Calibration Services Training

General Calibration Information

Accreditations

•  Accreditations provide recognition by an authoritative body that an organization or individual is competent to carry out specific tasks.

•  This gives assurance that the test or inspection results are valid.

•  Assurance of accurate results contributes to protection of public health and safety, environmental protection and trade facilitation.

What is Laboratory Accreditation? •  Laboratory accreditation provides a means of determining the competence of

laboratories to perform specific types of testing, measurement and calibration.

•  As laboratory accreditation involves an independent assessment by technical experts, it also allows a laboratory to determine whether it is performing its work correctly and to appropriate standards.

•  Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to access reliable testing and

•  calibration services.

What is ISO/IEC 17025? •  It specifies the general requirements for the competence of testing and

calibration laboratories as defined by ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission).

•  ISO and IEC are two international standardization organizations that develop standards in a wide array of topics and subjects.

•  There are two main sections in ISO/IEC 17025 - Management Requirements and Technical Requirements.

•  Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory.

•  Technical requirements address the competence of staff, methodology and test/calibration equipment.

What is ISO/IEC 17025? (cont’d)

•  ISO/IEC 17025 allows laboratories to carry out procedures in their own ways, but an auditor may require the laboratory to justify the procedures using a particular method.

•  In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.

•  Many countries around the world have one or more organizations responsible for accreditation of their nation’s laboratories. Most of these accreditation bodies has now adopted an international standard, ISO/IEC 17025, as the basis for the accreditation of their country’s testing and calibration laboratories.

Mutual Recognition Arrangements

•  Adoption of an international standard, ISO/IEC 17025, has helped countries adopt a uniform approach to determining laboratory competence. This uniform approach allows countries with similar accreditation systems to establish agreements between themselves, based on mutual evaluation and acceptance of each other’s accreditation systems.

•  Such international agreements, usually called mutual recognition arrangements (MRA’s), are crucial in enabling test data to be accepted between these countries.

Mutual Recognition Arrangements (cont’d)

•  ILAC (International Laboratory Accreditation Cooperation) is the world’s principal international forum for the development of laboratory accreditation practices and procedures, the promotion of laboratory accreditation as a trade facilitation tool, the assistance of developing accreditation systems and the recognition of competent test facilities around the globe.

–  In order for accreditation bodies to recognize each others’ accreditation, ILAC worked to establish methods of evaluating accreditation bodies against a standard, ISO/IEC 17011

•  ISO/IEC 17011 specifies general requirements for all accreditation bodies, regardless of the type of conformity assessment body it seeks to accredit.

Regional Arrangement Bodies Working Under the ILAC Umbrella

•  In conjunction with ILAC, specific regions have also established co-operations

–  EA (European Accreditation Cooperation) is the European network of nationally recognized accreditation bodies based in the European geographical area

–  APLAC (Asia Pacific Laboratory Accreditation Corporation) is the organization in the Asia Pacific region responsible for accrediting testing and inspection facilities

–  SADCA (Southern Africa Accreditation Cooperation) is the regional accreditation body in Africa

–  IAAC (Inter-American Accreditation Cooperation) is an association of accreditation bodies in the Americas and other organizations interested in conformity assessment

–  NACLA (National Cooperation for Laboratory Accreditation) is the organization in the United States that mutually recognizes the work of the US accrediting bodies

•  A2LA and NVLAP removed themselves from NACLA citing redundancy in accreditation as well as financial issues

Regional Arrangement Bodies Working Under the ILAC Umbrella

•  These arrangement bodies help accreditation bodies mutually recognize each other in a systematic and formal way

•  They also help regulators by formally recognizing the processes and competence of the accrediting body

•  They help build trust between accrediting bodies and for their biggest stakeholders – labs, the public and regulatory agencies

Accreditations Bodies in the US •  NVLAP (National Voluntary Laboratory Accreditation Program) is a NIST (National Institute of

Standards and Technology) program which provides an unbiased 3rd party test and evaluation program to accredit laboratories in their respective fields to the ISO/IEC 17025 standard. NVLAP is in compliance with ISO/IEC 17011.

•  A2LA (American Association for Laboratory Accreditation) – a nonprofit, non-governmental, public service, membership society. A2LA provides comprehensive services in laboratory accreditation and laboratory-related training. Services are available to any type of organization, be it private or government. Laboratory accreditation is based on the internationally accepted standard, ISO/IEC 17025.

•  ACLASS – provides laboratory accreditation for testing and calibration laboratories to ISO/IEC 17025.

•  Perry Johnson Laboratories (PLJA) – offers accreditation to ISO/IEC 17025 for laboratories performing testing and/or calibration in a wide range of fields.

