Introduction to Quality Management Systems for Medical Devices

1. Introduction to Quality Management Systems for Medical Devices

2. Introduction to Quality Management Systems of for Medical Devices Sponsored by: Community College of Allegheny County Presented by: Calvin W. Eggers, Quality and Regulatory Consultant

3. Purpose of the course This course is intended to review the quality management system (QMS) requirements for medical device manufacturers and specifically the implementation of the QMS at Renal Solutions, Inc.

4. Expected Learning • Review the regulatory requirements for the Quality Management System (QMS) • Understand the concept and structure of a quality system • Identify the common elements and processes of a QMS and key requirements that apply to them • Differentiate between the medical device QMS and that of other industries • Locate information in the RSI quality manual • Learn personal quality system responsibilities

5. Triage of Knowledge

6. Course Agenda • Medical Regulatory Requirements • Compliance with ISO 13485 and FDA QSR • RSI Quality System Documents • System Clauses and Elements • Management Responsibility • Resources • Realization Processes • Measurement and Improvement • Additional Learning

7. Medical Regulatory Requirements for QMS • US/FDA: Quality Management System per 21 CFR820, Quality System Regulation • Europe, Canada, and Other International: QMS per EN/ISO 13485:2003, Medical devices – Quality management systems – Requirements for regulatory purposes • Additional directives, regulations, and standards as they pertain to the QMS

8. Is 13485 = 9000? • More emphasis on: • Specific records related to medical device requirements • Risk management • Work environment and cleanliness • Complaint handling and corrective action • Others • Less on customer satisfaction and continual improvement

9. What is a System? A regularly interacting or interdependent group of items forming a unified whole

10. What is a Quality System? • The quality management system consists of the organizational structure, responsibilities, procedures, specifications, processes, and resources that work together to comply with the company’s quality policy and meet the requirements of our customers and applicable regulatory requirements • Quality is the degree to which a set of inherent characteristics fulfils requirements

11. ISO 13485 Model

12. Documented System? We don’t use no stinking documents We don’t keep no stinking records

13. Requirements for a Documented Quality System • QSR • 820.40 Document Controls • 820.180 to 198: Records • ISO 13485 • Clause 4, Quality Management System • 4.2.2 Quality manual • 4.2.3 Control of Documents • 4.2.4 Control of Records

14. RSI Quality System Document Pyramid Quality Manual Procedures Work Instructions Forms Quality Records Work Instructions Work Instructions Work Instructions

15. RSI QMS Implementation • Quality Manual • QSM-001, Controlled document • Describes the QMS • Set policy for the organization based on • External regulations • Company business practices and plans • Company culture • Remainder of class will be based on QSM-001

16. Quality System Procedures • Implement policy through • Definition of processes • Assignment of responsibility and authority • Establishment of review and approval mechanisms • Maintenance of records • QSP-0xx; non-significant numbering • Referred to in quality manual section for respective process

17. Who is Responsible to Establish and Maintain Procedures? • Process Owner as Identified in Quality Manual • Establish = design process, write, validate • Maintain = respond to audits, revise for corrective action, changing conditions Owner:……………….

18. Third and Lower Tier Documents • Work Instruction (build, test, inspect, purchase) • Form or template for developing documents or keeping records • Can be established by procedures within the process • Records

19. Quality Manual Road Map • 1 to 3 -- Policy and introduction • 4 – • QMS description • Requirements for documents and records • 5 to 8 -- Requirements for processes • 9 --Trace of compliance

20. Typical Section Outline • General Policy • Detailed policy in outline form • Sub-processes • Specific requirements • Reference to owner and procedures

21. 1.0 Introduction and Scope • This section is intended to describe the scope of the quality management system (QMS) • Organization • Products • Compliance (Regulations and Standards) • Manual is intended for both external and internal purposes

22. 2.0 Quality Policy • Mission • Quality Policy

23. 3.0 Organization • High level • Responsibility for elements

24. 4.0 Quality Management System This section describes the quality management system (QMS) in general terms. The requirements of this section establish a basic structure for the QMS in the form of documents and records

25. Document Control • Changes only with approval by same persons or functions as original • Record of changes • Communicate changes and documents • Use only latest revision • On line version is only controlled copy • Control over standards and other documents of external origin

26. Document Control Procedures • QSP-002 Document Management • Document Control Group • All originators and users • QSP-030 Change Control • Document Control Group • All originators and users Owner: Document Management

27. Record Control • Record is a document that furnishes objective evidence of activities performed or results achieved • Quality record is one that relates to the quality management system

28. Procedures Required • Identifying, collecting, indexing, accessing, filing, storing, maintaining, and disposition • Storage location and archiving • Storage media (may be electronic) • Retention times • Methods of disposition

