I am currently working with a trading organization to obtain ISO 9001:2000 certification. It involves packaging and distribution of healthcare products (oral and external applications). The company obtains the formulation of each product from an overseas company, and manufacture is outsourced. The finished products are then delivered to the company for packaging, then distribute the finished product to pharmacies, Spa, Salons, and beauty shops.

I need clarification and advice on the followings:

1. Can Product Design & Development(in this case formualtion) be excluded from the Scope of QMS? What about Manufacturing (Product Realization) which is outsourced?
2. What are the specific regulatory requirements that need to be covered in addition to all the applicable clauses of ISO 9001:2000 QMS?

Comments/recommendation are welcomed from ALL forum members with ISO consulting experiece in this type of business. Please post samples of documents that are pertinent to this type of business operation, if you have them.

Thanks in advance for all your help.

Eric Ng

Hi Eric,

Actually the answer is dependent on what 'scope' of certification that you or your client desires.

1. If it's just trading (service), then manufacturing and design are out.
2. You can opt to include manufacturing or design (product development) if so desire in which case then you need to take care of the relevant sections of the ISO standard.
3. With regards to statutory requirements, I think others cannot help you. Check the website of the relevant section of the Ministry of Health (Malaysia) or Kementerian Kesihatan. Quite a number of changes were introduced recently.

Hi Eric,

Actually the answer is dependent on what 'scope' of certification that you or your client desires.

1. If it's just trading (service), then manufacturing and design are out.We have to be very careful. Outsourcing of processes is NOT a justification for exclusion. What if you "trade" a product that is NOT in compliance with regulatory requirements because it was not designed nor manufactured in accordance with the applicable regulations? Who is responsible for ensuring the regulatory compliance of the devices? "Don't ask, don't tell" policies here would be very risky for the trading company.

If you outsource processes, you still have to demonstrate control over such processes, in terms of compliance to the standard.

I am currently working with a trading organization to obtain ISO 9001:2000 certification. It involves packaging and distribution of healthcare products (oral and external applications). The company obtains the formulation of each product from an overseas company, and manufacture is outsourced. The finished products are then delivered to the company for packaging, then distribute the finished product to pharmacies, Spa, Salons, and beauty shops.

I need clarification and advice on the followings:

1. Can Product Design & Development(in this case formualtion) be excluded from the Scope of QMS? What about Manufacturing (Product Realization) which is outsourced?
2. What are the specific regulatory requirements that need to be covered in addition to all the applicable clauses of ISO 9001:2000 QMS?

Comments/recommendation are welcomed from ALL forum members with ISO consulting experiece in this type of business. Please post samples of documents that are pertinent to this type of business operation, if you have them.

Thanks in advance for all your help.

Eric Ng

Can you pl elaborate on ORAL and EXTERNAL APPLICATIONS ie. the products you are dealing in ? My concern is that if you supply to Pharmacies, are they Pharmaceuticals ?

If yes, its a totally different ball game and have to comply with different set of regulations. As suggested by Harry, you can refer to KEMENTERIAN KESIHATAN MALAYSIA (http://www.moh.gov.my/MohPortal/index.jsp)

I need clarification and advice on the followings:

1. Can Product Design & Development(in this case formualtion) be excluded from the Scope of QMS? What about Manufacturing (Product Realization) which is outsourced?
2. What are the specific regulatory requirements that need to be covered in addition to all the applicable clauses of ISO 9001:2000 QMS?



I must have misunderstood something here.

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

We have to be very careful. Outsourcing of processes is NOT a justification for exclusion. What if you "trade" a product that is NOT in compliance with regulatory requirements because it was not designed nor manufactured in accordance with the applicable regulations? Who is responsible for ensuring the regulatory compliance of the devices? "Don't ask, don't tell" policies here would be very risky for the trading company.

If you outsource processes, you still have to demonstrate control over such processes, in terms of compliance to the standard.

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 all. I now have a clearly picture on the scope and what can be excluded in the QMS. My original thought was right, manufacturing, even it is outsourced cannot be exlcuded.

With regards to meaning of the words " oral and external applications", it means the products consists of those apply to the skin and those that can be swallowed like medicine. I forgot to mention: the formulation is subject to approval by Local Ministry of Health prior to manufacturing. I have to look into all the regulatory requirements imposed by local authority, equivalent to FDA of USA.

Thank You ALL.

Eric:thanx:

Thank you all. I now have a clearly picture on the scope and what can be excluded in the QMS. My original thought was right, manufacturing, even it is outsourced cannot be exlcuded.

With regards to meaning of the words " oral and external applications", it means the products consists of those apply to the skin and those that can be swallowed like medicine. I forgot to mention: the formulation is subject to approval by Local Ministry of Health prior to manufacturing. I have to look into all the regulatory requirements imposed by local authority, equivalent to FDA of USA.

Thank You ALL.

Eric:thanx:

If you market in your country alone, then ensure all regulatory controls involved for manufacturing, sales etc are taken care in Malaysia.

Its good to get the FDA concepts included also but will not be mandatory.

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

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.


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

Eric

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

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