1.global perspective of accreditation-190707

7/28/2019 1.Global Perspective of Accreditation-190707

1/24

1

Global Perspective ofGlobal Perspective of

AccreditationAccreditation


2/24

2

ImportanceImportance

ofofLaboratory AccreditationLaboratory Accreditation


3/24

3

Importance of Output Data from Lab

INPUT

LABORATORY

DATA

DECISION

HEALTH, SAFETY

ENVIRONMENT

COMMERCE


4/24

4

Comparability in MeasurementsComparability in Measurements

Measurement traceability

Reference Material

Test Methods

Proficiency Testing

Uncertainty of measurement


5/24

5

COMPETENCE OF A LABORATORYCOMPETENCE OF A LABORATORY

In evaluating the competence of a laboratory, the

following methods are used:

On-the-spot assessment of the laboratory by theexperts.

By evaluating the results of a particular

test/measurement in a proficiency testingprogramme.


6/24

6

International Standards and Guides

applicable to laboratories

ISO/IEC 17000 : Conformity assessment -

Vocabulary and general

principles

ISO/IEC 17025: General Requirements for the

Competence of Testing &

Calibration Laboratories

ISO 15189 : Medical Laboratories -

Particular Requirements for

Quality and Competence


7/24

7

International Standards and Guides

applicable to laboratories

ISO/IEC Guide 43: Proficiency Testing by inter

laboratory comparisons

Part I & Part II

ISO/IEC 17011: General Requirements for

Accreditation Bodies AccreditingConformity Assessment Bodies


8/24

8

Types of Certification

First Party : Laboratory belongs to user, who is

Certification satisfied and uses for his own jobs

Second Party : Laboratory does not belong to

Certification user but user using his own meanscertifies the laboratory, and usesfor his own requirements .

Third Party : Certifying/Accreditation body for

Certification laboratories , is neither the ownerof the laboratory nor is the user.


9/24

9

The Roles of the International Laboratory

Accreditation Cooperation (ILAC)

To develop the principles and the practice oflaboratory accreditation

To harmonize procedures and criteria for

accreditation To assist in the development of new programmes

To facilitate mutual recognition of membersprogramme

To reduce technical barriers in trade

To improve International acceptability of testresults


10/24

10

Bilateral Mechanism MRA

A C F

B D G

E


11/24

11

ILAC

EAL APLAC

C C C C C C C

C C

C

C

C

Lab

Lab


12/24

12

Development of Laboratory Accreditation

War time test house scheme Australia 1943

NATA Australia 1946

Telarc New Zealand 1973

STP Denmark 1973

NVLAP USA 1976

ILAC International Conference 1977

A2LA USA 1978ISO/IEC Guide 25 - Requirements for Competence 1978

RNE France 1979

CSCP Canada 1980

NCTCF India 1981NABL India 1992

NAMAS UK 1981

HOKLAS Hong Kong 1985

EA - European Co-operation 1987

APLAC - Asia Pacific Co-operation 1992


13/24

13

MRA Developments

GATT Technical Barriers - re-test, re-inspection requirements

Australia - New Zealand Laboratory MRA - 1981

Then Australia and New Zealand with UK, Sweden,Netherlands, etc.

EA multilateral MRAs (include Aus, NZ, HK,Singapore, USA)

APLAC multilateral MRA - 1997 ILAC World-wide multilateral MRA joining EA and

APLAC and other regions - being developed


14/24

14

MRA Evaluations

Based on APLAC MR 001 requirements

International teams of trained evaluators

Possible pre-evaluation

Documentation review (two days):

ISO/IEC Guide 58 compliance of management

system

Accreditation criteria consistent with ISO/IEC

17025 Independence and authority


15/24

15

MRA EvaluationsOn-site evaluation (five days):

Review of records Training and competence of assessors

Assessments properly conducted and up-to-date

Appropriate committees and grantingarrangements

Traceability of measurement

Reporting and close out of corrective action requests

and follow-up if required

Acceptance by APLAC MRA Council and signing on

Ongoing surveillance evaluations


16/24

16

A Typical Accreditation Body

National accreditation body is a statutory body

May be established by Act of Parliament

(NABL has been established by the Cabinet)

