Implementing the ISO 17025:2017 standard
Implementing the ISO 17025:2017 standard is an essential step for laboratories to ensure the competence, impartiality, and consistency of their testing and calibration activities. This standard provides a framework for laboratories to meet the requirements for accreditation and improve their quality management systems.
The implementation of the ISO 17025:2017 standard involves several steps, including:
Gap analysis: The first step in implementing the ISO 17025:2017 standard is to conduct a gap analysis to identify areas where the laboratory’s current quality management system does not meet the standard’s requirements. This analysis helps to determine the extent of the changes that need to be made to the laboratory’s quality management system.
Management commitment: The laboratory’s management must demonstrate a commitment to the implementation of the ISO 17025:2017 standard. This involves allocating resources, establishing clear roles and responsibilities, and ensuring that all staff members understand the importance of complying with the standard.
Quality management system development: The ISO 17025:2017 standard requires laboratories to have a quality management system in place that meets the requirements of the standard. This involves developing and implementing policies and procedures that cover all aspects of the laboratory’s operations, including sample handling, testing and calibration, equipment maintenance, and record keeping.
Competence assessment: The ISO 17025:2017 standard requires laboratories to demonstrate the competence of their staff, including their technical knowledge, skills, and experience. This involves conducting an assessment of staff members’ competence and identifying any training or development needs.
Risk management: The ISO 17025:2017 standard requires laboratories to identify and manage risks associated with their operations. This involves conducting a risk assessment and implementing appropriate measures to mitigate identified risks.
Document control: The ISO 17025:2017 standard requires laboratories to have a document control system in place that ensures the integrity of their documentation. This involves establishing procedures for the creation, review, approval, and distribution of all laboratory documents.
Internal audits: The ISO 17025:2017 standard requires laboratories to conduct internal audits to ensure that their quality management system is operating effectively. This involves selecting a team of auditors who are independent of the areas being audited and who have the necessary knowledge and skills to conduct the audit.
Management review: The ISO 17025:2017 standard requires laboratories to conduct a management review of their quality management system at least once a year. This involves reviewing the laboratory’s performance against its objectives, identifying areas for improvement, and taking appropriate corrective actions.
In conclusion, the implementation of the ISO 17025:2017 standard is a vital step for laboratories to ensure the competence, impartiality, and consistency of their testing and calibration activities. By following the steps outlined above, laboratories can develop and implement a quality management system that meets the requirements of the standard and provides their customers with reliable and accurate results.