EN ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”

1. Dr. Wolfgang Garche Saxony-Anhalt Environmental Protection Agency Department Air Quality Monitoring, Information, Assessment EN ISO/IEC 17025“General requirements for the competence of testing and calibration laboratories”

2. What means accreditation in accordance to EN ISO/IEC 17025 Confirmation of competence of a testing or calibration laboratory by an independent third party, the accreditation body, to carry out specific tests and/or calibrations. Usually there are national regulations for one or several accreditation bodies in each country. The accreditation bodies cooperate in international organisations: Europe: European Accreditation Cooperation (EA) Worldwide: International Laboratory Accreditation Cooperation (ILAC)

3. Scope of accreditation A laboratory may apply quality assurance procedures according to EN ISO 17025 to all or a part of its operations. Quality management is supported by a clear statement of activities, • which ideally should define the range of work, • without restricting the laboratory's operation. The scope is typically defined in terms of:  • range of products, materials or sample types • measurements (or types of measurements) • specification or method/equipment/technique • concentration range and uncertainty

4. Management requirements • organisation • quality system • document control • review of requests, tenders and contracts • subcontracting of tests and calibrations • purchasing services and supplies • service to the client • complaints • control of nonconforming testing and /or calibration work • corrective action • preventive action • internal audits • management reviews

5. Technical requirements • personnel • accommodation and environmental conditions • test and calibration methods and method validation • equipment • measurement traceability • sampling • complaints • handling of test calibration items • assuring the quality of test and calibration items • reporting the results

6. Organisation • legal responsibility • meeting the requirements of this International Standard, satisfying the needs of the client, the regulatory authorities or organisations providing recognition • The management system shall cover work carried out in all facilities: - laboratory's permanent facilities, - at sites away from its permanent facilities, - or in associated temporary or mobile facilities • Responsibilities of key personnel shall be defined in order to identify potential conflicts of interest • managerial and technical personnel with the authority and resources needed to carry out their duties • specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations • technical management with overall responsibility for the technical operations • appoint a member of staff as quality manager

7. Quality System • Establishing, implementing and maintaining a quality system appropriate to the scope of its activities. • Documenting its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results. • The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. Quality manual The laboratory's quality system policies and objectives shall be defined in a quality manual (however named). Quality policy statement The overall objectives shall be documented in a quality policy statement. The quality policy statement shall be issued under the authority of the chief executive.

8. Documentation QMH • description of organisation • quality policy statement • range of services, quality objectives, responsibilities • general statements that requirements of EN ISO 17025 are complied Procedure instructions • descriptions of the applied procedures for fulfilment of the requirements of EN ISO 17025 • descriptions of special procedures used for specific operating processes Standard Operation Procedures (SOP‘s) • detailed guidelines for the execution of single works Forms, Lists, Control Charts • formal templates and working tools for the creation of test records and for the documentation of measurements, tests, audits, etc.

9. Management Reviews Laboratory's executive management shall periodically conduct a review about the laboratory's quality system testing and/or calibration activities: ensure their continuing suitability effectiveness, and to introduce necessary changes or improvements Review shall take into account: • the suitability of policies and procedures • reports from managerial and surveyor personnel • the outcome of recent internal audits • corrective and preventive actions • assessments by external bodies • the results of interlaboratory comparisons or proficiency tests • changes in the volume and type of the work • client feedback • complaints • other relevant factors, such as quality control activities, resources and staff training

10. Technical Requirements General Factors which determine the correctness and reliability of the tests and/or calibrations performed by a laboratory: • human factors • accommodation and environmental conditions • test and calibration methods and method validation • equipment) • measurement traceability • sampling • the handling of test and calibration items

11. Personnel Requirements for personnel: • Ensuring the competence of all who operate specific equipment, perform tests and/or calibrations, evaluate results, and sign test reports and calibration certificates. • Personnel certification: the laboratory is responsible for fulfilling specified personnel certification requirements. • Training programme • Supervising additional personnel • Authorization

12. Accommodation and Environmental Conditions • Laboratory facilities • Monitoring the environmental conditions Tests and calibrations shall be stopped when the environmental conditions jeopardize the results of the tests and/or calibrations. • Preventing cross-contamination • Access to the laboratory • Good housekeeping

13. Test and Calibration Methods and Method Validation • Using appropriate methods and procedures for all tests and/or calibrations within its scope. • The laboratory shall have instructions on the use and operation of all relevant equipment, and on the handling and preparation of items for testing and/or calibration, • shall be kept up to date and shall be available for the personnel • Selection of methods • Laboratory developed methods • Non-standard methods • Validation of methods • Estimation of uncertainty of measurement • Control of data

14. Equipment Records of Equipment shall include at least the following: • the identity of the item of equipment and its software • the manufacturer's name, type identification, and serial number or other unique identification • checks that equipment complies with the specification • the current location, where appropriate • the manufacturer's instructions, if available, or reference to their location • dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the date of next calibration • the maintenance plan, where appropriate, and maintenance carried out to date • any damage, malfunction, modification or repair to the equipment

15. Measurement Traceability • The laboratory shall have an established programme and procedure for the calibration of its equipment. • Such a programme should include a system for selecting, using, calibrating, checking, controlling and maintaining measurement standards, reference materials used as measurement standards, and measuring and test equipment used to perform tests and calibrations. • Specific requirements for calibration laboratories: - traceable to the International System of Units (SI) (Systeme international d'unites). Testing • Reference standards and reference materials

16. Further Requirements • Sampling • Handling of test and calibration items • Assuring the quality of test and calibration results

17. Reporting the Results Results shall be reported • accurately, • clearly, • unambiguously • objectively • in accordance with any specific instructions in the test or calibration methods.

18. Test Reports and Calibration Certificates A test report or calibration certificate shall include at least the following information: • a title (e.g. "Test Report" or "Calibration Certificate") • the name and address of the laboratory • unique identification of the test report or calibration certificate (such as the serial number), • the name and address of the client • identification of the method used • a description of and unambiguous identification of the item(s) tested or calibrated • the date of receipt of the test or calibration item(s) where this is critical to the validity and application of the results, and the date(s) of performance of the test or calibration • the test or calibration results • the name(s), function(s) and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate

19. Calibration Certificates shall include: • the conditions (e.g. environmental) under which the calibrations were made that have an influence an the measurement results • the uncertainty of measurement and/or a statement of compliance with an identified metrological specification • evidence that the measurements are traceable

20. Many Thanks for your Attention!