Where can we find Statutory and Regulatory Requirements related to our Product?

A

Andrews

#1
Where can we find out the Statutory and regulatory Requirements related to the products we supply?. We manufacture parts as per international Standards/ Customer Drawing
 
Last edited by a moderator:
Elsmar Forum Sponsor
A

Aaron Lupo

#4
Re: Statutory Requirements

Originally posted by Andrews
Where can we find out the Statutory and regulatory Requirements related to the products we supply?. We manufacture parts as per international Standards/ Customer Drawing
What type of things are you making?
 
A

aliakbar

#5
I am facing the same problem

My company does not manufacture but only provides technical services
on X-ray,CT, ultrasound, Angio units to hospitals and clinics.

The government health department regularly conducts inspection of our
premises and we keep the records

other then that the Pakistan Nuclear Radiation Authority PNRA also send us
radiation badges and guidelines that are followed and relevant records are kept.

but i am still worried bout other issues for example earthing requirements in electronic labs and other stuff. There could tons of other issues.

and i am very worried about the fact that the Audit may result in critical NCs because we deal in health care equipment, no directions from Govt or others to be found .

what should i do ?

Our certification audit is due in a month

thanx in advance
 
M

MIREGMGR

#6
Certification to what standard?

Are you in fact conforming fully to that standard?

Audits verify compliance with the requirements of a standard. Perhaps I misunderstand your question, but those requirements are what you must meet.

Is there some basis for being concerned regarding auditor expectations other than the documented requirements of the relevant standard?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
what should i do ?
That is a tough question. Based on your description of the situation, your organization does not have a good handle about the legal requirements associated with the provision of your services. Since the kind of services you are involved with have high risks (health care related equipment), it seems to me that you have a MAJOR, FUNDAMENTAL gap in your QMS.

Any organization that does not comprehensively identify and (attempt to) comply with legal requirements associated with their products/services and their operation is gambling with their future and customers health.

A true candidate to the "CONCRETE LIFE-JACKET AWARD"
 
A

aliakbar

#8
we are going for ISO 9001:2000.

We have not undertook the audit till now.

The situation is not as bad as you think, The requirements that the government wants are satisfied but I am not sure what the auditors for ISO 9001:2000 will think ?
I hope this clarified the question.

I need to know the basics for electronic labs and health care equipment
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
and i am very worried about the fact that the Audit may result in critical NCs because we deal in health care equipment, no directions from Govt or others to be found
The situation is not as bad as you think, The requirements that the government wants are satisfied but I am not sure what the auditors for ISO 9001:2000 will think ?
I hope this clarified the question.
I don't think your posts are clear.
 
M

MIREGMGR

#10
I need to know the basics for electronic labs and health care equipment
??

Everything you need to know...certainly the "basics"... is in the standards to which you are to conform, and the regulations applicable to you.

If you were asking a subtle conformance philosophy question, or a strategic issue regarding how to approach an identified inconsistency between a standard's approach to a particular issue and the applicable clinical needs of your product users, a discussion would be understandable...but it's hard to understand why anyone would need to inquire regarding the "basics". Just read the standards.
 
Thread starter Similar threads Forum Replies Date
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
M Where can I find examples of PPAP? APQP and PPAP 6
J Where can I find the latest update to Reach and ROHS? REACH and RoHS Conversations 7
G Where to find Proficiency Test provider for photometrics (spectral %R, %T, photo density) General Measurement Device and Calibration Topics 9
M Plating standards - Where to find information AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
Proud Liberal DFMEA / PFMEA linkage - Where in the standards do I find it? FMEA and Control Plans 5
N Where I can find an Excel sample/template for recording Delivery Time and Cost Excel .xls Spreadsheet Templates and Tools 2
R Specification on flare testing extruded aluminum - Where to find Design and Development of Products and Processes 1
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Where can I find an English version of Japan's PMD Act? Other ISO and International Standards and European Regulations 2
S Where to Find DEV and DFE numbers on FDA Website Other Medical Device and Orthopedic Related Topics 3
N Where to find a Qualified FDA Supplier Auditor located in China China Medical Device Regulations 7
G Where I could find any project HSE plan templates Occupational Health & Safety Management Standards 4
A Where to find a Draft Copy of IATF 16949:2016? IATF 16949 - Automotive Quality Systems Standard 23
I Where to find VDA 6.3 Robust Production Process (rpp) PDF file ? VDA Standards - Germany's Automotive Standards 1
P Where to find the UMDNS code for CE Mark CE Marking (Conformité Européene) / CB Scheme 1
X Where to find UAE medical device registration regulation and guidelines Other Medical Device Regulations World-Wide 3
P Where to find conformance statistics for ISO 15189 Other Medical Device Regulations World-Wide 1
J Where can I find a product's CE Mark Number? CE Marking (Conformité Européene) / CB Scheme 20
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Where can I find the NADCAP Audit Criteria for all the processes? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
L Where to find ISO27000 Annex A? General Auditing Discussions 2
W Where to find the Daimler DBL 6992 10 new (old) standard Customer and Company Specific Requirements 1
V Where I can find an AAR form on Ford Covisint? APQP and PPAP 1
G Where to find the ANSI Z1.9 Rosetta Stone Capability, Accuracy and Stability - Processes, Machines, etc. 9
R How and Where can I find IFU (Instructions For Use) examples? ISO 13485:2016 - Medical Device Quality Management Systems 6
V Where to find Red/White Rust Rating Requirements? APQP and PPAP 4
P VDA 2 - Where to find EMPB (Erstmusterpr?fbericht) bilingual forms VDA Standards - Germany's Automotive Standards 2
K Where do I find Frequencies and Composite Scale in Minitab? Using Minitab Software 2
V Where do I find Adverse Event Database for Medical Devices? Quality Manager and Management Related Issues 1
S Where can I find a (Methods-Time Measurement) MTM-UAS Table? Human Factors and Ergonomics in Engineering 1
V Where to find FORD Specific PPAP Training Training - Internal, External, Online and Distance Learning 3
S Where can I find the World Bank Regulations Texts? Other ISO and International Standards and European Regulations 6
S Where can I find a list of CE Approved Products? CE Marking (Conformité Européene) / CB Scheme 4
J Where to find info about equivalent standards? ESD issues Other ISO and International Standards and European Regulations 4
B Where to find the 510(k) Device Listing Number 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
K ISO Certified, now where to find work? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Marc Inspectors find safety flaws where airline food is prepared Travel - Hotels, Motels, Planes and Trains 5
J Where to find new GD&T (geometric dimensioning and tolerancing) standards? Various Other Specifications, Standards, and related Requirements 2
Q Where can I find the MDD definition of Labeling? EU Medical Device Regulations 7
O Where to find FAA Part 21 Federal Aviation Administration (FAA) Standards and Requirements 3
G Where to find Ggg-g-17 - Spec is related to GAGE, FILLET AND RADIUS Customer and Company Specific Requirements 7
sathis Where to find MIL Standard 8A,8B - Used for Dimensioning and Tolerancing Quality Tools, Improvement and Analysis 3
D Where to find Customer Specific Requirements Customer and Company Specific Requirements 6
Q Where to find CFR 820/GMP Training DVDs Book, Video, Blog and Web Site Reviews and Recommendations 7
M Where to find Medical Software Products on the internet? Software Quality Assurance 3
J Bias example-about Df=10.8 - Where to find the df table Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
R Where I can find a list of (Notified Chemical) substances? RoHS, REACH, ELV, IMDS and Restricted Substances 6

Similar threads

Top Bottom