Introduction of SAC

Accreditation and Role of

Proficiency Testing in

Accreditation

Kolin Low

121212

Outline

• Introduction of SAC & Accreditation

• Mutual Recognition Arrangement

• Accreditation & Traceability

• Role of Proficiency Testing in Accreditation

• International Trend

SAC Background

• 1986: Singapore Laboratory Accreditation Scheme (SINGLAS) launched under then SISIR

• October 1996: SAC established under a MOU between the Ministry of Trade and Industry (MTI) & the then Singapore Confederation of Industries (SCI)

– Need for accreditation of ISO 9000 certification bodies

• 1998: Transfer of SINGLAS from then PSB to SAC

• April 2002: SAC transferred to SPRING

– To facilitate G-to-G MRAs and FTAs

– Prompted by FTA negotiations with Japan

– SPRING provides secretariat support to SAC

• Independent Council

– Industry, government, regulatory authorities, professional

bodies, tertiary institutions

– Terms of Reference include:

• Development of accreditation schemes

• Decisions on accreditation

• Policy formulation

• Review and advise on finances

• Council Committees

– Laboratory Accreditation (CCLA)

– Inspection Bodies (CCIB)

– Management Systems and Product (CCMP)

– Good Laboratory Practices (CCGLP)

Governance

Singapore Accreditation Council

Singapore Accreditation Council (SAC)

Overview of SAC Laboratory

Accreditation Scheme (SINGLAS)

• Singapore Laboratory Accreditation Scheme (SAC-

SINGLAS)

• Established in 1986

• Laboratory assessments based on ISO/IEC 17025 & ISO

15189

• More than 300 laboratories accredited in testing,

calibration and medical

Medical

Civil Engineering

Electrical

Calibration &

Measurement Mechanical

Non Destructive

Medical Imaging

Environmental

Chemical & Biological

SAC-SINGLAS Accreditation Fields

Gaming

8

Singapore Accreditation Council

Accreditation

A pool of qualified and competent

CABs that meet international

standards to support industry

needs

Management / Development

Improved capabilities of CABs to

enhance accreditation

infrastructure

Promotion

Recognition and Acceptance of

accredited services, both in

Singapore and overseas, for

trade facilitation and commerce

STRATEGIC OUTCOMES

MISSION

To accredit and promote conformity assessment bodies so as to enhance the

competitiveness of Singapore based enterprises

Strategy 1

Provide an effective and

robust accreditation

system

Strategy 2

Develop CAB’s capability

to meet international

standards

Strategy 3

Raise profile and

increase acceptance

of SAC’s

accreditation

Strategy 4

Elevate and influence

international

positioning of SAC

Accreditation : third-party attestation related to

a conformity assessment body (CAB) conveying

formal demonstration of its competence to carry

out specific conformity assessment tasks.

Accreditation

Benefits of Accreditation

Maintain integrity and transparency

Give users confidence

Enhance productivity

– reduce costs & delays in obtaining product approvals

– removal of redundant and duplicate testing

Facilitate trade and market access

Reduce risk of conformity assessment being employed as a trade barrier

Enhance regulatory efficiency

Support the government in FTA negotiations

Mutual Recognition

Arrangement (MRA)

Mutual Recognition Arrangement (MRA)

Accreditation

Body

CABs

Products / Systems

Accredit

Test /

inspect /

certify

Confidence

ISO/IEC 17011

ISO/IEC 17025

ISO 15189

ISO/IEC 17020

ISO/IEC 17021

ISO/IEC G65

International

Specifications &

Standards

Accreditation

Body

Products / Systems

Accredit

Confidence

Mutual Recognition

CABs

Test /

inspect /

certify

MRA – “Tested once, recognised everywhere”

Facilitate Market Access

SAC MRAs

Since 1997, SAC has signed numerous MRAs & MLAs with up to 78 signatories

• Testing

• Calibration

• Inspection

ILAC

• Testing

• Calibration

• Inspection

APLAC*

• Mgmt System

• Prod Cert

IAF

• Mgmt System

• Prod Cert

PAC

Scope: Scope:

Scope: Scope:

ISO/IEC 17025 & 17020

ISO/IEC 17021 & Guide 65

International Regional

* SAC is the APLAC Chair for the term 2011/12

Gaining Support Locally

NEA & PUB

HPB

HDB & BCA

MPA

FSSD AVA

HSA

CAAS

MOM

Accreditation & Traceability

(Calibration & Measurement field of

Laboratory Scheme)

Traceability of Measurement

NMIs

Accredited Cal Labs (Level 1)

Accredited Cal Labs

(Level 2…N)

User

SI Units

Provide Measurement Standards recognised by BIPM

Unbroken Chain of Measurement

Traceable to SI Unit through Accredited

Laboratories Network

Various applications in Trade,

Industry, etc

Gre

ate

r U

nce

rta

inty

With ISO/IEC 17025 endorsed calibration reports

SI Units

SAC Accredited

Calibration Labs

Various Application in Trade, Industry,

Governments, Defence, Science,

Engineering, etc

National Measurement System in Singapore

Calibration Technical

Assessments

Alt: Overseas

NMIs *

Alt: Labs

accredited by

SAC’s peers*

Objective: To ensure reliable and accurate measurement

within Singapore and throughout different continents * Recognised by CIPM MRA & ILAC MRA

Int’l System

of Units

National Measurement

Standards

Accreditation

programme for

calibration

End users

Dire

ct C

alib

ratio

n

Gre

ate

r U

ncert

ain

ty

Measurement Uncertainty

•Real measurements are never perfect. A measurement result

is only complete if it is accompanied by a statement of the

uncertainty in the measurement.

