How can I revise my QMS documents to meet requirements of ISO 9001: 2008

K

K.Vinay kumar

#1
We already had documentation and procedures for our Company's QMS as ISO 9001 : 2000 but how can I revise these documentation and procedures based on ISO 9001 : 2008
 
Elsmar Forum Sponsor

Stijloor

Leader
Super Moderator
#2
We already had documentation and procedures for our Company's QMS as ISO 9001 : 2000 but how can I revise these documentation and procedures based on ISO 9001 : 2008
No changes required. Now, if you included the year 2000 in any document references, you may want to delete the year, or change it to 2008. That's it.

Stijloor.
 

Le Chiffre

Quite Involved in Discussions
#3
The only condition my registrar stated was that we had bought a copy of the 2008 standard, I guess that was reasonable.
 
#4
We already had documentation and procedures for our Company's QMS as ISO 9001 : 2000 but how can I revise these documentation and procedures based on ISO 9001 : 2008
As you review your existing documentation and procedures, do make a check if you have :
1. A procedure for maintenance and disaster management of your communication system, (your central database servers, e-mail servers., etc..)
2. Determined and met the requirement of adequate lighting in your facility to meet your activities performed.
 

SteelMaiden

Super Moderator
Trusted Information Resource
#5
Make sure you check out the related discussions listed at the bottom of this page. Basically, you need to get a copy of the standard, look at what changes were made and see if any of them affect your system...taking that one step further, I'd suggest that you document the fact that you did the review along with any (if any) changes you decide on.
 
#6
As you review your existing documentation and procedures, do make a check if you have :
1. A procedure for maintenance and disaster management of your communication system, (your central database servers, e-mail servers., etc..)
2. Determined and met the requirement of adequate lighting in your facility to meet your activities performed.
Why does anyone have to do these things? Could you please explain for the benefit of others who may have the same question, why upgrading to ISO 9001:2008 would necessitate this?
 
#7
Why does anyone have to do these things? Could you please explain for the benefit of others who may have the same question, why upgrading to ISO 9001:2008 would necessitate this?
Clause 6.3 (Infrastructure)
More clear includes information systems as example

Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is
performed and includes, for example physical,
environmental and other factors such as noise,
temperature, humidity, lighting, or weather

There could be many more finer things done to make the QMS more robust. The attached presentation is just one example of the interpretation.
Some of the other could be defining outsourced processes and the controls established, identification of any customer supplied intellectual property that is managed by the organization, if not really focused in the existing QMS of the organization.
 

Attachments

Randy

Super Moderator
#8
Take out any reference to the revision year and then leave 'em alone...With the understanding that they are coreect and conforming to begin with
 
Thread starter Similar threads Forum Replies Date
E Preparing for the ASQ CPGP (GMP professional exam), how to revise and remember the vast syllabus? ASQ - American Society for Quality 2
qualprod Annual SWOT for 4.1? I plan to revise quality objectives and strategic route ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Is it mandatory to revise MSDS every three years? ISO 14001:2015 Specific Discussions 3
T Revise Quality Manual when a Company Reorganizes? Document Control Systems, Procedures, Forms and Templates 4
S Revise or to Not Design Input Document for On-Market Cleared Class II Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Is there a Need to Revise all Documents due to Changes in Company Logo? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Do we need to revise our Quality Policy for ISO/IEC 17025:2005? ISO 17025 related Discussions 2
Randy The Need to Update / Revise Work Instructions and Procedures Miscellaneous Environmental Standards and EMS Related Discussions 5
S Disparity between Job Descriptions in QMS & Contract ISO 13485:2016 - Medical Device Quality Management Systems 6
qualprod Minimize tomention other positions to ease the QMS management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S QMS certificate and Samlping EU Medical Device Regulations 0
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
Y Must Initial importers have any QMS? US Food and Drug Administration (FDA) 1
qualprod QMS global effectiveness? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q 13485 QMS turnkey ISO 13485:2016 - Medical Device Quality Management Systems 10
K New to Medical Device QMS and would like advice ISO 13485:2016 - Medical Device Quality Management Systems 9
N QMS standard for a research based Organisation Quality Manager and Management Related Issues 1
Moncia Integrated QMS and audit Other ISO and International Standards and European Regulations 5
J New QMS Auditor - seeking opportunities to gain audit experience Career and Occupation Discussions 3
Sam Lazzara Record signature requirements in proposed FDA 21 CFR 820 QMS Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
qualprod External consultant into a QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S Changing PCB Assembler and impact on QMS and MDD CE Certificate EU Medical Device Regulations 2
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
A CDRH Learn and DICE for Building a QMS 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A QMS inside a Non medical device firm ISO 13485:2016 - Medical Device Quality Management Systems 4
S HELP in setting-up QMS Quality Tools, Improvement and Analysis 4
S How long the QMS must be maintained after device EOL? ISO 13485:2016 - Medical Device Quality Management Systems 6
K Processes interaction of QMS Process Maps, Process Mapping and Turtle Diagrams 4
P Can I exempt products/services from my AS9100 QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J0anne QMS Implementation Iran ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
Watchcat When to begin putting together postmarket production QMS for a mobile app? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
B QMS Functional Safety Checklist ISO 26262 - Road vehicles – Functional safety 0
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
M Sharing QMS Documents with Customers Document Control Systems, Procedures, Forms and Templates 13
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D QMS Realignment after business splits into 2 different companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
A SaaS SaMD - Impact QMS ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO9001 QMS: Quality Manual Examples & Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
qualprod Can a consultant be audited instead of QMS responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
Ed Panek How to address a QMS Entry Error ISO 13485:2016 - Medical Device Quality Management Systems 8
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
R QMS for Medical products & Pharmaceutical Drugs in one facility Medical Device and FDA Regulations and Standards News 3
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 10

Similar threads

Top Bottom