ISO DIS 9001:2000 - Interim Standard

K

Karen

#1
ISO 9001:2000 DIS?

One day left for delivery of DIS. Will it be on time? I am still confused about some of the allignmnet of the old 4.10,4.12, and 4.9. Are 4.10 and 4.12 now combined under 8.2.3? And how is 4.9 split up? I am implementing a Quality Management System in a company that is new to ISO so we are documenting it in the revised format.

As usual, thank you in advance.
 
Elsmar Forum Sponsor
D

David Mullins

#2
As you may have read elsewhere, and I can confirm for you (as I am holding it in my hand - THE STANDARD), Australia has already (November 15th) published the ISO/DIS 9001:2000 standard as an Australian and New Zealand Interim Standard.
 
R

Roger Eastin

#3
I'm not sure how you get a hold of the Australian version, but in the States I think you'll have to wait for ASQ and/or ANSI to publish it. The last that I read on this is that it will be late November or December before it is published here. Since this is the last day of November and there doesn't appear to be any sign of it yet, December is our month! Maybe our Australian colleagues could answer any specific questions that you have, though.
 

Marc

Fully vaccinated are you?
Leader
#4
I got the CD2 draft from BSI - but it was expensive - like US$50 or so. I haven't really looked yet for the 'latest'.

There is a matrix near the front of the CD2 draft which 'aligns' the 2000 version with the 1994 revision.
 
D

David Mullins

#5
In regard to Karen's original alignment problem, ISO/DIS 9001:2000 provides the matrix at Annex B. '1994' clause 4.10 corresponds to 7.1 + 7.5.1 + 8.1 + 8.2.4 of '2000'. clause 4.12 corresponds to 7.5.1
I'd suggest that one system level procedure would cover the field for these for most companies.
4.9 corresponds to 7.1 + 7.5.1 + 7.5.5

P.S. some of the clauses/requirements have been deleted and softened from CD2.

Standards Australia also has a handbook which explains the changes from ISO 9001:1994 to ISO/DIS 9001:2000.
 
J

James Gutherson

#6
As David said, the standard is out in Australia as an 'interim standard', meaning you have to you pay for it rather than getting a free copy of the DIS. That aside you can download a copy of 9001 from the Australian Standards Association website at ***DEAD LINK REMOVED*** for A$30.60 which is about US$20 at the moment or you can get 9004, which has all the elements from 9001 and goes further into the contineous improvement side of things, for A$42.30 (US$27).
The copy of 9004 does'nt have the conversion matrix however, maybe David can tell us if 9001 does, but I would think that 4.10 (Inspection and Testing) and 4.12 (Inspection and Test Status) would now be covered by 8.2.3 (Measurement and Monitoring or Product). BTW my copy of 9004 shows it's own item 8.2.3 as 'Measurement and monitoring of product', but it shows the 9001 item 8.2.3 as 'M & m of processes'. I think this is a misprint. Anyway I feel 4.10 and 4.12 would fall under 'M & m of product' what ever it's number.
As to 4.9 (Process Control) it is really covered in several places in 7 (Product Realization) (Note how ISO have corrupted our spelling of 'realiSation'). 7.1 addresses the Planning aspect from 4.9, 7.5 looks at the procedures for producing, verifying, delivering and servicing the product. We now jump out to 6.3 and 6.4 for the facilities and work environment and then over to 8.2.3 (or what ever) for measurment and monitioring of the product before coming back to 75. for maintenance of the equipment.
That's my interpretation anyway.
My advice, don't get to hung up about the numbers and which pidgeon hole to put them into, you probably do most of the things asked for anyway or you wouldn't be in business. Read the paragraph, work out what the intent, and ask your self "How do we handle that?"
The new structure is, to me anyway, far more logical and easier to follow and a big improvement. (It's actually 90% in line with the way I structured my system 2 years ago, well done ISO!)
 
R

Roger Eastin

#7
For those of you in the States, the following might be of interest:

"Mid-Week Announcements from the ISO 9000:2000 Discussion Group

***DEAD LINK REMOVED***

December 1, 1999

FIRST NOTE: Many of you have been asking when the draft international
standard ISO 9001:2000 will be available to the public. The ASQ in the
United States called me yesterday to say that January 15, 2000 is the
official release date in this country. Mark your calendars and call them
at 800-248-1946 to get a copy."

So much for December, but at least we have a date!!
 

Marc

Fully vaccinated are you?
Leader
#9
ISO 9001:2000 Discussion (Sponsored by the ISO 9000 Support Group)
***DEAD LINK REMOVED***

December 3, 1999

The ISO 9001:2000 DIS is out!

