EN ISO/IEC 17025 - Technical Requirements Wolfgang Garche Environmental Protection Agency Department Air Quality Monitoring, Information, Assessment 1
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. Directive on ambient air quality and cleaner air for Europe Annex I C. Quality assurance for ambient air quality assessment, data validation To ensure accuracy of measurements and compliance with the data quality objectives, the appropriate competent authorities and bodies designated pursuant to Article 3 shall ensure: that the national laboratories, are accredited according to EN/ISO 17025 by 2010 for the reference methods referred to in Annex VI 2
Technical requirements 1. personnel 2. accommodation and environmental conditions 3. test and calibration methods and method validation 4. equipment 5. measurement traceability 6. reference standards and reference materials 7. handling of test and calibration items 8. assuring the quality of test and calibration items 3
1. Personnel appropriate staff (quantity and qualification) personnel training and education procedures for identifying training needs effectiveness of training actions shall be evaluated own personnel (employed by or under contract to the laboratory) authorization of specific personnel to perform specific types of sampling, tests or calibrations to issue test reports and calibration certificates to operate particular types of equipment 4
2. Accommodations 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 5
3. Test and calibration methods and method validation Reference methods mentioned in Annex VI: EN 14212:2005 "Ambient air quality Standard method for the measurement of the concentration of sulphur dioxide by ultraviolet fluorescence EN 14211:2005 "Ambient air quality Standard method for the measurement of the concentration of nitrogen dioxide and nitrogen monoxide by chemiluminescence EN 14902:2005 "Standard method for measurement of Pb/Cd/As/Ni in the PM10 fraction of suspended particulate matter" EN 12341:1999 "Air Quality Determination of the PM10 fraction of suspended particulate matter Reference method and field test procedure to demonstrate reference equivalence of measurement methods" EN 14907:2005 "Standard gravimetric measurement method for the determination of the PM2,5 mass fraction of suspended particulate matter" EN 14662:2005, parts 1, 2 and 3 "Ambient air quality Standard method for measurement of benzene concentrations" EN 14626:2005 "Ambient air quality Standard method for the measurement of the concentration of carbon monoxide by non-dispersive infrared spectroscopy" EN 14625:2005 "Ambient air quality Standard method for the measurement of the concentration of ozone by ultraviolet photometry" 6
Other needed methods and procedures for: the calibration of analysers and other test and measurement devices the certification of test gases (from cylinders or generators) the production of test gas mixtures (permeation, dilution, etc) (e.g. ISO 6145-10 Permeation method) A Member State may use any other method if it can be demonstrated that the results are equivalent to the reference method. Validation of applied methods and procedures Non-standard methods Laboratory designed/developed methods Standard methods used outside their intended scope Amplifications and modifications of standard methods 7
Estimation of uncertainty of measurements A calibration laboratory shall have and apply a procedure to estimate the uncertainty of measurements for all calibrations and types of calibration. (EN ISO 20988 Air quality Guidelines for estimating measurement uncertainty ENV 13005 Guide to the Expression of Uncertainty in Measurement (GUM) ) 8
4. Equipment Laboratory shall be furnished with all items of sampling, measurement and test equipment for the correct performance of the tests and/or calibrations (5.5.1). Equipment used for testing, calibration and sampling shall be capable of achieving the required accuracy and shall comply with the specifications relevant for the tests and/or calibrations concerned (5.5.2). Directive on ambient air quality and cleaner air for Europe All new equipment purchased for implementation of this Directive must comply with the reference method or equivalent by two years after the date of entry into force of this Directive. All equipment used in fixed measurements must comply with the reference method or equivalent by five years after the date of entry into force of this Directive 9
5. Measurement traceability If calibration is a dominant factor of the uncertainty budget the requirements of 5.6.2.1 should be strictly followed (5.6.2.2) The programme for calibration of equipment shall be designed and operate so as to ensure that calibrations and measurements are traceable to the International System of Units (SI) Directive on ambient air quality and cleaner air for Europe The appropriate competent authorities and bodies designated pursuant to Article 3 shall ensure: that all measurements undertaken in relation to the assessment of ambient air quality pursuant to Articles 6 and 9 are traceable in accordance with the requirements set out in Section 5.6.2.2. of the ISO/IEC 17025:2005 10
Traceability can be established by means of an unbroken chain of calibrations or comparisons. The link to SI units may be achieved by reference to national standards. When using external calibration services, traceability shall be assured by the use of services from laboratories that can demonstrate competence, measurement capability and traceability. Calibration certificates shall contain the measurement results, including the measurement uncertainty and/or a statement of compliance with a identified meteorological specification. 11
6. Reference standards and reference materials Laboratory shall have a programme and procedure for the calibration of its reference standards (RS). RS shall be calibrated by a body that can provide traceability RS shall be used for calibrations only Reference materials shall be traceable to SI units or to certified reference materials (CRM) Internal reference materials shall be checked (if practicable) Intermediate checks are needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and reference materials. Checks shall be carried out to defined procedures and schedules. (5.6.3) 12
7. Handling of test and calibration items Laboratory shall have procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and /or calibration items, including all provisions necessary to protect the integrity of the test or calibration item a system for identifying test and/or calibration items procedures and appropriate facilities for avoiding deterioration, loss or damage to the test or calibration items 13
8. Assuring the quality of test and calibration items Laboratory shall have quality control procedures for monitoring the validity of tests and calibrations. Resulting data shall be recorded in such a way that trends are detectable. Where practicable statistical methods shall be applied to the reviewing of the results. This monitoring shall be planned. The monitoring may include: regular use of certified reference material participation in interlaboratory comparisons or proficiency-testing programmes replicate tests or calibrations using the same or different methods Quality control data shall be analysed and, where they are found to be outside pre-defined criteria, planned actions shall be taken to correct the problem. 14
Scope of accreditation: reference methods specified in Annex VI calibration procedures for analysers, measurement and control facilities for volume flows, temperature and pressure sensors procedures for the preparation of test gas mixtures 15
Many Thanks for your Attention! 16