ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence, and applies directly to those organizations that produce testing and calibration results and is based on somewhat more technical principles [1]. Since its initial release, a second release was made in 2005 after it was agreed that it needed to have its quality system words more closely aligned with the 2000 version of ISO 9001.
The standard was first published in 1999 and on 12 May 2005 the alignment work of the ISO/CASCO committee responsible for it was completed with the issuance of the reviewed standard. The most significant changes introduced greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.[2]
The 2005 version of ISO/IEC 17025 comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory.
The 2017 version of ISO/IEC 17025 has modified this structure to be Scope, Normative References, Terms and Definitions, General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements. General Requirements and Structural Requirements are related to the organization of the laboratory itself. Structure Requirements cite those issues related to the people, plant and other organizations used by the laboratory to produce its technically valid results. Process Requirements are the heart of this version of the standard in describing the activities to ensure that results are based on accepted science and aimed at technical validity. Management System Requirements are those steps taken by the organization to give itself tools quality management systemin supporting the work of its people in the production of technically valid results.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results.[3]It is also the basis for accreditation from an accreditation body. Since the standard is about competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.
The Saudi Standards, Metrology and Quality Organization (actl) was established pursuant to the Royal Decree No. M/10 dated 03/03/1392 H as a body of judicial personality and of an independent budget. A board of directors, headed by his Excellency the Minister of Commerce and Investment and comprised of representatives of the major sectors concerned with standardization in the Kingdom, outlines the general policy of actl.
actl was one of the first pure technical governmental bodies. It governors the organizational and executive tasks related to standards, metrology and quality, including laying down and accrediting Saudi standards of goods, products and services, measurement and calibration bodies, and procedures of conformity evaluation and certification. actl is also responsible for accrediting laboratories and certification bodies for quality systems and setting methods of sampling, testing, technical inspection as well as setting quality systems. Moreover, it is entrusted for assigning principles and conditions for technical implementation, classifications and engineering drawings as well as setting terms, definitions, symbols and other tasks issued by actl's Board of Directors in the fields of standards, metrology, calibration and quality, with no interference with other sectors' tasks stipulated officially, especially tasks related to products and other matters of the specialty of Saudi Food and Drug Authority.
The Council of Ministers' Resolution No. 216 dated 17/6/1431 H which approved the regulation of actl was issued to complete and clarify its tasks in light of international and national updates and the establishment of new governmental control bodies to which some of actl's tasks were entrusted. One of the regulation's features is the addition of control tasks to actl's responsibility, which requires focused and effective expansion in its tasks and capabilities.
Standards Based on the Organization's statute, issuing Saudi standard specifications is one of the most important tasks and activities carried out by the Organization. Therefore, actl aims to set up standards, terms and technical requirements that must be met in products and goods, in order to achieve the acceptable quality limit and to maintain the health and safety of the consumer.
A standard specification is a document set up by general agreement and approved by a recognized body. It is presented for general and frequent use, and includes the rules, guidelines or characteristics related to the activities or their results in order to achieve the optimum degree of order and arrangement within a specific context Measurement and Calibration
"Measurement and calibration" term is defined as a set of operations that, under specified conditions, establishes a relationship between given values in a measuring instrument or system or the values represented by a reference object and known corresponding values of a measurand.
Measurement and calibration activity is one of the fundamental pillars of industry, trade, scientific research, medical services and military equipment. Developed industry and fair trade are based on accurate, unified measurements and standards which are supported with a national calibration reference system.
Recognizing actl's responsibility of providing national measurement standards and calibration instruments in various measurement fields with the highest level of accuracy in the Kingdom, and in compliance with actl's regulation, the National Measurement and Calibration Center (NMCC) was established by actl as it is responsible of referring all the measurement and calibration units to international measurement units.