De-Mystifying Calibration Accreditation · De-Mystifying Calibration Accreditation 15 Jan 2013 Ryan...

De-Mystifying Calibration

Accreditation 15 Jan 2013

Ryan FischerLaboratory Accreditation Bureau

Chair, NCSLI 183 Accreditation

Resources Committee

Bob SternAgilent Technologies, Inc.

Co-chair, NCSLI 174 Standards

Writing Committee

How fast do cars travel on average on Interstate

Highways?

Hint: Answer is not the posted speed limit.

De-facto speed limit is what the police enforce.

How can end users know your instruments are tested properly

according to ISO/IEC 17025, ANSI Z540.3, or even Z540-1?

Hint: It’s not just what a calibrationlab claims.

It’s about what is enforced.

1

2

Why CalibrateWhat is it?

CalibrationAdjustmentsWho can do it?

MeasurementUncertaintyHow accurate?

3

4 TraceabilityWhy important?

5Standards

ComplianceWhich ones?

6Z540.3

ComplianceHow?

7

AccreditationWhy it matters?

Calibration Modules

Nov 13

Dec 13

Dec 13

Jan 15

Feb13

Why Calibrate?1

YouTube calibration videos

www.YouTube.com/AgilentCalRepair

1 Why Calibrate http://youtu.be/HwSxBRaxn_4

2 Adjustments http://youtu.be/IqsLmYgtoOg

3 Accuracy/Uncertainty http://youtu.be/ENvl8BYzMG0

4 Traceability http://youtu.be/-eMQ0KakIyQ

5 Standards compliance http://youtu.be/8s2Xx3C0_ds

6 Accreditation http://youtu.be/SH2wewUBlr8

7 ANSI Z540.3

10½

min

www.YouTube.com/AgilentCalRepair

http://youtu.be/HwSxBRaxn_4



http://youtu.be/IqsLmYgtoOg



http://youtu.be/ENvl8BYzMG0



http://youtu.be/-eMQ0KakIyQ




http://youtu.be/8s2Xx3C0_ds



http://youtu.be/SH2wewUBlr8



Why Calibrate?1

What are your calibration service expectations?

When you send an

instrument for

calibration to an

outside lab, what

do you expect them

to do?

Why Calibrate?1

What is calibration?

1. Characterize your

device/instrument

Measure the actual performance!

2. How Accurate? Measurement Uncertainty

3. Pass or Fail? Statement of Conformance

4. Advise client if found

out-of-tolerance.

Adjust, if instructed, and repeat

calibration.

Accreditation is the

confirmation of competence

and skills according to

ISO/IEC 17025 by a (3rd

party) accreditation body.

Formal definition at: http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf

http://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf

Why Calibrate?1

Attn: Engineers! Identify the key specs for your company -

and check how your instrument performed.

Remember:The measurement report is physical

evidence of work performed!

REVIEW

Why it matters, even if you don’t

order an “Accredited Cal”

NCSL INTERNATIONALSERVING THE WORLD OF MEASUREMENT SINCE 1961

Accreditation

Bob SternAgilent Technologies, Inc.

Co-chair, NCSLI 174 Standards

Writing Committee

Ryan FischerLaboratory Accreditation Bureau

Chair, NCSLI 183 Accreditation

Resources Committee

183 Accreditation Committee


What is accreditation?

Per ISO/IEC 17000:2004 “it is a third-party attestation related to a conformity

assessment body conveying formal demonstration of its competence to carry out

specific conformity assessment tasks” covering:

• technical competence of staff

• 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



To which standards will you comply?

ILAC is the "International Laboratory Accreditation Cooperation" - a network of mutual recognition arrangements

among accreditation bodies.

ISO/IEC 17025: 2005 General Requirements for the

Competence of Testing and Calibration

Laboratories

ISO/IEC Guide 98-3:2008 Guide for Expression of Uncertainty of

Measurements

ILAC-G8 Guidelines on Assessment and Reporting

of Compliance with Specification

ILAC-P14 Policy for Uncertainty in Calibration

ANSI/NCSL Z540-1-1994 rescinded 2007

ANSI/NCSL Z540.3-2006 Requirements for the calibration of

Measuring and Test Equipment

ISO 9001:2008 Quality management systems - requirements



ILAC-MRA (Mutual recognition arrangement)

https://www.ilac.org/documents/mra%20signatories.pdf

Each accreditation body signatory to the Arrangement

agrees to abide by its terms and conditions and by

the ILAC evaluation procedures and shall:

• Maintain conformance with the current version of

ISO/IEC 17011, related ILAC guidance documents,

and a few, but important, supplementary

requirements, and

• Ensure that all accredited laboratories comply with

ISO/IEC 17025 or ISO 15189 (for medical testing

laboratories) and related ILAC policy and guidance

documents.

