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Overview; ISO/IEC 17025 – 2005
What is Quality?
• Degree to which a set of inherent characteristics
fulfils requirements
“Quality is "fitness for purpose".
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Overview; ISO/IEC 17025 – 2005
WHAT IS
ISO ?
• ISO -Greek word “isos” means “equal”, pronunciation “eye-
soh”
• ISO is a worldwide federation of national standards from more
than 140 countries, called “International Organization for
Standardization”.
• ISO is a non-governmental organization established in1947
with head quarters in Geneva, Switzerland.
• IEC-International Electro technical Committee 17025-is the
number
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THE INTERNATIONAL PICTURE
NABL ,as an accreditation body, operates its own system as per ISO/IEC 17011 .
NABL is signatory to APLAC / ILAC Mutual Recognition Arrangements (MRA) since
2000 after its first evaluation by APLAC .
Second & Third evaluation by APLAC in 2004 & 2008 respectively.
Fourth evaluation Completed in Sep. 2012,next is due in 2016.
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Overview; ISO/IEC 17025 – 2005.
Benefits of ISO 17025 Accreditation
• A systematic approach to control all its processes and well defined procedures and
supporting documentation.
• Laboratories implementing Management System as per ISO/IEG 17025 standard
helps them in improving their ability to consistently produce valid results.
• Achieve international recognition of its technical competence gain the confidence of
customers and interested parties, as well as open doors to new market both locally
and international.
• Greater quality awareness amongst employees and reduced defects, scraps, rework
failures and service.
• Have a better corporate image in the eyes of regulators, customers, employees as
well as the society at large.
• Savings in terms of time and money due to reduction or elimination of the need for
re-testing of products
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Overview; ISO/IEC 17025 – 2005.
Benefits of ISO 17025 Accreditation
•Better control of laboratory operations and feedback to laboratories as to whether
they have sound Quality Assurance System and are technically competent.
•Control laboratory methods variation.
•Increase of confidence in Testing / Calibration data and personnel performing work.
•Validity and appropriateness of test methods.
•Traceability of measurements and calibrations to national standards.
•Suitability, calibration and maintenance of test equipment & Testing environment.
•Sampling, handling and transportation of test items Quality assurance of test and
calibration data. Potential increase in business due to enhanced customer confidence
and satisfaction.
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Overview; ISO/IEC 17025 – 2005
Application of ISO 17025:2005
A Bench Mark for Performance
• Benchmark for maintaining the competence
• Areas for improvement
Marketing advantage
• Accreditation is an effective marketing tool for testing, calibration and measurement
laboratories.
• Laboratory accreditation is highly regarded both nationally and internationally as a
reliable indicator of technical competence.
• Many accreditation bodies also publish a directory of their accredited laboratories,
which includes the laboratories' contact details plus information on their testing
capabilities. This is another means of promoting a laboratory's accredited services to
potential customers.
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Who should go for 17025 Accreditation?
ISO/IEC17025:2005 is applicable to all laboratories regardless of the number
of personnel or the extent of the scope o testing and/or calibration activities.
When a laboratory does not undertake one or more of the activities covered
by ISO/IEC17025:2005 ,such as sampling and the design/development of new
methods , the requirements of those clauses do not apply.
In
com
plete
need
to
include
som
e
points
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NATIONAL ACCREDITATION BOARD FOR TESTING AND
CALIBRATION LABORATORIES (NABL) IN INDIA
• It is an autonomous body
• Registered under Societies Act in1992
• Under the aegis of Department of Science & Technology,
Government of India.
www.nabl-india.org
NABL –FUNCTIONING ROLE IN INDIA
• Grants accreditation in almost all areas of science, engineering and medical testing.
• The international standards followed are :
ISO 15189:2007 (for Medical Testing) ,
ISO/IEC 17025:2005 (for Testing, calibration) &
ISO 17043:2010 (for PT providers)
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Structure of ISO/IEC 17025
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Technical requirements
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Scope of ISO/IEC 17025
Covers General Requirements of Laboratory performing Testing and calibrations using -
• Standard methods,
• Non standard methods
• Laboratory-developed methods
Applicable to all organizations performing tests and/or calibrations, These include, for
example, First-party, second party and third-party, and where testing and/or calibrations
forms part of inspections and product verifications.
