TRANSITIONING FROM ISO 9001:2008 TO ISO 13485:2003GOING AFTER MEDICAL DEVICE BUSINESS,ASQ Las Vegas section 705 December 16, 2009 Presented by Michelle M. Johnston, RAC Advanced Quality System Solutions,The Medical Device Sector,2,$100B industry More “recession-proof” than other sectors but hit in 2008/2009 Ageing US population (baby boomers) Growth in the following segments: Cardiac Orthopedic (record level of private equity) Neurotechnology (electronic devices interact with the nervous system) 15k medical device companies 400k jobs,What the Heck is EN ISO 13485:2003?,3,Quality system standard intended for medical device industry Format based on ISO 9001, process approach Intended to promote harmonization in the global market Regulators dont recognize ISO 9001,What the Heck is EN ISO 13485:2003?,4,Emphasis on effectiveness of quality management system as opposed to improvement More controls than ISO 9001 Higher the risk of the device=more controls However, if you dont manufacture the finished device, not all requirements are applicable,What the Heck is EN ISO 13485:2003?,5,It is the medical device manufacturers 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,From A Manufacturers Perspective,6,Assurance that their suppliers have adequate controls in place Selecting a supplier who is registered to ISO 13485 can mean reduced monitoring by the manufacturer From a regulatory perspective, much greater scrutiny on how manufacturers evaluate and monitor their suppliers. High visibility recalls where problems originated at the supplier.,What are the Differences?,7,Lets examine some of the important differences between ISO 9001 and ISO 13485,What are the Differences?,8,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 In the regulatory world, customer satisfaction and continuous improvement are superseded by the safety and effectiveness of medical devices.,1.2 Application,9,Can only exclude section 7.3, Design and Developmenthowever, other regulations may preclude this Other requirements in section 7 may be non-applicable based on the nature of the medical device (sterilization, implants) or activities performed by the organization Exclusions/non-applications to be justified,4.1 General Requirements,10,The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.,4.2 Documentation Requirements,11,The quality management system documentation shall include: Any other documentation requirements specified by national or regional regulations.,4.2 Documentation Requirements,12,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, and installation and servicing, if appropriate,4.2 Documentation Requirements,13,The Quality Manual must outline the structure of the documentation used in the quality management system. Typically 4-tier structure: Quality manual SOPs Work instructions Forms/records,4.2.4 Records,14,The importance of records in the medical device industry cannot be overstated. Universal rule: If it isnt documented, it wasnt done. Documentation, documentation, documentation Stringent rules regarding recording of information Blue or black ink only No crossouts, write overs Most organizations have a Good Documentation Practices procedure and intensive training.,4.2.4 Records,15,Retention requirements based on the lifetime of the device Retention equivalent to lifetime of device or not less than 2 years from date of release for distribution Other regulations have more stringent requirements Most medical device manufacturers do not often destroy records Records specific to the medical device industry Device History Record (traveler, work order) Adverse event reports to regulatory agencies,5Management Responsibility,16,Management must maintain the effectiveness of the quality management system Independence and authority of those who perform tasks affecting quality Management rep promotes customer and regulatory requirements throughout the organization Management review must include new or revised regulatory requirements,6Resource Management,17,Determine and provide resources to implement the QMS and maintain its effectiveness And to meet customer and regulatory requirements May need a documented procedure to satisfy other regulatory requirements,6.3 Infrastructure,18,Preventive Maintenance Documented requirements for maintenance Records maintained,6.4 Work Environment,19,Can be very critical, dependent on the device Controls must be established