ISO17025 standard

In this educational article, we want to talk about the importance of ISO 17025 standard and also the importance of ISO 17025 training. Twenty years ago, it was rare to find a manufacturer with an accredited laboratory on site. To obtain certification, developers had to send their product from the manufacturer to the nearest ABC research laboratory. Sending products to an outside lab is a waste of time and money for the product developer – and a lost opportunity for the manufacturer.

ISO/IEC 17025 was voted on in late 1999 and was adopted internationally in 2000. Adopted as a replacement for the ISO/IEC 25 and EN 45001 guidelines, ISO/IEC 17025 approved all general requirements for the qualification of testing and calibration laboratories. Undertaking ISO 17025: 1999 some requirements with ISO 9001: 1994, shared a standard for quality management systems, which forever linked the two regulations.

In 2000, the ISO9001 standard was revised, which meant that ISO/IEC 17025 had to be updated to reflect this change. ISO members have approved the changes and ISO/IEC 17025: 2000 became the standard that laboratories must follow. Unfortunately, since ISO/IEC 17025 and ISO 9001 are closely related, these two standards are often confused.

The additional stage in the product cycle was not ignored by manufacturers – they simply did not know how to use this capital. The 1999 edition of ISO/IEC 17025 (General requirements for the qualification of testing and calibration laboratories) changed everything as the new standard brought everything under one roof.

ISO17025 standard

ISO 17025 is the international standard for testing and calibration laboratories. It is a set of requirements that laboratories use to demonstrate that they have a quality management system and are technically capable of doing what they do. This standard applies to all organizations that perform testing or calibration. can be used. For example, first-, second-, and third-party laboratories and laboratories whose testing and/or calibration form part of product inspection and certification.

ISO / IEC 17025 can be used in all laboratories regardless of the number of personnel or the scope of testing activities or calibration activities. When a laboratory does not perform one or more activities covered by ISO/IEC 17025, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.

ISO 17025

ISO/IEC 17025 is used by laboratories to develop their management system for quality, administrative and technical work. Customers of the laboratory, regulatory authorities and accredited institutions can also use it to confirm or recognize the competence of the laboratories. ISO/IEC 17025 is not intended to be used as a basis for the certification of laboratories.

Compliance with regulatory and safety requirements for laboratories is not covered by ISO/IEC 17025.

In most countries, ISO/IEC 17025 is the standard to which most laboratories must hold their accreditation in order to be considered technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a laboratory that is not accredited. Originally known as ISO/IEC Guide 25, it was originally issued by the International Organization for Standardization in 1999 as ISO/IEC 17025. This course standard is the published version. In 1999, 2005 and 2017. The most important change between the 1999 and 2005 editions was the greater emphasis on senior management responsibilities, explicit requirements for continuous improvement of the management system itself, and customer relations.

What does ISO 17025 certification mean?

To achieve ISO 17025 certification, the laboratory’s qualification system is fully evaluated by a third party. Assessments are conducted regularly to maintain certification. ISO 17025 certification can only be done by an authorized accreditation body. Evaluation means that the laboratory has met the terms and conditions of ISO17025 requirements and is considered competent by the accreditation authorities to provide calibration services and test results.

Benefits of ISO 17025 accreditation
  1. A systematic approach to control all your processes and defined procedures and supporting documentation.
  2. Achieving international recognition of one’s technical competence will gain the trust of customers and interested parties, as well as open doors to new domestic and international markets.
  3. Greater awareness of quality among employees and reduction of defects, waste, re-failure and service improvement.
  4. Have a better image of the company from the perspective of regulators, customers, employees as well as society in general.
  5. Potential increase in business due to increased confidence and customer satisfaction.
  6. Savings in time and money by reducing or eliminating the need to retest products.
  7. Better control of laboratory operations and feedback to laboratories on whether they have sound quality assurance systems and are technically competent.
  8. Changing laboratory methods.
  9. Increased confidence in test/calibration data and staff performance.
  10. Validity and appropriateness of test methods.
  11. Traceability of measurements and calibrations with national standards.
  12. Suitability, calibration and maintenance of test equipment and test environment.
  13. Sampling, use and transportation of test items to ensure the quality of test and calibration data.
Key steps towards ISO 17025 accreditation
  • There are eight important steps in laboratory accreditation:
  • Management determines the owner of the project
  • The project owner studies the details of the standard, supporting literature, and other relevant information
  • The project owner defines the initial scope of the accreditation and works with the laboratory professionals to develop a list of requirements
  • The project owner and lab specialists conduct a gap analysis to determine the differences between the requirements and what is currently being implemented in the lab.
  • Based on the result of the gap analysis, the project owner, laboratory
  • Specialists, financial and documentation specialists and external consultants estimate the costs of accreditation
  • Estimated costs are presented to management along with incremental opportunities.
  • Management decides to continue its credit.
  • The project owner directs the implementation process.

The main benefits of implementing and implementing ISO / IEC 17025

  1. Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs involved should be considered before taking action.
  2. Implementing ISO/IEC 17025 as part of laboratory quality initiatives has laboratory and business benefits such as:
  3. Access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation also helps to obtain more contracts from organizations that do not issue official authorization, but prefer accredited laboratories in competitive conditions.
  4. The national and international reputation and image of the laboratory has improved.
  5. Continuous improvement of data quality and laboratory effectiveness.
  6. Having a basis for most other quality systems related to laboratories, such as good manufacturing practices and good laboratory methods.

The connection of ISO 17025 standard with other standards

It is recommended to continuously implement basic standards such as ISO 9001 quality management system standard before receiving specialized certificates or simultaneously with this, such as ISO 17025 certification. Because it can be claimed that this standard is the basis of all system standards.

It is also recommended for medical and medical laboratories, if they intend to implement quality management system standards, before implementing the standard related to their industry, i.e. ISO 15189 standard, ISO 9001 standard or IMS integrated management system. implement

Result

Basically, ISO 17025 is a quality system (like ISO 9001) designed to ensure the quality and repeatability of a business product or service. For this purpose, the standard does not define exactly how the processes should be carried out, but rather a set of instructions and controlled results that specific procedures must ensure. For example, the 17025 standard requires that calibration reference sensors have adequate tracking and calibration control. How each of these areas is done is up to the practitioner (such as choosing an appropriate interval for calibration) but in the end, the choice of process/procedure must be documented, repeatable, defensible and yield quality results. The quality system is proven by its results. “Don’t just talk the talk (methodology), but walk the walk (proven by objective evidence)” as reviewed in the internal and external audit process.

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