What Is ISO / IEC 17025:2017
It is the main ISO standard used by testing and calibration laboratories. In most countries, ISO / IEC 17025 is the standard by which most laboratories must have accreditation to be considered technically competent. In most cases, suppliers and regulatory authorities will not accept test or calibration results from labs that are not accredited. Originally known as ISO / IEC Guide 25, ISO / IEC 17025 was originally issued by the International Organization for Standardization in 1999. There are many similarities to the ISO 9000 standard, but ISO / IEC 17025 is more specific in requirements for competence and applies directly to organizations. – an organization that produces test and calibration results and is based on somewhat more technical principles. Laboratories use ISO / IEC 17025 to implement a quality system aimed at increasing their ability to consistently produce valid results. It is also the basis for accreditation from accreditation bodies.
There have been three releases in 1999, 2005 and 2017. The most significant changes between the 1999 and 2005 releases are a greater emphasis on senior management responsibilities, explicit requirements for continuous improvement of the management system itself, and communication with customers. It is also more closely aligned with the ISO 9001:2000 version
Requirements – requirements
- Context Organization
- Leadership
- Planning
- Support
- Operation
- Performance
- Evaluation
- Improvement
Benefits Implementation
Companies will get many benefits by implementing this international standard management system, including :
- A systematic approach to control all processes and well-defined procedures and supporting documentation
- Achieving international recognition for its technical competence earns the trust of customers and interested parties, and opens doors to new markets both locally and internationally
- Better quality awareness among employees and reduce defects, scrap, failure and rework recovery services
- Have a better corporate image in the eyes of regulators, customers, employees and the wider community
- Potential for increased business due to increased customer trust and satisfaction
- Savings in time and money due to reducing or eliminating the need for product retesting
- Better control of laboratory operations and feedback to the laboratory, whether they have a Guarantee System
- Sound quality and technically competent
- Controls a variety of laboratory methods
- Increase confidence in testing / calibrating data and personnel performing work
- Validity and suitability of test methods
- Capable of trace measurement and calibration to national standards
- Compliance, calibration and maintenance of test equipment & testing environment
- Sampling, handling and transportation of test goods quality assurance of testing and calibration data
Consultation program
1. Gap Analysis
- Review the maturity level of the current management system implemented by the company and to determine gaps with standard requirements
2. Management system creation
- Creating a management system with a system level that aims to facilitate the implementation and understanding of employees in implementing this management system standard
3. Training
- Equip employees with a thorough understanding of a good quality management system so that they can maintain consistency in implementation even though they are no longer accompanied by a consultant
Preparation for consultation
Several things that need to be prepared by the company before the consultation process, namely :
- Forming a committee team for the implementation of the quality management system consisting of representatives from each department
- Collect all documents currently used in managing the company
- Company legality data for registration requirements to the certification body