ISO 13485 LA case studies
ISO 13485 LA · Put your knowledge to work in context.
The PECB Certified ISO 13485 Lead Auditor credential is a professional certification for people who audit Medical Devices Quality Management Systems (MDQMS) against ISO 13485. PECB describes the associated training as building the expertise to perform an MDQMS audit by applying widely recognized audit principles, procedures, and techniques, and as preparing you to plan and carry out internal and external audits in line with ISO 19011 and the ISO/IEC 17021-1 certification process. The ISO 13485 LA case studies are 5 cases and about 2,835 words.
1Outsourced Sterilization and the Risk-Based Process Approach
A contract manufacturer of Class III orthopedic implants outsources ethylene oxide sterilization to a single supplier. The QMS scope includes sterilization as an outsourced process.
572 words, about 3 min2Spreadsheet Change Without Validation in Batch Release
A manufacturer of infusion pumps uses a custom spreadsheet and a commercial electronic document management system to review and release batch records. In March, the quality manager modified the spreadsheet formula for averaging pump flow-rate test results to exclude the highest and lowest values.
568 words, about 3 min3Planning a Constrained Surveillance Audit With a Prior Major NC
You are lead auditor for a three-day surveillance audit of a contract manufacturer with two buildings. Building A makes Class II surgical staplers.
572 words, about 3 min4Expired Calibration Standard and Pressure at the Closing Meeting
During a process audit of final inspection for glucose test strips, the auditor observes an inspector using a calibration solution bottle with an expiry date of 12 January; today is 3 February. The inspector says the bottle was opened last week and the label is from the old bottle; a new bottle is in the cabinet.
577 words, about 3 min5Major NC Closure, CAPA Sufficiency, and a Tender Deadline
At the closing meeting of an initial certification audit for a Class IIb wound dressing manufacturer, the lead auditor documents one major nonconformity: the complaint handling process has no documented procedure for evaluating adverse events, and records for 14 complaints received in the last 12 months show no review for regulatory reporting. The client disputes the major classification, saying complaints were logged and reviewed informally and no patient harm occurred.
546 words, about 3 min