SBS - The best value in QMS software

Has anyone made an ISO9001:2015 vs. ISO9001:2008 Matrix

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#11
Re: ISO9001:2015 vrs ISO9001:2008 Matrix

It is based on feedback from an ISO TC176 member who stated that he did not think there would be significant changes between now and release. I didnt mean to offend, I am just trying to ensure that we (my organisation) are prepared and not leaving everything until the launch.
To me it's like making a movie or designing a product. You start out with what is projected, but you follow along with every script change. I agree with your proactive approach, and I also do not think there will be significant changes between now and release. I do expect a few changes to how some aspects will be audited, but that is another story.
 
Elsmar Forum Sponsor

TPMB4

Quite Involved in Discussions
#13
Unlucky with your timings with the re-cert January 2016. If the standard gets released December 2015 I guess that means you will among the first who have to get certified to it. I'm guessing if issued mid December 2015 then by mid December 2018 you will have to be certified to 9001 2015 hence my above comment. So I reckon you are right to work on it now before it is out in full version. You will obviously be working on this and watching/incorporating changes as they become known.

I just can't see them making any big changes now that missing them would give cause to an NC. No reason for that view just that so far down the journey to the new standard they must have got the big ideas straight and it is mostly clarification through minor wording tweaks. I mean with the change to 2000 version, which I understand had the big idea of changing to process approach, had that down early on not in the last year of a long change process. The big ideas are out in the draft so why not look at where your current QMS is against them. No change until later on but work out the change needed is surely part of what a QMS is at least partly about, change management.
 
#14
Unlucky with your timings with the re-cert January 2016. If the standard gets released December 2015 I guess that means you will among the first who have to get certified to it.
Not at all. The transition period is 3 years! Once the standard is released, new certifications are to the 2015 version, a transition can do whatever in the 3 years.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#15
Thing is, what's the point in waiting? I did several implementations as the 2000 version was being drafted. We implemented to the 2000 draft/DIS but they registered to the 1994 standard as the 2000 version wasn't out yet. When the time came they were ready with *very* few (and very minor) changes before they went through the 2000 version audit by their registrars.

This isn't rocket science, and the changes are less dramatic than consultants and others ready to make a profit make it out to be (for some reason). If it takes a company 3 years to make changes, the company has bigger problems than ISO 9001.
 
A

andrewg

#16
The changes do not look massive to me. Mostly what a good ISO based company should already be doing. I agree, I do not see the point in waiting and I will be hoping to transfer to ISO9001:2015 as soon as possible (assuming release goes to plan etc).

Thanks,

Andy
 
M
#19
Sorry to drag this thread up again, but I have a question about the 'Summary of Changes' doc.

Under point 1 it says: "Top managers are required to engage in the most important QMS activities as opposed to simply ensuring that these activities occur."

From this John has extrapolated that "It looks as if the internal audit team should include at least one top manager."

I have a copy of the DIS in front of me at the moment, and having just pored over it for a second time, I can't find where either of these things is even suggested. Can anyone point me to where I should be looking? Thanks.
 

John Broomfield

Staff member
Super Moderator
#20
mweb,

Thanks for asking.

Please take a look at the clause 5.1.1 and you'll see what top management is directly responsible for instead of making sure someone else does it.

But the recommendation to include a top manager on the audit team comes from clause 7.2 where the competence requirements apply not only to those who affect product quality, but also to persons who affect the "quality performance" of the organization.

The "quality performance" of an organization depends on top management, ergo the competence requirements now plainly apply to the top managers.

Thus far internal auditors rarely, if ever, investigate how the competence of top management is determined and ensured.

To audit the verifications of the competence of top management and their fulfillment of the other top management requirements, I see a need for a top manager on the internal audit team.

This may be nothing more that the existing management rep who, after all, is meant to be a member of top management. They should, however, check to ensure that they are authorized by the very top manager to do this.

I would get that authority in writing.

John
 
Thread starter Similar threads Forum Replies Date
M Has anyone made a DCX PSO plant book? Customer and Company Specific Requirements 1
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
T Has anyone completed the AS9100D Quality Manual transition? Quality Management System (QMS) Manuals 1
D Has anyone taken the AS9100 Delta course / exam? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
D Medica show in Dusseldorf - Has anyone else gone? Other Medical Device and Orthopedic Related Topics 3
A AS9100C to D - Has anyone done a gap analysis? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
T Has anyone been through the ISO 14001:2015 process? ISO 14001:2015 Specific Discussions 12
Marc Has anyone here gotten Gigabyte Fiberoptics (Internet) to home? Coffee Break and Water Cooler Discussions 3
M Has anyone had their electronic system scrutinized in an FDA inspection? Records and Data - Quality, Legal and Other Evidence 16
P Has anyone ever heard of the Eastern Weighing and Inspection Bureau? Calibration and Metrology Software and Hardware 1
M Has anyone successfully challenged the new IATF site extension change? IATF 16949 - Automotive Quality Systems Standard 36
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
I Has anyone read BIP 0115:2014? ISO 13485:2016 - Medical Device Quality Management Systems 5
D ?Pa? Capability Index - Has anyone ever heard of this? Capability, Accuracy and Stability - Processes, Machines, etc. 5
optomist1 Has anyone recently taken the GD&T ASME Y14.5M Certification Exam Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
T Has anyone considered what logic is? Coffee Break and Water Cooler Discussions 23
Jim Wynne Has Anyone Had Trouble with IMDS 8.0? RoHS, REACH, ELV, IMDS and Restricted Substances 17
G Has anyone used shlomo Aviv-lean consultant? Lean in Manufacturing and Service Industries 1
M Has anyone purchased their powerball tickets? 17 May 2013 Coffee Break and Water Cooler Discussions 8
T Has anyone done both Quality and Facility Security Officer (FSO) roles ? Career and Occupation Discussions 8
M Has anyone used SGS as a CB (Certification Body)? Registrars and Notified Bodies 4
R Mix Multi-Site/Individual Certification - Has this ever happened to anyone? Miscellaneous Environmental Standards and EMS Related Discussions 14
B Has anyone used Arena Software Simulation? Process Maps, Process Mapping and Turtle Diagrams 10
C Has anyone used GageWare Software? Quality Assurance and Compliance Software Tools and Solutions 4
M Has anyone used "Paradigm 3" software to Control their Quality or Management System? Quality Tools, Improvement and Analysis 2
Q Has Anyone Heard of Quality University (Online Courses) Training - Internal, External, Online and Distance Learning 2
P Has anyone ever heard of "Quality Gates" (Volkswagen term?) - APQP and PPAP APQP and PPAP 11
A Has anyone tried a DAC (Digital to Analog Converter)? After Work and Weekend Discussion Topics 5
I Has anyone ever heard of Registrar QSRD-International? Registrars and Notified Bodies 36
M Has anyone of you have experience with the World Class Manufacturing system? Lean in Manufacturing and Service Industries 6
K Does anyone has experience with determining if Lubricants and Greases are Food Grade? Food Safety - ISO 22000, HACCP (21 CFR 120) 6
R SOPs in Manufacturing - Has anyone got a management process that works? Document Control Systems, Procedures, Forms and Templates 4
K Has anyone had experience dealing with SEDEX (Supplier Ethical Data Exchange)? Customer and Company Specific Requirements 4
B Has anyone developed an OHSAS 18001 Safety Management System Balanced Scorecard? Occupational Health & Safety Management Standards 13

Similar threads

Top Bottom