Should we register to ISO 9001:2008 or ISO 9001:2015?

C

ChrisTGW

I'd appreciate some feedback from the group.....my company is beginning its ISO "Path" this year. We currently are NOT certified to any standard, so assuming 2015 goes "live" in January, 2016, would we have to certify to that Standard if we don't certify to 2008 by 31 December 2015?
 
S

Sean Kelley

Re: Should we register to ISO 9901:2008 or ISO 9001:2015?

Have not seen the official ruling yet but that would be pretty quick to get up to speed on the new standard. Typically if you are already certified when the new version comes out there is 3 years to upgrade.

I would check with the registrar you are choosing or call a few of them up to ask this question to them. Might be helpful to your cause to get an email or something in writing if they will do that.
 

Helmut Jilling

Auditor / Consultant
I'd appreciate some feedback from the group.....my company is beginning its ISO "Path" this year. We currently are NOT certified to any standard, so assuming 2015 goes "live" in January, 2016, would we have to certify to that Standard if we don't certify to 2008 by 31 December 2015?

No. It is not even a standard yet, so it would be difficult to implement it fully without seeing the final version. You can certify to the current 2008 version for the next couple years... I would build it based on 2008, and upgrade the additional requirements slowly over the next couple years.


Make sure you implement the system correctly, based on processes, and the upgrade will be pretty simple. If you are not clear, send me a private email, or post some questions here. A little professional guidance and training at the beginning would make it a lot smoother.
 

Eredhel

Quality Manager
We are a small shop and had planned on waiting for the 2015 update. But we switched gears and are nearing our 2008 stage I audit. I'm now very glad we are pursuing 2008. Just by getting ready for our internal audits we are nearly ISO compliant and that transition has been smooth and steady. Now we just need a laundry list and we will be comfortable taking the next step. If we had gone ahead with waiting or prepping for 2015 we would not be nearly as far along.
 
M

Mallya

I think the important thing is your plan of action if you plan to get certified in 2015 you better continue with 2008 version and you have a lot of time to upgrade up to 2018.
But if you plan certification in 2016 you better wait 2015 version release.
New version is expected around September with minor changes including introduction of Risk Management issues. So I believe it would easier to update your system by addition of new stuff in 2008 version to get 2015 version.

Benny
 

kzachawk

Involved In Discussions
Chris, if you feel the need to register to an ISO standard, then register to the 2008 version, especially if you are a small business.

I would wait and see if its even feasible for your business to afford to implement the 2015 revision if you determine that to be necessary. The full ramifications of the 2015 revision and its paradigm shift away from quality and into risk management might be far to daunting a task for any small business to undertake. I have spent time with many of the pros who are attempting to setup instruction for the new revision and have discovered that there are issues related to intent which they have not considered.

If you are going to consider the 2015 revision, then read both ISO 31000 and 31010 and discuss those and the DIS version of 9001:2015 with your legal representatives. There could potentially be huge product liability issues related to the 2015 version of ISO 9001.
Quality management systems don't on their own improve quality, that is a decision a business must personally make related to serving its customers (ISO or no ISO). Many companies make the mistake of implementing a QMS, as a means of improving quality, and where there are some prescriptive controls (in 2008 version), it's still the responsibility of the organization to define its customers and their expectations as well as the controls which will be put in place in order to assure those expectations are continually adhered to.

It would be my suggestion to fully understand what your committing your organization to by registering to a prescribed ISO Management System Standard. There will be costs associated with implementing and maintaining such as standard.
 

Sidney Vianna

Post Responsibly
Leader
Admin
If you are going to consider the 2015 revision, then read both ISO 31000 and 31010 and discuss those and the DIS version of 9001:2015 with your legal representatives. There could potentially be huge product liability issues related to the 2015 version of ISO 9001.
Please provide the requirement from the ISO 9001:2015 DIS that, if remains in the final IS, would create ANY NEW product liability issues.

The vast majority of ISO 9001 certified organizations are small enterprises that have no "legal cousel" or equivalent. As long as any organization is in business, they have product liability risks to contend with. Irrespective of the fact if they follow ISO 9001, or not.

As for the need to read (and understand) ISO 31000 and 31010, it is totally unnecessary, in my opinion.
 

Stijloor

Leader
Super Moderator
Please provide the requirement from the ISO 9001:2015 DIS that, if remains in the final IS, would create ANY NEW product liability issues.

The vast majority of ISO 9001 certified organizations are small enterprises that have no "legal counsel" or equivalent. As long as any organization is in business, they have product liability risks to contend with. Irrespective of the fact if they follow ISO 9001, or not.

As for the need to read (and understand) ISO 31000 and 31010, it is totally unnecessary, in my opinion.

