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Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

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Technical & Quality Specification To Assure Competent Calibration Services

By

Integrity Solutions Group, Inc.

6419 Bridgewood Terrace Boca Raton, FL 33433 USA Phone 561-289-9137 Efax: 978-285-6589

Web Page: http://www.integrity-solutions.org Email: [email protected]

Note:

This document is meant to be reasonably complete as a working document, but as a generic document it can not reflect the unique requirements of the User or Policies that may be mandatory from a procuring organization or third party. It is expected and prudent that some tailoring to this document to reflect the specific User conditions and needs will occur, including deletion of this instructive note..

© Integrity Solutions Group. Inc. This document is available for use (as a foundation document) based on clear attribution/credit in user documentation to Integrity Solutions Group, Inc. and the author (e.g., a statement such as, this current specification is based on a modification of Integrity Solutions Group, Inc. Technical & Quality Specification to Assure Competent Calibration Services By L. Gradin). Other guidance documents are available from Integrity Solutions Group for competence in test, calibration, uncertainty estimates, and service acceptance. Refer to http://www.integrity-solutions.org

Integrity Solutions-- "Where integrity, attention to detail, cost-effective action, and commitment assure quality performance"

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

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TABLE OF CONTENTS

SECTION TITLE Cover (Approval) Sheet Table of Contents 1.0 2.0 3.0 4.0 5.0 Purpose Scope References General Technical and Quality Requirements Certification And Documentation Requirements Records Types of Calibration Special EMC Calibration Requirements PAGE 1 2 3 3 4 5 8

6.0 Annex A Annex B

12 13 16

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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1.0

PURPOSE The purpose of this reference specification is to establish the generic technical and quality requirements for calibration services in support of the procuring laboratory or other organization. Requirements to establish procurement requirements for vital calibration services are found in various industry standards (References 3.1-3.3, 3.5, 3.8-3.11). It is intended that this specification be issued only once with repeated or continuing calibration procurement only referencing this specification in descriptive wording in procurement document such as, "the technical and quality requirements shall be in accord with # ISG-RD1001-R09 already in the possession of the calibration laboratory or service provider". Other specific requirements unique to the calibration is found in the specific contract, purchase order, requisition, or task authorization, or equivalent procurement requirements document for the solicited calibration service. Example provisions may include: Specific device calibration methods obtained (e.g. antenna calibration for automotive electronics testing or Military EMC/EMI testing is usually in accord with SAE ARP 958 -1997 Society of Automotive Engineers, Aerospace Recommended Practice 958, Electromagnetic Interference Antennas, Standard Calibration Method). Confirmation of required uncertainty to be an expanded uncertainty expressed at approximately the 95% confidence level using a coverage factor of k=2 or another value (e.g. 99.7% confidence level using a coverage factor of k=3 for certain mission or life significant measurements).

Definition of required level of calibration as defined in Annex A (i.e. Types 1NA, 2NA, 3NA, 4A, or 5A, with types 4A and 5A being required in support of accredited test methods). Definition of required calibration mandated by specific test standards (e.g. ANSI C63.42001, clause 4.4, Reference 3.12 such as described in Annex B).

2. 0 SCOPE This reference specification is applicable to all calibration services which are required to support the quality of the procuring laboratory or other organization requiring quality in calibration services. Many aspects of service requirements of organizations supporting ISO/IEC 17025-1999 (or national versions of this standard such as JIS Q 17025-2000, ANSI/NCSL 17025-2000, BS

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

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EN 17025-2000) accredited calibrations or tests are included in this specification. This specification is generally applicable for the procuring laboratory relating to its scope of accredited tests1. The technical and quality aspects of this specification may be applicable to an in-house laboratory or organization providing calibration services that are not controlled by the quality system of the procuring party or otherwise functions as an independent entity of the procuring organization. Applicability is confirmed in official requirements documents imposed on the organization providing calibration services.

