Statuatory and Regulatory requirements related to product

T

thanigaivelu_a

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
 
somashekar

somashekar

Leader
Admin
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

qualprod

Trusted Information Resource
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



.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A ISO 13485 CERTIFICATION WITH REGULATORY ISO 13485:2016 - Medical Device Quality Management Systems 2
B Regulatory Reference for Controlled Drug Manufacturer Supplier Quality Assurance and other Supplier Issues 0
D FDA combo product-need to define direct & indirect impact regarding safety,quality & regulatory.Can anyone point me in right direction-SupplierMgmt 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Leigh76 Regulatory Path for Providing Sterile Product in Bulk Non-Sterile Form to Kit Packers US Medical Device Regulations 3
D Regulatory consultant with experience in auto injectables US Food and Drug Administration (FDA) 0
C MSc Dissertation Survey - Regulatory Approval Medical Device and FDA Regulations and Standards News 1
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
V Countries without Formal Regulatory Approval Process Other Medical Device Regulations World-Wide 0
P Crucial Suppliers Listed on Regulatory Certificates EU Medical Device Regulations 3
N Brexit Combination Product Regulatory pathway for UK (MHRA). UK Medical Device Regulations 1
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A CE-Mark regulatory advice - US based Organization CE Marking (Conformité Européene) / CB Scheme 6
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
Justanobody PAD printing and meeting regulatory requirements Manufacturing and Related Processes 10
A Metadata For Drugs, API's, Regulatory & Clinical Documents and Dossier Service Industry Specific Topics 2
S Training for PRRC (person responsible for regulatory compliance) EU Medical Device Regulations 3
V Software license key regulatory requirements Medical Information Technology, Medical Software and Health Informatics 9
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
C Regulatory Affairs in a start-up medical device company Career and Occupation Discussions 2
P Exclusion of clause 8.2.3 Reporting to regulatory authorities ISO 13485:2016 - Medical Device Quality Management Systems 7
A Readiness for consultancy in Regulatory Affairs Consultants and Consulting 5
A A good Regulatory Affairs Manager EU Medical Device Regulations 15
M Regulatory compliance ISO 14001 ISO 14001:2015 Specific Discussions 5
E Which regulatory framework for an app-based study for research purposes? EU Medical Device Regulations 1
JoCam FSN for regulatory breach EU Medical Device Regulations 4
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
P Transferring medical data from a device (Sec 201(h)): regulatory implications US Medical Device Regulations 3
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 3
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 6 – How Does This Even Happen? Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 5 – What's the Rush? Other US Medical Device Regulations 0
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Watchcat REGULATORY WATCHCAT - New RA Cartoon Other US Medical Device Regulations 4
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 3 - Rearranging the Regs Other US Medical Device Regulations 0
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Watchcat REGULATORY WATCHCAT De novo Post Mortem 2 - Disclosure and Accountability Other US Medical Device Regulations 11
Watchcat REGULATORY WATCHCAT De novo Post Mortem 1 - Regulatory Religion Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De novo Post Mortem Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - RIP "Mini-PMA" Other US Medical Device Regulations 0
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 3
Watchcat REGULATORY WATCHCAT - His Grandmother's Technology Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Samples & Labeling Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0

Similar threads

Top Bottom