Calibration of Electronic Test Equipment: An Introduction to ISO & Accreditation

Transcription

1 Calibration of Electronic Test Equipment: An Introduction to ISO & Accreditation

2 Presentation s Objectives What does Calibration mean? What is ISO 17025, what is Accreditation, and what is the difference? What s good and what s not so good? What does Agilent Italy offer? Page 2

3 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 instrument s performance with respect to the original equipment manufacturer s 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

4 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

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

6 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

7 What is Accreditation? A formal recognition process where an authoritative body reviews and approves a calibration lab s 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 ISO17025 does not replace ISO9000 Page 7

8 International Standards Quality Management System Requirements: ISO ISO 9000:1994 ISO/IEC 9000:2000 QS ISO/TS 16949:2002 Technical Management System Requirements: ISO Guide 25 ISO Guide 25 ISO/IEC 17025:1999 ISO/IEC 17025:1999 ISO/IEC 17025:2005 ISO/IEC 17025:2005 ISO/IEC & 2:1992 ISO/IEC & 2:1992 ISO/IEC 10012:2003 ISO/IEC 10012:2003 Page 8

9 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

10 ISO versus Accreditation Comparing Requirements Accreditation ISO Page 10

11 ISO versus Accreditation Ideal Situation Accreditation ISO ISO and Accreditation requirements are identical Page 11

12 ISO versus Accreditation Typical Single Country Situation Accreditation ISO Accreditation requirements are a super-set of ISO requirements Page 12

13 ISO versus Accreditation Typical Single Country Situation Accreditation ISO Some differences between them Page 13

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

15 ISO measurement requirements Validated Procedure As suggested in: ISO17025:2005 par ISO10012:2003 par it can be based on manufacturer performance test procedure. Page 15

16 ISO measurement requirements 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

17 ISO measurement requirements 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 and 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

18 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 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 calibration In Italy not applicable, only to specific standard. Under Accreditation, the Calibration definition is only the VIM Page 18

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

20 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 Accredited to ISO 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

21 Four aspects that need to be considered... A lab lab claim to to be be process-compliant. internal internal quality/technical audit audit Self Self assessed A lab lab can can sell sell a conformant (non-accredited) calibration service need need external audit audit A lab lab is is accredited Assessed by by an an Accreditation body body A lab lab can can sell sell a Accredited calibration service Check Check its its scope scope of of accreditation Could Could need need external audit audit Page 21

22 ISO & Accreditation Summary Good Points One standard covers all Internationally recognised Intends to introduce standardisation into the industry Provides users with better quality assurance Ideally suited to a laboratory specialist who knows exactly what he wants Points to ponder Partial testing allowed Still creates confusion Can give false sense of security Not ideal for the person who manages a large volume/range of equipment Not so focused on measurement industries requirements Page 22

23 What does Agilent Italy offer? Since 1964 a Calibration and Repair Service Center in Italy Centro SIT n.05 - In 1979 Agilent s 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

24 Accredited Laboratory Centro SIT 05 Uncertainty Uncertainty 3.5% 3.0% 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% Power Sensor CF Calibration 1 mw-1 GHz 0.7% 1.2% 1.2% 1.5% 1.6% 1.3% 2.4% 3.2% AgilentLab A Lab B Lab C Lab D Lab E Lab F Worst Case Reference Oscillator Calibration Fequency 10MHz 3E-11 3E-11 3E-11 2E-11 2E-11 1E-11 7E-12 7E-12 1E-11 3E-12 7E-12 5E-12 2E-12 3E-13 0E+00 AgilentLab ALab B Lab C Lab DLab E Lab FWorst Case 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 Page 24

25 Agilent ISO 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

26 Agilent s 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. A statement of specification compliance is issued. B and C are not adjusted to be closer to centre. Measured values D, E = FAIL. D s 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

27 For more information Agilent Metrology Forum 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 Information on the Centro SIT 05 and on the Calibration and Repair Service Center in Italy Page 27