Manufacturing Supply Chain - Medical Device Design: Innovation from Concept to Market - page 257

Table 10.1: Example Layout for Approved Suppliers List

Company Contact Certification Audit by Report Part Numbers

Fred Smith
Medical

James Machin ISO 13485 Certificate FSM1 X-101-1

0485 755664 (expires Nov

2013)

Audit 14 Jan
2012

100-0

[e-mail]

JMB Sterile
Packaging Inc.

John Brown ISO 9001 Certificate JMB1 All sterile packs.

jbrown@JMB
.com

(Nov 2015) Sterilization

services.

ISO 13485 Accelerated life

tests for std
packs

(Nov 2015)

10.2.4 Approved Supplier Register
Once you have completed your audit and you are satisfied, the 'potential supplier' becomes
an 'approved supplier'. This you need to record in an Approved Supplier Register. The report
should record the outcomes of the investigations described above; it should also contain the
relevant quality certificates (which must be kept up to date). A typical register entry for a
company may be as shown in Table 10.1 .

Obviously your register would contain all the relevant certificates and the suppliers list would
be an aide-memoire for both annual supplier audits (if required) and certificate updates. You
should include an audit of the register as a part of your annual internal audit process.

Note that this register has two further functions. The first is that it stops creative procurement
staff from purchasing items from the cheapest source only - this can play havoc with product
quality. The second is that it is an information file for your design process - this file tells
you “who is good at doing what” and hence who is the best person to bring in at the first
stages of a design process. In small companies this is very easy, but when the company gets
moderately large this type of information becomes invaluable. It is, after all, a simple contacts
management system .

10.2.5 Suggested Procedure
You must have a purchasing procedure to meet ISO 13485. We have come across these earlier
in the topic, however Figure 10.1 illustrates Section 10.2 as a procedure.

10.3 Packaging
Essentially packaging comes within two main criteria. There will always be some form of
internal pack that protects the device and (if necessary) its sterility. The second is the outer
case that is necessary for transportation and storage. Your packaging selection protocol must
encompass both aspects.