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OUTLINE OF LABORATORY MANAGEMENT SYSTEM BASED ON ISOIEC 17025 STANDARD

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Title: OUTLINE OF LABORATORY MANAGEMENT SYSTEM BASED ON ISOIEC 17025 STANDARD


1
OUTLINE OF LABORATORY MANAGEMENT SYSTEM BASED ON
ISO/IEC 17025 STANDARD
  • November 7, 2007
  • JICA Expert
  • GREEN BLUE CORPORATION
  • Dr. M. FUJIMURA

2
CONTENTS
  • ISO/IEC 170252000
  • ISO 9001 and 17025
  • Conformity Assessment and ISO Standard
  • Composition of the Standard
  • Assessment for Accreditation of 17025
  • Steps for Building a Laboratory Management
    System
  • (Assuring of the Quality of Test Results)
  • (Uncertainty of Measurement)

3
ISO/IEC 170252005 (Romanian version SR EN
ISO/CEI 170252005)
  • Title General Requirements for the Competence
    of
  • Testing and Calibration Laboratories
  • ISO International Organization for
    Standardization
  • IEC International Electrotechnical
    Commission
  • ISO 17025 is written as a general description
    applicable to both testing laboratories and
    calibration laboratories.
  • In case of a testing laboratory, it can be read
    by omitting the following words and phrases
    …and calibration lab., calibration lab., or
    calibration, and so on.

4
ISO 9001 and 17025
  • ISO 90012000
  • Title Quality Management Systems Requirements
  • Assure the quality of products/ services, and
    rise Customer Satisfaction.
  • Applicable for any kind of organizations, i.e.
    manufacturer, service company or governmental
    administration, etc.
  • For a testing laboratory, there are many
    difficult point and insufficient parts to
    understand.
  • Certified registration of ISO 9001 system itself
    does not assure the ability of taking proper data
    and results.

5
ISO 9001 and 17025
  • ISO/IEC 17025 (SR EN ISO/CEI 17025)
  • Any testing/ calibration laboratory shall satisfy
    all the requirements, in order to prove that the
    laboratory maintains the appropriate management
    systems, technical competence, and abilities to
    report proper results.
  • It should be used as the basis for the laboratory
    accreditation.
  • All the requirements of ISO 9001 relevant to the
    scope of testing services are incorporated.

6
Conformity Assessment and ISO Standard
  • Conformity assessment To check and confirm if
    the products or the process of services respect
    to some criteria, standards and regulations.

7

Conformity Assessment and ISO Standard
  • Certification To assure the conformity of a
    product, process and service with requirements
    through documents by a third party (besides the
    person concerned).
  • Accreditation To recognize officially the
    ability of institute or persons to perform a
    prescribed work and job by an authorized
    organization.
  • Unlike the ISO 9001, which certifies the
    functioning of organizations as a whole, the ISO
    17025 certifies the specific testing techniques.

8
Composition of the Standard
  • 1. Scope / 2. Normative references / 3. Terms and
    definitions
  • 4. Management requirements
  • 4.1 Organization / 4.2 Management system
  • 4.3 Document control
  • 4.4 Review of requests, tenders and contracts
  • 4.5 Subcontracting of tests
  • 4.6 Purchasing services and supplies
  • 4.7 Service to the customer / 4.8 Complaints
  • 4.9 Control of nonconforming testing work
  • 4.10 Improvement / 4.11 Corrective action
  • 4.12 Preventive action / 4.13 Control of records
  • 4.14 Internal audits / 4.15 Management reviews

9
Composition of the Standard
  • 5. Technical requirements
  • 5.1 General
  • 5.2 Personnel
  • 5.3 Accommodation and environmental conditions
  • 5.4 Test methods and method validation
  • 5.5 Equipment
  • 5.6 Measurement traceability
  • 5.7 Sampling
  • 5.8 Handling of test items
  • 5.9 Assuring the quality of test results
  • 5.10 Reporting the results

10
Assessment for Accreditation of 17025
  • Scope
  • The scope will be decided from both the testing
    field (measuring sample and item) and the testing
    technique (method).
  • Usually, the scope includes analysis items, and
    testing method (SR EN, STAS…).
  • What is the purpose and meaning for the
    laboratory to acquire the accreditation of the
    testing laboratory?
  • To establish the authority of the laboratory,
  • or
  • To improve the quality of the laboratory by
    building a management system.

11
Assessment for Accreditation of 17025
  • System assessment The whole quality management
    system will be checked based on the 17025.
  • Technical assessment Testing ability will be
    checked by 17025 requirements, for the prescribed
    testing method.
  • Document evaluation Corresponding SOPs (Standard
    operating procedures) shall be checked
    technically.
  • Field evaluation Actual testing work shall be
    correctly performed according to the SOP.