Note: ILAC is the "International Laboratory Accreditation Cooperation“

- a network of mutual recognition arrangements

among accreditation bodies.

https://www.ilac.org/documents/mra signatories.pdf

https://www.ilac.org/documents/mra signatories.pdf



Scope-of-accreditation

How it works

1. The calibration lab tells the AB which parameters it

seeks accreditation for

2. For each requested parameter the assessor then:

i. Assess quality system

ii. Spends time with the technicians assessing their

competency/measurement technique to measure this

particular parameter

iii. Assess the measurement uncertainty documentation

iv. Assess traceability path(s) to SI1 units via a NMI2 such

as NIST, NPL, PTB, NMIJ, etc.

1. SI = International System of units

2. NMI = National institute of Metrology

Agilent Service Center accreditation/ Roseville, CA



Compare cal lab quality

Check for accreditation, right?

Source : http://www.a2la.org/dirsearchnew/newsearch.cfm

Cal Lab XYZCal Lab ABC

Is this all you need to know?



Scope-of-accreditation – Cal labs XYZ vs. ABCXYZ Lab ABC Lab

I. Electrical – DC/Low Frequency

DC Voltage – Generate

DC Voltage – Measure

DC Current – Generate

DC Current – Measure

Resistance – Generate

Resistance - Measure

AC Current – Generate

AC Current - Measure

AC Voltage - Generate

AC Voltage - Measure

AC Voltage Flatness - Generate

AC Voltage Flatness - Measure

Resistance - Generate

Resistance - Generate - Shunts portion

Capacitance - Generate

Electrical Calibration of Thermocouple Indicators, Type J

II. Electrical – RF / MicrowaveAmplitude Modulation – Measure 7

Frequency Modulation - Measure 8

Digital Modulation - Measure

RF Absolute Power – Measure 5

Tuned RF Power

RF Absolute Power - Generate

Power Sensor Calibration Factor 9

Thermal Noise Figure System – Measure 9

Thermal Noise Measure

Pulse - Generate

Pulse - Measure

CISPR Pulse Response

Attenuation - Generate

Attenuation - Measure

Reflection S11 / S22 - Measure

Reflection S12 / S21 - Measure

Missing ’s

means the

lab is NOT

accredited

for these

parameters!



Nominal

Upper specification

Lower specification

Risk that your instrument

is operating out-of-spec

A B95%

expanded

uncertainty

interval

The risk to you of unaccredited parameters!

The actual instrument accuracy you can depend on is only as good as

the [expanded] measurement uncertainty of your last calibration.For parameters outside the CMC1, you have no idea

what the sizes of the yellow(MU) & red(risk) bars are!

1. CMC = Calibration Measurement Capability, see annex, https://www.ilac.org/documents/ILAC_P14_12_2010.pdf

https://www.ilac.org/documents/ILAC_P14_12_2010.pdf



Accredited Agilent service locations near you

www.agilent.com/find/assist

Agilent uses 15 accreditation bodies worldwide

www.agilent.com/find/assist

Country Accreditation Body Name

Australia NATA National Association of Testing Authorities

Brazil ACLASS ANSI-ASQ National Accreditation Board

Canada A2LA American Association for Laboratory Accreditation

China CNAS China National Accreditation Service for Conformity Assessment

France COFRAC Comité Français d'Accréditation

Germany UKAS United Kingdom Accreditation Service

India NABL National Accreditation Board for Testing and Calibration Laboratories

Israel ISRAC Israel Laboratory Accreditation Authority

Japan JCSS Japan Calibration Service System of International Accreditation

Korea KOLAS Korea Laboratory Accreditation Scheme

Malaysia SAMM Skim Akreditasi Makmal Malaysia (Malaysian Department of Standards laboratory accreditation

program)Mexico A2LA American Association for Laboratory Accreditation

Singapore SAC Singapore Accreditation Council

South Africa SANAS South African National Accreditation Service

Spain ENAC Entidad Nacional de Acreditación

Taiwan TAF Taiwan Accreditation Foundation

United Kingdom UKAS United Kingdom Accreditation Service

United States ACLASS or A2LA ANSI-ASQ National Accreditation Board or American Association for Laboratory Accreditation

Accredited Calibration Facilities



Checklist for “non-accredited” Cals1

1. Review the scope of accreditation for your cal supplier

2. Check to see that the scope covers the specified

parameters of your instrument(s).