29. Why Quality records? • Provide objective evidence of the achievement of customer and internal quality requirements • Verify effective operation of the QMS • Comply with regulatory requirements • Provide for traceability of devices and components • Provide information for corrective and preventative action and continuous improvement

30. Record Control Procedures • QSP-004 Record Management • All employees • Specific instructions in procedures for your process • Specific directions from your leaders Owner: Compliance and Regulatory Affairs

31. 9.0 Demonstration of compliance • 9.1 21 CFR 820 Quality System Regulation (FDA) • 9.2 ISO/EN 13485:2003 • 9.3 Other Regulations and Standard • Medical Devices Directive • Other 21 CFR (e.g., Clinicals, 510(k), etc.)

32. 9.0 Demonstration of compliance

33. 9.0 Demonstration of compliance

34. Course Agenda • Medical Regulatory Requirements • RSI Quality System Documents • Compliance with ISO 13485 and FDA QSR • System Clauses and Elements • Management Responsibility • Resources • Realization Processes • Measurement and Improvement • Additional Learning

35. ISO 13485:2003 Model 7.0 Realization Processes

36. 5.0 Management Responsibility • Executive Responsibility • Direction to establish Quality Policy • Management Representative • Alternate • Authorized Representative • Management Review • Quality Planning

37. Management Review • Hold regularly with inputs including • Status of QMS • Audits, Complaints, Corrective and Preventive Action • Metrics of processes • Actions for improvement • Records of meeting, including conclusion on suitability of QMS

38. Management Review Procedure • QSP-005 Management Review (Management and QA) Owner: CEO and Management Representative

39. Resources • 6.1 General • 6.2 Human Resources • 6.3 Infrastructure • 6.4 Working Environment • 6.5 Measurement Equipment • 6.6 Information Systems

40. 6.2 Human Resources • Sufficient personnel with appropriate background, education, and experience • Determine required competence • Provide training to ensure competence • Ensure that the assigned tasks are performed in accordance with the quality system and associated policies, procedures, and work instructions • Include instruction on the importance of the associate’s activities and their contribution to the quality objectives

41. Training • Identify the training needs and plan the training • Identify of device defects or nonconforming conditions that may occur as a result of improper performance • Identify types of defects that may be encountered on validation, verification, inspection, or test activities, • Include training on any special processes, and any need to work under special environmental conditions • Conduct the training • Evaluate effectiveness of training • Records of all training

42. Training Procedure • QSP-006 Training (All Leaders) • Everyone: Get trained; do quality system jobs only if trained Owner: Chief Financial Officer

43. 6.3 Infrastructure • Controlled conditions to ensure that devices meet their requirements and are shipped free of contamination • Buildings adequate, orderly, to prevent contamination and mix-up • Processing Equipment • Selected and designed to meet requirements • Cleaned, maintained, and adjusted

44. Infrastructure Procedures • None at this time Owner: Senior VP, Operations and Engineering

45. 6.4 Working Environment • Processes in compliance with all applicable Environmental, Health, and Safety requirements • Where necessary, control environmental conditions • Cleaning where necessary to meet specifications and prevent device or equipment contamination • Handle items sensitive to electrostatic discharge (ESD) per procedures. • Smoking prohibited • Eating and drinking limited to designated areas • Each associate help maintain a clean and safe work environment • Inform all associates who contact devices or components of requirements for health, cleanliness, personal practices, and attire as well as any adverse effects that the health of the associates could have on product quality • Train any employee who may be exposed to Blood Born Pathogens (BBP) in personal protective measures and the handling of BBP contaminates

46. Working Environment Procedures • None at this time Owner: Senior VP, Operations and Engineering

47. 6.5 Measurement Equipment • Measuring equipment used to provide evidence of conformity to requirements • Ensure that it is suitable for its intended use and to assure confidence in the measurements • Include selection, qualification, identification, preservation, calibration, and corrective action • Calibration based on primary standards that are traceable to National Institute of Standards and Technology (NIST) standards • Suppliers of calibration services shall be qualified

48. Measurement Equipment Procedure • QSP-007 Control of Measuring Equipment (QA and all who use equipment) • Procedure is based on outsourcing calibration • Everyone: use only if in current calibration Owner: Compliance and Regulatory Affairs

49. 6.6 Information Systems • Systems that support the quality management system shall be developed, operated, and maintained under controlled conditions • Adequate equipment, environment, software, procedures, and personnel • Validate all systems and software • Electronic record requirements • Electronic signature requirements

50. Information System Procedures • None at this time Owner: Chief Financial Officer