EN ISO/IEC 17025
The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), are the specialized system for worldwide standardization.
The International ISO / IEC 17025: 1999 standard was drafted by the “Committee for the Assessment of Conformity” of CASCO, in cooperation with the Technical Committee CEN / CLC TC1 “Criteria for Conformity Assessment Bodies”.
This International Standard has been prepared by the above organizations as a result of the extensive experience of the application of ISO IEC Guide 25 and EN 45001, which and replaced. This standard contains all the requirements to be met by testing and calibration laboratories should they wish to demonstrate that they implement a system of quality, that is technically competent and able to generate technically valid results.
The acceptance among the test results countries and calibration should be facilitated if laboratories comply with this International Standard and if they are accredited by agencies involved in mutual recognition agreements with equivalent bodies in other countries using this international Standard.
Nowadays in developed societies and modern states is obvious longer the requirement to produce products and services to meet specific requirements and specifications.
These requirements and specifications defined by the Quality Systems.
Regarding Laboratories for water and food analysis it is possible to follow (like any other production or service unit) International Standard ISO 9000 (formerly ISO 9001 and ISO 9002).
But that is NOT enough and acceptable for laboratories carrying out analysis-tests on water and food, or from the current reality of the market, even by European legislation, nor from the Greek legislation that has now been harmonized with that of the European Union (detailed information on existing legislation is given at the end of the document).
Instead, the legislation now and in the Country requires us to provide services for the performance-testing analyzes in water and food be made by laboratories to be accredited for this purpose in accordance with the International Standard ISO 17025 and NO according to ISO 9000.
The answer lies in the difference between simple Certification (in ISO 9000) and Accreditation of Laboratory of Water and Food (in ISO 17025)
DIFFERENT ACCREDITATION – ACCREDITATION
Increasing the use of systems for quality has determined the need to ensure that laboratories apply a system for quality, which is considered to conform to ISO 9000 (formerly ISO 9001 and ISO 9002) and the International Standard ISO 17025.
Therefore, it has taken care to incorporate all those requirements of ISO 9000 in Quality System governed by the International Standard ISO 17025, which are related to the subject of testing services and calibration and covered by the system for the laboratory quality . As if that is saying that the International Standard ISO 17025 is a broader set of quality requirements include contains as SUBTOTAL Quality System ISO 9000.
Therefore, testing and calibration laboratories that comply with this International Standard ISO 17025 also operate simultaneously and in accordance with ISO 9000.
Instead, the laboratories only comply with ISO 9000, are NOT the International Standard ISO 17025 and therefore simply should not confuse the two situations. If a workshop is simply certified with ISO 9000, then as mentioned, there is NO guarantee for technical competence, the ability of words to produce correct results and NOT a legal response to the laws on the type and conditions of existence of laboratories involved in water and food-exam tests.
The certification only in ISO 9000, does not prove by itself the laboratory capacity to provide technically valid data and results.
The ISO 9000 quality systems listed in the company and its ability to produce goods or provide services in accordance with customer requirements and are not standards for product certification that ie. A product meets specific standards.
To put it more simplified, a company that produces a product or a laboratory that is certified simply because it works with ISO 9000 Quality System, does not mean that it produces necessarily correct results. This is because the ISO Quality System 9000 requires simply to produce the product or in the case of laboratory results from tests of a specific stable manner, as described in the manual-quality policy booklet of the Corporation or the Workshop and which is to given how the client agrees.
But the Quality System ISO 9000
• NO puts requirements on the final product quality or effects encoding such Lab also
• NOT provide control procedures for the quality of analytical results – tests carried out, that they are indeed correct
• NOT dealing with the technical competence of the laboratory to produce technically valid test-test results in accordance with International and European requirements. Thus, the results yielded by analysis-testing of such laboratories do not have legal effect.
