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Tsimillis, K.: Accreditation or Certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality.

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Presentation on theme: "Tsimillis, K.: Accreditation or Certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality."— Presentation transcript:

1 Tsimillis, K.: Accreditation or Certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Accreditation or Certification for Laboratories? Kyriacos C. Tsimillis

2 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching In Todays Society… some trends are of importance free movement of goods elimination of technical barriers to trade broadening of quality concept

3 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Issues are… nowadays considered to be of highest importance as a result of increasing awareness of existing needs. This is illustrated in legislative requirements and high competition on quality aspects

4 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Specific Needs… exist in some sectors food health care services environmental studies New Approach Directives dangerous substances

5 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching There is a Need to… create an international technical language to ensure common understanding!

6 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching As a Result… efficient tools and mechanisms are required. Emphasis is given on their worldwide implementation in a harmonised way

7 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Tools and Mechanisms Standardization Laboratory infrastructure Quality management Metrology Accreditation GLP

8 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Tools and Mechanisms (cont.) Technical Notification Environmental management Modules/Notified Bodies Harmonised Standards Ecolabeling Occupational health and safety

9 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Infrastructure Required… consists of Laboratories Standardization bodies Certification bodies Inspection bodies Accreditation bodies

10 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching How can We be Sure that… products and services meet the specifications? By conformity assessment, i.e. checking that products and services meet the relevant standard´s specifications.

11 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Accreditation Product/ Service Supplier Consumer Legislation Inspection Body LaboratoryCertification Body Demands Market Conformity Assessment Requirements Demands

12 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching ISO/IEC Guide 2 and EN refer to definitions and terminology of standardization and related activities.

13 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Following the Definitions… Accreditation refers to competence to carry out specific tasks Certification refers to assurance of conformity to specified requirements

14 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Testing is Carried out… by laboratories in the private sector in – house second party third party in the public sector competent authorities

15 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching We need to Measure! If you cannot measure something it doesn't exist! Therefore we need methodology equipment personnel

16 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Role of Laboratories drafting of standards development of new methods implementation of standards, technical regulations and the legislation provision of services (testing, calibration, consultancy)

17 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Accreditation Body - Suppliers - Equipment - Reagents, CRMs Legislation Laboratories Calibration Laboratories LABORATORY Certification Body Clients The Laboratory Environment

18 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Laboratories Need… to demonstrate their technical competence and reliability to this end they need also to have policies how to estimate the uncertainty of their measurements

19 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Laboratories Operation is Based on… Quality System methodology equipment (suitability, calibration, maintenance, conditions) personnel (competence) determination of uncertainty

20 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Basic Documents for Laboratories ISO EA Guidelines ISO 9000 ISO (if applicable) GLP (if applicable) Legislation

21 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching To Avoid any Hidden Barriers… to the free movement of goods, services and personnel, conformity assessment activities should be homogeneous and be implemented according to relevant Guides of ISO/IEC and EA Guidelines

22 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Sources of Information

23 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Accreditation and Certification present both similarities related to the audit-based nature of the procedures and differences with regard to the tasks and the resulting procedure

24 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching They are Both Related to… quality assurance policies considered of high importance tools in todays society with regard to the free movement of goods

25 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching However… This is not enough and does not fit the purpose!

26 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching We Need Something More! We need tools for the assessment of the technical competence of laboratories to carry out specified tasks

27 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Is there any Confusion… on the use of these two procedures, their significance and their role within conformity assessment activities? If so, why does this happen?

28 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Can Both Activities… be used by laboratories to document their competence and the reliability of their results? Do these two procedures represent equivalent criteria?

29 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Main Differences Refer to… the objective and content the documentation assessors competence procedure of assessment the use of the logo how wide the scope is

30 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Differences in the Procedure refer to the following issues validation of test methods expression of uncertainty calibration of equipment competence of personnel

31 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching What about Uncertainty? How educated is the client to consider properly and make correct use of the expressed uncertainty of measurement?

