Procedures - New Revision or Original Issue - Upgrading to ISO9001:2000

C

C Emmons

#1
I have a silly question: I made the decision to keep all of the existing procedures under the previous ISO 9002:1994 standard. I am an the process of renumbering to and adding the new requirements in some of the existing procedures.

should I

A) Consider the procedure w/ new requiements as a revision to to old procedure?

B) Consider it an orginal issue again?

C) Does not really matter!
 
Elsmar Forum Sponsor
K
#2
Done it both ways-

Retired (documented the retirement) the "old" and issued as a new document number the "revised" procedure.

Rev'd up the "old" procedure keeping the same number.

Both worked, whichever is easier.;)
 
M

Michael T

#3
Re: New Revision or Original Issue

C Emmons said:

I have a silly question: I made the decision to keep all of the existing procedures under the previous ISO 9002:1994 standard. I am an the process of renumbering to and adding the new requirements in some of the existing procedures.

should I

A) Consider the procedure w/ new requiements as a revision to to old procedure?

B) Consider it an orginal issue again?

C) Does not really matter!
Not so silly....

I look at it this way... if you are fundamentally changing the content and intent of the procedure with the additions you are making - then it becomes a new procedure. If you are simply revising the procedure to fall in line with the new standard, but are not changing the basic premise of the procedure - then it is a revision.

Does it matter? I can't say. What's the difference between what you are doing and completely scapping the QMS and starting from scratch? To an auditor - I'd say, no it doesn't matter so long as your QMS reflects the requirments of the new standard. To you... it probably matters a whole lot... :vfunny:

Hope this helps!!!

Cheers!!

Mike
 
C

C Emmons

#4
Thank you for the quick response! Figures - I didnt think about it until I was half way through them!
 
Thread starter Similar threads Forum Replies Date
M Revision date for SOP (Standard Operating Procedures) ISO 13485:2016 - Medical Device Quality Management Systems 43
J Does ISO require that documents/procedures have a page/list of revision histories? Document Control Systems, Procedures, Forms and Templates 10
C Revision History Page on Procedures Back/Front of Doc Document Control Systems, Procedures, Forms and Templates 10
C Guidelines on record retention of obsoleted calibration procedures (Revision History) Records and Data - Quality, Legal and Other Evidence 9
T Errors & Omissions in Creating QMS Procedures AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
H Can Non-conforming outputs & Non-conformity & Corrective Action procedures be merged Nonconformance and Corrective Action 8
M AS9100 examples of procedures, quality manual, etc. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
T NDT Procedures Oil and Gas Industry Standards and Regulations 3
D ISO 9001:2015 Calibration Procedures Manufacturing and Related Processes 16
T MDR PMS System Vs. Plan Vs. Procedures EU Medical Device Regulations 3
B For professionals from an amateur: What are the differences between some plans and procedures? EU Medical Device Regulations 5
S Procedures and BPF about management of psychotropic pharmaceutical waste Medical Device and FDA Regulations and Standards News 0
T Help with updating procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6
C Calibration Procedures and ASTM CALIBRATION standard General Measurement Device and Calibration Topics 7
L PFMEA for test procedures (ISO 14971) ISO 14971 - Medical Device Risk Management 5
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Alternative Practices and Procedures Other US Medical Device Regulations 0
normhowe Procedures Only Grow; They Never Shrink. Quality Manager and Management Related Issues 30
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
Y Procedures on Contract Review Document Control Systems, Procedures, Forms and Templates 3
L Separate Corrective Action and Preventive Action Procedures ISO 13485:2016 - Medical Device Quality Management Systems 13
L Where to place the what/when/how/who/where procedures in a multi-regulation AS9110C organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
R Scientific Operating Procedures For Sterilization Practices in India PSA/2012/1 Other Medical Device Regulations World-Wide 0
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
DuncanGibbons Are the IQ OQ & PQ procedures applicable to the aerospace industry? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 10
A Recall/Adverse event report procedures in Kuwait/Qatar/Kenya Other Medical Device and Orthopedic Related Topics 3
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
F Recommended practice for furnishing Technical Procedures ISO 17025 related Discussions 1
B Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 Clause 7.4.1 - Requirements for Procedures ISO 17025 related Discussions 4
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N ISO 9001: 2015 - Example standards policies, procedures, acknowledgements and checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Quality System Processes without Documented Procedures Document Control Systems, Procedures, Forms and Templates 39
L IATF 16949 requirements for Product Safety Procedures IATF 16949 - Automotive Quality Systems Standard 14
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
M FDA News The FDA Issues Final Rule on Medical Device Classification Procedures Medical Device and FDA Regulations and Standards News 0
K Assigning the Correct Procedures Applicable to Job Titles General Auditing Discussions 15
M Medical Device News FDA's Policies and Procedures Should Better Address Postmarket Cybersecurity Risk to Medical Devices Other US Medical Device Regulations 0
Q MDSAP Regions and how to include in procedures Other Medical Device Related Standards 2
M Translate Procedures into Spanish Other Medical Device Regulations World-Wide 5
J Nonconforming product procedures SOP help :) Nonconformance and Corrective Action 2
P How to have employees buy-in of quality procedures. Best practices? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M IATF Clause 8.4.2.2 - What procedures does this apply to? IATF 16949 - Automotive Quality Systems Standard 1
S Which ISO 9001 Clause applies to "Procedures are outdated"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 31

Similar threads

Top Bottom