3. For any parameters your instrument requires not covered

in the scope, ask the cal lab what is the expanded

uncertainty for those performance tests.

Your risk of being out-of-specification after cal is lowest when

the expanded uncertainty is known and is significantly smaller

than the instrument spec.

1. Note: this checklist already performed with “Accredited Cals”.



Specific requirements to include an AB1 symbol on

a calibration certificate (a.k.a. “Accredited Cal”)

Americas• ISO/IEC 17025:2005

• ILAC-P8:12/2012 ILAC-MRA: Supplementary Requirements and

Guidelines for the Use of Accreditation Symbols and for Claims of

Accreditation Status by Accredited Laboratories & Inspection Bodies

• ILAC-P14 ILAC Policy for Uncertainty in Calibration

• ISO GUM measurement uncertainty for all

measured points

• All measurements within scope-of-accreditation or

annotated in report, if not.

Europe, Japan, Far East• Same as above plus

• Pass/Fail/Uncertain reporting per ILAC-G8

1. “AB” means Accreditation Body



Guidelines on the Reporting of Compliance with

Specification - ILAC-G8:03/2009

Source: www.ilac.org/documents/ILAC_G8_03_2009.pdf



ILAC-G8, paragraph 2.3 (c) non-compliance



ILAC-G8, par. 2.3 Non-compliance

In Case 2 …”It is not possible to state compliance

using a 95% coverage probability for the expanded

uncertainty although the measurement result is

below the limit.”

Standards Compliance5

Agilent Wording: ILAC-G8, Case 2

Agilent Cal + Uncertainties

Passed ‡ : P‡

The measured values of the equipment were in

specification at the points tested with measurement

uncertainty not taken into account.

A portion of the expanded measurement uncertainty

intervals centered about one or more measured values

exceeded specification.

Consequently, compliance with specification cannot be

declared based on the stated coverage probability.

Note: Wording reflects official standards text as closely as possible. P ‡ is “P double-dagger”

ISO/IEC 17025, Paragraph

5.10.4.2

ILAC-G8, Paragraph 2.3


Standards Compliance5

Agilent Wording: ILAC-G8, Case 3

Agilent Cal + Uncertainties

Note: Wording reflects official standards text as closely as possible.

Failed ‡ : F‡

One or more measured values of the equipment were

out of specification at the points tested with

measurement uncertainty not taken into account.

A portion of the expanded measurement

uncertainty intervals centered about one or more

measured values were in specification.

Consequently, non-compliance with specification

cannot be declared based on the stated coverage

probability.



ISO/IEC 17025, Paragraph

5.10.4.2



ILAC policy for uncertainty in calibration ILAC-P14

http://www.ilac.org/documents/ILAC_P14_12_2010.pdf



Excerpt: ILAC-P14, section 6

ILAC policy for uncertainty in calibration

http://www.ilac.org/documents/ILAC_P14_12_2010.pdf

Sample report: Agilent Cal + uncertainties + Guardbanding

Accreditation Webcast summary

• Review the scope-of-accreditation for your cal supplier

• Essentially, all measurements performed at Agilent service

centers or on-site are within the scope-of-accreditation

• Whether or not you request / order the specific deliverables

that allow us to include the accreditation body symbol,

Agilent always uses the same:

• (automated) test procedure

• test equipment

• measurement uncertainty

Why Calibrate?1

Please register for the free upcoming calibration Webcast:

www.agilent.com/find/calibrationwebcasts

w3) 15 Jan 2013 “De-Mystifying Calibration Accreditation”

4) 13 Feb 2013 “How to Comply with ANSI Z540.3”

On-Demand:

1) 8 Nov 2012 “Calibration: Why it Matters to You and What it Should Include”

2) 13 Dec 2012 “Calibration Traceability & Standards Compliance”

If you have Z540-1 requirements today, you should learn about Z540.3

http://www.agilent.com/find/calibrationwebcasts

Questions and Answers

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