Statuatory and Regulatory requirements related to product

T

thanigaivelu_a

#1
Hi:)

Can anybody clarify the meaning of "Statuatory and Regulatory requirements related to product" as mentioned in ISO 9001:2008.We manufacture Offshore structures.It involved different activities like Fabrication,Coating and Radiographic testing....These are activities related directly to our product.We identify the applicable legal requirements for these activities,since it directly affects the product.Apart from this we have indirect activities like security system,F&A,HR and canteen which are not directly related to product we manufacture also requires legal requirements.so my question is that whether we should include the Legal complaince of these indirect activities in to our QMS.


Regards
Thanigaivelu
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Hello Thanigaivelu ...
GREETINGS ... and Welcome to the COVE.
The indirect activities that you state are your organization requirements to be in business. These are to be maintained as necessary but need not be an inclusion into your ISO9001 QMS. This is the straight answer.
However please check and be sure that the "Statutory and Regulatory requirements related to product" are all identified and applied within your QMS. Perhaps these could include welder's qualification requirements, as an example.
 

qualprod

Trusted Information Resource
#3
Somashekar

Where can I find in 2015 that statutory and legal requirements are only for products and services and dont apply for other areas of business?
e.g. why to worry about for local accounting legal requirements?
If those activities are not related directly to products?
However, some auditors ask organizations to include such regulations with the next argument " why dont include accounting rules, if they could affect indirectly products and services)?

I refer to a mechanical parts manufacturing organizations.

Could someone assist in this issue?

Thanks



.
 
Thread starter Similar threads Forum Replies Date
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 3
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 10
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3
Watchcat Year of the Regulatory Watchcat Other US Medical Device Regulations 6
W Updated EU MDR regulatory matrix wanted ISO 13485:2016 - Medical Device Quality Management Systems 43
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
Ronen E Legal counselling and Medical Devices Regulatory Affairs Other Medical Device Regulations World-Wide 2
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
S Regulatory strategy for Third party plugin in a PACS EU Medical Device Regulations 1
S Regulatory Medical Device PMA Plans US Food and Drug Administration (FDA) 2
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Draft Guidance – Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal F Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
M Informational CDRH’s Regulatory Science Priorities Medical Device and FDA Regulations and Standards News 3
M Informational IMDRF draft document – Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews Medical Device and FDA Regulations and Standards News 0
D What foreign language proficiency would give the biggest edge to medical device regulatory affairs professionals in the world today or in future? Career and Occupation Discussions 6
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
M Informational IMDRF Consultation – Personalized Medical Devices – Regulatory Pathways Medical Device and FDA Regulations and Standards News 0
M Informational EU – MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.22 (05-2019) Medical Device and FDA Regulations and Standards News 2
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
M Informational FDA Invites You to the 2019 Regulatory Education for Industry (REdI) Annual Conference Medical Device and FDA Regulations and Standards News 0
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
M Informational TGA – Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Informational TGA Consultation: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices Medical Device and FDA Regulations and Standards News 0
C Person Responsible for Regulatory Compliance - The RA guy/girl Employment Act EU Medical Device Regulations 4

Similar threads

Top Bottom