•  L.A.B. (Laboratory Accreditation Bureau) – established to provide ISO/IEC 17025 laboratory accreditation services to independent and captive, testing and calibration laboratories. Laboratory Accreditation Bureau is recognized to ISO/IEC 17011 for assessing laboratories to ISO/IEC 17025

Other Accreditation Bodies

•  UKAS (United Kingdom Accreditation Service) is the sole national accreditation body in the UK recognized by government to assess, against internationally agreed standards, organizations that provide certification, testing, inspection and calibration services.

Certificates

•  Troemner offers 8 types of certificates:

–  NVLAP Accredited Mass Code Report of Mass Values –  NVLAP Accredited Primary Reference Certificate –  NVLAP Accredited Calibration Certificate –  UKAS Accredited Calibration Certificate –  NVLAP Accredited Density Determination Certificate –  NVLAP Accredited Magnetic Susceptibility Certificate –  Traceable Calibration Certificate –  Statement of Accuracy

NVLAP Accredited Certificate •  The NVLAP Accredited Certificate is a detailed, multi-page weight certificate designed to

meet the following requirements:

–  FDA (Food and Drug Administration) –  GMP (Good Measurement Practices) –  GLP –  DOD –  ANSI/NCSL Z540-1 –  Nuclear Requirements

•  The NIST-administered National Voluntary Laboratory Accreditation Program approves all procedures for this detailed weight certificate. The measurement process follows the recommendations of NIST Handbook 145.

•  Troemner NVLAP Lab Code is 105013-0

NVLAP Calibration Certificate (cont’d)

•  NVLAP Certificate includes the following:

–  Date of Calibration –  Serial Number and ID Number –  Accuracy Class –  True Mass Values –  Conventional Mass Values –  Conventional Mass Corrections –  Uncertainty of the measurement process for each weight –  Tolerance –  Standards Calibration Information –  Procedure Used –  Directly Traceable to NIST –  As Found / As Left Data –  Environmental Conditions –  Construction and assumed density of weights –  Calibration procedures used

UKAS Accredited Certificate •  This certificate applies only to weight calibration

•  Similar to the NVLAP Certificate in content and form, however more widely accepted in the European community.

•  It meets the requirements of the United Kingdom Accreditation Service (UKAS)

•  This certificate of weight calibration is universally accepted throughout the world.

•  Troemner is presently the only UKAS accredited United States mass metrology laboratory offering its customers this internationally recognized certificate

•  Additionally Troemner’s UKAS accreditation fulfills the requirements of ISO/IEC 17025

•  Troemner’s UKAS Lab Code is 0516

NVLAP Density Determination Certificate

•  This certificate applies only to weight calibration

•  Troemner’s mass metrology lab can determine the actual density of one-piece mass standards that range in size from 1g to 5kg

•  Troemner is the only private accredited laboratory in the United States for this calibration

•  Troemner provides this service to reduce uncertainty of calibrating one-piece precision ASTM Class 000, 00, 0, Class E0 and OIML Class E1 and E2 weights

•  This process utilizes a state of the art balance immersed in a fluorinated fluid, a series of measurements are compared to a NIST traceable density standard to determine the density value

Magnetic Susceptibility Determination Certificate

•  This certificate applies only to weight calibration

•  Troemner has the capability of measuring the magnetic field intensity and the potential magnetic susceptibility of stainless steel mass standards between 1g and 10kg

•  Troemner is the only private accredited laboratory in the United States for this calibration

Traceable Calibration Certificate

•  Designed for laboratories and companies that require traceability but do not need to meet any stringent regulatory requirements

•  In contrast to NVLAP or UKAS calibration procedures, the Traceable Weight Certificate measurement process is based on a single standard and utilizes one series of comparisons

Traceable Calibration Certificate (cont’d)

•  Traceable Certificate includes the following:

–  Date of Calibration –  Serial Number and ID Number –  Accuracy Class –  Nominal Value of Each Weight –  Mass Correction, Tolerance and Uncertainty –  Statement of Traceability to NIST –  As Found / As Left Data

Statement of Accuracy

•  Weights supplied without weight certificates (with the exception of Economical Stainless Steel, Stainless Steel Test Weights and Cast Iron Weights) come with a Statement of Accuracy.

•  This statement guarantees that the product has been manufactured to meet the tolerance specifications for its class.

•  NOTE: The Statement of Accuracy does not provide traceability and is not suitable for quality or regulatory requirements.

