What you need to do now to be prepared for the revised ISO 13485

It has been three and a half years in the making with many stops and starts, but it now looks fairly certain that the revised ISO 13485 will be released next year. Hammering out a revision to the international quality management system (QMS) for medical manufacturers has been a long, arduous process, concedes Frank Pokrop, Director, Quality and Regulatory Affairs, at medical technology company CareFusion (San Diego, CA), but the end is near. "Barring any additional bumps in the road, which cannot be ruled out, we should see the revised standard published in the first quarter of 2016," says Pokrop. Once the standard has been released, manufacturers will have three years to implement it. Although that may seem like a generous amount of time, companies that need to comply with the revised document would be well advised to start drafting a strategy now, says Pokrop. "The revised standard is 30 to 40% longer than the current version and it features a number of changes," he says, some of which may be daunting to manufacturers.

The entire document has been reformatted, as the numbering and clauses will change to accommodate new clauses. More substantively, "there are eight to 10 major changes, notably a strengthening of supplier controls, which need to be formally included in the scope of the OEM's work, and an emphasis on risk analysis and management, which is quite different from the current process-oriented approach," says Pokrop. "The revision includes a new statement that the standard may be used by suppliers or other external parties that provide a product or service to medical device manufacturers. And the standard now includes regulatory requirements, terms that were not present in the earlier version."


Thousands of exhibitors and three full days of conferences await attendees at the nation's largest medical manufacturing event in Anaheim, CA, from Feb. 9 to 11, 2016. MD&M West is co-located with PLASTEC West at the Anaheim Convention Center.


StethoscopeRegarding the new risk-based approach, "it is essential that the manufacturer specifies how the risk is managed, and how the risk of one process affects other risk aspects of the QMS," write Bill Enos, Global Head of Microbiology at BSI Healthcare, and Mark Swanson, President and Lead Consultant, H&M Consulting Group, in a white paper itemizing the proposed changes. "As outlined in the new introduction, the organization's role shall be defined," they note. "Are you the legal manufacturer? Are you responsible for regulatory requirements, notifications, post-market surveillance (PMS), and vigilance? Are these requirements properly defined and documented? The proposed changes to this clause will require that this type of information be documented and justified accordingly," write Enos and Swanson.

They also stress that the organization has a responsibility to control outsourced processes and their associated risk and that a new section of the standard requires manufacturers to document processes for supplier approvals and for monitoring continued compliance.

Because the approach is fundamentally different from the current process approach, Enos and Swanson recommend that companies conduct a gap analysis to determine a baseline of changes that will need to be addressed.

Heading into 2016, Pokrop suggests that manufacturers take look at the current draft and bone up on its potential impact on manufacturing operations by downloading the previously referenced white paper (registration required) from the BSI website or consulting articles, such as "What To Expect From The Upcoming ISO 13485 Revisions, Part 1."

"Manufacturers should start mapping the current and proposed standards," adds Pokrop, "and it would be prudent to do an internal review regarding timing and implementation. Ask yourself: What is your current situation and where do you need to be in three years?" says Pokrop. The strengthening of supplier control processes should prompt manufacturers to fully understand risk-based decision making involving their supply chain. "If your suppliers aren't certified to ISO13485, what additional steps are you taking to ensure their quality systems are adequate?"

One more thing you should do is consider attending the nation's premier medical design and manufacturing exhibition and conference, MD&M West, which returns to the Anaheim Convention Center in Anaheim, CA, from Feb. 9 to 11, 2016. Pokrop is scheduled to discuss the ISO 13485 revision during a session devoted to quality assurance and risk management on Feb. 11. Meanwhile, on the show floor, you can find a number of standards organizations and consultants ready to offer their quality systems expertise.

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