Agilent-Introduction ISO 17025 & Accreditation

Calibration of Electronic Test Equipment:
An Introduction to ISO 17025 & Accreditation
Presentations Objectives
What does Calibration mean?
What is ISO 17025, what is Accreditation, and what is the
difference?
Whats good and whats not so good?
What does Agilent Italy offer?
Page 2
ISO17025 & Accreditation presentation

Copyright 2007 Agilent Technologies, Inc.
Defining Calibration
ISO-VIM-1993
International Vocabulary of Basic and General Terms in Metrology:
Calibration: a set of operations that establish, under specified
conditions, the relationship between values of quantities indicated by a
measuring instrument or measuring system, or values represented by a
material measure or reference material, and the corresponding values
realized by standards.
Agilent Technologies / other vendors / Industry required:
Calibration: comparing an instruments performance with respect to
the original equipment manufacturers specifications and full
traceability to the appropriate regional Authority. If it is needed,
proper adjustments is done.
This is applicable and required especially for complex Measurement &
Test Equipment (M&TE)
Page 3

What is ISO 17025?

ISO/IEC 17025:2005 is an international standard for
calibration and testing labs
Requires labs to demonstrate that they:
Operate a quality system
Processes, documentation and quality management system
Generate technically valid results
Traceability, equipment, procedures, personnel etc...
It takes relevant parts of ISO 9001 and adds the former

ISO Guide 25 to form a standard that is focused on the
measurement industry
Page 4

Who does use ISO 17025?

All national accreditation bodies have adopted ISO 17025
Several industries or countries have incorporated it into
their industry-specific or application-specific regulations
Some examples
ISO9000: par. 4.11 (1994) par.7.6 (2000) via ISO10012
QS-9000: quality standard for the automotive industry
AQAP Military Standards
OILM regulations
Page 5

Why this Standard?

A global standard to provide consistency
Customers need to determine the relative quality and capability of
different cal labs
Customers can compare the measurement results from different vendors
For multi-national companies, they can compare vendors in different countries
Customers gain a higher confidence level in the calibrations they

purchase
International trade is increased by reducing potential quality barriers
A third-party process to assess compliance

Vendors need to confirm their quality and competence
Can conduct an internal audit through their own quality department
Can undergo an external audit from each of their major customers
Vendors can now schedule a single third-party audit and become

accredited to a common set of requirements
Page 6

What is Accreditation?
A formal recognition process where an authoritative body
reviews and approves a calibration labs quality system
and technical competence
Each country has its own accreditation body
A2LA in U.S., UKAS in U.K., JCSS in Japan, SIT in Italy, etc.
Mutual recognition via ILAC/EA agreements

All accreditation bodies use ISO 17025
ISO17025 does not replace ISO9000
Page 7

International Standards
Quality Management System Requirements:
ISO/IEC9000:2000
9000:2000
ISO/IEC
ISO9000:1994
9000:1994
ISO
ISO/TS16949:2002
16949:2002
ISO/TS
QS-9000-1994
QS-9000-1994
Technical Management System Requirements:

ISOGuide
Guide25
25
ISO
ISO/IEC17025:1999
17025:1999
ISO/IEC
ISO/IEC10012-1
10012-1&&2:1992
2:1992
ISO/IEC
Page 8
ISO/IEC17025:2005
17025:2005
ISO/IEC
ISO/IEC10012:2003
10012:2003
ISO/IEC

What is the Scope of Accreditation?

Specific measurement parameters are accredited
Some small vendors are only accredited for few parameters such
as DC & AC voltage, DC & AC current, resistance
Some larger vendors are accredited for 15 or more parameters
Accredited parameters are documented in a public

document, the scope of accreditation
Includes approved parameters, ranges, and best measurement
capabilities
Page 9

ISO 17025 versus Accreditation
Comparing Requirements
Accreditation
ISO 17025
Page 10

Ideal Situation
Accreditation
ISO 17025
ISO 17025 and Accreditation

requirements are identical
Page 11

Typical Single Country Situation

Accreditation
ISO 17025
Accreditation requirements are a super-set of
ISO 17025 requirements
Page 12

Typical Single Country Situation

Accreditation
ISO 17025
Some differences between them
Page 13

Current Global Situation

Accreditation
Accreditation
Local differences
ISO 17025
Accreditation requirements (and sometimes how
ISO 17025 is interpreted) are slightly different
from country-to-country
Page 14

