The wording below is an original orientation. It does not quote the standards. International cooperation explains why membership of an arrangement is a separate question from knowledge of these standards.
ISO/IEC 17011
Competence of accreditation bodies
The operation of an accreditation body
ISO/IEC 17011 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
It addresses the structure of an accreditation body, the management of impartiality, the process from application to decision, the competence of personnel involved in accreditation, and the information made public about accredited bodies.
Reference to ISO/IEC 17011 on this site explains the standard that ordinarily frames an accreditation body’s own operation. It is not a statement that AKZERT has been assessed against it, or that any external body has confirmed conformity with it.
ISO/IEC 17025
Testing and calibration laboratories
Testing laboratories and calibration laboratories
ISO/IEC 17025 specifies general requirements for the competence, impartiality and consistent operation of laboratories. It is used for testing laboratories and for calibration laboratories.
The requirements cover structure, resources, process and management. For calibration, and for testing where the validity of the result depends on it, metrological traceability is a central concern. The scope of accreditation identifies the activities for which competence has been attested.
A laboratory may be competent for a defined list of methods and not for others. The standard does not confer a general licence to test or calibrate outside that list.
ISO 15189
Laboratorios médicos
Laboratorios médicos
ISO 15189 specifies requirements for quality and competence in medical laboratories. It is addressed to laboratories that examine materials derived from the human body for the purpose of providing information for the diagnosis, management, prevention or treatment of disease, or for the assessment of health.
The standard attends both to the management system and to the technical competence of the examination process, including pre-examination and post-examination activities where they affect the result.
It is the standard ordinarily used when accreditation of a medical laboratory is discussed. Publication of that fact here does not mean that AKZERT currently accredits medical laboratories.
ISO/IEC 17020
Organismos de inspección
Organismos de inspección
ISO/IEC 17020 specifies requirements for the competence of bodies performing inspection, and for the impartiality and consistency of their inspection activities.
Inspection relies on professional judgement to determine conformity with requirements. The standard distinguishes types of inspection body according to the degree of independence from the items inspected. The type, and the field of inspection, belong in the scope.
An inspection report or certificate is the attestation of the inspection body. Accreditation, where it exists, attests the competence of that body for the inspections named in the scope.
ISO/IEC 17021-1
Management system certification bodies
Bodies certifying management systems
ISO/IEC 17021-1 specifies requirements for bodies that audit and certify management systems. It is concerned with the competence, consistency and impartiality of the certification body.
Further parts of the ISO/IEC 17021 series, and related competence documents, address particular management systems. A scope of accreditation names the management systems and the schemes for which the certification body has been attested.
Certification of a company’s management system is the act of the certification body. Accreditation considers whether that body is competent to certify the systems named in its scope.
ISO/IEC 17024
Personnel certification bodies
Bodies certifying persons
ISO/IEC 17024 specifies requirements for a body certifying persons, including the development and maintenance of a certification scheme and the fair and valid assessment of candidates.
The standard separates the interests of training, examination and certification where that separation is needed for impartiality. The scope identifies the schemes, or categories of person, for which the body is accredited.
A certificate issued to a person is the attestation of the certification body. Accreditation attests the competence of the body to operate the named scheme.
ISO/IEC 17065
Product certification bodies
Bodies certifying products, processes and services
ISO/IEC 17065 specifies requirements for the competence, consistent operation and impartiality of bodies certifying products, processes and services.
The scope of accreditation identifies the schemes and the categories of product, process or service. The certification body evaluates conformity with the scheme and decides whether to grant certification. Accreditation considers the competence of that body for the schemes named.
A product certificate is not itself an accreditation certificate. The two documents answer different questions and are issued by different bodies.