A LOT more clarification from ISO TC176 is necessary. If not, it's going to be a big mess. Clear interpretations will be needed to aid organizations and auditors. Example? Even after 15 years, the "Process Approach" is still misunderstood.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
For those just starting out now I would recommend sticking to the 2008 version while you can, I think you can migrate to the 2015 version once you have the procedures and other disciplines set.
 

Big Jim

Admin
I echo Stijloor's comment about the process approach still not being very well understood. Until they provide a better definition than something with inputs and outputs that adds value we will still be adrift.

We do know that there will be a three year transition to the new standard. The intent is that most companies will transition when they are due for recertification.

We also know that ISO considers the two standards to be commercially equivalent so you should not be getting customers pushing you to move to the new standard before you are ready.

Additionally we know that the old standard ends in three years, so if an organization gets registered to the old standard after the new one is published, they will not get a full three years of certification.

And another thing we know is that at the end of two years, auditors will no longer be able to audit to the old standard.

Like others have posted, there is no good reason to wait for the new standard. Move ahead now and you will reap the benefits of certification sooner. You will have plenty of time to transition.
 
Thread starter Similar threads Forum Replies Date
I If i do not want to be an initial importer should i register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
G What should be in the Quality Open Items Register Document Control Systems, Procedures, Forms and Templates 5
T How much information should I keep in my Master Document Register? Document Control Systems, Procedures, Forms and Templates 8
L Question about who should register the foreign medical device establishment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G What information should a nonconformance register contain? Nonconformance and Corrective Action 10
T Should I register for QS-9000 today? QS-9000 - American Automotive Manufacturers Standard 4
S Should we register to QS-9000 or TS 16949? Registrars and Notified Bodies 7
P QS9000 or TR 16949? Which should we register to? Management wants one or the other QS-9000 - American Automotive Manufacturers Standard 4
J What Device Should I use for Gage Study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
T What should be considered or asked to certified body auditors before selecting them for AS9100 Audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
U How should we build the FDA inspection preparedness team for FDA inspections at factories? General Auditing Discussions 0
MaHoDie How deep should be risk control tracebility IEC 62304 - Medical Device Software Life Cycle Processes 3
K Departmental KPI not met - should the Auditor raise a NC for it IATF 16949 - Automotive Quality Systems Standard 10
DuncanGibbons How to determine process stability for a process whose outputs should be steadily increasing? Capability, Accuracy and Stability - Processes, Machines, etc. 4
A CE mark symbol should be on the package? EU Medical Device Regulations 1
M What should be measurement method in control plan if you are defining Control method as work instruction. Manufacturing and Related Processes 5
T Should PMS and PMCF plans be 2 separate documents? EU Medical Device Regulations 8
C When should I take endotoxin testing? EU Medical Device Regulations 3
Dazzur Difficulty in determining who should be addressing NCRs Nonconformance and Corrective Action 9
M Should DoC be updated every time Technical Documentation is revised? EU Medical Device Regulations 2
F How often should Gage R&R's be updated? Is there a recommended time-frame? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Which certificate should I start with from ASQ, CQIA or CQE? (or should I take something else) Professional Certifications and Degrees 4
E Please help! ! I AM FRASTRATED SO MUCH! Should inactive ingredient be included in the unit formula if it is removed during the manufacturing process? US Food and Drug Administration (FDA) 0
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
qualprod Do sum of results of quality objectives should met a high level goal? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Should I perform several Gage R&R for every caliper to cover all specs range of use? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
E Opening meeting for Third-Party Audit--Who should say what? General Auditing Discussions 22
8 MSA--Should I Use Parts or Gage Pins? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
B Should I buy IEC 62304:2006, IEC 62304:2006/AMD 1:2015 or both? EU Medical Device Regulations 1
W "Accurate to ±2%" means "64% of measurements should be within 2% of the actual value"? US Medical Device Regulations 4
H Should we stop inspecting a part if its never been rejected? Reliability Analysis - Predictions, Testing and Standards 6
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 4
M Should there be another column in the Optimization section (step 6) of AIAG-VDA DFMEA form? FMEA and Control Plans 1
C By when should harmonized standards be complied with? EU Medical Device Regulations 5
W Strategy for determining which components from a system should be "ME EQUIPMENT" -- home healthcare environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
B Documented information - Should be controlled? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q Is engineering a process and should it have its own process turtle? IATF 16949 - Automotive Quality Systems Standard 7
P Which MDCG Document should I use for PMS Plan and PSUR? EU Medical Device Regulations 2
M Who should quality representative report to? ISO 13485:2016 - Medical Device Quality Management Systems 5
H When should the first PSUR be issued? EU Medical Device Regulations 5
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
C When should you quit programming? Job Openings, Consulting and Employment Opportunities 9
C Should resolution be included in uncertainty budget for digital caliper or micrometer calibration? Measurement Uncertainty (MU) 5
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
T How should I approach REACH, CM, etc. as a job shop? RoHS, REACH, ELV, IMDS and Restricted Substances 18
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14

Similar threads

Top Bottom