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13485 revision:
What it means for medical device OEMs and their supply chains
The medical technology industry
has gone through some changes in the last 14 years, as has its regulatory
environment, and it was time that ISO 13485 reflected that evolution. The global
standard for medical device quality management systems recently underwent its
first revision since 2003, and it contains a number of changes that must be
taken into account by medical device manufacturers and their critical suppliers.
And, yes, there is a deadline: Companies must show compliance to ISO 13485:2016
by March 1, 2019. That might seem a ways off, but Notified Bodies have a lot on
their plate right now, and audits are taking longer than ever before.
PlasticsToday checked in with Garth Conrad, Vice President, Quality, at C. R.
Bard, now part of BD, to learn more about how the revision affects the medical
manufacturing space.
“There are three things I would
focus on in the revision,” said Conrad: The approach to risk management, greater
convergence with FDA CFR Part 820 and supply-chain management.
Previously, ISO 13485 essentially
compartmentalized risk management activities around product development and
post-market complaints. “The revision comprehensively takes risk management and
applies it throughout the controls of a quality management system,” said Conrad.
“The new version drives you to consider risk in all areas of your quality
system—purchasing controls, management review and the basic documentation system
for managing change control. Different levels of risk management now are
incorporated into your system,” explained Conrad.
ISO 13485:2016 also integrates
“more of the flavor of what you see in FDA CFR Part 820 in terms of
requirements,” said Conrad. “Regulators around the world are beginning to
converge to a more common set of requirements and expectations.” The European
Union’s new Medical Device Regulation (MDR), which starts to go into effect in
2020, was influenced by the breast implant scandal, in which a French
manufacturer of implants was found to be using non-medical grade silicone. As a
result, the MDR includes a number of safeguards that were absent in the Medical
Device Directive, which it replaces. “ISO 13485:2016 was drafted a little before
then, but it did capture some of [the same] expectations,” said Conrad.
The third foot of this
three-legged stool is supply chain management. “Regulators understand that the
majority of medical devices are not made by OEMs, who have deep and wide supply
chains,” said Conrad. “As such, quite a bit of information in the revision
relates to purchasing controls and flow-down of requirements into the OEM’s
supply base.”
While medtech OEMs are not
required to work with suppliers that have ISO certification, they must ensure
that suppliers have adequate quality control systems in place. “Maintaining ISO
certification guarantees a certain level of compliance. If OEMs require ISO
certification from their suppliers, they are in the game at a certain level of
performance,” said Conrad. Other avenues are available, he added, including
FDA’s Medical Device Single Audit Program (MDSAP).
Suppliers certified to ISO 13485,
however, should exercise due diligence and upgrade to the 2016 revision,
particularly if they are categorized as critical suppliers. “As an OEM, part of
our certification when we gain CE marking or clearance requires that critical
suppliers be identified and maintained as part of the certificate,” explained
Conrad. “Critical supplier classification is based on the component they are
producing or material or service they are delivering. It will be a little
different for everybody.” Contract sterilizers would be considered critical
suppliers, for example, and that classification could apply to a plastics
processor to whom production is being outsourced, added Conrad.
For companies marketing medical
devices in Europe this can be a do-or-die situation. After March 1, 2019, OEMs
may not use components manufactured by suppliers that are not in compliance with
ISO 13485:2016 until the non-compliance issue has been resolved. It is
imperative for any medical device manufacturer doing business in countries that
recognize CE marking to monitor the progress of their suppliers in obtaining ISO
13485:2016 certification.
Procrastination is not a viable
strategy, even if the compliance deadline seems fairly distant. Auditors and
Notified Bodies are stretched very thin right now, according to Conrad. Not only
are they dealing with the ISO 13485:2016 revision, they are also wrapped up with
MDSAP compliance, which is set to start next January, and the European Union’s
Medical Device Regulation. “That’s further out—2020 to 2022—but the amount of
work associated with that is immense,” said Conrad. “In our experience, the
response time for audits and the certification update process has been 25 to 50%
longer than in the past.”
As a final note, Conrad offered
three key considerations for companies implementing the ISO 13485 revision.
First, it’s important to “perform
a thorough gap assessment comparing the revised standard to your internal
controls. That will set you on the right path for the things you need to do.”
Second, compliance is the
beginning, not the end, of the process. “If you’re using the standard as a
minimum compliance item and that’s all you do within your company, you’re
missing the bar in terms of what the standard is trying to do, which is to drive
a culture of improvement within your business. Use it as a guideline, but don’t
stop there. Continue to improve the systems and processes you have.”
And the third thing is to do it
now, stressed Conrad. “If you have gaps, you will have time to fix them before
the compliance deadline.”
https://www.plasticstoday.com/medical/iso-13485-revisionwhat-it-means-medical-device-oems-and-their-supply-chains/52691156758042/page/0/1
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