This Standard is for use by labs in developing their management system for
Quality, administrative and technical operations.
Lab customers, regulatory authorities and accreditation bodies may also use it in
confirming or recognizing the competence of laboratories.
This Standard is not intended to be used as the basis for certification of
laboratories.
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Requirements of ISO/IEC 17025 : 2005
4. MANAGEMENT REQUIREMENTS
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Request, tender and contract review
4.5 Sub-contracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Records
4.14 Internal audits
4.15 Management reviews
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Requirements of ISO/IEC 17025 : 2005 Contd..,
5. TECHNICAL REQUIREMENTS
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling and transportation of test and calibration items
5.9 Assuring the quality of test and calibration results
5.10 Reporting the results.
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4.2.1 Establish, maintain and implement Quality System appropriate to the scope of
activities
4.2.2 Management System Policies and Objectives shall be defined in Quality
Manual. Quality Policy shall be issued under the authority of chief executive and shall
Contain
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4.4 REVIEW OF REQUESTS, TENDERS AND CONTRACTS
4.4.2 Maintenance of records of review
4.4.3 Review also to cover sub-contracted work
4.4.4 Customer to be informed any deviation
4.4.5 Amendments to a contract shall also to be
reviewed and communicated
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4.5 SUBCONTRACTING OF TESTS AND CALIBRATIONS
4.5.1 If laboratory sub-contracts the work, this shall be done on suitable
subcontractors: satisfying the requirements of this standard
4.5.2 Information to Customer on such arrangement
4.5.3 Laboratory shall be responsible for subcontractor’s work
4.5.4 Maintenance of register of subcontractors ca
4.6 SUBCONTRACTING OF TESTS AND CALIBRATIONS
4.6.1 Procedure for selection and purchasing of services and supplies that affect quality
of tests/ calibration
4.6.2 Use of purchased materials only after inspection / verification
4.6.3 Review and approval of purchase documents before release
4.6.4 Evaluation of suppliers and maintenance of records ( for critical materials)
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4.7 SERVICE TO Customer
Laboratory shall afford Customer cooperation to clarify Customer’s request and monitor
performance of laboratory in relation to work performed and protect confidentiality of
other Customers
4.8 COMPLAINTS
Procedure for resolution of complaints from Customers and other parties
Maintenance of Records of Complaints
4.9 CONTROL OF NONCONFORMING TESTING/ CALIBRATION
4.9.1 Procedure for dealing with nonconforming testing/ calibration. The procedure shall
ensure
a) Authority for management of nonconforming work to be defined
b) Evaluation of nonconforming work
c) Notification to Customer, if needed
d) Defined responsibility for resumption of work
4.9.2 In case of possibility of recurrence , initiation of suitable corrective action
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4.10 COMPLAINTS
The laboratory shall continually improve the effectiveness of its management system
through the use of the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions and management review.
4.11 CORRECTIVE ACTION
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4.13 CONTROL OF RECORDS
4.13.1 GENERAL
4.13.1.1 Procedure for Quality and Technical Records (identification, collection,
indexing, access filing, storage, maintenance and disposal)
4.13.1.2 Records shall be legible
4.13.1.3 Security of records
4.13.1.4 Procedure for protection and back-up
4.13.2 TECHNICAL REPORTS
4.13.2.1 Records of original observations, derived data and personnel responsible for
checking
4.13.2.2 Observations, data and conclusions shall be made when they are made
4.13.2.3 When mistakes occur the changes are entered after crossing the original
observation; not by erasing
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4.15 MANAGEMENT REVIEWS
4.15.1 Predetermined procedure and schedule for Management review.
The review shall cover
•Suitability of policies and procedures
•Reports from Management and supervisors
• Outcome of Internal Audits
•Corrective and Preventive actions
•Assessment by external agencies
•Inter-laboratory comparisons/ proficiency testing
•Changes in volume and type of work
•Customer feedback / complaints
4.15.2 Records of Management Review and follow
up for actions