3.0 3.1 3.2

REFERENCES

ISO 10012-1-1992 "Quality Assurance Requirements for Measurements Equipment" ANSI/NCSL Z540-1-19942 "Calibration Laboratories and Measuring And Test Equipment-up General Requirements". 3.3 ISO/IEC 17025 ­ 1999 "General Requirements for the Competence of Testing and Calibration Laboratories" 3.4 ISO "Guide to the Expression of Uncertainty in Measurement"3 (or national equivalent such as ANSI/NCSL Z540-24) 3.5 ISO/TS 16949:19995, "Quality systems -- Automotive suppliers -- Particular requirements for the application of ISO 9001:1994" 3.6 EA-4-116, "Calibration and Maintenance of Measuring and Test Equipment in Testing Laboratories" 3.7 EA-10-15 . "EA Guidelines on the Calibration of Digital Multimeters" 3.8 ISO/TS 16949:2002, "Quality systems -- Automotive suppliers -- Particular requirements for the application of ISO 9001:2000" 3.9 ISO 9001:2000, "Quality management systems -- Requirements" 3.10 NASA Policy Directive NPD 8730.1, May 22.1998, "Metrology and Calibration"7

1

Special cases of unique knowledge or skill of a calibration laboratory that is not accredited for the scope of accreditation may be accepted by the Accredition Body. This ordinarily requires additional data on proprietary knowledge and special technical and quality aspects of the non-accredited service provider. Such service providers are expected to support such information needs. 2 In lieu of ANSI/NCSL Z540-1 the calibration supplier located outside North America may substitute EA-4-11, unless ANSI/NCSL Z540-1 is specified in separate Customer purchase order documents. 3 International Organization for Standardization (ISO), Guide to the Expression of Uncertainty in Measurement, Geneva, Switzerland, 1995 or 4 ANSI/NCSL Z540-2," American National Standard for Expressing Uncertainty - U.S. Guide to the Expression of Uncertainty in Measurement', 1996 5 This standard (in use worldwide) clause 4.10.6 describes the requirements for compliance with ISO/IEC 17025-1999 or accreditation thereto. The latest version ISO/TS 16949:2002 (that supports ISO 9001:2000) includes these requirements in clause 7.6.3. 6 Refer to footnote 2

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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3.11 JIS Q 17025 ­ 2000 "General Requirements for the Competence of Testing and Calibration Laboratories"8 3.12 ANSI C63.4-2001, Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz 3.13 ISO 10012:2003"Quality Assurance Requirements for Measurements Equipment"

4.0 4.1

GENERAL TECHNICAL and QUALITY REQUIREMENTS The procuring laboratory or other organization (i.e. the identified contact on the procuring laboratory purchase order) is to be notified by the calibration laboratory if the as-received condition of the instrument is out of the manufacturer's tolerance or the tolerance specified by the procuring laboratory. The specific tolerance established by the manufacturer is to be provided in support of an in tolerance determination by the calibration laboratory. When an item is out of the manufacturer's tolerance, or the tolerance specified by the procuring laboratory, actual calibration of range and magnitude of error is to be supplied to the procuring laboratory. No adjustment or repairs is to be performed without prior consent of the procuring laboratory or other organization. A written agreement is recommended to be in place that describes the adjustment criterion (e.g., 70% of tolerance) to preclude receipt of an "in tolerance" calibrated item that is approaching or is at a tolerance limit. For a measurement point that is adjusted the limit can be set with additional margin (e.g. at 2050% of the specification limit) for the adjusted measurement points. Any adjustment, repair and method thereof are to be noted on the calibration certificate. The supplier shall implement a quality program in accordance with the requirements of ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 170252000, BS EN 17025-2000) accepted by the procuring laboratory. The provisions of ANSI/NCSL Z540-1, Part II shall be applicable except the calibration supplier shall

4.2

4.3

4.4 4.5

It is believed that this ISG ­RD-1001 document is sufficient to support the NASA directive that the calibration laboratory competency requirements identified in ISO 9000, ISO Guide 25 equivalent, NCSL/ANSI Z540-1-1994 is assured. 8 This ia a national equivalent to ISO/IEC 17025-1999 used in Japan. This or other appropriated equivalents (e.g. BS EN 17025-2000) may be used, consistent with the arrangements established by nationally and internationally recognized authorities.

