ISO 17025 Laboratory Management System Malaysia
What Is ISO 17025 ?
ISO 17025 is an international standard which sets out the general requirements for the competence of testing and calibration laboratories. In major countries, ISO/IEC 17025 is the standard most labs must hold accreditation in order to be deemed technically competent.
In Malaysia, laboratories can apply for ISO 17025 accreditation under Skim Akreditasi Makmal Malaysia (SAMM) which is governed by the Department of Standard Malaysia (DSM).
What's ISO 17025 For Me (My Laboratory)?
ISO 17025 accreditation offers numerous advantages for laboratory, contributing to their success and growth in the competitive market:
Enhanced Credibility and Competence: ISO 17025 certification demonstrates a laboratory’s commitment to quality and competence. It provides confidence to customers, regulators, and stakeholders that the laboratory follows internationally recognized practices and produces accurate and reliable test results. This certification enhances the laboratory’s credibility, reputation, and competitiveness in the industry.
Compliance with International Standards: ISO 17025 ensures that laboratories comply with internationally accepted standards for testing and calibration. By implementing the standard, laboratories align their processes and procedures with recognized best practices. This enables them to demonstrate compliance with regulatory requirements, meet customer expectations, and maintain consistency in test results.
Improved Quality Management System: ISO 17025 requires laboratories to establish a robust quality management system. This includes procedures for document control, equipment calibration, personnel competency, sample handling, and reporting of results. Implementing the standard helps laboratories streamline their processes, improve efficiency, and ensure that quality is consistently maintained throughout the testing and calibration activities.
Reliable and Accurate Test Results: ISO 17025 emphasizes the importance of accuracy and reliability in test and calibration results. It requires laboratories to establish and maintain traceability to national or international measurement standards. By implementing the standard, laboratories enhance the accuracy of their measurements, reduce measurement uncertainties, and provide reliable results to their clients.
Customer Satisfaction: ISO 17025 certification enhances customer confidence in the laboratory’s ability to deliver accurate and reliable results. It assures customers that the laboratory follows recognized quality practices, has competent staff, and operates with integrity. This leads to increased customer satisfaction, repeat business, and positive word-of-mouth recommendations.
International Recognition and Acceptance: ISO 17025 is recognized and accepted globally. Laboratories with ISO 17025 certification have a competitive advantage when participating in international collaborations, research projects, and regulatory activities. The certification facilitates acceptance of test results across borders and promotes harmonization of laboratory practices on a global scale.
How To Obtain ISO 17025 Accreditation Malaysia?
The process of obtaining ISO 17025 accreditation involves several key steps:
Gap Analysis: Perform a thorough assessment of the laboratory’s current practices and processes against the requirements of ISO 17025. This gap analysis helps identify areas that need improvement and provides a roadmap for implementing the standard. It also helps determine the scope of the quality management system within the laboratory.
System Development: Based on the gap analysis, develop and implement the necessary policies, procedures, and controls to establish a quality management system that complies with ISO 17025. This includes developing procedures for document control, equipment calibration, personnel competency, sample handling, and reporting of results. The laboratory should also establish processes for internal audits and management reviews.
Training and Competency: Ensure that laboratory personnel receive appropriate training on the requirements of ISO 17025 and the laboratory’s quality management system. This includes training on standard operating procedures, equipment usage, measurement techniques, and data analysis. Competency assessments should be conducted to ensure that personnel have the necessary skills and knowledge to perform their tasks effectively.
Implementation and Operation: Implement the quality management system within the laboratory and ensure that all personnel are aware of their roles and responsibilities. This involves integrating the procedures into daily laboratory activities, conducting tests and calibrations according to documented procedures, and continuously monitoring and controlling the quality of the laboratory’s operations. This includes ensuring that equipment is calibrated and maintained, samples are handled properly, and test methods are followed accurately. Regular performance checks, data analysis, and proficiency testing should be conducted to verify the laboratory’s competence and the reliability of its results.
