Conformity assessment is the term given to different techniques that ensure a product, process, service, management system, person or organisation fulfils specified requirements.
This section describes the main conformity assessment techniques and explains how to combine them to form conformity assessment schemes.
The main conformity assessment techniques and their most common applications can be described as in the icons below. In some instances one conformity assessment technique may encompass another, e.g. an inspection can include a test technique, or a product evaluation may take into account a test report or an inspection report. How these conformity assessment techniques are used and interrelated is often prescribed in a specific mandatory or voluntary conformity assessment scheme.
Assessment applies to the process of determining whether an organisation fulfils requirements related to its technical competence. An example is the assessment of conformity assessment bodies (e.g. laboratories, inspection bodies, certification bodies and validation/verification bodies) to ensure that the results that they produce can be relied upon.
The following International Standards set out requirements for how assessments are undertaken:
- Conformity assessmentRequirements for accreditation bodies accrediting conformity assessment bodies
- Conformity assessmentGeneral requirements for peer assessment of conformity assessment bodies and accreditation bodies
An audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Audit criteria are contained in policies, procedures and requirements adopted by an organization and may include applicable laws and regulations, policies, procedures, standards, management system requirements, contractual requirements or industry/business sector codes of conduct.
Audit criteria are used as a reference against which conformity is determined.
Audit evidence comprises of records, statements of fact or other information relevant to the audit criteria which are verifiable. Audit evidence may be qualitative or quantitative.
Evaluation is the process of gathering evidence about whether an object of conformity, such as a product, process or service, meets specified requirements. It is also sometimes used in the context of person certification.
Evaluation includes the ‘selection’ and ‘determination’ functions described in the functional approach, including:
- confirming the specific objects to be evaluated;
- confirming the specific requirements that those objects must fulfil;
- sampling the specified objects;
- applying one or more determination techniques such as testing, inspection and auditing, and also other activities such as studying the design drawings and specifications to ascertain whether the features required to meet the specified requirements are adequately defined;
- collating the evidence from the above techniques prior to a decision on overall conformity being made.
Examination is one of the terms used almost interchangeably to cover a number of techniques, but it is used in a more specific way when referring to methods for certifying the competence of a person. In this context, examination is defined as a mechanism that measures a candidate's competence by one or more means, such as written, oral, practical and observational, as defined in the certification scheme.
Examinations need to be planned and structured in a manner which ensures that all specified requirements are objectively and systematically verified, with sufficient documented evidence produced to confirm the competence of the candidate.
- Conformity assessmentGeneral requirements for bodies operating certification of persons
Inspection is a form of conformity assessment which has a long history. Some inspection activities are closely aligned with testing activities; others may be closely associated with certification activities (and particularly product certification); while other inspection is a stand-alone activity without any relation to testing or certification. One of the key aspects of inspection is that the determination of conformity with specific requirements is made on the basis of professional judgment of the inspection bodies’ personnel. This underlines the fact that the competence of inspection bodies is highly dependent on the knowledge, experience and interpretive skills of the inspection bodies’ personnel.
Inspection as a conformity assessment technique can include:
- visual examination of physical items;
- measurement or testing of physical items;
- examination of specification documents such as design drawings;
- comparison of the findings with the requirements of specification documents or with generally accepted good practice in the field; and
- drawing up a report on the results of the inspection.
Testing, measurement and calibration are the most prevalent conformity assessment techniques used. ISO/IEC 17000 defines testing as (…) determination of one or more characteristics of an object of conformity assessment, according to a procedure. A procedure is defined as a specified way to carry out an activity or a process. A note to the definition of testing states that testing typically applies to materials, products or processes. In the case of testing used for conformity assessment, the characteristics will be included in the ‘specified requirements’ which form the focus of the testing.
Requirements for testing and calibration laboratories include all of the elements essential to the conduct of testing for conformity assessment:
- competent people;
- validated test methods which are repeatable and reproducible;
- properly maintained and calibrated equipment;
- measurements which are traceable to the SI standard units of measurement;
- sampling and handling of test items; and
- correct reporting and interpretation of testing results.
Testing applies in public health and safety, commerce, manufacturing, construction, environmental monitoring, transport, agriculture, quarantine, forensic sciences, meteorology, telecommunications, mining, forestry, defence, professional services and trade.
- General requirements for the competence of testing and calibration laboratories
topics on conformity assessment