7

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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obtain customer acceptance for any identified calibration interval based on ANSI/NCSL Z540-1 clause 18.10 to assure compliance with ISO/IEC 17025-1999 clause 5.10.4.4 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 170252000). The calibration lab shall not reference a standard interval in a regulation or standard unless such regulation or standard is identified in contract documents. These standards may be supplemented by ISO 10012-1 "Quality Assurance Requirements for Measurements Equipment". ISO/IEC 17025-1999 takes precedence over other standards, unless such standards add to the minimum requirements of ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 170252000). 4.6 Work being performed in satisfaction of the purchase order which references this specification is subject to audits, surveillance, and / or inspection by the procuring laboratory or organization personnel and / or customer's representative while in process or prior to shipment from your plant at the discretion of the procuring laboratory or organization. All work stipulated in the purchase order is to be performed at the vendors facility unless the procuring laboratory or organization is formally notified prior to sub-contracting specific operations. When requested, you are required to provide an un-priced copy of your purchase order for sub-vended operations to the procuring laboratory or organization. Also sub-vended work is subject to the inspection requirements as set forth in 4.6 above. Quality Documentation requirements are as stated in this reference specification or the purchase order and must be forwarded to the procuring laboratory or organization before or with shipment, with the purchase order details taking precedent over this specification. The vendor shall promptly document deviations from contractual requirements such as deviation from specifications, codes, drawings, procedures, etc9., and request through the procuring laboratory disposition of the affected equipment.

4.7

4.8

4.9

4.10 Packaging and packing shall afford protection against damage and contamination during shipment from the subcontractor, vendor or supplier to the procuring laboratory or organization or destination indicated on the purchase order. 4.11 The services described in the purchase order shall be in full compliance with your current scope of accreditation (see clause 4.12) and procuring organization approved quality manual/procedures. No calibrations by an accredited lab to a purchase order

The calibration of specialized test equipment for compliance to ASTM, IEC, CISPR or other standards that is defined in manufacturer instruction, service, calibration manual shall include full calibration for specialized tasks unless waived in writing by procuring organization.

9

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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referencing this specification shall be made if the scope of accreditation is not current or the scope does not envelop the item and calibration method required for instrument calibrations ­ all deviations require procuring agency approval in writing. The procuring laboratory or organization shall be advised of any changes to the manual before proceeding with the above referenced purchase order. 4.12 The supplier laboratory shall be specifically accredited to ISO/IEC 17025-1999 for the scope of services provided under the procuring laboratory or other organization procurement. Accreditation shall be by A2LA or NIST/NVLAP, JCSS, JAB, JNLA UKAS, NATA, SCC, or other nationally recognized Accrediting Body (APLAC fully recognized, EA fully recognized, NACLA recognized if US or Canada based). 4.13 Any deviations to this specification, ANSI/NCSL Z540-1, ISO 10012-1, or other procurement documents that the supplier believes requires clarification shall be submitted in writing to Purchaser with sufficient detail for review. 4.14 Consistent with ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 17025-2000) clause 5.4.2, methods selected shall meet the needs of the client and be appropriate for the tests and/or calibrations it undertakes. Consequently, the latest manufacturer instruction or service manual shall be used (and identified) in the calibration certificate unless the client issues a specific method document as part of the contract. Abbreviated specifications such in sales literature shall not be used without customer acceptance in writing. If a manufacturer instructions include different levels of calibration (e.g. full performance, checks only, major parameters only) only the full method shall be used without customer acceptance in writing. 4.15 If a parameter on the Measuring and Test Equipment (M&TE) providing an indication or display during a measurement or transmits this data electronically (e.g. by an electronic bus) or includes an application duration (e.g. application of a timed stress such as voltage or force for a specified period) that is not enveloped during calibration other means to demonstrate this parameter shall be developed and customer approved. Use of Military or other "standard" methods are acceptable if they are more comprehensive than manufacturer's instructions and envelop all measurement parameters. Efforts to this effect must be provided to client, if manufacturer calibration methods are not used. The Customer must approve in writing any tolerance value utilized that is greater than manufacturer's specification value as such a calibration does not restore the item being calibrated to the use specification that customer may have procured the instrument for.. 4.16 Any non-standard method or calibration supplier developed method requires validation per ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 170252000, BS EN 17025-2000) clause 5.4.5 with the method provided to the customer for approval. Method definition shall specify the characteristics and permissible measurement uncertainties (or tolerance limits) required to satisfy defined requirements. The procedure

