Presentation on theme: "ASQ Las Vegas section 705 December 16, 2009"— Presentation transcript:
1Transitioning from ISO 9001:2008 to ISO 13485:2003—Going After Medical Device Business ASQ Las Vegas section 705December 16, 2009Presented by Michelle M. Johnston, RACAdvanced Quality System Solutions
2The Medical Device Sector $100B industryMore “recession-proof” than other sectors but hit in 2008/2009Ageing US population (baby boomers)Growth in the following segments:CardiacOrthopedic (record level of private equity)Neurotechnology (electronic devices interact with the nervous system)15k medical device companies>400k jobs
3What the Heck is EN ISO 13485:2003?Quality system standard intended for medical device industryFormat based on ISO 9001, process approachIntended to promote harmonization in the global marketRegulators don’t recognize ISO 9001
4What the Heck is EN ISO 13485:2003?Emphasis on effectiveness of quality management system as opposed to improvementMore controls than ISO 9001Higher the risk of the device=more controlsHowever, if you don’t manufacture the finished device, not all requirements are applicable
5What the Heck is EN ISO 13485:2003?It is the medical device manufacturer’s responsibility to define and implement the requirements.As applicable, they will pass along the requirements to their suppliers, usually in the form of a purchase spec or Supplier Agreement
6From A Manufacturer’s Perspective Assurance that their suppliers have adequate controls in placeSelecting a supplier who is registered to ISO can mean reduced monitoring by the manufacturerFrom a regulatory perspective, much greater scrutiny on how manufacturer’s evaluate and monitor their suppliers. High visibility recalls where problems originated at the supplier.
7What are the Differences? Let’s examine some of the important differences between ISO 9001 and ISO 13485
8What are the Differences? The biggest difference is the intent of the standard. In the regulatory world, customer satisfaction and continuous improvement are superseded by the safety and effectiveness of medical devices.
91.2 ApplicationCan only exclude section 7.3, Design and Development—however, other regulations may preclude thisOther requirements in section 7 may be non-applicable based on the nature of the medical device (sterilization, implants) or activities performed by the organizationExclusions/non-applications to be justified
104.1 General RequirementsThe organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.
114.2 Documentation Requirements The quality management system documentation shall include:Any other documentation requirements specified by national or regional regulations.
124.2 Documentation Requirements There is a requirement or a particular type of document, commonly referred to as a Device Master Record.The organization shall establish and maintain a file containing documents defining for each type / model of medical device product specifications and quality system requirements (process and quality assurance) for:complete manufacturing, andinstallation and servicing, if appropriate
134.2 Documentation Requirements The Quality Manual must outline the structure of the documentation used in the quality management system.Typically 4-tier structure:Quality manualSOPsWork instructionsForms/records
144.2.4 RecordsThe importance of records in the medical device industry cannot be overstated.Universal rule: If it isn’t documented, it wasn’t done.Documentation, documentation, documentationStringent rules regarding recording of informationBlue or black ink onlyNo crossouts, write oversMost organizations have a Good Documentation Practices procedure and intensive training.
154.2.4 RecordsRetention requirements based on the lifetime of the deviceRetention equivalent to lifetime of device or not less than 2 years from date of release for distributionOther regulations have more stringent requirementsMost medical device manufacturers do not often destroy recordsRecords specific to the medical device industryDevice History Record (traveler, work order)Adverse event reports to regulatory agencies
165—Management Responsibility Management must maintain the effectiveness of the quality management systemIndependence and authority of those who perform tasks affecting qualityManagement rep promotes customer and regulatory requirements throughout the organizationManagement review must include new or revised regulatory requirements
176—Resource ManagementDetermine and provide resources to implement the QMS and maintain its effectivenessAnd to meet customer and regulatory requirementsMay need a documented procedure to satisfy other regulatory requirements
186.3 Infrastructure Preventive Maintenance Documented requirements for maintenanceRecords maintained
196.4 Work Environment Can be very critical, dependent on the device Controls must be established if the environment could adversely impact the medical device (concern for devices intended to be sterilized)Cleanroom or environmentally controlled manufacturingGowningDocumented procedure for environmental controls and monitoringNo food and drink
206.4 Work EnvironmentControls for used (returned) product to prevent contaminationPersonnel who work under special environmental conditions must be trained
216.4 Work Environment Can also include ESD controls Designated ESD work areasWrist/ankle strapsDaily testing or continuous monitoringHandling and storage of ESD sensitive devicesRecords
227.1 Planning of Product Realization Specific reference to ISO 14971—Medical Devices Risk ManagementMedical device manufacturers would expect suppliers to have a documented pFMEA in place.
237.3 Design and Development A documented procedure is required.More records are requiredDesign inputs must include safety and performance requirementsDesign inputs must be approvedRecords of design outputs are requiredIndependent person required at design reviewClinical evaluation as part of design validation
247.4 Purchasing Documented procedure required FDA requirement: Where appropriate, purchasing documents will include an agreement that the supplier will notify the manufacturer of any changes to the product or service so that the manufacturer may assess the impact of the change on the finished deviceUnauthorized changes can have a significant impact and result in recalls by the manufacturerEvaluation of suppliers is typically risk-based
257.5 Production and Service Provision The availability of documented procedures, requirements, work instructions, and reference materials and reference measurement procedures as necessaryThe implementation of defined operations for labelling and packagingRecord that shows manufacturing history including quantity. Record shall be reviewed and approved.
267.5 Production and Service Provision Cleanliness of product and contamination controlA documented procedure is requiredIntended for devices sold sterile orDevices to be sterilized by the end userInstallation and servicing procedures and controlsSpecific requirements for sterile and implantable devices
277.5 Production and Service Provision Procedure for the validation of computer softwareRecords of these activitiesProcedure for ID and traceability—more stringent controls or implantable devicesProcedure to distinguished returned product from conforming productStatus of product—must be known at all times throughout the product realization processProcedure for the preservation of product conformity— handling, storage
287.5 Production and Service Provision Procedure for devices with a limited shelf life or special storage conditionsStorage conditions will be controlled and recorded.Procedure required for calibration activities
298.2 Monitoring and Measurement Specific requirements for customer complaints as opposed to customer satisfactionSome types of complaints must be reported to regulatory agencies
308.2.4 Monitoring and Measurement of Product Documented procedure for inspection activitiesSpecific requirements for active implantable and implantable devices
318.3 Control of Nonconforming Product UAI disposition only if regulatory requirements continue to be metMust record person who authorizes UAIWork instructions for rework activitiesDetermine and document any adverse impact of rework on the device
328.5.1 General (Improvement) Customer complaintsDocumented procedures for product recallsMust record reason if a complaint is not followed by CAPAProcedure for notification of complaints to regulatory agencies
338.5.2 CAPA Record the results of any investigation Determine the effectiveness of the corrective action takenSame for preventive action