Changes I have to make in the QMS - ISO 9000:2000 to ISO 9000:2008

S

Shripad Panvalkar

#1
Hi all,

What all changes I have to make in the QMS while shifting from ISO 9000:2000 to ISO 9000:2008 ?
 
Elsmar Forum Sponsor
V

vipin_kumar

#2
Re: shifting from ISO 9000:2000 to ISO 9000:2008

As far as i understood the folowing are the main changes
1. Selection and evaluation criteria for venders/sub-contractors must be there and there progress must be monitored. i.e. the responsibility lies with the organization itself.
2. Effectiveness of the corrective action to be monitered.
3. MR should be an employee of the organization and pereferbly from management.
4. other changes are minor changes and are at the backside of 2008 standard.

Regards
Vipin
 

Big Jim

Super Moderator
#3
Re: shifting from ISO 9000:2000 to ISO 9000:2008

I would suggest that you contact your registrar and see if they have some sort of a summary of the changes. Many do.

There are no new requirements. The revision essentially cleaned up some minor ambiguities discovered since publication of the 2000 version.

You need to confirm that your understanding and practice is in line with the revisions. Many companies do not need to make any changes other than replace ISO 9001:2000 with ISO 9001:2008 in their documentation. It would be best to keep some sort of a record to show your auditor that you did confirm that you considered the wording changes.

If your registrar does not have such a summary, PM me and I will send you one.
 
D

DrM2u

#4
Hi all,

What all changes I have to make in the QMS while shifting from ISO 9000:2000 to ISO 9000:2008 ?
Here is the answer you are seeking::read:

- Get your copy of ISO 9001:2008; if you don't have one, buy one
- Look at Annex B; it highlights the changes from 2000 to 2008 version as addtitions or deletions

Overall, there are no major/significant changes. Most changes are clarifications on old requirements. There are a few minor additions but nothing puzzling. Your rgistrar should be able to provide you with some guidance over the phone or a gap analysis during the next audit.

Corrections to Vipin's reply:
- the requirement IS NOT for the MR to be an employee of the organization, it IS for the MR to be part of the organization's management
- there are no changes to clause 7.4 (selection criteria and monitoring of suppliers)
 

Randy

Super Moderator
#5
You really don't have to do anything different as previously stated.

Stay away from people that say you have to change because lightning going to strike real close.
 
Thread starter Similar threads Forum Replies Date
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
supadrai Changes to QMS - Contract Term ISO 13485:2016 - Medical Device Quality Management Systems 4
M Notifying Registrar of Significant QMS changes ISO 13485:2016 - Medical Device Quality Management Systems 2
R QMS changes before Annual External Audit Quality Manager and Management Related Issues 8
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
S Customer Provide Control Procedure & Changes of Products and QMS Control Procedure ISO 13485:2016 - Medical Device Quality Management Systems 5
A Management Review Input - Changes that could affect the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Aware of Subtle change from AS9100B - QMS Documentation and Changes (4.2.1) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
G Reporting QMS changes to third party auditors (certification bodies aka registrars) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Kind of Changes that affect the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D No Changes in the QMS since last audit - Need to Re-audit for coming Surveillance? Internal Auditing 17
Q QMS documentation changes - Typos and grammar corrections ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Inform Customer of Changes to QMS (Quality Management System)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sean Kelley Changes that affect the QMS in Management Review - Clause 5.6.2 Management Review Meetings and related Processes 2
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 2
R What are the changes in 5th Edition of FMEA manual? FMEA and Control Plans 6
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M What are the changes in supervising according to ISO17025? ISO 17025 related Discussions 7
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
A Changes to an already certified product (IIb, MDR) EU Medical Device Regulations 1
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
J Ethicon suture box design changes - 2019 Other Medical Device Regulations World-Wide 2
E Changes to medical device submitted through a variation? EU Medical Device Regulations 1
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1

Similar threads

Top Bottom