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ISO 17025
What is the ISO 17025 Standard?What Are the Benefits to Implementing ISO 17025?
Areas Where ISO 17025 Has Been Implemented
What are some of the Requirements for this Standard?
Implementation, Training, and Coaching Services
Internal Audit Services of Your QMS
Third-Party Audit Services of Your Supplier's QMS
Validation Studies
What is the ISO 17025 Standard?
ISO 17025 is the evolution of the ISO / IEC Guide 25, a joint partnership between the International Organization for Standardization and the International Electrotechnical Commission. This document is called the General Requirements for the Competence of Calibration and Testing Laboratories.
This standard was developed specifically to give guidance to lab managers on both quality management and the technical requirements for the proper operation of a laboratory. Thus, ISO 17025 can be thought of as the technical compliment to ISO 9000. As a matter of fact, any organization who meets the requirements for ISO 17025 automatically is ISO 9000 compliant (but the converse is not true).
- ISO 17025 is to provide a third-party demonstration to customers that the laboratory has the technical and managerial capabilities to perform specific tests, measurements, or calibrations, to stated standards or to customized procedures within their bounds of stated accuracies, chosen test methods & equipment.
While the ISO 9000 requirements are generic and can be used by any type of organization, the ISO 17025 requirements are specific to laboratory functions. This standard addresses issues such as: the technical competence of personnel, ethical behavior of staff, use of well-defined test and calibration procedures, participation in proficiency testing (i.e.: interlaboratory comparisons and/or reference materials), and provide guidance on the contents of test reports and certificates generated. As such, this standard fits nicely within the framework of the new ISO 9000 (2000) and the GLP standards.
One function of the ISO 17025 standard is to demonstrate the lab's abilities to carry out specific tests and/or calibrations. The accreditation certificate will state the tests, equipment used and the degree of accuracies obtained.
In Canada, it is the SCC that accredits laboratories. This is done through their Program for Accreditation of Laboratories in Canada (PALCAN). They have partnerships with the NRC, CAEAL, and CFIA (Canadian Food Inspection Agency – division of Health Canada).
Another critical reason why it was developed, was to harmonize laboratory accreditation and acceptance of test data throughout the world. Just recently, the Standards Council of Canada (SCC) announced that they have signed a Mutual Recognition Agreement (MRA) between 28 major trading partners with Canada, including the U.S.A. (as recognized by the NSF, NIST and A2LA). All of these countries will now be required to accept the test results performed by accredited members of these other countries. This should make it easier for companies to market their goods and services to these other member countries.
One of the attractive aspects for achieving this standard is that the fee is dependant on the number of tests for which the lab is seeking accreditation. Therefore, for smaller labs one can have as few or as many tests accredited as they wish. Another difference between ISO 9000 and ISO 17025 (ISO/IEC Guide 25) is the accreditation audit. The latter requires an assessor who must have technical expertise in the testing procedures and equipment being inspected.
What Are the Benefits to Implementing ISO 17025?
- Provides valid test data that the customer (whether internal or external) can trust;
- Strong quality control, qualified processes and demonstrations of staff competence provide a greater degree of data defensibility;
- Provide excellent third-party recognition to your customers;
- Should lead to fewer re-analysis of samples;
- Clear definition of roles, responsibilities, and authority, provide for greater efficiency in operation of the laboratory;
- Audit and assessment activity by laboratory customers can be reduced through third party recognition;
- Increased efficiency will lead to a reduction in operating costs;
- Increased efficiency will result in less re-analysis of samples. This too, effects the cost of operations in a positive way;
- Increased efficiency and reduction of re-analysis will decrease customer complaints and should contribute to decreased turnaround time for analyses; and
- Increased efficiency should also free up capacity to increase throughput and provide for increased business.
Areas Where ISO 17025 Has Been Implemented
In the EU, it is almost an unwritten rule that companies within their economic community have this accreditation to freely market their product or service. In contrast, North America is only starting to grasp its importance. Upon viewing the SCC’s website listing the accredited Canadian labs, it appears that as much as 90% of these organizations are in the Toronto to Montreal corridor.
Surprisingly the leaders are not the Private sector. Numerous Public institutions such as Environment Canada, Fisheries & Oceans Canada, Health Canada, CFIA, NRC, AECL, RCMP, CSA, Agriculture & Agri-Food Canada, and provincial organizations such as the ARC, SRC, and Alberta Agriculture. There is also a large host of Municipalities who have embraced this standard. Within the Private sector, the environmental analytical labs appear to be the present leader.
