Integrate our system with ISO 9000:2000

A

alexi

#1
This is Alexi
Our company is ISO 9002 certified since September 1999. Our first surveillance will be on March 2000. In connection to the coming version of ISO 9000:2000, is it true that we could update our system in line to ISO 9000:2000 on our third surveillance or we could just update it right after the official release of ISO 9000:2000? And what will happen to our previous documentation after we change the system? I hope you could help me ..By studying ISO 9000:2000, it already gives me a headache, that's whay I want to have some advance information from the experts..
Thanks for reading my mail....
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Leader
Admin
#2
I can't remember the specifics, however I think you have a year or 2 after release of ISO9001:2000 (Dec 2000?) to comply.
 

barb butrym

Quite Involved in Discussions
#3
the registrars are starting to add some of the requirements to the audits now....as "opportunities for improvement" only of course...just to get you looking at them. The typical requirement is you will start being assessed (ever so gingerly, reporting the status quo) at the first visit after the final release, and you have 2 years to pull it together, some say 3 visits. Its pretty much registrar dependant how they phase it in.
My suggestion is to get a hold of a cross reference, add your stuff to it, make it part of the QA manual...start to address the holes if there are any. Then if you want to attack the entire system format, you have all the time in the world...as a change is not required, just compliance to the content.
The cross reference will guide you and the auditor anywhere you need to go.

Lets not forget......the auditor will be converting his thought process as well....the new standard will be a bear to audit, given how difficult it is to teach an old dog new tricks.

[This message has been edited by barb butrym (edited 18 January 2000).]
 
C

Christian Lupo

#4
The RAB discourages ISO-9000:2000 registration before the document is officialy released (11/2000). Which means accredited registrars probably will not issue any certification until 11/00. The RAB's official policy is that it is ok for registrars to perform "baseline" audits to the 2000 standard by adding a little time on to surveillance (or registration) audits. This will not be considered consulting. From the time the standard is released, compaies will be given 3 years to upgrade to the 2000 revision. Companies will be able to be certified to the 1994 version 6 months after the release of the 2000 revision, after which all new registrations must be to the new standard. During that 6 month period registrars are allowed to issue certificates to either version.
 
R

Russ Jackson

#5
Alexi, your registrar should provide you with some information on their plans and process for assessing your quality system to the new standard and the time frame for you to achieve compliance. It will not occur in a short time. They allow reasonable time for you to make the transition. Make sure that this is a point of discussion when you have your surveillance in March. The Registrar can make noises about using the 2000 version but they cannot reasonably expect you to initiate any significant changes until the standard is published.
 
M
#6
You may find some valuable info on the official website for ISO & TC176. Basically you can start to implement new concepts raised in y2k revision as soon as you feel confident.
We are offering to audit our clients to 9ky2k requirements, and identifying areas which have not been addressed. I have re-written our self-evaluation checklists around ISO9001:2000(DIS) and our training courses also include new requirements. We have been conducting process-focussed audits for the last 3 years so that is not an issue for most of our clients (or auditors). Where clients have documented their system around the clauses of the system, we have said they will not need to rewrite the structure around the 4 sections of the 2000 revision although they will have to make sure they have inserted any additional requirements. Also, the current revision is DIS (draft international standard) which may change potentially prior to its launch as a standard towards the end of this year. Also, the transition period should be three years from the issue of the standard, so you are looking at around Nov 2003 to have your system ready. No need to panic!

------------------
Mark G.
 