12
Steps for Building a Laboratory Management System
  • It is necessary to understand adequately the
    purpose of the standard for all the laboratory
    personnel.
  • Step 1 The decisions by a responsible person
  • Why do we build a laboratory management system?
  • For what purpose do we need the accreditation?
  • ? To consolidate the base of the administration.
  • ? To increase the competition power.
  • ? To guarantee the credibility of the measurement
    data

13
Steps for Building a Laboratory Management System
  • Step 2 Building the working group
  • To appoint the persons in charge
  • To make the laboratory staff aware that it is
    necessary for the entire personnel of the
    laboratory to be involved and to cooperate.
  • To present the responsibility and the authority
    of the persons in charge.
  • To conduct lectures and training for the staff in
    order to understand the requirements of ISO
    17025.

14
Steps for Building a Laboratory Management System
  • Step 3 Setting the Scope of accreditation
  • To decide what items and methods are in the scope
    of accreditation.
  • To choose the standard testing method, officially
    approved by the government.
  • Step 4 Statement of the Quality Policies and
    establishment of Overall Objectives
  • The top management issue the quality policies.
  • To explain the purpose of acquiring the
    accreditation.
  • To make and present the entire schedule.

15
Steps for Building a Laboratory Management System
  • Step 5 Understanding the actual situations
  • To understand the actual situations of the
    laboratory organization and responsibility /
    authority of the persons in charge.
  • To arrange the order of work related to the
    testing.
  • (receive samples ? perform tests ? make reports)
  • To assign the responsibility of each person.
  • Specifying the Business process flow
  • Core process Main process
  • Supporting process Maintenance of the
    equipment, Staff training, Purchase, Internal
    audit, etc.
  • To review the existing documents and use them.

16
Steps for Building a Laboratory Management System
  • Step 6 Making a draft of the Quality Manual
    (QM) and arranging the documents
  • Existing state of business process and
    responsibility / authority.
  • Confronting the draft with the requirements of
    17025.
  • If some part which does not apply to the
    requirement or any missing part is found, the
    document should be amended.
  • Step 7 Process analysis
  • To subdivide the laboratory activities (works).

17
Steps for Building a Laboratory Management System
  • STEP 8 Making the Standard Operational
    Procedures (SOPs)
  • To write down the operations made.
  • SOPs should not necessarily be limited to
    sentence.
  • Flow-charts, tables and illustrations are
    sometimes very useful.
  • SOPs are most important items in order to secure
    the reliability of each test and analysis.
  • Testing method can be quoted from the standard,
    however, we need to incorporate the specific
    know-how or experience of each laboratory into
    the SOPs.

18
Steps for Building a Laboratory Management System
  • Step 9 Explanation of QM and SOPs to the
    laboratory staff.
  • Explanation and lecture of the QM, quality
    documents and SOPs to the laboratory staff.
  • Step 10 Applying the system
  • To start of applying the system documents when
    they are complete.
  • If there is any inconvenience or disagreement, it
    should be corrected.

19
Steps for Building a Laboratory Management System
  • Step 11
  • Internal audit and revision of the documents
  • Initial stage to check the system documents.
  • Next stage to check the actual process and work
    with the agreed documents.
  • Training of the internal auditor.
  • Step 12
  • Perfection of the system !!

20
Assuring the Quality of Test Results (5.9)
  • Routine checking of reference standards
  • Replicate tests
  • Retesting the retained samples
  • Proficiency testing programs
  • In order to maintain the laboratory competence
    and the quality assurance, proficiency test is
    recommended.
  • The scheme of proficiency test is determined in
    ISO/IEC Guide 43.
  • Inter-laboratory comparison scheme Small
    samples of exactly the kind are distributed to
    the participating laboratories.
  • Correlation of results for different parameter of
    samples.

21
Uncertainty of Measurement
  • Definition
  • The parameter of dispersion properties, which is
    rationally connected to the values of
    measurement,
  • The average of repeatedly measured values
  • ? be used as the estimation of the true value.
  • Its standard deviation
  • ? be used as standard uncertainty of the
    repeatable factor.

22
Uncertainty of Measurement
  • Estimation of uncertainty (5.4.6.2)
  • Testing laboratories shall have and apply
    procedures for estimating uncertainty of
    measurement.
  • In some cases of test method may preclude
    calculation of uncertainty statistically valid
  • The laboratory shall at least attempt to
    identify all components of uncertainty….
  • Reasonable estimation shall be based on
    knowledge …, i.e., previous experience,
    validation data, etc.

23
Uncertainty of Measurement
  • Estimation procedure
  • 1) List up the all factors of uncertainty.
  • 2) Estimate the amount of the uncertainty by
    rational measures.
  • Type A Statistical calculation from actual
    measured data.
  • Type B Quotation from a calibration report and a
    description of specification.
  • 3) Calculate the Standard uncertainty?X and Y
  • v(X2 Y2)
  • 4) Multiply 2 (k 2), then indicates an
    Expanded uncertainty which means 95
    confidential level.

24
  • OUTLINE OF LABORATORY MANAGEMENT SYSTEM
  • BASED ON ISO/IEC 17025 STANDARD
  • The End
  • Thank you for your attention.
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