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ISO 17025

Testing and calibration laboratories

What is ISO 17025?

ISO 17025 is the quality management system and the main standard for testing and calibration laboratories. ISO 17025 is an international standard developed by ISO (International Organization for Standardization) and the International Electrotechnical Commission (IEC) in coordination with the Conformity Assessment Committee (CASCO), which specifies the requirements that testing and calibration laboratories must meet. In addition, the standard provides requirements to be met by testing and calibration laboratories and facilitates the harmonization of quality criteria.

The ISO 17025 standard is based on two main parts: The first part contains performance requirements. The second is based on technical requirements. This standard also provides requirements related to quality management such as document control and corrective actions.

The ISO 17025 certificate specifies a set of protocols required to validate a testing and calibration laboratory’s technical capabilities and quality standards. Therefore, this ISO certification demonstrates a laboratory’s ability to consistently provide accurate results, in addition to complying with existing regulations and meeting customer expectations. ISO 17025 assesses technical competence in laboratory testing and calibration services and applies to organizations that produce test and calibration results.

What is the purpose of ISO 17025?

The main objective of ISO 17025 is to ensure technical competence and the reliability of analytical results. They use management requirements and technical requirements that affect the quality of work done in laboratories.

These requirements are used as a tool to disseminate collective knowledge. This facilitates employee integration, provides flexibility in adapting to environmental changes, and allows problems to be identified for early resolution.

For this reason, this standard is useful for any organization that needs to implement packaging test methods for their products. This includes all types of laboratories, whether owned by the government, industry, or indeed any other organization.

What are the benefits of implementing the ISO 17025 standard?

Implementing ISO 17025:2017 has many benefits. Although there may be initial costs associated with accreditation to the standard, it is critical to understand that having ISO 17025 will provide you with long-term benefits that are well worth the effort.

* Global Reputation

Once you achieve ISO 17025, your laboratory can gain a reputation and demonstrate that it has high standards, setting it above the competition. Moreover, when you have a positive reputation among auditors and regulatory departments, it helps to increase the reputation of the laboratory not only locally, but also nationally and internationally.

*Reduce costs

ISO 17025:2017 has detailed guidelines and requires laboratories to check the results carefully. Obtaining accurate and precise results helps minimize laboratory operating costs. Money is saved when retesting is reduced. Overall, the standard establishes parameters to control laboratory operations and thus reduce operating costs.

* Facilitates collaboration between laboratories and other organizations

This certification facilitates cooperation between organizations across national borders, as it establishes a quality standard for the results obtained. Therefore, it also boosts international trade.

* A systematic approach

ISO 17025:2017 requires laboratories to have a systematic approach to their activities. Consequently, this helps maintain laboratory protocols.

* Improving the laboratory test environment

The validity and appropriateness of the test methods in a controlled environment led to more accurate results. This ensures quality for your customers as well as for your laboratory. When laboratory testing is improved, time and several tests are saved, and in turn, you save money. This standard also has detailed instructions for tools and equipment, which in turn reduces repair and the level of defects

* Increase the level of customer satisfaction

Laboratories will easily gain their and future customers’ trust because ISO is a globally accepted standard. ISO 17025 requirements ensure that your laboratory operates efficiently, and consistently and is dedicated to delivering the highest quality results, thereby providing customer satisfaction.

* Documentation

ISO 17025:2017 requires proper documentation of all processes, changes made, errors or discrepancies and helps reduce problems, overall consistency, and better results in the laboratory. When proper documentation is followed, employees become more accountable.

* Morale and training of employees

This standard requires training for employees. Employees can improve their roles, responsibilities, and knowledge and diversify their skill sets. This often boosts employee morale and provides them with the necessary training to become competent.


What are the requirements of ISO 17025?

The ISO 17025 standard describes a set of technical requirements that lead to an increase in the quality of work performed in laboratories:

How to guarantee the competence of the technical staff

Procedures that are followed to ensure the quality of equipment, facilities, and environmental conditions.

Methods for choosing the tests and calibrations to be used by the laboratory.

Methods used to sample, measure traceability, and move objects during testing

Selected procedures for quality assurance and reporting of results

In addition, the laboratory must specify a series of administrative requirements:

Information about the organization, its legal status, and confidential information processing

How to implement a quality management system

Existing procedures for document control

How to manage customer service and potential complaints

Outsourcing protocols

Procedures followed to improve the management system and QMS: preventive and corrective actions, records control, internal audits, and senior management review methods.

For which organizations is ISO 17025 suitable?

ISO 17025 is useful for any organization that performs testing, sampling, or calibration and wants reliable results. This includes all types of laboratories, whether they belong to the government, industry, or any other organization. This standard is also useful for universities, research centers, governments, regulators, inspection agencies, product certification bodies, and other conformity assessment bodies that need to perform testing, sampling, or calibration.

The international standard ISO 17025 is therefore applicable to all laboratories, regardless of the size or scope of the tests and calibration methods. It is used by laboratories to develop their management system for quality, body, and technical operations.