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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format shall meet the level of detail in the note to ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 17025-2000) clause 5.4.4. For digital multimeters the guidance of EA-10-15 shall be adopted if manufacturer's instructions are not available. 4.17 If all parameters are not confirmed or calibrated, or is calibrated only for a specific client process (e.g. calibrating only the type K thermocouple measure function on a multi-function calibrator) the calibration certificates and calibration labels or equivalent shall indicated limited calibration status with clear definition of scope of calibration provided. 4.18 Where determination of measurement uncertainty is not applicable as the method performance is within the defined control limits, the laboratory shall assure (and demonstration request) that method performance is within the defined control limits of the reference test method. 4.19 The measurement uncertainty reported for site (not controlled environment) calibrations may be different (often larger) than that stated for the permanent laboratory. In estimating the on-site uncertainties, the laboratory shall consider the appropriate environment that can be expected at site. Allowance must be made for aspects such as the environment at the place of calibration and for other possible adverse effects such as those caused by transportation of the calibration equipment. In addition, equipment brought to a site calibration maybe less accurate or be used in a manner that uncertainty in resolution on site is greater than in the typical controlled environment. Calibration certificates shall clearly identify if calibration is at Purchaser site location. 5.0 CERTIFICATION AND DOCUMENTATION REQUIREMENTS All documentation submitted for items and services specified herein shall be legible, reproducible and capable of microfilming. 5.1 A certificate of calibration attesting to comparisons to standards of known accuracy traceable to the SI system through a national measurement institute (see clause 5.1.12) such as the National Institute of Standards and Technology (NIST), another national measurement institute from the nation that has an accreditation body acceptable to A2LA or NIST/NVLAP, JCSS, JAB, JNLA UKAS, NATA, SCC, or other nationally recognized Accrediting Body (APLAC fully recognized, EA fully recognized, NACLA recognized if US or Canada based), or nationally accepted procedures or standard shall be required. The following minimum information shall be required on the certificate; a title, i.e. Calibration Report or Calibration Certificate.

5.1.1

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5.1.2

unique identification of the certificate or report (such as the serial number), and of each page, and the total number of pages; name and address of customer, the procuring laboratory;

5.1.3

5.1.4 description and identification of the item calibrated 5.1.5 5.1.6 5.1.7 characterization and condition of the item calibrated dates of performance of calibration,; clear identification of the calibration procedure used, or description of any non-standard methods used If a manufacturer standard or procedure is used provide a copy and evidence that the requirements has been met. Refer to these specification clauses 4.14 and 4.16. Vague or ambiguous procedure or method reference to "standard specification" or "manufacturer's manual" or "manufacturer's specification" is not acceptable traceability to the procedural document. any deviation from, additions to or exclusions from the calibration method, and any other information relevant to the specific calibration, such as environmental conditions; measurements, examination and derived results, supported by tables, graphs, sketches and photographs, as appropriate , and any failures identified [Preference is for all quantitative data, not just an indication of condition (e.g. in tolerance). As a minimum provide quantitative data for as found and if out of tolerance as left differs from as found provide data] 5.1.9 A statement of the estimated uncertainty in a TUR (Test Uncertainty Ratio) of the calibration results shall be defined (in terms of the uncertainty of the measurement process) The TUR units shall be consistent (i.e. percentage values to the same base value, dB first converted to linear values, etc.). Provide expanded uncertainty calculations or provide uncertainty ratio clear statements if greater then 4:1 in accordance with the ISO "Guide to the Expression of Uncertainty in Measurement." (or national equivalent such as ANSI/NCSL Z540-2). Test uncertainty ratios must be calculated using expanded uncertainties of the measurement and a minimum 95% confidence interval with reported coverage factor unless waived in writing by the procuring laboratory. Refer to clause 5.6 for consideration of in tolerance conditions and the decision rule to consider uncertainty. 5.1.10 a signature and title, or an equivalent identification of the person accepting responsibility for the content of the certificate or report and the date of issue;