If a laboratory for water analysis and food is accredited according to ISO 17025
checked thoroughly on preliminary basis and test whether qualifies in terms of personnel composition, instruments, organization, financial etc. To march to normal after a few months to accredited inspection
checked annually and major inspection every 5 years to comply with standards on a daily basis regarding:
o The calibration of the instrument, from the smallest to the biggest, which should be specific construction specifications and performance accuracy
o The scientific competence and continuing training of all personnel, both scientific, and administrative.
o The ability to respond to requirements imposed by the quality system ISO 17025 in terms of internal audits and internal, and external quality control with blind samples in question can show among many other exhibits in the adequacy of the laboratory to produce correct results in the tests performs.
Accreditation is granted by the National Accreditation Council covered by Greek Standards Organisation (ELOT) and the Ministry of Development. The National Accreditation Council also supervised by the European Accreditation and controlled to the quality of its work.
The results produced by an Accredited Laboratory have legal force and are accepted in European but also in international environment.
No longer in force in Europe Another division of Laboratories in government or not, university or non-etc. The only distinction that exists between accredited and non.
This is easily understood to the extent that clearly understands that the ability to produce research work and even high quality should not be confused or be related to the ability of a laboratory not only produces through the entire range of personnel, procedures and equipment technically adequate work, but they are at all times and to prove it. This course beyond since the purpose of such workshops is to research and teaching production and not performing routine tests.
But from where clear laws need such laboratories?
ACCREDITATION AND GREEK LEGISLATION
The need for Accredited (not Certified) Lab recently reflected in the Greek Legislation:
The Law no. 2741, published in Official Gazette 199 / A / 09.28.1999 and the duties and responsibilities of the Single Food Agency determined the following:
o “A” food laboratories “means the State General Laboratory and other government laboratories, including laboratories of higher educational institutions, and private laboratories accredited by the responsible for the accreditation of state institution in accordance with the criteria for the operation of testing laboratories set with European standard EN 45001, which analyzes food samples out. ”
Here we should note that the standard EN 45001 was replaced in late 1999 by the International Standard ISO 17025, and the charge of the State Accreditation Agency is the National Accreditation System (ESYD).
In the Joint Ministerial Decision Y2 / 2600/2001 “Quality of drinking water in compliance with Directive 98/83 / EC of the European Council of November 3, 1998″ as published in the Government Gazette 892 / B / 11.7.2001 , which is implemented by 25.12.2003, specified below:
ANNEX III: REQUIREMENTS FOR THE ANALYSIS OF PARAMETERS
“The co-competent authorities shall ensure that any laboratory at which samples are analyzed has a quality system which is audited periodically by the appointed body, not controlled by the lab.”
Article 2 Definitions: “validation”: as method validation (validation) is defined as the process of proving that the method gives the correct result regarding eg at predetermined detection limits, selectivity / specificity, repeatability and reproducibility and linearity. This term is further defined in ISO / IEC 17025 ”
Article 12 §3: “The laboratory analyzes for the test, control and additional monitoring of water intended for human consumption in accordance with Annex II carried out by operators in the local government organized workshops, Municipal Water Utility and sewerage and Water Supply companies or private accredited laboratory and if all the above meet the requirements of Annex III. laboratory monitoring control analysis for the other competent authorities shall be carried through collaborating laboratories with the FSA, provided that all these laboratories comply with the requirements Annex III and the registration requirements of the FSA workshops registry. ”
HOW TO FIND WHAT ARE ACCREDITED LABORATORIES?
Note: Essential is the search of Accreditation Scope for each laboratory, indicating analytical tests (assays) for which the laboratory is accredited. The Accreditation Scope, includes Laboratory analyzes for attracting the Accreditation ie. The analyzes for which the laboratory has been assessed and judged to be capable of running with accredited way. A lab can perform other analysis, but without being accredited. In the latter case, the Department may not use the ESYD logo (ie the identification mark at the top point of the document), the certificates of analyzes.
• ISO: International Organization for Standardization – INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
• IEC: International Electrotechnical Commission – International Electrotechnical Commission
• CEN: European Committee for Standardization – COMITE EUROPEEN DE NORMALISATION-EUROPEAN COMMITTEE FOR STANDARDIZATION
• TC1: Technical Committee 1 – TECHNICAL COMMITTEE 1
• CASCO: COMMITTEE ON CONFORMITY ASSESSMENT