The ISO/IEC 17025: 2005 standard was developed as a special purpose standard for laboratories to specify the general requirements for their technical competence. While the standard is generic, it also recognizes that for accreditation purposes, (i.e. for independent recognition of a laboratory’s competence to perform specific tests, or calibrations) the standard may require development of guidelines to explain its use in specific areas of testing or measurement.
ISO/IEC 17025 -2005 has two major components, namely management requirements and technical requirements. The management requirements are written in language relevant to laboratory operation but were developed to meet the systems requirements of ISO 9001-1994 and ISO 9002-1994.
WHY ISO / IEC 17025? : –
- Improved quality
- Improved efficiency, productivity and effectiveness
- Improved level of motivation, co-operation, workmanship and quality awareness
- Improved communication and quality information and greater quality awareness
- Greater control of processes and activities throughout organisation.
- An onward journey of improvement is possible on an on-going basis
- Provide hot tips on analysis of data as well as measure uncertainty and perfect record keeping.
- Provide guideline for doing testing and measurement in detail.
- Provide guidelines and better control for maintenance of instruments, environment control, preservation of test records etc
- Establish the best system for the product storage and handling.
- Helps in dealing with issues of implementing the OSHA (Occupational, Safety, Health Assessment) laboratory standards as well as THE ACCREDITATION MEMBER BODY accreditation.
- Provide guidance for emergency response of laboratory for fire, radiation, chemical spillage, biological spill, and personal injury as well as reduce accidents.
- Helps in making complete training manual with details of all test procedures and it helps in training any new staff as well as consistency of Quality of testing is maintained in spite of high staff turnover
WHY NOT ISO / IEC 17025?
- Do not want to spend money.
- Monopoly supplier.
- Do not want to export.
- Customers do not care.
- Unlimited resources.
- Do not believe in involving people.
- Do not want to train employees.
- Enjoy fire fighting and quick fixes.
- Believe – Quality does not pay.
- Do not want to commit anything on paper.
- Expect miracles to overcome challenge.
- Have other sources of income and don’t want to grow.
ISO / IEC 17025: 2005 DOCUMENTATION: –
The total documentation for a comprehensive management system under ISO / IEC 17025 can be represented by the four-tier system in a pyramid shown in the figure – 1.
- ISO 17025 Quality Manual:- It states the Quality Policy and describes the macro level Management system including details for how the standard requirements shall be fulfilled in the company.
- Quality Procedures: – It is normally called as middle management hand book and describes department activity for a system approach to supply consistent Quality Product. They are considered to be the core of the system documentation and confidential documents. They describe how the tasks and functions of the various departments should be performed to meet the requirements of the ISO / IEC 17025: 2005 standard and the Quality Policy of the company.
- Work Instructions / Operating Procedure: – These documents are required for the Testing and or calibration purpose otherwise affects Quality of testing and or calibration
- Quality Records, Forms:- Forms, records etc. are supporting documents used by the company to record information for different procedures followed.
The global objectives of the implementation of ISO / IEC 17025 : 2005 are: –
- To establish Quality in testing and reliability
- To prevent risk
- To detect deviations
- To correct errors
- To improve efficiency
- To ensure data quality and integrity.
ISO 17025 consultant provides information about iso 17025 standard implementation and requirements. In the iso 17025 certification basic requirements is iso 17025 manual, iso quality procedure, SOP and quality system implementation.
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