Quality and Medical Devices: ISO 13485:2003 Quality Management System requirements for Medical Devices manufacturers O3 Enterprise s.r.l. ISO 13485 Quality Management Systems Medical Device
O3 Enterprise University of Trieste Spin-off Company, created in 2008 Company goals: Offer open solutions to the health-care Offer professional and innovative services to the community based on its open products
Open Approach For O3 Enterprise open approach means: Open Source Open Standard Open Interoperability Independence
EN/ISO 13485:2012 Medical devices Quality management systems Requirements for regulatory purposes O3 Enterprise s.r.l. ISO 13485 Quality Management Systems Medical Device
What is a Quality Management System (QMS)? Quality Management System (QMS) the organizational structure responsibilities procedures processes resources Goals comply with the company s quality policy meet the requirements of the customers meet applicable regulatory requirements
Regulatory requirements for QMS Medical devices (MDs) US: FDA Title 21, Part 820 Quality System Regulation Europe, Canada and other - international: EN/ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes ISO/TR 14969:2004 Medical devices Quality management systems Guidance on application of ISO 13485:2003
ISO 13485 Model Model of a process-based Quality Management System Key: Value-adding activities Information flow ISO/TR 14969:2004 Medical devices Quality Management System Guidance on application of ISO 13485
ISO 13485 Model Model of a process-based Quality Management System Key: Value-adding activities Information flow Chapter 4. Ch.5. Ch.8. Ch.6. Ch.7. ISO/TR 14969:2004 Medical devices Quality Management System Guidance on application of ISO 13485
4. QMS and requirements for documentation Quality Manual The most important document, usually organised as the Standard Scope of the QMS Organization Quality policy Quality Objectives Products Compliance Regulations and Standards Documented procedures for QMS and for products
4. QMS and requirements for documentation Other documents Procedures Work Instructions Records Form/template for developing documents or keeping record
4. QMS and requirements for documentation Control of documents Changes only with approval by the original approving function or another designated function Records shall be maintained Communicate changes to everyone Changes in documents, procedures Use only latest revision Available version is only the last version Old versions shall be saved Records of changes, activities
4. QMS and requirements for documentation Why Quality records? Provide objective evidence of the achievements of quality requirements Verify effective operation of the QMS Comply with regulatory requirements Provide for traceability of devices and components Provide information for Corrective action Preventive action Non conformity Provide information for continuous improvement
5. Management Responsibility Duties of Top Management: provide evidence of its commitment to the development and implementation of the QMS mantain the QMS effectiveness Establish Quality Policy Quality Planning Management Representative Management Review
5. Management Responsibility Management Review Hold regularly with appropriate executive attendance Define inputs including Status of QMS Status of preventive and corrective actions Result of Audits Customer feedback and complaints Processes performance and product conformity Maintain records Conclusion on suitability of QMS Actions for improvement
6. Resource Management The organization shall provide the resources needed to implement the QMS to mantain the QMS effectiveness to meet regulatory and customer requirements Types of resources: Human Resources Infrastructure Work environment
6. Resource Management Human resources Personnel with appropriate background, education and experience Determine required competence Job Descriptions Training to ensure competence Test to evaluate the effectiveness Maintain records Education, training, skills and experience
6. Resource Management Infrastructure Controlled conditions MDs meet their requirements MDs are free of contamination Buildings and workspaces adequate Process equipment (both HW and SW) Selected and designer to meet requirement Cleaned, maintained and adjusted Maintain records
6. Resource Management Work environment Requirements for health, cleanliness and clothing of personnel Prevent personnel contamination Limitation on eating, drinking and smoking Control environmental conditions Clean where necessary to meet specifications Prevent device or equipment contamination Maintain records
7. Product Realization Planning Plan, develop and maintain processes needed for product realization Use risk management methods Pay attention to Quality objectives Requirements of the QMS and of the products Maintain records Processes and products meet requirements
7. Product Realization Customer-related processes Define customer requirements Products, delivery, post-delivery activities Ensure effective communication with customers Product information, pricing, contracts Feedback, complaints Advisory Notice Information and training for safe and effective use of the MD Maintain records
7. Product Realization Design and Development Plan and control the Design and Development of all MDs and their labeling in order to assure Safety Clinical utility Effectiveness Reliability Meeting the requirements
7. Product Realization Purchasing Manage the supply of materials / products / services and outosourced products and services Evaluation of suppliers Maintain record of approved suppliers Evaluation of purchasing Conformity to requirements Verification of purchased product Inspection of records Manage records of purchasing process
7. Product Realization Production and service provision Processes must be performed under controlled conditions Following instructions Qualified and trained personnel Controlled environment Control Attention to cleaning/sterilization processes
7. Product Realization Production and service provision Identification and traceability Unique serial number Labeling Batch number for consumables Status identification Preservation of product
8. Measurement, Analysis and Improvement Monitoring, measurement, analysis and improvement processes Demonstrate conformity of products Ensure conformity of QMS Maintain the effectiveness of the QMS Goals Processes Results Feedback
8. Measurement, Analysis and Improvement Feedback and Complaints From all sources Related to Employees Customers Quality Durability Reliability Documented procedure Maintain record Safety Effectiveness Labeling Packaging Performance
8. Measurement, Analysis and Improvement Internal Audit Conduct at planned intervals At least once a year Ensure all aspects of the QMS are implemented and maintained compliance with applicable regulatory standards Identify areas for improvement Auditor without direct responsibility for area Maintain report Report to Management Review Non Conformity
8. Measurement, Analysis and Improvement Non Conformity NC Identify non conforming material/product/process Prevent its unintended use Detect and eliminate all causes of Non Conformity
8. Measurement, Analysis and Improvement How do you solve a NC? Review the NC Determine the causes Evaluate the need for action to ensure that NC do not recur Correction Eliminate a detected NC Corrective Action Eliminate the causes of a detected NC Prevent recurrence of the problem Determine and implement action(s) needed Verify implementation Maintain record Track completion
8. Measurement, Analysis and Improvement Preventive Action Eliminate the causes of a potential NC Prevent the occurrence of an NC identify, analyze and eliminate potential quality problems analyze information from Processes that affect product quality Audit results Quality records Service reports Customer complaints Adverse Event Reports
Case study How can we do that? O3 Enterprise s.r.l. ISO 13485 Quality Management Systems Medical Device
JIRA an issue tracking system Proprietary issue tracking product, developed by Atlassian bug tracking issue tracking project management functions
Non Conformity Issuetype: NonConformity Types of NCs: Audit external audits Customers Internal internal activities Priority of NCs: Critical Major Minor Subtask: Preventive action Correction Corrective Action
Non Conformity Issuetype: NonConformity Types of NCs: Audit external audits Customers Internal internal activities Priority of NCs: Critical Major Minor Subtask: Preventive action Correction Corrective Action
Customer satisfaction Feedback: Customer survey Employee Survey Complaints
Customer satisfaction Related to Quality Reliability Safety Effectiveness Performance About Staff Communication Products Services
Customer satisfaction Analysis of data Analysis of customer suggestions Continuous Improvement Record maintaned on Jira Customers Project
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