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

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 DrawingAnother one!:bigwave:

Elsmar.com/Forums/showthread.php?s=&threadid=2679&highlight=Statutory+and+Regulatory

Most of the prints we receive have S/R requirements on the print.

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?

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

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?

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"

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

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 foundThe 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.

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.

I don't think your posts are clear.

I apologize for the inconvenience. Let me rephrase.

We are including only our engineering department for an ISO9001:2000 audit. This will be a certification audit.
We do undergo audits conducted by a Govt. Department for compliance and we keep the records. But these audits conducted by the Govt. are not very detailed. They dont check all the requirements set by regulatory authorities.

Now we are looking at a registrar who will audit us for ISO 9001:2000 and I am not sure if the audit will result in complete compliance with regulatory and statutory requirements.

I want to ask that what is the best way to satisfy the audit regarding the statutory and regulatory requirements and how does the auditor look for evidence of satisfaction or compliance ?

thanx