Internal Audit: Conduct internal audits to assess the laboratory’s compliance with the requirements of ISO 17025 and the effectiveness of its quality management system. Internal auditors, who are independent of the areas being audited, review procedures, records, and practices to identify any non-conformities or areas for improvement. Audit findings are documented, and corrective actions are initiated to address identified issues.
Management Review: Top management should conduct periodic reviews of the laboratory’s quality management system to evaluate its effectiveness, suitability, and opportunities for improvement. These reviews provide a platform for assessing the laboratory’s performance, reviewing objectives and targets, and identifying areas for enhancement. Management reviews ensure that the system remains aligned with organizational goals and drives continual improvement.
Accreditation: To obtain ISO 17025 accreditation in Malaysia, laboratories must apply the lab accreditation under Skim Akreditasi Makmal Malaysia (SAMM) where the DSM assessor(s) will evaluates the laboratory’s compliance with ISO 17025 requirements through a rigorous assessment process. This includes a documentation review, on-site assessment, and proficiency testing. If the laboratory meets the requirements of the standard and demonstrates competence, it is granted ISO 17025 accreditation.
Continual Improvement: ISO 17025 emphasizes the importance of continual improvement in the laboratory’s quality management system and operations. Laboratories should strive to enhance their practices by monitoring performance indicators, analyzing data, implementing corrective and preventive actions, and participating in inter-laboratory comparisons. Regular reviews of the quality management system, staff training, and engagement with stakeholders can provide valuable insights and opportunities for innovation and progress.
How Can We Help?
Our ISO 17025 Consultancy Approach:
1. Gap Analysis:
– Perform a detailed analysis of the laboratory’s existing processes, documentation, and practices.
– Identify gaps between the current state and ISO 17025 requirements.
– Document findings and recommendations for improvement.
2. Training:
– Provide customized training sessions to familiarize employees with ISO 17025 concepts, requirements, and implementation strategies.
– Offer specialized training for key personnel involved in the laboratory management system.
3. Documentation:
– Assist in developing and implementing a comprehensive laboratory management system documentation.
– Create or update policies, procedures, work instructions, and forms to align with ISO 17025 requirements.
– Ensure clear documentation of processes, responsibilities, and controls.
4. Internal Audit Support:
– Conduct internal audits to assess the laboratory’s compliance with ISO 17025 requirements.
– Provide guidance and support in conducting audits, including audit planning, checklists, and report preparation.
– Identify nonconformities and provide recommendations for corrective actions.
5. Management Review Support:
– Assist in facilitating management review meetings to evaluate the effectiveness of the laboratory management system.
– Provide guidance in analyzing performance data, customer feedback, and audit results.
– Help identify improvement opportunities and define actions for continual improvement.
6. DSM Audit Support:
– Prepare the laboratory for DSM audit.
7. Closeout:
– Collaborate with the laboratory to address any nonconformities identified during the audit.
– Celebrate the successful achievement of ISO 17025 accreditation.
ISO 17025 Malaysia – Case Study
NGS Lab, sought to elevate its standards by implementing ISO 17025. Engaging the expertise of JC Simplified System consultant, Mr. Mak, the lab embarked on a transformative journey.
With unwavering dedication, Mr. Mak guided the team through the intricate requirements of ISO 17025, emphasizing the criticality of accuracy and proficiency. He conducted comprehensive training sessions, fostering a deep understanding of the standard among the laboratory technicians, instilling a culture of meticulousness and precision.
Collaboratively, they revised the laboratory’s procedures, introducing meticulous documentation practices and stringent quality control measures. Mr. Mak ‘s astute guidance facilitated the establishment of a robust quality management system, tailored to the laboratory’s specific calibration needs.
Months of concerted efforts paid off as NGS Lab attained the prestigious ISO 17025 accreditation, a testament to their unwavering commitment to accuracy and reliability. Under Mr. Mak ‘s guidance, the laboratory not only met the standard’s rigorous demands but also cultivated a reputation for excellence, attracting a diverse clientele and cementing its position as a trusted authority in precision calibration.