SBS - The Best Value in QMS software

Legal Register - Does anyone have an example of a legal register?

R

Richard W

#1
Does anyone have an example of a legal register - or could explain how one is maintained.

I have a number of things we need to comply with

Packaging waste regs / WEE directive / product testing legislation etc. But all of this stuff is all over the place.

Legal register maintenance is on my audit agenda, so other than the fact I know it is a gap and will get picked up, I actually think it would be useful

Any Thoughts

Cheers

Richard
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi Richard,

I did a search in the Post Attachments List - see the green button in the header - and found these two examples for you to look at.

I want to reassure you if I can that there's no one right way to make a legal register. It is just a list of the regulations and other (as in Legal and Other requirements) requirements such as packaging, delivery, temperature controls, and even chlorine-free for some specialty components and the substances they come in contact with. You could arrange them by type, by source, by reason... I see all kinds.
 
R

Reg Morrison

#3
Richard, if you scroll down this page, you will find 5 similar discussion threads. The search feature in this forum is very powerful. Please try it.
 

Colin

Quite Involved in Discussions
#4
It depends on which country you are in and what type of business and do you want OHS and/or EMS. There is no such thing as a standard list of legislation, although certain pieces of legislation are common.
 
Thread starter Similar threads Forum Replies Date
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
L Examples of a Legal Register - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
T What to include in our Legal Register? Miscellaneous Environmental Standards and EMS Related Discussions 8
T Legal Register Guidance - ISO 14001 ISO 14001:2015 Specific Discussions 7
B Register of Regulations - ISO 14001 4.3.2 "Legal and other Requirements" requirements ISO 14001:2015 Specific Discussions 4
J Assistance on ISO14001 - Preliminary assessment of my Environmental Legal Register ISO 14001:2015 Specific Discussions 1
S Legal (and other Requirements) Register for ISO 14001 ISO 14001:2015 Specific Discussions 40
T Legal Register for OHSAS 18001 Occupational Health & Safety Management Standards 41
M MDR legal actions - manufacturers CE Marking (Conformité Européene) / CB Scheme 8
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
J How to keep MDD certificate valid when legal manufacturer has liquidity problem EU Medical Device Regulations 0
T Quality auditor legal right to see Board meeting minutes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
G Launching a Legal Manufacturer (Dos and Donts) EU Medical Device Regulations 1
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
D Relabelling a component that will be sold as a spare part - Do I become legal manufacturer? EU Medical Device Regulations 2
K Legal manufacturer vs Actual manufacturer EU Medical Device Regulations 4
I Is the contract mfg. mentioned in legal manufacturer EC certificate? CE Marking (Conformité Européene) / CB Scheme 4
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 8
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 8
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 25
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
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 3
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

Similar threads

Top Bottom