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Minimizing Barriers and Maximizing Profits of Lab Services with ISO/IEC 17025
Quality Management System
2016-11-10
Measurement has become one of the widest range socio-economic activities on a global scale. Many aspects of life including food safety, environmental protection, and health are dependent on chemical analyses that are done through laboratories. By relying on the laboratory measurement, customer confidence should be achieved only by increasing the accuracy of produced data in labs. Therefore, laboratory accreditation which is achieved by implementing ISO/IEC 17025 - General requirement for the competence of testing and calibration laboratories - is ideal because it is the process that defines the competence of labs in delivering precise results which create confidence in the decision-making process, assures safety, and eliminates redundancy.
Nonetheless, by eliminating the need for retesting, while using accurate and reliable data, globally recognized accredited laboratories are realizing cost reduction and minimizing technical barriers to international trades. Essentially, this internationally recognized standard provides consistent quality of products; proves credibility and delivers global trust.
Historically, ISO 9001 has been used as a guideline to ensure quality process in calibration, inspection, and testing of laboratories. While ISO 9001 is a general standard specifying the requirements for a quality management system, ISO/IEC 17025 states the technical requirements for the competence of testing and calibration laboratories, hence ISO/IEC 17025 comprises of management and technical requirements. Even though the ISO 9001 standard is an effective tool for management evaluation, it is not appropriate for evaluation of a laboratory’s technical competence. Both standards address aspects of laboratories’ capability as well as consistency in calibration procedures and results.
Yet, ISO/IEC 17025 accredited labs may have strong reason to also maintain an ISO 9001 certification because of the non-testing activities undertaken in the process of generating analytical/calibration data, test and measurement results such as; human resource, marketing, information/communication and education. It is very important for labs to have such activities recognized through an ISO 9001 certification process.
Organizations may use calibration and testing for the following reasons:
- To ensure that a product is ready for the market
- To make sure that the product is safe and pre-forms properly
- To meet regulatory requirements
- To have product certified
Moreover, calibration laboratories have ensured that the measurements made by the manufacturer and labs are valid and traceable to international standards. Laboratories can equally include testing and calibration, so both types can be accredited under the same standard -ISO/IEC 17025.
The importance of ISO/IEC 17025 laboratory accreditation
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To establish and validate testing competence: The establishment of a quality management system in laboratories that conforms to ISO/IEC 17025 is a challenging task. Therefore, this standard is considered to be one of the most important standards for calibration and testing laboratories recognized globally. Complying with ISO/IEC 17025 will demonstrate and enable laboratories to identify where the organizational operations are met and which technical requirements are required by this standard and in what specific areas, consequently providing guidance in achieving compliance. Genuinely, laboratories accredited with ISO/IEC 17025 have demonstrated and are proficient by producing exact and reliable test and calibration data.
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International recognition: Globally countries have developed a uniform approach to determining laboratory competence based on ISO/IEC 17025. Mutual Recognition Agreements (MRAs) allow countries to establish agreements amongst themselves, based on a mutual evaluation, thereby making test and calibration data acceptable worldwide. This system offers ISO/IEC 17025 accredited labs international recognition by exposing them to foreign markets, which leads to reduced costs and product retesting in other countries because data generated from an accredited laboratory eliminates the need for retesting in another country.
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Marketing edge: ISO/IEC 17025 accredited labs are able to submit bids and tenders to contractors that require independently verified labs, local or foreign. Likewise, since most accreditation bodies maintain a publicly displayed register of accredited laboratories – including contact details, this is a means of projecting the laboratory’s services to potential clients.
- Customer satisfaction: The presence of quality assurance, through ISO/IEC 17025 accreditation, reduces uncertainties associated with key environmental and health decisions and guarantees clients that errors in test results are minimized, in turn, increasing customers confidence.
Furthermore, this standard clearly defines the importance of confidentiality of the customers’ information, therefore being accredited with ISO/IEC 17025, laboratories have the responsibility to secure and protect all the information, particularly electronic information. In other words, ISO/IEC 17025 accreditation helps you minimize risk by assuring that you are selecting a technically competent lab that has a quality system in place. Organizations’ qualified staff provides a ready means for customers to find quality, consistent testing, and calibration service, by providing necessary competency and expressing capability of meeting all of the calibration testing needs.
How Accredited Laboratories conform to ISO/IEC 17025 Requirements
Some of the key technical requirements of the standard include:
- Verification of personnel competency
- Calibration and equipment maintenance
- Quality assurance of test and calibration results
- Method validation
- Estimation of measurement uncertainty
- Participation in proficiency testing
Key players in the accreditation process
Implementers: well-trained implementers have a thorough understanding of the management and technical requirements of ISO/IEC 17025. They successfully initiate and implement a laboratory management system based on the standard, and monitor the performance of the system in preparation for certification.
Assessors: assessors are professionals with the lab experience in the fields of testing and calibration for which they will be performing assessments. They are integral to planning, initiating and conducting ISO/IEC 17025 certification audits. Subsequently, they report on the assessment activities and ensure follow-ups and are bound by confidentiality and professionalism in the course of the audit.
Technical Experts: a technical expert is a person who provides specific knowledge or expertise to audit the team. This is necessitated by the nature of the specific process to be assessed, his skill set and experience.
PECB is a certification body for persons, management systems, and products for a wide range of international standards. As a global provider of training, examination, audit, and certification services, PECB offers its expertise in multiple fields, including Laboratory Management System based on ISO/IEC 17025.
About the authors
Sherif Mehmeti is a Portfolio Marketing Manager for Quality Management Systems at PECB. He is in charge of conducting market research while developing and providing information related to Quality Management Systems at PECB. If you have any questions, please do not hesitate to contact: marketing.qms@pecb.com.
Dotun Bolade is an Analytical Chemist/Environmental Scientist by training and practice with years of experience in laboratory instrumentation and automation. For him, ISO management systems have become second nature having worked in environments where ISO 9001, 14001, 18001 and 17025 have been fully implemented. He is a Certified PECB ISO/IEC 17025 Lead Assessor, ISO 14001, 9001 & 29001 Lead Implementer and Certified Trainer. Dotun is a PECB Partner and Managing Consultant, EN2SOL PNP LIMITED. Contact: dotun.bolade@energysolutionsng.com.
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