On December 1st I finally got my copy of the draft international standards 9000, 9001, and 9004. We’ll discuss these first. The replies to this week’s discussion are below.

A comparison of the DIS of ISO 9001 and the second committee draft indicates that a rope was thrown around CD2 and drawn tight to squeeze down the standard. The language of the DIS is tight and concise. There are still a few mistakes to be cleaned up, but the DIS has the same requirements as the second committee draft.

There are some minor changes to note. For one, Legal Requirements as a separate sub-element has been dropped. Instead, it is mentioned as being part of the quality management system. The quality manual has to contain justification for exclusions from the requirements of the standard. Infrastructure has changed names to "Facilities," reflecting a better definition of its scope. A good part of Section 8 has been reduced in language and combined with similar requirements to create a better element on Measurement.

Therefore, we can proceed as before with a discussion on the upcoming standard without the need to change much from previous discussions. Monday, we will continue with Section 6. The difference now is that I will have the DIS. If you want the DIS you need to live in a country that has released it, such as England, Sweden, or Australia. The U.S. readers might have to wait over a month to get a copy. However, copies can be purchased on the internet at the Standards Australia site.

If you have found any dramatic changes in the DIS, let us know.
 
R

Roger Eastin

#10
I was browsing the ISO.ch website and tucked away in the discussion of ISO9000:2000 was a little "blurb" on ISO19011 (called "Environmental Management"). ISO19011(for those of you, like me, that never heard of it) is the absorption of ISO9000 into ISO14000. One grand environmental and quality standard that is due for release in the fall of 2001!

EDITING NOTE: in the ISO 10011 Dead - 19011 Evolves thread, Dennis Arter states:
ISO 19011, the integrated standard for internal auditing of quality and environmental management systems, isplanned for release as a DIS in the September-October 2000 time frame to correspond with the release of ISO 9001:2000 as an FDIS. This will be one of the four core documents contained in the ISO 9000 family.
I had heard that discussions were taking place to do this, but I didn't know that its release was that close(close by ISO standards, anyway!). Has anyone seen a copy of this document? According to the ISO.ch site, the Committee Draft (CD) has been released. Again, just when you thought it was safe to come out and not be pelted by yet another standard...here it comes. (This must be the ISO version of a Stephen King novel.)

[This message has been edited by Marc Smith (edited 22 December 1999).]
 
Thread starter Similar threads Forum Replies Date
P ISO/DIS 9001:2015 Vs ISO 9001:2008 in a Food Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B The 25-04-2000 Vote - Did the vote about DIS ISO 9001:2000 obtained 75% of yes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Marc Implement to the DIS of ISO 9001:2000 now? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Marc ISO Releases DIS Versions of ISO 9001 Year 2000 Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
Marc Validation Program for ISO/DIS 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
K ISO 9001:2000 DIS? One day left for delivery of DIS. Will it be on time? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
Richard Regalado Informational ISO/IEC DIS 27002:2022, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 1
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 6
T CEN/TS 12390-9, ISO-DIS 4846, CEN/TR 15177 Information needed Other ISO and International Standards and European Regulations 3
G ISO/DIS 14045 - Anyone have an early draft copy? Miscellaneous Environmental Standards and EMS Related Discussions 2
R ISO/DIS 9004 Managing for the sustained success of an organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Marc Adobe's PDF Format Is Now ISO 32000 DIS Other ISO and International Standards and European Regulations 1
W New draft: ISO/DIS 27799: Health Informatics - Security Management in Health Other ISO and International Standards and European Regulations 3
Govind ISO/DIS 17021 vs. Guide 62 and 66 - What are the differences and comparisons? Other ISO and International Standards and European Regulations 15
S DIS ISO 14001 Vote and TC207 SC1 Meeting 1-3 March 2004 (Paris) ISO 14001:2015 Specific Discussions 23
Claes Gefvenberg ISO 14001:2004 DIS (Final Draft) due March 2004 ISO 14001:2015 Specific Discussions 52
L ISO/DIS TS16949:2002 IATF 16949 - Automotive Quality Systems Standard 9
L Customer Related standards in ISO/DIS 9000:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Marc ISO/DIS 10015 Guidelines for Training Other ISO and International Standards and European Regulations 3
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 62
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L ISO 20417 crucial changes Other Medical Device Related Standards 1
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
LabCat Internal SOP for a validated (ISO) method? ISO 17025 related Discussions 2
L Confusion about ISO 14644 Other Medical Device Related Standards 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
Q ISO Training Providers to fix careless workers? Training - Internal, External, Online and Distance Learning 19
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10

Similar threads

Top Bottom