UNDERSTANDING THE SCOPE OF ACCREDITATION

1. UNDERSTANDING THE SCOPE OF ACCREDITATION 009-04/009-13

2. ACCREDITATION-A BRIEF HISTORY • 1962 the DOD issues Mil-C-45662 which became MIL-STD-45662A, the defacto standard for all calibrations within the DOD and US Industry. • Commercial Labs were audited by the Navy and scope was identified by phase packages-Dimensional, Electrical, Mechanical etc. (Scope) • 1994 the National Conference of Standards Labs (NCSL) and American National Standards Institute (ANSI) published ANSI/NCSL Z540-1 • 1995 the DOD retired MIL-STD-45662A and adopted Z540-1 in its entirety in 1998 as NAVAIR 17-35-QAC-01, NAVSEA 04-4734 • Commercial Labs continued under Navy audit • 1999 the International Standards Organization (ISO) wrote ISO 17025 • The DOD was told that to audit to Commercial Standards their Auditors would have to meet the requirements for an ISO Lead Assessor • 2000 the Navy returns to the QAC-01 and authorizes Commercial Labs to become accredited by NAVSEA approved Accrediting Bodies • 2005 ANSI/ISO/IEC 17025:2005 Approved • 2006 ANSI Z540.3-2006 Approved • 2017 ANSI/ISO/IEC 17025:2017 Approved (Rewritten to line up with ISO 9001:2015)

3. 009-04 REFERENCES • 2.1 Standard Items • 2.2 9001-2008 • Provides guidance on setting up a QMS that meets 9001:2008 • 2.3 9001:2015 • Provides guidance on setting up a QMS that meets 9001:2015 • 2.4 Z540-3 American National Standard • Reference provides guidance to Calibration Labs in the USA • 2.5 17025 International Standard • Reference provides guidance to Calibration Labs Internationally

4. 009-04 REFERENCES (CONT.) • 2.6 NAVSEA 04-4734 • Reference provides guidance to NAVY Calibration Labs • 2.7 SSPC QP-1 • Paint Inspection Reference

5. 009-04 REFERENCES (CONT.) • 2.8 METRL • Navy Calibration Bible IN 6 Sections • Section 1 General Information • Section 2 Generic Calibration Intervals by Type • Section 3 Calibration Requirements and Interval by Model # • Section 4 Approved Calibration Procedures • Section 5 Calibration Related Documents • Section 6 NAVY METCAL Policy METRL is discussed in detail in the Interval Presentation

6. FY 18 chg 2 • 3.2.7 Control of Monitoring and Measuring Devices: • Address all areas of Paragraph 7.6 of 2.2. • Talks about your requirements in your Quality Management System (QMS) • Determine the level of control needed to provide evidence that the work you do meets your requirements

7. FY 18 CHG 2(CONT.) • When necessary (in your eyes) to ensure valid results your equipment shall (from ISO 9001:2008 para 7.6) • Be calibrated • Be adjusted as necessary • Have a sticker • Have Cal Voids or other methods to prevent adjustment • Be protected from damage

8. FY 18 CHG 2(CONT.) • Ensure if an item is found Out of Tolerance that you check to see if it affected work that was performed • Maintain Records • Calibration laboratories shall be accredited to either ANSI Z540.3 or ISO 17025 by a Commercial Accreditation Activity, or certified by a Navy Certification Activity to QAC-01, and the scope of accreditation must cover the appropriate measurement parameters and ranges of the calibrations performed.

9. 009-04 • FY 20 • 3.2.1.1 Calibration laboratories must be accredited to either ANSI Z540.3 or ISO 17025 by a Commercial Accreditation Activity, or certified by a Navy Certification Activity to QAC-01, and the scope of accreditation must cover the appropriate measurement parameters and ranges of the calibrations performed. • Really less requirements stated, but perhaps the shift is in trusting that since requirements are in ISO 9001:2015 they don’t need to be restated in the Standard Item

10. ACCREDITING BODIES • Approval comes from NAVSEA 04RM3 • Current criteria is NACLA Approved Auditing Body • ANSI-ASQ National Accreditation Board (ANAB) • Laboratory Accreditation Bureau (L-A-B), • Perry Johnson Registrars (PJLA), • The American Association for Laboratory Accreditation (A2LA), • National Voluntary Laboratory Accreditation Program (NVLAP), • International Accreditation Service (IAS),

11. LABORATORY SCOPE OF ACCREDITATION • The scope of accreditation of a calibration laboratory is the official and detailed statement of the activities for which the laboratory is accredited. • The role of the Accreditation Body is to ensure (to an adequate degree of confidence) that the laboratory has the competence to offer the service defined in the scope. • KEY WORDS • Competence • Accreditation is having a Management System and demonstrating competency • Service defined in the scope • Laboratories are accredited for specific tests or calibrations and particular test or calibration specifications

