Changing from ISO9000 to ISO9001:2000 need help

S

sjrutland

My question is do I have to change my quality manual or is the one I have for ISO9000 good enough? I am new to ISO so if this seems like a really dumn question I apoligize. But even if it is dumn I still need an answer. I thank you all. I have learned so much from this forum. I am still very much a rookie but I am learning.

Stan :confused:
 
Wes Bucey

Wes Bucey

Prophet of Profit
sjrutland said:
My question is do I have to change my quality manual or is the one I have for ISO9000 good enough? I am new to ISO so if this seems like a really dumn question I apoligize. But even if it is dumn I still need an answer. I thank you all. I have learned so much from this forum. I am still very much a rookie but I am learning.

Stan confused.gif
Click to expand...
Essentially you need to perform a "gap analysis" to determine the "gaps" between your current system and the updated ISO9k2k (my shorthand for ISO9001:2000)

ISO has tips and documents to help you. Go here
http://www.iso.org/iso/en/iso9000-14000/iso9000/selection_use/implementing.html
for a quick overview of implementing ISO9k2k. Search throughout the Cove and elsewhere for "gap analysis" "upgrading ISO" and other terms which other Covers suggest.

One thing to keep in mind - this may seem daunting, but lots of folks have done it and it can be tedious, but not painful.

In terms of changing your manual, why not take a look at the thread:
http://elsmar.com/Forums/showthread.php?t=4866&highlight=four+page
and you may be induced to convert your current manual to a process-oriented one which may be more useful to your organization in the long run.
 
Al Rosen

Al Rosen

Leader
Super Moderator
sjrutland said:
My question is do I have to change my quality manual or is the one I have for ISO9000 good enough? I am new to ISO so if this seems like a really dumn question I apoligize. But even if it is dumn I still need an answer. I thank you all. I have learned so much from this forum. I am still very much a rookie but I am learning.

Stan :confused:
Click to expand...
That depends upon what your manual now says, but more than likely you will need to tweak it some. Do a search in the forum for threads that address this subject. Here's one to start.
 
Q

qualitygoddess - 2010

What the Registrar Says

Much as we don't like to hear it, the layout of the manual is often dictated by some requirements from the registration firms. For example, there is one well-respected firm that wants to see an index that provides cross-references of your manual section to the ISO 9001:2K standard and to procedures. They cannot give you a nonconformance, but the registrar will ask you to make this reference to "help" their auditors be more effective. It is in your interest to do so, because then the auditor spends less time at your facility looking for the references.

I suggest you speak to your registrar. Many times they also offer helpful website information that can assist you with the transition.

:tg:
 
S

sjrutland

The advise is well taken

Thank you all for the great advise. Our old quality manual is the 100 pages
type so I am going to take the advise to make it as brief as possible but still meet all the requirements. Again I thank everyone who makes getting an answer to a problem very easy and painless.

Stan :yes:
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Changing our DMS/ECM to a Wiki. Advice on best practices and changes of paradigm? Document Control Systems, Procedures, Forms and Templates 0
T New process capability analysis required when changing a product on the same line? IATF 16949 - Automotive Quality Systems Standard 6
N Changing PRRC in Eudamed EU Medical Device Regulations 1
S Changing UK Responsible Person UK Medical Device Regulations 0
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
B How to change hour format to text but not changing the number ? Excel .xls Spreadsheet Templates and Tools 1
A Changing Notified Body EU Medical Device Regulations 6
H Traceability after changing the machine IATF 16949 - Automotive Quality Systems Standard 13
M Changing Investigational Device from Non-Sterile to Sterile - what are the implications? Other Medical Device and Orthopedic Related Topics 3
Q Changing calibration frequency Calibration and Metrology Software and Hardware 18
S Changing revision status of a reviewed document Manufacturing and Related Processes 12
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
D Clothes changing in pharmaceutical factory Manufacturing and Related Processes 8
M Changing supplier of critical raw material (III class device) Other Medical Device and Orthopedic Related Topics 1
K Changing the Address in 510(K) Approved Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T AS9100 - Changing PEARs target AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 41
C FDA on changing acceptance criteria re: analytical method validation US Food and Drug Administration (FDA) 1
V Statistical basis and justification while comparing / changing sampling plans Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 11
K Changing from Procedure based to Process based Competency Evaluations General Auditing Discussions 5
J Steps when changing material for class 1 medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Marc Email Addresses - Changing your email address Elsmar Xenforo Forum Software Instructions and Help 0
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
A IMDS - Changing the Locked Weight Value RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Changing Templates Approval Field Document Control Systems, Procedures, Forms and Templates 5
P Romer Arm - Profile of a Surface Changing General Measurement Device and Calibration Topics 4
D Changing software classification via software - IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
L MINITAB 17 - Changing Data Using Minitab Software 3
S Process validation when changing location ISO 13485:2016 - Medical Device Quality Management Systems 10
Don Fardie CAPA vs. Risk Assessment - Changing a product material for better performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Changing Registrars Registrars and Notified Bodies 15
MDD_QNA Changing the Layout of Medical Device Label(s) CE Marking (Conformité Européene) / CB Scheme 3
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
J Changing of our New Hire Orientation Training Records Training - Internal, External, Online and Distance Learning 12
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Is anyone changing their ISO 14001:2004 EMS Policy? ISO 14001:2015 Specific Discussions 8
Q Changing Terminology in ISO 9001:2015 - Documentation Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Changing Indication of Use for a Class IIa Medical Device EU Medical Device Regulations 2
B Changing out Thermocouple - Is new calibration required? General Measurement Device and Calibration Topics 1
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
shimonv Changing the Label of a Medical Device product in the field Other US Medical Device Regulations 5
E Information required about changing an off shelf part 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Changing FMEA template to include Detection Ranking for the PFMEA FMEA and Control Plans 2
WCHorn Changing Sampling Accept Number to Zero, Arbitrarily AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
M Amending CFDA Registration for changing site of shipment China Medical Device Regulations 2
S Gage R&R on Potentially Changing Parts - Guidance Needed Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R Re-registration of medical device in Russia - "changing holder" Other Medical Device Regulations World-Wide 1
R Changing CE Mark on Documentation ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom