experiencing "hard times" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
W Is it required to stamp obsolete hard copy DHR's "obsolete"? ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
L Do you need to save hard copies of obsolete documents? Document Control Systems, Procedures, Forms and Templates 10
Q Do hard copies of quality records have to be retained? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S Are 2 Hard Copies of Procedures and Instructions Required? ISO 13485:2016 - Medical Device Quality Management Systems 6
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
W Great way to work hard for your career Career and Occupation Discussions 4
R Height gauge to measure short hard to access heights General Measurement Device and Calibration Topics 3
A Identification of Customer Property: Customer-Supplied Thumb Drives & Ext Hard Drives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Having a hard time closing CAR/ PAR Nonconformance and Corrective Action 13
S Why is it so hard to close out the CAPAs ? Nonconformance and Corrective Action 16
G Could I destroy my DHR hard copy after 2 years after pdf'ing them ? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Best Fit Alignment vs. Hard Datums Calibration and Metrology Software and Hardware 5
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6
N Boss is too hard on me.... Career and Occupation Discussions 48
G Document Control - Are hard copies required in addition to soft copies maintained? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
L Does ISO 9001 require that hard copies of documents be archived? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
C Hard Copy Documents not in Fireproof Cabinets - Document Storage Questions... ISO 13485:2016 - Medical Device Quality Management Systems 3
I MDNR (Medical Devices National Registry) and Hard Copy Other Medical Device Regulations World-Wide 3
T Eliminating "Hard Copy" Manuals from our Office and Shop Floor - Documentation Medium ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Why are GOOD Internal Auditors so hard to find? Internal Auditing 35
P Hard Milling Process - Dealing with Within Part Variation for SPC Statistical Analysis Tools, Techniques and SPC 18
Q Uncontrolled Hard Copy (Paper) Document Validity Period Document Control Systems, Procedures, Forms and Templates 12
B Hard Gage Rentals - Thread Gages or Thread Rings General Measurement Device and Calibration Topics 3
Marc Tearing Apart a McAfee Hard-Sell Anti-Virus Ad After Work and Weekend Discussion Topics 6
Jen Kirley Trying to back up a dead hard drive - how to do it? Coffee Break and Water Cooler Discussions 17
S Auslogics Defrag - Hard Drive Defragmentation After Work and Weekend Discussion Topics 9
J U.S. National Archives offers reward for missing hard drive After Work and Weekend Discussion Topics 1
C Specification (hardness) for stainless steel SUS 310 3/4 Hard Manufacturing and Related Processes 3
BradM It's a hard luck life Funny Stuff - Jokes and Humour 0
S MSDS Records - Is a hard copy required if I have a scanned copy? Miscellaneous Environmental Standards and EMS Related Discussions 14
I FMEA Detection Rating - What is Soft or Hard? FMEA and Control Plans 7
V Hard copies from 10-20 years ago - Document Control and Retention Times question Document Control Systems, Procedures, Forms and Templates 19
P Six Sigma Certification Test - How hard is the Six Sigma Certification Test? Professional Certifications and Degrees 6
ScottK Disposing of old hard drives - Best method to destroy data? After Work and Weekend Discussion Topics 17
J What Hardness for .090 Thick Silicone Bronze, Extra Hard Temper (cda 65500-h06) Manufacturing and Related Processes 5
M Does ISO9001 require that a hard copy of a signed procedure be kept? Document Control Systems, Procedures, Forms and Templates 7
J MS Windows XP Pro Hard Drive Defrag (defragmentation) question After Work and Weekend Discussion Topics 26
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
Marc 50th Anniversary of the First Hard Drive - Sept. 13, 1956 After Work and Weekend Discussion Topics 8
J New QA Manager - Top Management is Divided - Between a rock and a hard place IATF 16949 - Automotive Quality Systems Standard 73
D Hard to change factors in DOE (Split Plot Designs) - Injection Molded Parts Design and Development of Products and Processes 15
M Long hard work pays off - 8 months - ISO9001 Certification Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
F Need help about being more socialized - Hard to fit into my groups to some extent Career and Occupation Discussions 4
M CA (corrective action) or Continuous Improvement? It's hard to decide. Nonconformance and Corrective Action 19

Similar threads

Top Bottom