Manufacturing Supply Chain - Medical Device Design: Innovation from Concept to Market - page 255

Identification of certification level is of paramount importance. If you are dealing with an ISO
9001 or ISO 13485 registered company then you know that their document trail is going to
meet your needs to delegate the responsibility of quality auditing to their notified body.
Rule of manufacturing 2: Always use an ISO 9001 supplier as a minimum requirement.
It cannot be emphasized enough how much Rule 2 will help you. Without this minimum
certification requirement you will have to perform full audits of the company in question
yourself . This in turn means you must be a qualified external auditor. Do you really want this
added burden? You may if you are making a very high risk device, but for most companies
audit by certification is more than adequate.
Rule of manufacturing 3: For Class II devices and above always look for ISO 13485
certification or equivalent.
Rule of manufacturing 4: For implants look for a history of implant manufacture.
Rules 1- 4 make perfect sense. They basically state that you should use someone who knows
what they are doing. Do not be tempted to cut costs by dropping your own standards. The
same rules can be applied to services too; for example,
Rule of manufacturing 5: For delivery of sterilization services use a recognized sterile
service provider.
You may think this is obvious, but some sterile packagers only provide a packaging service.
Some pack and sterilize. Some will also design your pack, test it, then pack and sterilize. You
must ensure they have the certificates and track record for the service you want.
10.2.1 Samples
Before you put any supplier on an approved suppliers list you should always obtain samples.
This does not mean simply looking in a salesman's briefcase and looking at sales specimens;
it means getting them to make something from your device and then holding them to this
quality when it goes into batch production.
You may be asking why. The first point is that you want to ensure they can make the item to
the quality you want. You will be amazed how the same drawing of a component can result in
a variety of finishes, even if it is a complete drawing. The second reason is that any company
can produce one excellent item, but can they produce 20 to 1000 excellent items? You can
then use this sample as your check for the production runs.
Another good reason for asking for samples is that in your quotation process you will find
that suppliers have “sweet spots.” Some items they can produce with relative ease, because