ISO 17025:2017 is an international standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.
This standard is applicable to laboratories performing tests and calibrations, including sampling. It ensures that laboratories can produce valid and reliable results, meeting the needs of customers and regulatory authorities while fostering confidence in their competence and quality management.
Key Components of ISO 17025:2017
- Management Requirements:
Laboratories must establish a quality management system that ensures effective operational control and compliance with applicable regulations. This includes documented policies and procedures for management practices. - Technical Requirements:
The standard outlines technical requirements for laboratories, including the need for competent personnel, adequate facilities, equipment calibration and maintenance, and testing methodologies. - Impartiality and Confidentiality:
Laboratories must demonstrate impartiality in their operations and maintain confidentiality regarding the results and customer information. - Quality Assurance and Control:
Continuous quality assurance practices must be implemented to ensure the accuracy and reliability of test and calibration results. This includes regular internal audits and management reviews. - Validation of Methods:
Laboratories must validate and verify testing and calibration methods to ensure their appropriateness and accuracy for the intended purposes.
TotalCert Consulting’s Services for ISO 17025:2017
Gap Assessment
- Conduct an initial evaluation of your laboratory’s current practices against ISO 17025 requirements to identify areas for improvement and compliance gaps.
Documentation Development
- Assist in creating and maintaining the required quality management system documentation, including policies, procedures, and work instructions tailored to ISO 17025.
Training and Competence Development
- Provide training for laboratory personnel to ensure they understand the requirements of ISO 17025 and their roles in maintaining compliance and quality.
Implementation Support
- Guide your laboratory through the implementation of ISO 17025, ensuring processes and methods align with the standard’s requirements.
Internal Audits
- Conduct internal audits to assess compliance with ISO 17025, identifying non-conformities and opportunities for improvement before the certification audit.
Certification Support
- Facilitate the certification process with a Recognised certification body accredited under the International Accreditation Forum (IAF), assisting with corrective actions if necessary.
Project Timeline
The typical timeline for implementing ISO 17025:2017 ranges from three to five months, depending on the size and complexity of the laboratory and the current state of its quality management practices. This includes the initial gap assessment, documentation development, system implementation, training, internal audits, and certification audit facilitation.
Why Choose TotalCert Consulting ISO 17025:2017 ?
Laboratory Expertise
Our consultants have extensive experience in laboratory operations and ISO standards, providing insights tailored to your specific laboratory needs.
Comprehensive Services
We support clients throughout the entire certification process, ensuring compliance with ISO 17025 from initial assessment to certification and beyond.
Tailored Solutions
Our consulting approach is customised to meet your laboratory’s specific requirements, ensuring a practical pathway to achieving and maintaining ISO 17025 certification.