5.1.8

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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5.1.11 special limitations of use; and traceability of standards statement. supplier shall identify their applicable quality system program by reference to their Quality Assurance/Control Manual revision and/or date. 5.1.12 Provide a traceability statement to the International System of Units (SI) (Système international d'unités) through a national measurement institute [e.g. NIST or other national level authority (see paragraph 5.1] or by reference to other means as described in ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 170252000, BS EN 17025-2000) clause 5.6.2.2.1. 5.1.13 Positively states that there are no special limitations of use imposed on the calibration item or equivalent to positively assert all calibration requirements are met. 5.1.14 For calibrations at Purchaser facilities, calibration certificates must specifically identify calibration points, and any limits that do not meet the manufacturer's complete specification. Limitations to calibration for Purchaser must be stated on the certificates and a limited calibration indication on calibration labels. All such facility calibrations shall be performed under the calibration Laboratory scope of accreditation, including the use of personnel specifically certified competent under the accreditation program. 5.1.15 For M&TE such as chart recorders provide the uncertainty of the recorded indication consistent with clause considering resolution of the record, chart range, etc. to assure the actual uncertainties in the chart recorder mode is known. When such M&TE include digital display also, indicate the uncertainty of this display. 5.2 Clearly indicate the compliance with ISO/IEC 17025 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 17025-2000) on Calibration Certificates. If calibration laboratory is also accredited to ANSI/NCSL Z540-1 and this is specified indicate this on Calibration Certificates. All calibration shall be under the accredited calibration program unless specifically waived in writing by the Purchaser (Also see clause 5.4). Include the LOGO of the Accreditation Body plus the specific Accreditation Body certification number or lab code or equivalent as established by the Accreditation Body for the certificates issued under the scope of accreditation. Provide clear indication (size 10 point font or larger) if a parameter calibrated is not enveloped under scope of accreditation (even if this action is Purchaser approved). Provide copy of current Accreditation Certification and scope of accreditation for A2LA or NIST/NVLAP, UKAS, SCC, NATA, JCSS, JAB, JNLA UKAS, NATA, SCC, or other nationally recognized Accrediting Body (APLAC fully recognized, EA fully recognized, NACLA recognized if US or Canada based) or other Purchaser accepted10 Accrediting

5.3

10

In practice a recognized Accreditation Body is one acceptable to the Accreditation Body used by the Purchaser.

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Body documented acceptable to Purchaser, including full scope of accreditation with each calibration or place Purchaser on a controlled distribution for updates. 5.4 If calibration activity is not accredited, provide copy of controlled quality manual and supporting evidence of assessments/audits from credible independent agency, firm, organization for review prior to performing calibration for procuring organization acceptance in writing. Supplier must receive written Purchaser approval for any calibrations not enveloped by the scope of accreditation described in clause 5.2 above. The data on the certificate shall use the accepted terms of ISO/IEC Guide 2 or the VIM as defined in clause 3 of ISO/IEC 17025-1999 or national equivalent (e.g. ANSI/NCSL 17025-2000, JIS Q 17025-2000, BS EN 17025-2000). Terms such as accuracy, error, or precision shall not be used in lieu of uncertainty of measurement. Indication of in tolerance shall include the criteria used for the determination of in tolerance condition. The decision rule used to determine the in tolerance or out of tolerance condition considering Uncertainty of Measurement (or TURs as applicable) shall be provided in the calibration certificate or report or other written and approved document submitted to Purchaser. To establish an audit trail for traceability, a proper calibration result reported in the calibration certificate or report shall include: the assigned value, a stated uncertainty, identification of the standards used in the calibration, and the specification of any environmental conditions of the calibration where correction factors should be applied, if the standard or equipment were to be used under different environmental conditions.

5.5

5.6

5.7

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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6.0 6.1

RECORDS Purchaser prefers that all records shall be maintained for a minimum of seven years at the calibration facility. If the standard retention period for records is less than seven years, the procuring laboratory or organization shall be notified in writing of the actual retention period. If no notification is forthcoming from the calibration lab the calibration lab shall maintain all calibration records related to the procuring laboratory for a period of seven years minimum. It is expected that this time period is enveloped by lab standards at no additional cost to Purchaser. If additional costs are incurred this shall be agreed to with purchaser. The calibration laboratory shall provide a Certificate of Compliance/Conformance signed by a qualified and authorized party as defined in the calibration laboratory Quality Manual. This certification shall include the purchase order number, this specification number, and any special requirements in an accompanying purchase order or contract document. All documentation provided shall be legible and suitable for microfilming (i.e. clean, having clear discernible characters and markings, unique document identification, of standard size such as 8-12 X 11 inches in US, A4 in Japan, UK,, and Israel, 8-12 X 14, and without any damage jeopardizing readability). All data for a complete calibration record shall be provided with the returned and calibrated instrument unless agreed otherwise in writing. Should the calibration facility be authorized to retain supporting data, the Purchaser shall have an opportunity to acquire possession of such records prior to disposal at no additional cost to Purchaser should the calibration laboratory no longer retain quality records. Adequate identification of methods used to calculate the result of measurement and its uncertainty shall be available either in the Calibration Certificate and submitted reports or in the records of the measurement test or calibration retained by the lab including: (a) Sufficient documentation of the steps and calculations in the data analysis to enable a repeat calculation if necessary; (b) All corrections and constants used in the analysis, and their sources; (c) Sufficient documentation to show how the uncertainty is calculated.