NVLAP Accredited Mass Code Report of Mass Values

•  Troemner offers a detailed statistical analysis of mass values

•  Report follows a carefully designed high-end calibration procedure that compares the customers weights to Troemner’s primary standards

•  This results in the highest possible statistical confidence level for the customers weights

•  The multi-page Report is the same report one would receive if weights were calibrated directly by NIST

Order Forms and Statement of Decontamination •  Order forms are available under the Calibration Services section for each category

•  The Statement of Decontamination must be signed off on and is necessary for the protection of Troemner employees to prevent exposure to possibly hazardous chemicals and materials

•  Troemner will not process any order that is received in house without this paperwork

Why Calibrate?

•  People calibrate their weights and devices for the following reasons:

–  maintain traceability to NIST –  conform to standards and guidelines –  build confidence in measurement through history –  process controls – better yields

When do you Calibrate? – Calibration Intervals

•  Calibration is determined on the use of the weights/devices

•  Can be determined by manufacturers although the use of the equipment outweighs the manufacturers suggested calibration interval

•  Troemner recommends yearly calibration on weights and devices

•  Calibration intervals need to be determined by the customer depending on their company policies, guidelines, external requirement, use of the device and other factors

Why Calibrate at Troemner •  Why should a customer use Troemner for their calibration services?

–  CONSISTENCY, CONFIDENCE, CUSTOMIZATION

•  Philosophy – To provide the highest level of quality calibration by pursuing every measurement detail in order to achieve the most accurate and repeatable calibrations in the industry

•  Stable and Tightly Controlled Environment – Troemner maintains one of the largest and most advanced state-of-the-art independent metrology laboratories in the world with excellent controls to keep the environment stable – stable temperature and humidity, low vibrations and low air velocity

•  Finest Equipment – For each measurement discipline, Troemner possesses the finest calibration equipment available. Achieving the highest precision possible with the lowest measurement uncertainties.

Why Calibrate at Troemner (cont’d)

•  Highly Skilled Metrologists and Technicians – Troemner has a highly trained staff of certified metrologists and NIST trained calibrators capable of making precise measurements and monitoring calibration processes.

•  Measurement System – Troemner’s measurement system is rigorously reviewed. Troemner’s multiple primary standards are directly traceable to NIST.

•  Proprietary Calibration Software – Troemner’s software verifies the accuracy of each measurement, reduces error and identifies measurements that fall outside acceptable limits to eliminate the possibility of a suspect calibration leaving the building.

•  Documented Procedures – Procedures are documented for every step of the calibration process

Why Calibrate at Troemner (cont’d)

•  Registration and Accreditations – Troemner is committed to achieving the highest levels of accreditation for all of its calibration technologies. Troemner’s Calibration System is ISO 9001 registered and conforms to ISO/IEC 17025 and ANSI/NCSL Z540-1 standards. Troemner is NVLAP (Lab Code 105013-0) accredited for many of its measurement disciplines including mass, temperature, pipettes, humidity and pressure. Troemner is also a UKAS Accredited Calibration Laboratory No. 0516 for mass calibration.

•  Troemner offers several levels of service and certificates for each calibration.

•  Troemner can add needed information to a customer’s certificates and compliance documentation.

•  Adjustment, repair and calibration all from one source.

Procedure for Sending Devices for Calibration •  Devices to be sent in for calibration should be returned with all necessary forms

completed and placed in the box in plain view.

•  A Statement of Decontamination must be signed off on for all devices coming into Troemner for calibration

•  Payment information should be included. For open accounts customers should include a PO with their package or faxed/emailed into Troemner. For credit card or payment in advance customers, include payment information/check with package or contact Troemner with this information to avoid delay in processing order

•  Once the order is received if payment information is missing, a Troemner inside sales representative will contact the customer to ensure that the proper paperwork and information is received.

•  Orders will not be processed without necessary paperwork and payment details

Procedure for Sending Devices for Calibration (cont’d)

•  The devices should be packaged carefully in a sturdy carton to avoid movement and shifting of devices which will help to avoid shipping damage

•  Include a packing list of any items, accessories, etc. that are included in the shipment

•  All necessary paperwork should be included in the package

Available Calibration Services •  Troemner offers the following calibration services:

–  Mass/Weight Calibration: NVLAP and UKAS Accreditations

–  Temperature Calibration: NVLAP Accredited

–  Humidity Calibration: NVLAP Accredited

–  Pressure Calibration: NVLAP Accredited

–  Mass Flow Calibration: NVLAP Accredited

–  Pipette Calibration: NVLAP Accredited

–  Dimensional Calibration: NVLAP Accredited

–  Electrical Calibration: NVLAP Accredited

–  Time and Frequency Calibration: NVLAP Accredited