ISO 17025 is an international standard code that outlines general requirements for laboratories all around the world. It is the main standard for laboratories and if implemented at your business – can benefit your organization in various ways. Let us look at why it is important, what are its basic layouts, and what the implementations entail.
Introduction to ISO 17025
Iso 17025 sets out requirements for the competent, impartial, and consistent operations of laboratories, specifying the discipline and decorum that must be followed in laboratory operations. This international standard helps in promoting confidence in a laboratory’s ability to provide reliable and consistent sampling and calibration results. The most recent standards code is ISO/IEC 17025:2017, revised in 2017. The International Electro-technical Commission (IEC) and the International Organization for Standardization (ISO) collaborated to publish ISO 17025.
A laboratory is accredited after its results are assessed for a certain period of time, and deemed consistent and accurate. A lab working effectively and meeting the standard requirements is certified with ISO 17025 only after confirmation by the accreditation body.
Who undergoes iso 17025 accreditation
This accreditation is used by independently-owned laboratories or a lab unit that is part of a large organization. These standards instruct labs to follow specific procedures and methods that are involved in sampling or measurement activities.
WHAT are TESTING AND CALIBRATION LABORATORIES
A testing laboratory determines the quality of a particular product. An example is of water purification company that is producing mineral water bottles. It is the responsibility of lab personnel to check the quantity of the minerals and salts that are present in the final product, and to compare them with the standard values. Similarly, a calibration lab is associated with comparing measurement instruments of unknown accuracy to those of known accuracy. An example is a dial indicator used to measure close tolerances of holes that are drilled in metal pieces.
Importance of ISO 17025
Laboratory sampling, conformity assessment, and testing are crucial enabling factors for technology and trade. ISO 17025 assists in the coordination of standard methods and procedures, helping laboratories and their associated bodies to streamline their procedures.
MAIN SECTIONS OF ISO 17025
ISO 17025 consists of the following sections. Let us understand about each section one by one.
- GENERAL REQUIRMENTS
- STRUCTURAL REQUIRMENTS
- RESOURCE REQUIREMENTS
- PROCESS REQUIRMNTS
- MANAGEMENT SYSTEM REQUIRMENTS
Section 4: General Requirements
Section 4 incorporates two significant requirements necessary for maintaining the confidence and trust users place on testing and calibration laboratories. Under this section, no laboratory is allowed to compromise on the quality of its results. In addition, laboratories are also required to keep all results and information confidential.
Section 5: Structural Requirements
This section defines the essential components which outline a laboratory’s operations, its commitment to an effective management system and its range of activities. It also requires that the resources being used by an accredited lab are from reliable sources.
Section 6: Resource Requirements
Section 6 includes six clauses that highlight the requirement for the laboratory to perform its laboratory activities. This consists of the personnel, facilities, equipment, systems, and support services.
Section 7: Process Requirements
This section covers 11 core procedures that must be followed by a lab with ISO 17025 accreditation for improving its efficiency. The section begins with reviewing tenders, requests, and contracts. This section is considered the most important and the most technical part of the code. This section incorporates selection, validation and verification methods that are used by the laboratory during sampling and handling of test items.
Section 8: Management Systems Requirements
This section incorporates quality management systems, documentation such as objectives and policies, records and control of documentation, and addressing opportunities, improvement, and corrective actions. An internal audit is also performed by a legal entity to review and check whether an accredited lab is following managerial and general standards as per the requirements of ISO 17025.
ISO 17025 ACCREDITATION IS GOOD FOR YOUR ORGANIZATION
Gaining ISO 17025 accreditation is good for your laboratory for the following reasons.
- Increases customer confidence
- Creates a proactive risk-based business and quality culture
- Assures your laboratory’s creditability
- Creates an environment of professionalism and pride