ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes. Theresa McCarthy

Transcription

1 ISO 13485:2016 Medical Devices-Quality Management Systems- Requirements for Regulatory Purposes Theresa McCarthy

2 Welcome and Introductions Please interview and collect: Name Primary Quality Management System (QMS) Responsibilities

3 Agenda Learn about changes to ISO 13485:2016 Medical Devices QMS Regulatory Requirements Review your organization s ISO Quality Manual against the current standard Consider how 21 CFR 820 relates to the ISO 13485:2016 updates

4 Review Section 1 Scope Topic/Requirement 2 Normative References 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis and Improvement MDD Medical Devices Directive

5 Description of ISO Details requirements for QMS for design and manufacture of medical devices/ivd. Initially published in Harmonised with ISO First step in complying with EU regulatory requirements. Audited against & MDD/MDR. Equates with 21 CFR 820. Main difference, FDA don t certify compliance with QSR.

6 Things to Keep in Mind The standard can be used by an organization involved in one or more stages of the life cycle of a medical device including design, development, production, storage and distribution installation or servicing of medical devices and well as for the design, development and provision of associate activities (e.g technical support). ISO can also be used by internal and external parties, including certification bodies, to assess the organization s ability to meet customer and regulatory requirements. BSI Vendor Management

7 What is ISO The standard is published by ISO, the International Organization for Standardization, and is available through National Standards Bodies. TC 210

8 Things to Keep in Mind 9001 vs Current version is aligned with ISO 9001: Structure remains Clause 4,5,6,7, Follows Annex SL is a high-level structure created by ISO to provide a universal high-level structure, identical core text, and common terms and definitions for all management system standards. It was designed to make it easier for organizations that have to comply with more than one management system standard. May 13, 2015

9 Introduction The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted The preferred method to prove conformity is the certification of the Quality Management System according ISO and ISO by a Notified Body. The result of a positive assessment is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union Compliance with ISO is often seen as the first step in achieving compliance with European regulatory requirements.

10 CE Marking

11 Areas of increased emphasis ISO rd edition: Regulatory requirements Risk management Validation, verification and design transfer Outsourced processes and supplier control Feedback

12 Lets Keep In Mind Regulatory requirements ISO 13485:2016 Regulatory requirements appears 37 times* PQS Requirements Are based on regulations. We have a LEGAL OBLIGATION to comply with regulations.

13 New definitions: Clause 3 Authorized representative Purchas ed product Distributor Importer Clinical evaluatio n Medical device family Manufacturer Sterile barrier system Risk management Lifecycle Performance evaluation Complain t Postmarket surveillan ce Risk

14 Clause 3 Definitions 20 of Them 3.2 Authorized Representative Natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter s obligation under the country or jurisdiction's legislation (source GHTF/SG1/N0555:2009, 5.2) n055-definition-terms pdf International Medical Device Regulators Forum The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

15 3.3 Clinical Evaluation 3.3 Clinical Evaluation Assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. GHTF/SG5/N4/2010 Therefore, there may be questions regarding residual risks that should be answered in the post market phase through the use of one or more systematic post-market clinical follow-up studies. MEDDEV 2.7/1 revision 4 June CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC Note

16 Clause 4 Quality Management System - General General Requirements Document the Role of the Organization Manufacturer Authorized Representative Virtual Organization Legal Manufacturer Awareness of the increased regulatory and risk based approach Change Management Evaluated for impact on medical devices produced in QMS Control of Outsourced Processes Quality Agreements Validation of Software associate with QMS SAP, Track wise, ERP, ISOTrain

17 4.2 Documentation Requirements Non-application relating to clauses 6,7,8 Exclusions Medical Device File: DHF Additional controls related to security and integrity Confidential health information

18 Quality Management System Medical Device File Management Review Quality Manual Quality Procedures Work Instructions Corrective and Preventive Action Records Internal Audit