ISO 17025 measurement requirements

Validated Procedure
As suggested in:
ISO17025:2005 par. 5.4.2
ISO10012:2003 par. 6.2.1
it can be based on manufacturer performance test

procedure.
Page 15


Measurement Uncertainties
Is: Point-by-point measurement uncertainty
Per ISO Guide to the Expression of Uncertainty in Measurement
(GUM) or EA4/02 guide or UKAS M3003 etc.
Measurement uncertainty must be provided for all parameters
Is not: general table of best measurement uncertainties
Page 16


Statement of Compliance
If a vendor states that the unit
complies with a specification, then
the measurement uncertainty must
be taken into account
Specification can be manufacturer
specification as suggested in
ISO10012:2003 par. 6.3.1 and 7.1.4
To take into account uncertainty you
can follow ILAC-G8 guide or M3003
guide
If adjustments are done, PRE & POST
results MUST be reported
Page 17

Accreditation requirements/differences
Country-specific requirements
Validated Procedure
Must be approved by local accreditation body
Could be different of manufacturer recommended
Measurement Uncertainties
Should be the same as the ISO 17025 calibration
In Italy measurement uncertainty can be provided only for
parameters/ranges in the Scope of Accreditation
State of Compliance
Should be the same as the ISO 17025 calibration
In Italy not applicable, only to specific standard. Under
Accreditation, the Calibration definition is only the VIM
Page 18

Accreditation requirements/differences
Country-specific requirements
Often this means limited calibration compared with
manufacturer requirements for Complex M&TE
Page 19

Checklist for Calibration Customers

Confirm what level of compliance is required for your industry or country
For example, QS-9000 or Military standards requirements are more rigorous
Ask yourself the following questions:

Which kind of vendor do you need?
Complies with ISO 17025, but may not meet all the requirements of the local
accreditation body
Accredited to ISO17025
Which kind of calibration do you need?
Complies with ISO 17025
Accredited to ISO17025.
o but, is the vendor accredited for all the parameters that your equipment requires?
o Are the uncertainties corrects for your equipment requirements?
Page 20

Four aspects that need to be considered...
AAlab
labclaim
claimto
tobe
be17025
17025
process-compliant.
process-compliant.
labisis
AAlab
17025accredited
accredited
17025
internal
internal
quality/technical
quality/technicalaudit
audit
Self
Selfassessed
assessed
Assessedby
byan
an
Assessed
Accreditationbody
body
Accreditation
Page 21
labcan
cansell
sellaa1702517025AAlab
conformant(non-accredited)
(non-accredited)
conformant
calibrationservice
service
calibration
AAlab
labcan
cansell
sellaa17025
17025
Accredited
Accreditedcalibration
calibration
service
service
needexternal
external
need
audit
audit
Check
Checkits
itsscope
scopeof
ofaccreditation
accreditation
Could
Couldneed
needexternal
externalaudit
audit

ISO 17025 & Accreditation Summary

Good Points
Points to ponder
One standard covers all
Partial testing allowed
Internationally recognised
Still creates confusion
Intends to introduce
standardisation into the industry
Can give false sense of security
Provides users with better quality

assurance
Ideally suited to a laboratory
specialist who knows exactly what
he wants
Page 22
Not ideal for the person who

manages a large volume/range of
equipment
Not so focused on measurement
industries requirements

What does Agilent Italy offer?

Since 1964 a Calibration and Repair
Service Center in Italy
Centro SIT n.05 - In 1979 Agilents
metrological standard laboratory was
the first one to be accredited by SIT
for electronic quantities
Quality System registered to
ISO9001:2000
Technical System accredited to
ISO17025:2005
It can do Accredited and ISO17025
conformant calibration
Page 23

Accredited Laboratory Centro SIT 05

Power Sensor CF Calibration 1 mW-1 GHz
3.2%
3.5%
3.0%
2.4%
Uncertainty
2.5%
2.0%
1.2% 1.2%
1.5%
1.5% 1.6%
1.3%
0.7%
1.0%
0.5%
0.0%
AgilentLab A Lab B Lab C Lab D Lab E Lab F Worst

Case
Reference Oscillator Calibration

Fequency 10MHz
3E-11
3E-11
Uncertainty
3E-11
2E-11
2E-11
1E-11
7E-12
5E-12 3E-13
1E-11
7E-12
7E-12
3E-12
2E-12
0E+00
AgilentLab ALab B Lab C Lab DLab E Lab FWorst
Case
Page 24
Accredited quantities: DC Voltage, DC