User and/or government funded, not for

profit organisation

General third-party accreditation body

Internationally recognized through MRAs


17/24

17

Functions of An Accreditation Body

To promote the development and maintenance of

good practice in testing and measuring

To establish and maintain international

recognition for its national accreditation

programmes


18/24

18

NABL Accredits For:

Biological

ChemicalElectricalElectronicsFluid-Flow

MechanicalNon-Destructive

Testing etc.Clinical

Forensic

Electro-Technical

Mechanical

Radiological

Thermal & Optical

Fluid-Flow etc

TestingTesting

LaboratoriesLaboratories CalibrationCalibration

LaboratoriesLaboratories


19/24

19

Certification

Procedure by which a third-party (certification body)

gives a written assurance that a product, process orservice (of an organisation) conforms to specified

requirements

Specified requirements - ISO 9001 Assures the client that the organisation has in place an

effective quality or environmental managementsystem

Does not confer technical credibility of the test result

Certification is not appropriate for laboratories or

inspection bodies


20/24

20

Accreditation

Procedure by which an authoritative body (NABL)

gives formal recognition that a body (laboratory) orperson (signatory) is competent to carry out specifictasks (scope)

Criteria - ISO/IEC 17025 (includes all those

requirements of ISO 9001 relevant to the scope oflaboratories)

Assures the client that the procedures and test resultsare technically valid

Recognizes the technical competence of laboratorystaff

Endorses the the laboratory operates the themanagement system effectively


21/24

21

BENEFITS OFBENEFITS OF

ACCREDITATIONACCREDITATIONNational and international recognition Public and industry acceptance Assurance to clients of good laboratory practice

Provides global equivalence Provides comparability in measurements Decision makers can rely on test results Improves staff motivation

Ensures better support in the event of legalchallenge

Saves money by getting it right at first time.

C f it A t St tConformit Assessment Str ct re


22/24

22

Conformity Assessment StructureConformity Assessment StructureInternational

Mutual Recognition

(ILAC )

GOVERNMENTGOVERNMENT

Recognizes Accreditation BodiesRecognizes Accreditation Bodies

International

Mutual recognition

( IAF )

Regional

Mutual Recognition

( APLAC )

Regional

Mutual recognition

( PAC )

Laboratories

Test items/

Materials

or Calibrate

Equipment.

ISO/IES 17025

InspectionBodies

Inspect designs,

Processes,

Products,

Services, Plant

ISO/IEC 17020

ProductCertifier

License

Products to use

a Cert. MarkISO/IEC -Guide 65

QMS Certifiers

Certify Quality

Management

systems

ISO/IEC

Guide 62

EMS CertifiersCertify

Environmental

Management

SystemsISO/IEC Guide 66

Personnel

Certify

Personnel as

Competent

ISO/IEC

17024

Generates

technically

valid test

results /

calibration

data

Design,processes

Products

Services ,Plant

are certified(Standard/

Specifications)

An Item or

Material is

Certified

(Standards/

Specifications)

Companies are

certified

ISO 9001: 2000

Companies are

Certified

ISO 14001

Personnel

Are Certified

To Check

Against

Requirements

Accreditation Bodies

Accredited laboratories , Inspection Bodies, Certification Bodies

(ISO/IEC 17011)


23/24

23

Spectrum of Laboratory Accreditation

PROCEDURES RULESEXAMINATION

OF QM

ASSESSMENT SURVEILLANCE

LABORATORY

ACCREDITATION

ACTIVITIES

ACCREDITATIN

CERTIFICATE SCOPE

T

C

NABL

NABL NEWS

NABL Website

ASSESSORS

TRAINING

MONITORING

NATA

A2LA

SCC

IAS

PROFICIENCY

TESTING

PROGRAMME

ILAC

APLAC

INTERNATIONAL

LINKAGES


24/24

24

ThanksThanks

1.global perspective of accreditation-190707

Documents