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January 2016 • SMT Magazine 49 inherits the risk associated with these compo- nents which further complicates the risk man- agement plan. A substantial portion of the risk has already been designed into the product before the EMS has seen the design and as a result the control plan may require additional test/inspection steps, which may have been avoidable if these risks were identified and addressed earlier in the development life cycle. Las Marias: how do you get to become an ap- proved or qualified supplier or manufacturer for medical electronics? Morrison: Compliance with ISO 13485 is often seen as the first step to becoming an approved or qualified supplier or manufacturer for medi- cal electronics. ISO 9001 is generally harmo- nized with ISO 13485, but the primary differ- ences are as follows: • Regulatory requirements are promoted as a management responsibility • Demonstrated controls in the work en- vironment must be in place to ensure product safety through employee train- ing, manufacturing area policies and pro- cedures, records including handling of material, product and tooling • Specific processes and procedures with a focus on risk management activities and design control activities during product process development, including risk man- agement and control plans • Specific requirements for inspection and traceability of components with an em- phasis on critical components or aspects of the device including product serializa- tion, label control and material lot control • Specific requirements for documentation and validation of processes including equipment/tool qualification, operating qualification of process operating proce- dures and methodology and performance qualification demonstrating capability and expected result • Specific requirements for verification of the effectiveness of corrective and preven- tive actions Quality management systems were audited by third-party certification bodies with dem- onstrated medical product risk management activities and control plans including docu- mented validation plans to support compliance with our processes and procedures. To support traceability, supplier procurement practices were updated to require lot codes from our sup- pliers, including full lot control from incom- ing through to shipment utilizing 21 CFR Part 820 certified serialization and manufacturing execution systems supporting integrated trace- ability records. MEDICaL ELECTrOnICS: rISkS anD OPPOrTunITIES FOr ELECTrOnICS ManuFaCTurErS FEATurE inTErViEw