ISO 9001:2000 Certification Project for a Healthcare Trading company

[Eric ng]

In Reply to Parent Post by tyker

I must have misunderstood something here.

Are you saying that this organization has healthcare products manufactured and sells them without knowing the regulatory requirements?

Of course, the organization needs to comply with all the necessary statutory, health and safety requirements. This will be reflected in QMS map (not yet developed) and comprehended in the documentation system.

Eric

[Eric ng]

In Reply to Parent Post by harry

You brought up a good point that was the cause of the recent spate of changes in regulatory requirements over here. ISO aside, a trading company can sell a product of their own brand but with other companies specifications but would need to get registration and approval from the relevant authority for these. Otherwise, they can sell products with approved formulations or specifications by using the approval of the manufacturer or party owning the formulation. These are for pure 'trading' companies or 'agencies'. They do not own the formulations but may or may not own the brand. By registration, they are responsible to ensure that prohibited substances are not found in their product.

Where one is involved with packaging and contract manufacturing (where you own the formulation and entrust another party to manufacture), that is out sourcing and manufacturing cannot be excluded for ISO purpose.

Sidney is right that you need to be careful - a lot hinges on the detail arrangements.

Thank you, Sydney and Harry for enlightening me about the risks involved in the certification process for the organization,

Eric

[somashekar]

Have you considered going for the ISO 13485 ? Makes sense i feel. Guess you know more about it .... Good luck
Somashekar
India

[Eric ng]

In Reply to Parent Post by somashekar

Have you considered going for the ISO 13485 ? Makes sense i feel. Guess you know more about it .... Good luck
Somashekar
India

ISO 13485 is meant for Medical Devices. Since this company's main operation is trading, the scope of certification will involved only trading processes. The value of course is limited, of course, but that is what the business owner can afford because of tight budget and human resource lmitation (only 10 employees). The product realization process involves mainly administration of orders, sales/marketing, and delivery of goods. All the healthcare products have been approved by Malaysia's Ministry of Health.

Thanks for your suggestion any way.

Eric Ng