Thread starter Similar threads Forum Replies Date
S Can we integrate both ISO 9001:2015 and API Q1 Management System Standards Quality Management System (QMS) Manuals 11
E System Integration - How to integrate ISO 14064 and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H How to integrate ISO 9001:2000 with ISO 22000 (Food Safety Management System)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H How to Integrate System Audit, Manufacture Process Audit and Product Audit Process Audits and Layered Process Audits 5
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
Y How can i integrate ISO 13845 into ISO 27001? ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO 13485:2016 - How I can integrate a risk management approach in our SOPs ISO 13485:2016 - Medical Device Quality Management Systems 1
B Shop Drawings that Integrate Information from a Database Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D How to integrate SQF with ISO 9001:2008 Food Safety - ISO 22000, HACCP (21 CFR 120) 5
H How to integrate ISO/TS 16949 & ISO9001 Quality Systems - Plastic Injection Mold IATF 16949 - Automotive Quality Systems Standard 7
M To Integrate or not to Integrate (ISO9001, ISO14001 & OHSAS18001) Miscellaneous Environmental Standards and EMS Related Discussions 2
P An IMS organization can integrate CMMI with IMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
F How to Integrate Audits and Audits Schedule - ISO 9001 and OHSAS 18001 Occupational Health & Safety Management Standards 2
Y Program which will Integrate all of our PPAP forms Document Control Systems, Procedures, Forms and Templates 5
BradM How to Integrate ISO 17025 with current QMS ISO 17025 related Discussions 23
S I'm looking for handbook to integrate ISO 9001, ISO 14001 and Ohsas 18k Book, Video, Blog and Web Site Reviews and Recommendations 4
G The most effective way to integrate CMDCAS requirements into Quality Manual ISO 13485:2016 - Medical Device Quality Management Systems 4
Q What if I want to integrate Policy of QMS, EMS and OHS-MS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D What are the master steps to integrate Iso9001 in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
G Software verification vs. system verification IEC 62304 - Medical Device Software Life Cycle Processes 3
D Electronic Document Management System ISO 13485:2016 - Medical Device Quality Management Systems 6
N Computerized System Validation ISO 13485:2016 - Medical Device Quality Management Systems 8
R First Time Managing Calibration and Measurement System. Need Help. General Measurement Device and Calibration Topics 11
F Protection from mains in a ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T What is a Quality Management System? Manufacturing and Related Processes 18
W Posting Non-Quality System instructions on the Production Floor Manufacturing and Related Processes 13
U FSC Due Diligence System (DDS) summary report... Sustainability, Green Initiatives and Ecology 0
T MDR PMS System Vs. Plan Vs. Procedures EU Medical Device Regulations 3
C. Tejeda Computer system validation approach for Minitab Statistical software Software Quality Assurance 7
M Sterile barrier system with outer protective packaging Symbol EU Medical Device Regulations 10
L ISO 11607-1 Packaging system validation Design and Development of Products and Processes 9
Sidney Vianna IATF 16949 News IATF Performance Complaint Management System (IATF CMS) within the IATF Database IATF 16949 - Automotive Quality Systems Standard 4
J Cloud Based System Qualification and Validation (including 21 CFR Part 11) 7
E Verifying our build system IEC 62304 - Medical Device Software Life Cycle Processes 2
D Class III license: Add new device to the license system Canada Medical Device Regulations 1
PQ Systems Recipe for Success! 10 Ingredients for a Healthy Gage Management System Using GAGEpack Software 0
T ISO quality system software such as MQ1 (which is what we currently use) Document Control Systems, Procedures, Forms and Templates 8
I CQI-15 Welding System Assessment 2nd edition - Does not require Ultrasonic Welding anymore? Customer and Company Specific Requirements 0
A Product Update and executing only affected System Tests, leaving out unaffected ones IEC 62304 - Medical Device Software Life Cycle Processes 5
L Language of quality system in case of FDA inspection US Food and Drug Administration (FDA) 1
blackholequasar Validation of new ERP system ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Vision system process validation Manufacturing and Related Processes 1
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
E Marketing, product and system requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Structure Technical File for a system EU Medical Device Regulations 0
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
PQ Systems Audit Prep – Time for a System Health Check Using GAGEpack Software 0
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
A Applying agile model for Computer system Validation Medical Device and FDA Regulations and Standards News 3
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 7

Similar threads

Top Bottom