About ISO/IEC 17025
- What is ISO/IEC 17025?
- Why implement ISO/IEC 17025?
- Requirements of conformity
- Accreditation, conformity assessment and certification
Today, standardization is the most important issue in creating, maintaining and improving the quality of services and products and is used by research centers and manufacturing organizations as a common language of communication. Both have a major role in quality control and development.
The ISO / IEC 17025 International Standard, explains the “General requirements for the competence of testing and calibration laboratories.” This standard has merged the requirements of ISO / IEC Guide 25 and EN 45001, and has replaced both of them. It includes all the requirements that test and calibration laboratories have to fulfill in order to demonstrate their technical competency and ability to provide valid results.
The application of this standard facilitates the collaboration between laboratories and other organizations and helps to exchange information and experiences and harmonizes testing methods and procedures.
• Competitive advertising advantage over ordinary labs
• Increase of customer satisfaction
• International acknowledgement of results
• Ability to work with inspection bodies and (inter)national quality control institutions
• Overall regulation and consistency in daily lab activities
• Alignment of all processes and task with the lab goals and policies
• Programmed training based on needs and future plans
• Customized procedure to handle test items (reception, identification, storage before or after test)
• Periodic control of equipment performance based on an appropriate schedule
• Particular procedures of recording during-test observations and raw results for tracking or future retrieval
• Uniform reporting format
• Appropriate procedures for archiving internal/external documents, records, data-sheets, catalogues, manuals etc.
• Procedure to protect and preserve electronic data
• Systematic processes of improvement and corrective actions
• Collection of customer feedback for use in future laboratory plans
The ISO / IEC 17025: 2005 is composed of two main parts: management requirements (including 15 clauses) and technical requirements (including 10 clauses). Conformity to all these requirements is needed to show qualification of the laboratory in accordance with this standard.
The management requirements deal mostly with documentation, records, internal audits, purchasing, improvements, corrective and preventive actions, management reviews, goals, policies etc.
The technical requirements include sampling, calibration, personnel competency, training, reporting, measurement uncertainty, quality control of test results, inter-laboratory test-result comparisons and such.
Of course, in addition to the above-mentioned items, a laboratory that seeks to obtain a certificate of conformity to this standard, must satisfy the demands of customers, national regulatory authorities and accreditation / certification bodies.
Conformity assessment is a process in which an organization's activities are assessed against the requirements of a recognized standard and then reported.
The Conformity Assessment Body (CAB) is an organization that performs the conformity assessment process. CAB issues certificates of conformity, and hence are known as Certification Bodies (CBs) too.
The CABs follow these four steps for assessment:
1. Planning the audit(s) in coordination with the requesting organization
2. Performing the audit(s) to assess the organization against a reference standard
3. Issuing the certificate of conformity or reporting the non-conformities
4. Carrying out annual audits to extend the validity of the certification
CABs may deploy agencies across the world to expand their services. These agencies will do the above-mentioned steps and issue a certificate under the credentials of their central offices.
Accreditation is a process in which a conformity assessment body is evaluated in terms of impartiality and competency. Accreditation to a CAB is carried out by an Accreditation Body (AB).
ABs are established in many countries. Each AB may accredit several CABs in accordance with national laws and internal regulations. CBs receive certificates of accreditation from ABs, which show that they are competent to run the process of assessment against certain standards and are allowed to issue corresponding certificates of conformity to organizations.
CBs are, however, allowed to assess organizations and issue certificates outside the accredited scope, but these certificates will lack the approval of the AB and may be not recognized by national or international authorities.
To create a framework to support international trade, ABs need to come to some coordination arrangement to recognize each other’s accredited CBs.
The coordination of ABs are managed by the International Accreditation Forum (IAF), in the fields of management systems, products, services, personnel and other similar programs of conformity assessment, and the International Laboratory Accreditation Cooperation (ILAC), in the field of laboratory and inspection accreditation.
Accreditation bodies are admitted to the above-named foundations after an evaluation of their operations. This is done by a peer evaluation team which is charged to ensure that the applicant member complies fully with both the international standards and the foundation requirements. Once an accreditation body is a member, it is required to recognize the certificates issued by CBs accredited by all other member ABs within their scopes.