19 Clause 5 Management Responsibility Increase focus on Regulatory Requirements Documented procedures for Management Review Documented planned intervals Expanded inputs and outputs Complaint handling Reporting to regulatory authorities Changes needed to respond to applicable new or revised regulatory requirements

20 Clause 6 Resource Management 6.2 Human Resources Documented processes for competence, awareness and training Risk based training effectiveness monitoring 6.3 Infrastructure Processes for preventing product mix-up Information systems infrastructure Maintenance intervals for production or monitoring equipment 6.4 Work Environment Documented requirements for work environment Contamination controls for sterile medical devices

21 Clause 7 Product Realization 7.1 Planning of Product Realization Processes for Risk Management ISO IEC Requirements for storage, handling, distribution and traceability 7.2 Customer Related Processes Requirement and availability for any user training Documented processes for communicating with stakeholders, including regulatory authorities

22 7.3 Design and Development Documentation = Design History File Product Consistently meet specifications and Safe and Effective for its Intended Use

23 7.3 Design and Development Traceability of design inputs to outputs Required resources, including competence of personnel involved in design projects Additional details and documentation for verification and validation plans, including statistical techniques, sampling rationale and representative product and records Documented procedures for design transfer and design change Design and development files

24 7.4 Purchasing Evidence of increased focus on supplier monitoring and risk Documented agreements for prior notification of changes to supplied product Flow Down? AS9100? Linkage between verification of purchased product and change control

25 7.5 Production and Service Provision Qualification of infrastructure Analysis of service records Documented procedures for validation including statistical techniques, sampling rationale, revalidation Validation requirements for processes that cannot be subsequently monitored Procedures for risk based software validation Documented procedures for product identification/status during production, UDI if required Validation of sterile barrier systems Suitability of packaging systems Recording of measuring equipment adjustments

26 Clause 8 Measurement Analysis and Improvement Monitoring and Measurement: Linkages between customer feedback into risk management Documented processes for ascertaining whether customer requirements have been met Documented procedures for complaint handling Communication processes for informing third parties of complaints Documented plans for internal audits at defined intervals Processes for the identification of test equipment

27 8.3 Control of Nonconforming Product Processes for communication with external parties regarding non-conforming product Additional controls for managing concessions Linkages between rework and regulatory requirements

28 Analysis of Data 8.4 Additional sources of data such as service records and audits Procedures that cover the application of statistical techniques Linkages between the analysis and improvement of processes

29 8.5 Improvement How actions are taken without undue delay Evaluation of actions for adverse effects on regulatory requirements and product safety and performance Correction: Root Cause: Corrective Action: Preventive Action: Effectiveness Check

30 European Medical Device Regulations 2017/745 (MDR European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic Regulations 2017/746 (IVDR) are published May 5, 2017 in the Official Journal of the European Union (OJEU), May 4 th, 2017.

31 What are the key change highlights Classification criteria change - Reclassification of some device. Technical Documentation (Technical file) defined requirements, including Post Market Surveillance Change from Essential Requirement to General safety and performance enhanced with new requirements Person Responsible for Regulatory Compliance Affects manufacturers and Authorised Representatives, including person(s) qualification requirements and responsibilities. EU Declaration of Conformity amended minimum content requirements UDI for ALL types/classes of Medical Devices phased/transition period

32 What are the key change highlights European Databank on all Medical Devices including IVD s. Clinical Evaluation Report minimum requirements for person writing them and they are to be Included within the Technical Documents and updated/maintained Post-market surveillance system, plan and reporting requirements to be included in Technical Documents Periodic Safety Update Report Annual requirement to be submitted to Notified Body New requirements for Notified Bodies May impact on registration of new devices and re-classification of existing ones.

33 ISO 13485: 2016 Process Based Quality Management System 4.0 Quality Management System Process Approach 5.0 Management Responsibility Customers Customers 6.0 Resource Management 8.0 Measurement, analysis and improvement Satisfaction Requirements input 7.0 Product Realization output Product

34 Questions?