As one can see, this standard can be implemented for anyone who performs testing, measuring, or calibrating. Just a few more examples include:
- measuring physical properties such as: mass, length, time, electricity, radiation, power, pressure, temperature, humidity;
- in-house or commercial labs;
- Federal, Provincial, and Municipal governments who are more than ever outsourcing their testing requirements to private labs;
- environmental monitoring of air, water, soil for quality (through CAEAL’s partnership);
- electrical product safety and properties;
- food safety (through CFIA’s partnership);
- agricultural and animal products;
- mineral assays;
- forensic investigations;
- analyses of chemicals, pharmaceuticals, cosmetics, oilfield and refinery products;
- construction and pipeline materials and integrity;
- communication equipment and electrical appliances; and
- medical (Haematology, Microbiology, Urology, and Immunology).
What are some of the Requirements for this Standard?
This standard can generally be sub-divided into two main categories: a) Management System requirements and b) Technical requirements. In addition to the usual ISO 9000 requirements, just a few of the requirements unique to ISO 17025 are outlined below.
- Management System Requirements: The laboratory shall:
- be legally identifiable;
- identify its approved signatories;
- identify its’ scope of calibrations and/or tests;
- have arrangements to ensure that its personnel are free from any commercial, financial, and other pressures which might adversely affect the quality of their work;
- have a ratio of supervisory to non-supervisory personnel such as to provide adequate supervision;
- where relevant, have documented policy and procedures to ensure the protection of clients’ confidential information and proprietary rights;
- where appropriate, participate in interlaboratory comparisons and proficiency testing programmes, use reference materials, or other internal Q.C. protocols;
- ensure the quality of results provided to clients by implementing checks (using internal Q.C. protocols, replicate testing, etc.);
- have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions;
- advise and seek the approval of the client in writing when it intends to sub-contract specific tests or calibrations to another laboratory;
- afford clients the right to monitor the performance of the laboratory in relation to the work performed;
- ensure that adequate records are retained in case of the need for future dispute resolution;
- have procedures to protect data held on computers at all times and to prevent unauthorized access to or amendment of data on computers; and
- have periodic Management Reviews which include the results of any inter-laboratory comparisons, or proficiency tests, and any changes in the volume and; type of work undertaken.
- Technical Requirements: The laboratory shall:
- ensure that personnel who make professional judgements are competent and have the applicable theoretical and practical backgrounds. They must also have integrity and a good reputation;
- maintain records of the relevant competence, educational and professional qualification of all technical personnel;
- define and control access to and the use of all areas affecting the quality of the testing and/or calibration activities;
- include procedures for the sampling, handling, transport, storage, and preparation of items to be tested and/or calibrated;
- include the identity of the personnel responsible for the sampling, performance of each test and/or calibration and checking of results;
- use test and/or calibration methods which preferably are those published as international or national standards;
- inform the client when the method proposed by the client is considered to be inappropriate or out-of-date;
- validate their methods to confirm that they are suitable for their intended use;
- be able to estimate measurement uncertainties when this is a customer requirement;
- perform appropriate checks on calculations and data transfers;
- establish calibration programmes for key instruments; and
- establish equipment maintenance procedures and schedules.
Implementation, Training, and Coaching Services
We can:
- conduct an assessment of your present Quality Management System and procedures;
- perform a "Gap Analysis" to determine the deficiencies;
- provide a general overview for Management and Staff;
- assist with writing and revising of policies, procedures, validations, and forms;
- select and coach personnel involved in the implementation process;
- provide detailed training to individual departments, regarding specific ISO 17025 requirements;
- conduct the Internal Quality Audit, and assist with implementing the required corrective actions;
- liaise with the registration Auditor / Registrar;
- be present and provide consultation during the Registration Audit; and
- perform regular follow-ups, thereafter.
Internal Audit Services of Your QMS
We can provide an objective and unbiased review, to assess conformance to the Standard and to determine the level of implementation and effectiveness of the quality system elements. We can identify opportunities for improvement, within the scope of the quality system, then provide recommendations based on our vast and varied experiences.
A report summarizing the audit findings and results are then submitted. This report is then used as an official quality record to aid in management review, customer approval, continuous improvement, and registration decisions.
Third-Party Audit Services of Your Supplier's QMS
ICS can let you know whether your suppliers are meeting their contractual agreements, no matter where they are located throughout the world. These suppliers may include contract manufacturers and/or other testing laboratories.
No matter where your suppliers are located, we can most likely provide these services at less travel expenses. This is due to our network of strategic alliances or subcontracted auditors, or we may also have other clients in the city that your supplier is located.
Validation Studies
This is the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results. We can perform:
- Installation Qualifications;
- Operational Qualifications;
- Performance Qualifications;
- Retrospective Validations; and
- Prospective Validations.
ICS can prepare all of the required documentation and perform the actual work, when requested.