SBS - The Best Value in QMS software

Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949

#1
Hi all - I work for a company who seek compliance with the IATF 16949 standard, as well as 14001 and 45001. We are based in North Wales, UK. I have been asked to compile a register of all legal legislation relevant to health and safety, employment law, energy and environmental.

I wondered if anyone knew of any online resource that could help me with this - Basically a list of current UK legislation that a medium-sized manufacturing company would have to abide by.
Thanks everyone.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
Many people make "registers" with which to list their requirements. Randy is correct in that a register is not needed. However your legal and other requirements (now called requirements of interested parties) are effectively identified, tracked and fulfilled is up to the organization.

In case it helps, I attached an Excel-based EMS Planner in the Tracking External Oversight at a large Naval Shipyard thread.
 
#4
I concu with both Jen and Randy. Having procedures is no longer a requirement of the standard . The problem that creates is that it is very difficult to repeat something if there isn't a documented procedure to support it.
 
#7
Many people make "registers" with which to list their requirements. Randy is correct in that a register is not needed. However your legal and other requirements (now called requirements of interested parties) are effectively identified, tracked and fulfilled is up to the organization.

Many thanks Jen
 
Thread starter Similar threads Forum Replies Date
J The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices ISO 13485:2016 - Medical Device Quality Management Systems 3
D Necessity of external watchdog next to internal watchdog ISO 14971 - Medical Device Risk Management 1
D The necessity of a SECONDARY CIRCUITS in ME EQUIPMENT (IEC 60601-1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
M Interview question - IMS (Integrated Management Systems) a necessity or an ISO mistake? ISO 14001:2015 Specific Discussions 10
V P2, P3, P4 Necessity in regular VDA 6.3 Process Audits VDA Standards - Germany's Automotive Standards 4
D Necessity of Expanded GR&R for Multiple Test Systems Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
I Is ISO 14001 A 'nice to have' or a necessity? ISO 14001:2015 Specific Discussions 4
B Is there a necessity of two sets of KPIs for Delivery Process Quality Manager and Management Related Issues 15
M Limulus Amebocyte Lysate (LAL) Testing: A necessity on every lot? Other US Medical Device Regulations 7
Ajit Basrur Necessity of Calibration of Manufacturing Process Equipment Gages, Controllers, Etc. General Measurement Device and Calibration Topics 7
A Internal Audit Schedule Updates - Necessity of a revision date on the schedule Internal Auditing 8
S PPAP and Interchangeability - Necessity to re-PPAP when making an Engineering Change APQP and PPAP 5
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 15
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
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
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

Similar threads

Top Bottom