What is a pre-assessment?
Geoff Wood: A pre-assessment (PA) is a survey of a medical device manufacturer’s quality management system (QMS) held well in advance of a stage 1 and stage 2 initial audit (IA). The purpose behind a PA is to identify major gaps in an existing QMS.
Who benefits from the PA?
Wood: Manufacturing start-ups benefit the most, especially, if they do not currently hold a certification. This indicates that a manufacturer has an unproven QMS and may have a great number of gaps that will fail a stage 1 and stage 2 audit and lead to significant delay in obtaining ISO 13485:2016 or other certification.
However, any manufacturer, who plans to add a Medical Device (MD) certification (i.e. ISO 13485:2016, MDR, or MDSAP) and are new to MD manufacturing, benefit greatly. Typically, these manufacturers are established in other markets such as aerospace, semiconductor, or automotive and already hold other certification(s). For example, IATF for automotive, AS9100 for aerospace, IEC for semiconductor, and ISO 9001 for general QMS.
What benefit justifies the cost?
Wood: Timed right, at least 1 month in advance of the stage 1 audit, the PA will test the QMS, and there will be time to fill any gaps that were found. The benefit here is in being prepared with confidence going into the initial audits. At this point, the major gaps are addressed, and it is likely only minor findings will result. Another benefit is keeping the certification process as fast as possible—no undue delays sorting out major NC.
Here is an example of a recent PA conducted by DNV. An established manufacturer wanted to enter the MD market for the first time. They understood the marketing advantages of holding ISO 13485:2016 and so applied for the initial audit. The Quality Manager had some experience in medical devices and believed there were gaps in the system. He convinced management to invest in the PA. The PA was held, and several major gaps were identified. Had they waited until the stage 1 and stage 2 audits; these gaps would classify as major non-conformities. It would delay their certification by weeks or even months and then, probably, need to be audited again. This would have the end effect of greatly increased costs, much higher than adding the PA. Now the manufacturer is off and running to fill the NC gaps and will be ready in time for the stage 1.
Who offers Pre-Assessments?
Wood: You would need to ask for PA availability from your auditing organization. However, most AOs should have this service.
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