Current, DC Resistance, AC Voltage, AC
Current, AC Resistance, Capacitance,
Inductance, Attenuation, Frequency,
Reflection Coefficient, RF Power (& Cal
Factor)
Coming soon: Optical Power, Optical
Attenuation, Optical Wavelenght
Best uncertainties on the market
Since 1992 has successfully
partecipated to more than 20 ILC
national (SIT/INRIM) and
international (EA/ILAC)
Calibration on Agilent & Multivendor
Agilent ISO 17025 Conformant Calibration

Applicable to Agilent Complex M&TE, i.e. Spectrum, Network, RF &
MW Generator, Mobile Test-set etc...
Supported list on the Web.
Validated Procedure
Full parameters following Manufacturer Procedures
Measurement Uncertainty
All measurements following ISO GUM
Traceability
Guaranteed by Centro SIT 05, others Accredited Agilent Labs or
NMIs.
Statement of Compliance
Following ILAC-G8 & M3003
Page 25

Agilents treatment of the indeterminate situation

A = PASS.
B, C = PASS #. Performance falls within the measurement
uncertainty on the in-spec side.
The customer is notified on the measurement report that:
All measured values indicated by this data report lie
within specification. Due to measurement uncertainty, the
true values of one or more of these points may lie outside
of the specification, but there is a high probability that
these values lie within specification.
Measured values
A statement of specification compliance is issued. B and C are not

adjusted to be closer to centre.
D, E = FAIL. Ds Performance falls within measurement
uncertainty on the out-of-spec side and is considered a FAIL
E is totally out-of-spec with and without uncertainty
This pragmatic approach has met with general approval from users
Page 26

For more information

Agilent Metrology Forum
http://www.agilent.com/metrology
General information on calibration and standards
List of Agilent service centers/standards labs and their accredited
parameters
Calibration myths, metrology humor, and other articles of interest
http://www.agilent.com/metrology/sit_schedule.shtml
Information on the Centro SIT 05 and on the Calibration and Repair
Service Center in Italy
Page 27


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Calibration of Electronic Test Equipment:

An Introduction to ISO 17025 & Accreditation

ISO17025 & Accreditation presentation

ISO17025 & Accreditation presentation

What is ISO 17025?

It takes relevant parts of ISO 9001 and adds the former

ISO17025 & Accreditation presentation

Who does use ISO 17025?

ISO17025 & Accreditation presentation

Why this Standard?

Customers gain a higher confidence level in the calibrations they

A third-party process to assess compliance

Vendors can now schedule a single third-party audit and become

ISO17025 & Accreditation presentation

Mutual recognition via ILAC/EA agreements

ISO17025 & Accreditation presentation

Technical Management System Requirements:

ISO17025 & Accreditation presentation

What is the Scope of Accreditation?

Accredited parameters are documented in a public

ISO17025 & Accreditation presentation

ISO 17025 versus Accreditation

ISO17025 & Accreditation presentation

ISO 17025 versus Accreditation

ISO 17025 and Accreditation

ISO17025 & Accreditation presentation

ISO 17025 versus Accreditation

Typical Single Country Situation

ISO17025 & Accreditation presentation

ISO 17025 versus Accreditation

Typical Single Country Situation

ISO17025 & Accreditation presentation

ISO 17025 versus Accreditation

Current Global Situation

ISO17025 & Accreditation presentation

ISO 17025 measurement requirements

it can be based on manufacturer performance test

ISO17025 & Accreditation presentation

ISO 17025 measurement requirements

Is not: general table of best measurement uncertainties

ISO17025 & Accreditation presentation

ISO 17025 measurement requirements

ISO17025 & Accreditation presentation

ISO17025 & Accreditation presentation

ISO17025 & Accreditation presentation

Checklist for Calibration Customers

Ask yourself the following questions:

ISO17025 & Accreditation presentation

Four aspects that need to be considered...

ISO17025 & Accreditation presentation

ISO 17025 & Accreditation Summary

One standard covers all

Partial testing allowed

Still creates confusion

Can give false sense of security

Provides users with better quality

Not ideal for the person who

ISO17025 & Accreditation presentation

Agilent-Introduction ISO 17025 & Accreditation

Agilent-Introduction ISO 17025 & Accreditation

Agilent-Introduction ISO 17025 & Accreditation