32 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Meaning of Uncertainty is not well understood by the clients. They may not choose a laboratory which produces results that are uncertain to some extent!

33 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Technical Competence of Personnel Means… Suitable academic qualifications Adequate experience/training Awareness and familiarisation with particular methods and techniques

34 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Quality Means… meeting the customers needs. How clear are these needs for the customers and how are they expressed in the communication with the laboratories?

35 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Who are the Customers? competent authorities industrial units purchasers individuals other laboratories

36 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching ISO 9000 Provides… for suppliers and sub-contractors to be included in the approved list. Relevant requirements are specified in the Quality System.

37 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Most Usual Requirement… is ISO 9000 certification this refers also to laboratories that are listed as approved suppliers/ subcontractors

38 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching A Survey was Carried out… by ILAC in 1996 to evaluate the competence of the laboratories, the needs of their customers and market trends.

39 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching According to the Survey… a small percentage of laboratories are certified big laboratories use accreditation for ISO 9000 compliance accreditation is preferred to certification to demonstrate technical competence

40 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Suggestions were Made … for the revision of ISO/IEC Guide 25 and EN and harmonization with ISO 9000 on management issues this would facilitate the promotion of mutual recognition of this part of the system.

41 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Standard ISO has replaced the former European standard EN to ensure a worldwide acceptance of a unique document for the assessment of laboratories under accreditation

42 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching 1999 Edition of the Standard provides for a clarification of the situation it classifies the main requirements in two main categories, the Management Issues and the Technical Competence Issues.

43 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Structure of the Standard… enables a direct correlation with ISO 9000:1994. ISO specifies management requirements and technical requirements in separate chapters. The former corresponds to ISO 9000 requirements

44 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Therefore the Two Standards… can easily be correlated and provide the basis for comparison of the two procedures they refer to

45 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Standard ISO 9000:2000 is a new version of the previously existing ISO 9000 series. This fact doesnt alter the findings of the correlation made above

46 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching It is Expected that… in this way an agreement for mutual recognition could be established thus enabling laboratories to avoid duplication in work and additional costs.

47 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching To Achieve Reliability… a Laboratory needs to take some basic steps, starting with the preparation and implementation of a Quality System.

48 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Establishing Reliability… Accreditation Reliability Competence of personnel Suitability of equipment Calibration of equipment Interlaboratory comparisons Method validation Quality System

49 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching When Taking the First Step… the Laboratory should prepare and implement a Quality System as described by either ISO 9000 or ISO This step does not impose the need for certification

50 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Further to a Quality System…. We need to ensure factors contributing to the reliability of the Laboratory Technical competence of personnel Adequacy of infrastructure Fitness of methodology

51 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching The Scope of Accreditation usually includes only few of the methods carried out in the laboratory. These methods are the ones for which technical competence is assessed. The Quality System covers the overall activity.

52 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching Laboratories Operating in certified industrial units have to meet the relevant requirements of ISO 9000 therefore they may find it easier to go on towards accreditation.

53 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching However, in Such a Case… one more requirement should be considered, i.e. the one referring to the documentation of the independence of the laboratory from the parent company.

54 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching It should be Clear that… if the need refers only to compliance with quality management issues, certification may be considered adequate accreditation may also be considered as equivalent with respect to these issues.

55 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching It should also be Clear that… if the need refers to the technical competence, accreditation of the laboratory with a detailed description of its scope is the appropriate means to demonstrate it.

56 Tsimillis, K.: Accreditation or certification for Laboratories?© Springer-Verlag Berlin Heidelberg 2003 In: Wenclawiak, Koch, Hadjicostas (eds.) Quality Assurance in Analytical Chemistry – Training and Teaching There is Still much more work to be carried out towards a better understanding and harmonisation of the approaches with regard to laboratory work and the use of test and calibration results


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