Quality Assurance International standards (ISO/CLSI) Susanne Karlsmose DTU Food, Denmark

Transcription

1 Quality Assurance International standards (ISO/CLSI) Susanne Karlsmose DTU Food, Denmark

2 Definition A quality management system can be defined as: Coordinated activities to direct and control an organization with regard to quality - ISO and CLSI defintion DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

3 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 3 3 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

4 Scope of ISO General requirements for competence tests calibrations sampling to confirm or recognize competence testing / calibration laboratories Quality Administrative Technical systems Does not cover compliance with regulatory and safety requirements for laboratory operations Assessment: 4 DTU Food, Norms Technical University and of Accreditation-Module Denmark 4

5 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 5 5 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

6 Scope of ISO Based on ISO 17025:1999 & 9001:2000 Medical Laboratory Particular requirements for quality & competence to confirm or recognize competence Laboratory quality management Technical processes Quality Administrative Technical systems 6 DTU Food, Technical University of Denmark Assessment: Norms and Accreditation-Module

7 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 7 7 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

8 ISO and CLSI standards ISO 17025:2005 General requirements for the competence of testing and calibration laboratories ISO 15189:2007 Medical laboratories Particular requirements for quality and competence ISO Clinical laboratory testing and in vitro diagnostic test systems Susceptibility testing of infectious agents CLSI -M07-A9 Methods for Dilution AST -VET01-S2/VET01-A4 Performance Standards Bacteria isolated from Animals -M100-S23 Performance Standards for AST -QMS01-A4 (formerly GP26-A4) Quality Management System: A Model for Laboratory Services 8 8 DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

9 Standardization Bodies International organizations include: ISO CLSI CEN WHO Assessment: Norms and Accreditation-Module 9 DTU Food, Technical University of Denmark 11 9

10 International Organization for Standardization world's largest developer and publisher of international standards standards are applicable to many kinds of organizations including clinical and public health laboratories Uses consensus process in developing standards Assessment: Norms and Accreditation-Module 10 DTU Food, Technical University of Denmark 11 10

11 Clinical and Laboratory Standards Institute global, nonprofit, standards-developing organization detailed; standards apply specifically to medical laboratories promotes the development and use of voluntary consensus standards and guidelines documents are developed by experts working on subcommittees or working groups (consensus process) Assessment: Norms and Accreditation-Module 11 DTU Food, Technical University of Denmark 11 11

12 European Committee for Standardization founded by the national standards bodies in the European Economic Community and associated countries general terms include openness and transparency, consensus, and integration Assessment: Norms and Accreditation-Module 12 DTU Food, Technical University of Denmark 11 12

13 World Health Organization has developed several standards for disease-specific diagnostic laboratories, such as polio, tuberculosis, influenza, measles Assessment: Norms and Accreditation-Module 13 DTU Food, Technical University of Denmark 11 13

14 Self-developed standards Many agencies, organizations, or regions develop their own accreditation requirements rather than using internationally recognized standards. Advantages: optimized for local use, recognized local strengths and weaknesses can be developed in progressive steps can lead to full international recognition Weaknesses: may be narrow or biased may not be recognized by other organizations Assessment: Norms and Accreditation-Module 14 DTU Food, Technical University of Denmark 11 14

15 To assure quality Def.: Coordinated activities to direct and control an organization with regard to quality A quality management system includes all aspects of the laboratory operation, i.e.: Organizational structure Processes Procedures The entire process of managing a sample must be considered: sample collection reporting and saving of results all processes in between DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

16 Organization Personnel Equipment Purchasing & Inventory Documents & Records Process Control Occurrence Management Information Management Assessment Twelve Quality System Essentials Quality management system model developed by CLSI (QMS01-A4) (and is fully compatible with ISO standards) Process Improvement Customer Service Facilities & Safety DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

17 Organization Personnel Equipment Purchasing & Inventory Documents & Records Process Control Occurrence Management Information Management Assessment Twelve Quality System Essentials Set of coordinated activities that function as building blocks for quality management Process Improvement Customer Service Facilities & Safety Management commitment is crucial! DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

18 Responsibilities Laboratory Director implements international or national standards seeks information about appropriate norms and standards seeks information about accreditation and certification processes uses outcomes to provide better service Technician aware of requirements contributes to meeting standards aware of assessment processes helps prepare for assessment Assessment: Norms and Accreditation-Module DTU Food, Technical University of Denmark Quality Manager explains the process for meeting standards to staff organizes the laboratory in preparation for assessments 18

