1. Workshop on Accreditation of Bodies Certifying Medical Devices Kiev, 17 - 18 November 2014

2. ISO 13485 Quality management system Dr. Simona Pârvu Ministry of Health Romania

3. ISO 13485  Was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes  It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose  The application of the quality system:  Must ensure that the products conform to the provisions of the Medical Devices Directive (MDD)

4. THE PRIMARY OBJECTIVE OF ISO 13485:  To facilitate harmonized medical device regulatory requirements for QMS  As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements  Because of these exclusions, organizations whose QMS conform to this International Standard cannot claim conformity to ISO 9001 unless their QMS conform to all the requirements of ISO 9001

5. WHAT IS A QUALITY SYSTEM?  The QMS 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

6. SCOPE  A QMS is designed to mitigate business risk through a systematic, statistical and factual based approach to creating and maintaining the process which delivers the customer required product or service / business objectives But  it is just part of an organizations internal control system

7. IS ISO 13485 = ISO 9001?  More emphasis in 13485 on: 1.Records meeting medical device requirements 2.Risk management 3.Work environment and cleanliness 4.Complaint handling and corrective action Less on customer satisfaction and continual improvemen t

8. STRUCTURE OF QMS  1. General Requirements  2. Documentation requirements a) General b) Quality Manual c) Control of Documents d) Control of Records

9. 1. GENERAL REQUIREMENTS  Describe the scope of the QMS: 1.organization and locations 2.products 3.compliance (Regulations and Standards)  Describe the document structure and types of documents  To help auditors, include trace from requirements to quality manual or procedures  Requirements for documents and records

10. ORGANIZATIONS WORKING IN THE FIELD OF MD  Must establish, document, implement and maintain a QMS and maintain its effectiveness in accordance with this standard  In this context the organization must: 1.identify the processes needed for QMS 2.if regulatory requirements permit exclusions of design and development controls, this can be used as justification for their exclusion from the QMS

11. If any of the requirements for the design and development is not applicable for the medical device for which the system is applied, the organization does not need to include that requirement in the system !

12. 2. DOCUMENTATION REQUIREMENTS:  What is to be done and by whom, when, where and how it is to be done, what materials, equipment and documents are to be used  How an activity is to be monitored and measured  Design History File, Technical File, Complaint File, device records, etc. Any exclusions? (Section 7 only!)

13. Product Realization-Exclusions  Exclusions of design and development (7.3) from the QMS is allowed only if allowed by regulation. See NOTE 2 of 7.1: The organization MAY also apply the requirements given in 7.3 to the development of product realization processes

14. Product Realization-Exclusions  Organizations whose quality management systems exclude design and development control (7.3 of ISO 13485), are still required to comply with the product verification and validation requirements as specified in 7.1 of ISO 13485 dealing with product realization  In such organizations, the controls included in 7.3 should be considered for all changes made to the product.  Such changes will require objective evidence (e.g., product verifications and validations, inspection and test specifications, revised procedures, etc.) of the results of the activities described in 7.3 of ISO 13485

15. Product Realization – Non applicability  “ Non-inclusion” of product realization requirements is allowed if those functions are not required by the nature of the medical device being provided by the organization.  For example, an organization providing single- use, sterile medical devices may not need to include within its quality management system elements related to installation and servicing.

16. THE DOCUMENTATION MUST INCLUDE:  documented declarations regarding the policies regarding to quality objectives  a quality manual  documented procedures required by this international standard  documents required by the organization to ensure the effectiveness of its planning, operations and the control of its processes  records : legible, identifiable and easily retrievable  records : established and maintained to provide evidence of compliance with the requirements and effective operation of the QMS  a documented procedure  any other document specified by national or regional reglementations.

17. THE SCOPE OF QMS DOCUMENTATION a)Can differ from one organization to another depending :  On the size of the organization and the type of its activities  Complexyti of processes  Staff competence.

18. b) QUALITY MANUAL Role:  Describes the QMS  Sets policy for the organization based on: 1.external regulations 2.company business practices and plans 3.company culture

19. THE QUALITY MANUAL WHICH MUST BE ESTABLISHED AND DEVELOPED BY THE ORGANIZATION MUST INCLUDE: 1.the scope of QMS 2.documented procedures established for the QMS 3.a description of the interaction between quality management processes

20. QUALITY SYSTEM c) PROCEDURES  Implement policy through  definition of processes  assignment of responsibility and authority  identification of review and approval mechanisms  maintenance of records  Should be referred to in the quality manual or otherwise summarized  Quality manual can be a collection of the high level procedures

21. d) CONTROL OF DOCUMENTS  Changes only with approval by same persons or functions as original  record of changes  Communicate changes and documents  Use only latest revision  define if it is paper or electronic version  Control over standards and other documents of external origin

22. CONTROL OF RECORDS  “ 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

23. BENEFITS OF QMS FOR MEDICAL DEVICES: customer satisfaction, business partners and legal requirements providing the authorities with proofs that the laws and regulations are respected minimize and control the risks preventing errors before they correct improved quality performance transparency and clarity of internal processes saving time and costs

24. TO WHOM IS THIS QUALITY ASSESSMENT SYSTEM ADDRESSED  to private companies that manufacture on a regular basis medical devices for medical laboratories  to companies that produce medical components  to consultants who design, manufacture and assemble medical instruments for medical laboratories

25. All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented : Written policies and procedures such as : 1.quality programs 2.quality plans 3.quality manuals 4. quality records

26. THE MEDICAL DEVICES DIRECTIVE (MDD) :  the manufacturer of medical devices keeps a product- related, adequate and efficacious quality system.  the MDD gives more flexibility to the device manufacturer in organizing his company according to size, social environment, culture of countries, and nature of the devices than the ISO 9001 standard.  On the other hand even ISO 9001 in combination with the additional requirements of EN ISO 13485, DOES NOT FULLY COVER the requirements of the MDD.

27. ADDITIONAL ASPECTS TO BE COVERED BY THE QMS the technical documentation reference to the essential requirements according to Annex I of the MDD information about harmonized standards and medical device regulations risk analysis labeling and instructions for use different languages post-marketing surveillance reporting under the vigilance system retention of certain documents

28. IT IS NO SECRET that a suitable quality system, which is implemented in all relevant stages, may be an important factor for maintaining and improving product safety and performance.

29. THE TASK OF THE NOTIFIED BODY (NB): to understand the culture of the manufacturer and to evaluate whether or not the QMS meets the minimum requirements of the MDD, and to give advice where deficiencies are detected

30. ISO 9001 & ISO 13485 for CE- MARK - QUALITY SYSTEMS  To believe that a QMS according to ISO 9001 is the key to CE-marking it is completely wrong !!!  The ISO 9001 of standards is the most popular way for the proper organization of a quality management system.  ISO 13485 it is another preferable possibility  But harmonized standards are not the only way to demonstrate compliance with the MDD !!!

31. Conclusion It is important to bear in mind that:  ISO standards are updated periodically - revisions and updates do occur and  ISO 13485 is due for an update in the next few years. As quality system standards are updated, you must ensure that QMS must keeps up with those updates in order the manufactures remain in compliance.

32. Thank you !