•Used to Quantify the Capability of the Laboratory

•Measurement Uncertainty is an essential element for

dissemination of measurement traceability.

Measured Result

Uncertainty of

Measurement

Proficiency Testing (PT)

and

Its Role in

Laboratory Accreditation

Good Result?

Good Mgmt

System

Reliable Method &

Lab Condition

Skilled Personnel

& Well-Maintained Equipment

Why Proficiency Testing?

Benchmarking

Benefits of Proficiency Testing

Evaluation and

monitoring of

lab

performance

Problem

Identification for

Improvement

Give User

Confidence

Effectiveness

and

comparability

methods

Validate

Measurement

Uncertainty of

labs

Support

Measurement

Traceability

Network

ISO/IEC 17025:2005 Clause 5.9.1 • The laboratory shall have QC Procedures, which may include:

SAC-SINGLAS PROF-001 Clause 1.1 • Participation in proficiency testing programmes is rendered

mandatory, as part of their requirements for accreditation.

Proficiency Testing Requirements

Use of

CRM

Inter-lab

or PT

Replicate

Tests

Retest or

Recal Correlation

of diff char

PT is an important tool for AB to assess

the competency of labs

An important tool for to assess the

competency of ABs for MRA purpose

ALSO

No PT Provider, Inter-lab Comparison was

deployed

Common Problems:

• Lack of reference laboratory

• Inappropriate lab(s) chosen

• Inappropriate artefact used

• Improper reporting and analysis of result

• Impartiality issues

Ad-hoc Measurement Audit with NMC conducted when

necessary

Current Problems

International Trend

for

Proficiency Testing

PT has been an important element for MRA

peer evaluation

More focus on Proficiency Testing for labs:

•More PT Providers internationally

•APLAC working on MRA for Accreditation of PT Providers

•More APLAC PT Programmes for MRA Signatories & Joint

PT with Asia Pacific Metrology Programme (APMP)

International Trend

Possible use of more extensive PT programme to

extend interval of lab assessment

Draft APLAC PT 0XX - Guidance on Alternative Means for

Laboratories To Demonstrate Proficiency

International Trend

SAC Accreditation of PT Provider

SAC Development on Accreditation Scheme for

PT Provider (ISO/IEC 17043)

•Expected to be launch in 2Q2013

•Interested PT Providers please contact SAC for more info

Benefits of using an accredited PT Provider

• 3rd party assessment of PT Provider for impartiality,

competence and independence

• PT programme in accordance with international

requirements

Identifying an SAC Endorsed Report

29

ABC

ABC Company Pte Ltd

The results reported herein have been performed in accordance with

the laboratory's terms of accreditation under the Singapore

Accreditation Council–Singapore Laboratory Accreditation Scheme

Calibration Certificate

for

Digital Thermometer

……..

……..

……..

Range: (20 to 30) °C

Quick Fact: a.ABC is accredited by SAC for calibration of digital thermometer from -10 °C to 100 °C

b.Mr Andy B C is the approved signatory for this scope and range

Approved by:

Mr Andy B C

Technical Manager

Andy B C This is an endorsed report

Recognised traceability

XYZ

XYZ Company Pte Ltd

The reference standards used are traceable to National Metrology

Centre Singapore

XYZ Company is accredited by SAC and operates in accordance with

ISO/IEC 17025.

Calibration Certificate

for

Digital Thermometer Quick Fact: a. XYZ is accredited, but NOT

for digital thermometer

……..

……..

……..

Range: (20 to 30) °C

Approved by:

Mr Xavier Y Z

Technical Manager

Xavier Y Z

This is NOT an endorsed report

Traceability NOT recognised

Choosing the right cal lab to ensure proper traceability

Checklist to ensure recognised traceability of measurement:

Is the lab accredited by the national Accreditation Body? If not, is it accredited by ILAC MRA signatory? (check ILAC website)

Does the scope of accreditation covers the required: • Calibration scope • Range • Calibration & Measurement Capability (Expressed as an Uncertainty)

Is the report an endorsed report?

If no laboratory accredited for the required scope:

Local National Metrology Institutes

Overseas NMIs recognised by BIPM MRA (check BIPM website) * For more details, please refer to SAC-SINGLAS 006 documents for SAC’s policy of

measurement traceability and other accreditation bodies for their relevant policies.

Assessment Process

Enquiry

Preliminary assessment

Formal application

Initial assessment

Award of Accreditation

Annual surveillance Renewal assessment

Renewal

Thank you

Kolin Low

kolin_low@spring.gov.sg

6279 3143