ISO/IEC 17025 is the global recognized standard that was developed specifically for testing
and calibration laboratories that intended seeking accreditation. It is also the
basis for accreditation from an accreditation body. The current release was published
in 2005. It covers testing and calibration performed using standard methods, non-standard
methods, and laboratory-developed methods. There are two main clauses in ISO/IEC 17025
Management Requirements are related to the operation and effectiveness of the
quality management system within the laboratory, and this clause has similar requirements
to ISO 9001.
Technical requirements includes factors which determines the correctness and reliability
of the tests and calibrations performed in laboratory namely competence of staff;
environment control; testing methodology; equipment and measurement traceability;
and reporting of test and calibration results.
Laboratories that can demonstrate compliance with ISO/IEC 17025 at assessment have
demonstrated they operate using sound management practices and are technically competent
to perform specific tests, calibrations and/or measurements as well as at the same
time are able to generate technically valid results for which they hold accreditation.
To maintain this recognition, laboratories are re-evaluated periodically by the
accreditation body to ensure their continued compliance with requirements, and to
check that their standard of operation is being maintained. The laboratory may also
be required to participate in relevant proficiency testing programs between reassessments,
as a further demonstration of technical competence.
Accredited laboratories usually issue test or calibration reports bearing the accreditation
body’s symbol or endorsement, as an indication of their accreditation.
Clients are encouraged to check with the laboratory as to what specific tests or
measurements they are accredited for, and for what ranges or uncertainties. This
information is usually specified in the laboratory’s scope of accreditation, issued
by the accreditation body. The description in the scope of accreditation also has
advantages for the customers of laboratories in enabling them to find the appropriate
laboratory or testing and calibration service. Laboratory accreditation bodies publish
the scopes of accreditation for their accredited laboratories in either hardcopy
directories or on the internet.
ISO/IEC 17025 is the main standard used by testing and calibration laboratories.
Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the
International Organization for Standardization in 1999. There are many commonalities
with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence
to the equation. And it applies directly to those organizations that produce testing
and calibration results. The final version of this standard is more closely aligned with the ISO 9001 in term of its quality system words which include greater emphasis on the responsibilities of senior management, and explicit requirements for continual improvement of the management system itself, and particularly, communication with the customer.
In the current global scenario, an essential pre-requisite of trade is that any
product or service is accepted formally in one economy, must also be free to circulate
in other economies without having to undergo extensive re-testing. WTO recognizes
that non-acceptance of test or calibration results and measurement data is a Technical
Barrier to Trade. Thus, accreditation is considered as the first essential step
for facilitating mutual acceptance of test or calibration results and measurement
data. In seeking of recognition, laboratories need to demonstrate full compliance
with both sections of ISO/IEC 17025 namely Management and Technical requirements
and successfully go through the third party assessment i.e by accreditation body.
Many countries around the world have one or more organizations responsible for the
accreditation of their nation’s laboratories. Most of these accreditation bodies
have now adopted ISO/IEC 17025 as the basis for accrediting their country’s testing
and calibration laboratories. This has helped countries employ a uniform approach
to determining laboratory competence. It has also encouraged laboratories to adopt
internationally accepted testing and measurement practices, where possible. In order
for accreditation bodies (at various part of the world) to recognize each others'
accreditations, the International Laboratory Accreditation Cooperation (ILAC) worked
to establish methods of evaluating accreditation bodies against another ISO standard
(ISO/IEC Guide 58 - which became ISO/IEC 17011).
Though, the Management Requirements of ISO/IEC 17025 has similarity with ISO 9001,
it cannot be interpreted to be the same as certification against the ISO 9000 series
Standards. Confidence in accreditation can only be obtained by a transparent system
of control over the accredited laboratories and an assurance given by the accreditation
body that the accredited laboratory constantly fulfils the accreditation criteria.
Thus, demonstration of compliance with Management and Technical Requirements will
allow the laboratories to operate a quality management system for their testing
and calibration activities that also meets the principles of ISO 9001 and at the
same time has the people, with the skills and knowledge, the environment with the
facilities and equipment, the quality control and the procedures that are required
to produce valid results.
Who can apply for ISO/IEC 17025
This International Standard is applicable to all organizations performing tests
and/or calibrations. These include, for example, first, second and third-party laboratories,
and laboratories where testing and/or calibration forms part of inspection and product
certification. The standard is also applicable to all laboratories regardless of
the number of personnel or the extent of the scope of testing and/or calibration
In addition to the use of this international standard by laboratories in developing
their management system for quality, administrative and technical operations, laboratory
customers, regulatory authorities and accreditation bodies may also use it in confirming
or recognizing the competence of laboratories. However, this International Standard
is not intended to be used as the basis for certification of laboratories.
Benefits of ISO 17025
Increase of confidence in Testing/ Calibration data and of personnel performing
Better control of laboratory operations and feedback to laboratories as to whether
they have sound Quality Assurance System and are technically competent.
Potential increase in business due to enhanced customer confidence and satisfaction.
Customers can search and identify the laboratories accredited by The Accreditation
Member Body for their specific requirements from their website or Directory of Accredited
Users of accredited laboratories will enjoy greater access for their products,
in both domestic and international markets, when tested by accredited laboratories.
Savings in terms of time and money due to reduction or elimination of the need
for re-testing of products.
Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Two types of auditing are required to become accredited to the standard: auditing
by an external accreditation body (external audit) and audits by internal staff
trained for this process (internal audits). The aim is a continual process of review
and assessment especially on demonstration of technical competency, to verify that
the system is working as it's supposed to, find out where it can improve and to
correct or prevent problems identified.
Choosing a Registrar
If you are considering seeking accreditation for your facility, the first thing
you’ll need to do is contact the appropriate accreditation body to see whether they
can accredit your range of testing or calibration services.
Most national accreditation bodies can provide comprehensive accreditation for:
Facilities undertaking any sort of testing, product or material evaluation,
calibration or measurement.
Private or government laboratories
One-person operations or large multi-disciplinary organizations.
Remote field operations and temporary laboratories.
Route to Registration
Laboratories can have either all or part of their testing and calibration activities
accredited. The accreditation process involves a thorough evaluation of all the
elements of a laboratory that contribute to the production of accurate and reliable
test or calibration data.
The evaluation process can take one to several days (usually 2 to 3 stages of assessment,
vary among accreditation bodies), and involves the use of specialist technical assessors
who evaluate the specific types of testing or measurement being performed. The assessment
criteria are based on the international standards ISO/IEC 17025, which are used
for evaluating laboratories throughout the world. Laboratory accreditation bodies
use this standard specifically to assess factors relevant to a laboratory’s ability
to produce precise, accurate test and calibration data, including the:
Technical competency of staff.
Validity and appropriateness of test or calibration methods.
Traceability of measurements and calibrations to national standards.
Suitability, calibration and maintenance of test or calibration equipment.
Testing or calibration environment
Sampling, handling and transportation of test or calibration items.
Quality assurance of test and calibration data.
At the end of the assessment a detailed report on the evaluation is presented to
the laboratory, highlighting any areas that require attention and corrective action
prior to the laboratory being recommended for accreditation.
Once accredited, the laboratory is re-evaluated periodically to ensure its continued
compliance with requirements, and to check that its standard of operation is being
maintained. The laboratory may also be required to participate in relevant proficiency
testing programs between reassessments, as a further demonstration of technical