12. SCOPE EXAMPLES

13. The successful Tool Room Manager/Calibration Clerk should have an understanding of which measurement areas are required. This is helpful when choosing a lab based on Scope. • Acousticalquantities such as microphones, sound level, artificial mastoids, and noise dosimeters; • Chemicalquantities such as pH meters, conductivity meters, and so on; • Dimensionalquantities including length measurements such as laser wavelength, length gages, line scales and distances, length measuring instruments, diameter, form error, roughness, thread quantities, coordinate measuring machines, machine tools and work pieces, and angle measurements such as angle gages, index tables and clinometers; • Electricalquantities including DC/Low Frequency (≤ 13 MHz) quantities such as voltage, current, voltage ratio, AC/DC transfer (voltage and current), power and energy, resistance, capacitance, inductance, dissipation factor, high voltage quantities, and high voltage impulse quantities as well as RF/Microwave (> 13 MHz) quantities such as impedance (reflection coefficient), power, attenuation, noise, and electric/magnetic field quantities;

14. Fluid Quantitiessuch as gas and liquid flow rate, volume of flowing gases and liquids, velocity of gases, mass and volume and density of gases and liquids, and viscosity; Ionizing radiation and radioactivityquantities including radiometric quantities, dosimetric quantities, radioprotection quantities, and activity of radioactive sources; Magnetic Quantitiessuch as magnetic flux density and magnetic material properties; Mechanicalquantities such as force, mass, weighing instruments, pressure and vacuum quantities, torque, acceleration and vibration, and hardness;

15. Optical Quantitiessuch as quantities of optical radiation, photometric quantities, and optical system properties; Thermodynamicquantities including resistance thermometry, thermocouples, liquid-in- glass thermometers, radiation thermometers, and humidity. Time and Frequencyquantities including time interval, frequency, rise time, and phase angle.

16. Having a basic knowledge of instrument range is also important. • If you have a 60,000 volt DC meter, you’ll want to select a lab that can calibrate DC Volts up to 60,000 VDC • ISO 17025 Labs are required to state their Scope in International System of Units (SI) • This can add to your woes understanding Scope when trying to convert from the Metric System etc.

17. WHAT SHOULD MY CAL PROVIDER DO FOR ME? • Selecting a Lab for all your calibration needs can simplify management of your Test and Measuring Equipment. • If an item is outside of the accredited ISO 17025/Z540-3 Calibration Labs capability they must: • Find a lab with the same accreditation requirements that were imposed on them • Notify you in writing and obtain approval from you to sub-contract the work • Portions or complete calibration certificates can not be copied without written consent from the original provider.

18. WHAT SHOULD MY CAL PROVIDER DO FOR ME? • Accredited Calibration Lab’s always try to meet a minimum of a 4:1 Test Accuracy Ratio + additional calculations. • The details of Uncertainties, Probabilities of False Acceptance/Rejection, and Test Uncertainty Ratios are best left to Metrologists and Calibration Engineers • These calculations ensure that all errors and probabilities are considered not just “My Standard is 4 times more accurate than your Unit under Test.

19. WHAT SHOULD MY CAL PROVIDER DO FOR ME? • This ensures an out of tolerance on your unit would not require you to recall work. (If you were using a 1% accurate gauge the error at .25% would not void your measurement. • This keeps you from having to understand the accuracy statements on the Scope.

20. WHAT IS THE NAVY LOOKING FOR? • Ensure the organization get it's M&TE calibrated by a calibration service provider (CSP) that has been "accredited" and/or "certified". • NAVY "NEEDS":  The Navy's "needs" (as it relates to calibrated M&TE) are fairly simple. • TRACEABILITY - we need to ensure measurements are traceable to SI Units.   • COMPETENCY - we need to know the CSP is competent to perform the calibration he's been asked to do.   • INTERVALS - we need intervals assigned that ensure acceptable reliability.

21. WHAT IS THE NAVY LOOKING FOR?(CONT.) • NAVY "NEEDS”(cont.): • ACCURACY - we need to know the M&TE we are using to make accept/reject decisions meet the stated accuracy specifications for that instrument. • OOT CONDITIONS - we need to know when an instrument, whose readings we have based maintenance decisions on, is found responding OOT. • And finally, OQE - we need tangible OQE that supports all of the above.  Our world is driven by OQE.   Accreditation/certification provides the OQE to demonstrate all of this. • Can a CSP do all of this without being accredited (or performing a calibration outside of his accredited scope of competency)?  Of course they can, but where is the OQE?. • During Audits the Navy compares calibration records held by the auditee to the cal lab’s scope.

22. QUESTIONS ???? • It is the goal to stimulate questions however…. • Please, due to the constraints of time, email your questions to chris@standardcal.com