Legal source to purchase a copy of the 9001:2015 Draft

Jaxter

Involved In Discussions
#1
Hi Everyone!

Can anyone recommend a legal resource where you can purchase a copy of the 9001:2015 Draft? I found a website that has a PDF download called

ISO/DIS 9001-2015 Draft
Quality management systems Requirements (Draft)


from Techstreet $78. I have purchased from them before. I purchased my 9001:2008 stds from them. I'm getting ready to update my QAM & QPM manuals and would like to incorporate the new standards in the revisions. Are the drafts for purchase now informative enough to be able to do updates. Will there be any major revisions on the final release compared to the drafts?

Thanks!
Jaxter
:thanx:
 
Elsmar Forum Sponsor
W

Walnut

#2
ISO 9001:2015 is now at the Draft International Stage. The voting just closed on changes for this revision and the next revision should be released next year and the Final release after September of 2015. Any standard you purchase now still may be changed but is good for review of what is likely to be new. It might be a good idea to hold off on any system changes until the Final Draft Release next year. Any changes after that should be minor.
Copies of the DIS standard can be bought from a number of places including ASQ and the ISO web site.
 

Jaxter

Involved In Discussions
#3
Thanks Walnut!

Just want to keep up with the upcoming changes. I am with a small company and all the writing / revisions / audits fall to me so I want to be prepared as much as possible. I've downloaded a lot of info on this subject from posts, so don't want to wait until the last minute to absorb all the new info.

Take Care,
Jaxter
 

Big Jim

Trusted Information Resource
#4
Hi Everyone!

Can anyone recommend a legal resource where you can purchase a copy of the 9001:2015 Draft? I found a website that has a PDF download called

ISO/DIS 9001-2015 Draft
Quality management systems Requirements (Draft)


from Techstreet $78. I have purchased from them before. I purchased my 9001:2008 stds from them. I'm getting ready to update my QAM & QPM manuals and would like to incorporate the new standards in the revisions. Are the drafts for purchase now informative enough to be able to do updates. Will there be any major revisions on the final release compared to the drafts?

Thanks!
Jaxter
:thanx:
Personally, I would not be making any changes yet, just keeping abreast of what the changes are likely to be.

It is DIS status at the moment, and shortly the FDIS (Final DIS) will be published. It seems to be the opinion of some that it is time you can start making changes. That is what I remember reading from a recent publication from one of the bodies that certifies auditors. Their thought is that not many changes are likely to happen on the transition from the DIS to the FDIS, and that no changes are expected between the FDIS and the actual release.

In other words, the situation is muddy. I'd let the waters clear up a bit first. Study for awareness, but don't act yet. But that's just my opinion for whatever it is worth.
 
Thread starter Similar threads Forum Replies Date
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
D Legal complications when using open source, freeware, shareware, etc. IEC 27001 - Information Security Management Systems (ISMS) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Donating sterilizing gel - Is it legal in Europe? EU Medical Device Regulations 1
A MDR Article 22 applicability - Legal manufacturer EU Medical Device Regulations 6
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Complaints and not the legal manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 20
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 22
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
M End of Life or Device transfer regulations for Legal Manufacturer Other Medical Device Regulations World-Wide 1
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
R In this type of Legal Manufacturer-CMO arrangement, what happens to the DHR? ISO 13485:2016 - Medical Device Quality Management Systems 1
J What are a Taiwanese Medical device subcontractor's legal responsibilities with Taiwan regulations? Other Medical Device Regulations World-Wide 2
B Interesting Discussion The legal aspects of Customer Specific Requirements (Contract Law). IATF 16949 - Automotive Quality Systems Standard 12
D EU MDR - Contract Manufacturer vs Legal Manufacturer EU Medical Device Regulations 4
C Legal or Regulatory Requirements as identified in our Environmental Aspects ISO 14001:2015 Specific Discussions 9
A Risks and Opportunities associated to Legal Compliance - 6.1.3 ISO 14001:2015 Specific Discussions 4
C Legal requirement for same indications as in Country of Origin Other Medical Device Regulations World-Wide 4
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
J Medical Devices sourced from Contract Manufacturers - Who is the legal manufacturer? EU Medical Device Regulations 13
amjadrana Legal Representation in Canada (Medical Devices) Canada Medical Device Regulations 1
R Is it legal to attend a trade show while you have a 510(k) application pending? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Bankrupt Legal Manufacturer and Its Products EU Medical Device Regulations 8
H Who is the Legal / Labeled Manufacturer? (Contract Manufacturers shipping to the EU) ISO 13485:2016 - Medical Device Quality Management Systems 1
L ISO 14001:2004 - Legal and Other Requirements ISO 14001:2015 Specific Discussions 4
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
A Is the Labour Code one of the legal requirements of ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Definition Legal Hold Notice - What is a Legal Hold Notice? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
B Taiwan Medical Device registration - Production or legal office Other Medical Device Regulations World-Wide 6
K ISO 9001:2015 and its Legal Ramifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S What is the Legal Limits of Fungi in Poultry Feed Food Safety - ISO 22000, HACCP (21 CFR 120) 2
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
somashekar Applying legal requirements in hazardous waste management. Miscellaneous Environmental Standards and EMS Related Discussions 1
A Active Implantable Medical Devices - Legal Traceability Requirements ISO 13485:2016 - Medical Device Quality Management Systems 7
O Medical Devices - Legal Manufacturer and Real Manufacturer EU Medical Device Regulations 5
C Battery Powered Beauty Products minimum Legal Certifications Requirements CE Marking (Conformité Européene) / CB Scheme 7
S OHSAS 18001 - 4.3.2 Legal and Other Requirements - Working document or template Occupational Health & Safety Management Standards 2
A One Medical Device - Two Legal Manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 5
cscalise Legal Obligation to report ISO 13485 Finding to FDA? Registrars and Notified Bodies 1
M Changing a Chinese Legal Agent China Medical Device Regulations 5
G How to approach ISO 50001 Legal Requirements Sustainability, Green Initiatives and Ecology 1
U Do we have to have foreign legal documents? (ISO13485 4.2.3 document control) ISO 13485:2016 - Medical Device Quality Management Systems 3
S Evaluation of legal compliance to ISO 14001 and OHSAS 18001 ISO 14001:2015 Specific Discussions 18
I International Sales Legal/Regulatory Gray Area? CE Marking (Conformité Européene) / CB Scheme 3
B What does this clause mean? 4.2.3 - Legal and Other Requirements ISO 14001:2015 Specific Discussions 7
Similar threads


















































Top Bottom