19 Standardization Standardized and quality assured methods Reliable and reproducible data DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

20 Standards/guidelines International standards describe the methods (DD and MIC) in detail: media, inoculum, incubation, etc. Standards: - ISO documents - Some CLSI documents (approved standard) Guidelines: - Some CLSI documents (approved guideline) - EUCAST (The European Committee on Antimicrobial Susceptibility Testing DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

21 Standardization our world All AST methods are extremely sensitive to variations Factors that influence the result of AST: - Size of inoculum - Contents and acidity (ph) of the broth or agar - Incubation time and temperature - Reading procedures Moreover, for the diffusion methods: - Diffusion rate of the antimicrobial into the agar - Depth of the agar - Dryness of the agar - Growth rate of the bacteria DTU DTU Food, Food, Technical Technical University University of Denmark of Denmark

22 Personnel human resources job qualifications job descriptions training competency assessment professional development continuing education 22 Introduction DTU Food, Technical Laboratory University of Denmark Quality Management 22

23 Equipment Monitor temperatures of: incubators refrigerators freezers Perform function checks for: pipettes autoclaves ph meter weights and measures Maintain records Management assures: Responsibility assigned Relevant training of personnel 23 DTU Food, Technical University of Denmark 23

24 Occurrence Management complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions 24 DTU Food, Technical University of Denmark 24

25 What went wrong? The organism was misidentified A typo/clerical error was made Switch of strains/samples The wrong test was ordered The sample was not preserved properly Contamination Growth Inoculation Incubation Media Etc 25 QC Antimicrobial DTU Food, Technical University Susceptibility of Denmark Testing - Module 8 25

26 Laboratory Assessment Internal External Proficiency testing (EQA) Inspections Accreditations 26 DTU Food, Technical University of Denmark 26

27 Questions arise Does the laboratory need certification/ accreditation? Which standards should the laboratory use? Which regulation is relevant? Assessment: Norms and Accreditation-Module 27 DTU Food, Technical University of Denmark 11 27

28 Definitions Certification (ISO/IEC 17000) Procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements. Examples of certification standards: - ISO 9001: ISO Accreditation (ISO 15189) Procedure by which an authoritative body gives formal recognition that a body or person is competent to care out specific tasks. Examples of accreditation standards: - ISO ISO Assessment: Norms and Accreditation-Module 28 DTU Food, Technical University of Denmark 11 28

29 Approved Knowledgeable Competent staff Certification and Accreditation Bodies Standardsbased Objective Assessment: Norms and Accreditation-Module 29 DTU Food, Technical University of Denmark 11 29

30 Accreditation outcomes strength and integrity of the quality system are measured continual monitoring of the quality system recognition for efforts recognition as delivering accurate and reproducible results recognition of compliance with the quality standards and norms used for the assessment Awarded to Quality Lab 2013 Assessment: Norms and Accreditation-Module 30 DTU Food, Technical University of Denmark 11 30

31 Also, accredited labs tend to - perform better on proficiency testing - are more likely to have a working quality management system BUT 31 Accreditation does not guarantee success, it is only one step along the quality journey Continual improvement is necessary! Assessment: Norms and Accreditation-Module 31 DTU Food, Technical University of Denmark 11

32 Summary Standards form the basis for quality practices. They are developed by organizations. A method standard is a method standard. If modified, the standard was not followed. Method guidelines may be adjusted/modified. Accreditation and certification are processes that recognize that a laboratory meets the designated standards. Accreditation is an important step in the continual improvement of the quality management system. Assessment: Norms and Accreditation-Module 32 Assessment: DTU Food, Technical Norms University and Accreditation-Module of Denmark

33 Implementing Quality Management does not guarantee an ERROR-FREE Laboratory But it detects errors that may occur and prevents them from recurring 33 Introduction DTU Food, Technical Laboratory University of Denmark Quality Management 33

34 Laboratories not implementing a quality management system guarantees UNDETECTED ERRORS 34 DTU Food, Technical University of Denmark

35 Ref.: and further information, see: Thanks for your attention! 35 DTU Food, Technical University of Denmark 35