Are Your Suppliers Ready?
The ISO Standard has been released and manufacturers need to ensure their
supplier quality-related procedures are compliant.
James Shore • Director of Quality, Titan Medical Inc.
John Freije • Principal Consultant and Owner, Freije Quality Engineering LLC
The international standard ISO 13485:2016 for Medical De- vices quality management systems was published in March 2016. One of the key changes included the“strengthening
of supplier control processes” to be more harmonized with the U.S.
Food and Drug Administration’s (FDA) 21 CFR 820.50 Purchasing
controls. Now, OEMs need to ensure all supplier quality-related
procedures are compliant. This article will provide the necessary
information to perform a gap analysis, as well as identify areas for
making existing systems more robust. It will also provide a tool that
can be used to assist in the reduction of this potential risk.
Historical Information of FDA Warning Letter Citing
Purchasing controls have always been among the areas of focus
by the FDA. An analysis from 2004 to 2014 shows, on average,
40 percent of all warning letters (WL) cite inadequate purchas-
ing controls (PC) (Graph 1). With the recent changes being more
harmonized with 21 CFR 820.50 and the increase in outsourc-
ing, supplier management will continue to be an area of focus for
Graph 2 provides a breakdown of specific areas that are being
cited within the warning letters. By focusing on the areas most
cited, one could expect to reduce occurrence and risk involved
ISO 13485:2016 Revision—
Major Changes to Supplier Quality
Fortunately, the changes made to the ISO standard are more
harmonized with 21 CFR 820.50. For those companies that understand and comply with the quality system regulation (QSR),
this transition should be a straightforward, easy gap analysis
The major changes made in this ISO standard revision were
made to the three areas under sub-clause 7.4:
• 7. 4.1 Purchasing Process
• 7. 4.2 Purchasing Information
• 7. 4. 3 Verification of Purchased Product
Courtesy of Freije Engineering LLC1