6.2

6.3

6.4

6.5

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Annex A Types of Calibration

Refer to Separate Purchase Documents for Specific Requirement. All Accredited Labs shall specifically indicate as part of their contract review to Customer that Accredited Calibrations (as applicable) are not being furnished if Customer requirement for Type of Calibration is unclear. The level of calibration certificate information from the supplier shall include various options, dependent on contract provisions, site calibrations, standard industry practice, and our specification or purchase order definition for calibration as follows: Calibrations Not Enveloped Under Accredited Calibration11 Type 1NA - Routine Non-Accredited Calibration. These calibrations and related certificates will include traceability to an NMI (e.g. NIST traceability in US), calibration labels, in-tolerance indication, or out-of-tolerance actual readings, if applicable. This calibration type is utilized when customer orally or in written documents requests just a "C of C'" or Certificate of Conformance as a reduced price effort. Type 2NA - Routine Non-Accredited Quantitative Calibration. These calibrations and related certificates will include an NMI (e.g. NIST traceability in US), calibration labels, full test documentation of "As-Found" and "As-Left" calibration or test points, pass-fail or allowable tolerance values. This calibration type is utilized when customer orally or in written documents requests a calibration without any specific reference to a metrological standard or method. Type 3NA - Routine Non-Accredited Site or Customer Spec Calibration. These calibrations will be a variation of Routine and Quantitative Calibrations as described above that may be limited to only specific test points requested or agreed to in writing with our customers to reflect site, process, and customer needs. Type 4NA - Non-Accredited Quantitative Calibration to Military Specifications. These calibrations and related certificates will include an NMI (e.g. NIST traceability in US), calibration labels, full test documentation of "As-Found" and "As-Left" calibration or test points, pass-fail or allowable tolerance values, completion of full required data per military standards (e.g. 33K or TO 1720 series). This calibration type is utilized when customer orally or in written documents requests a calibration to Military Specifications.

11

This is a general definition of calibration categories, all calibrations must adhere to the full specification unless

waiver to the requirements is obtained from Purchaser in writing.

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

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Type 5NA - Non-Accredited Quantitative Calibration to Manufacturer's Defined Methods. These calibrations and related certificates will include an NMI (e.g. NIST traceability in US), calibration labels, full test documentation of "As-Found" and "As-Left" calibration or test points, pass-fail or allowable tolerance values, completion of full required data per Manufacturers Defined Methods. This calibration type is utilized when customer orally or in written documents requests a calibration to a Manufacturer's Defined Methods.. Type 6NA - Non-Accredited Quantitative Calibration to Industry Defined Reference Defined Standard Methods. These calibrations and related certificates will include an NMI (e.g. NIST traceability in US), calibration labels, full test documentation of "AsFound" and "As-Left" calibration or test points, pass-fail or allowable tolerance values, completion of full required data per Defined Industry Reference Defined Standard Methods (e.g. GGG-G-15C or ASME B89.1.9-2002 for Gage Blocks). This calibration type is utilized when customer orally or in written documents requests a calibration to a Defined Industry Reference Defined Standard Methods.

Calibrations Enveloped Under Accredited Calibration Type 1A - Accredited Normal Calibration. These calibrations and related certificates will be the same as the Quantitative Calibration (i.e. Type 2NA) with the effort also in full compliance with accredited calibration lab duties. The application of the Accreditation Body Reference and Certification indication attests to this and makes the certificates subject to Accreditation Body assessment. This calibration type is utilized when customer in written documents accepts this calibration type without any specific reference to a metrological standard or method. Type 2A - Accredited Site or Customer Spec Calibration. These calibrations and related certificates will be the same as the Site or Customer Spec Calibration (i.e. Type 3NA) with the effort in full compliance with accredited calibration lab duties, subject to contract satisfaction for the scope of test point calibration defined. The application of the Accreditation Body Reference and Certification indication attests to this and makes the certificates subject to Accreditation Body assessment. Type 3A - Accredited Quantitative Calibration to Military Specifications. These calibrations and related certificates will be the same as the Quantitative Calibration to Military Specifications (i.e. Type 4NA) with the effort in full compliance with accredited calibration lab duties, subject to contract satisfaction for the scope of test point calibration defined. The application of the Accreditation Body Reference and Certification indication attests to this and makes the certificates subject to Accreditation Body assessment.

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

Division/Location

Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

Specific Modifier/Preparer Checked and Approved Date (dd/mm/yyyy)

User Identification:

ISG #

Rev

Doc. # ISG-RD1001-R12

XXXXX YYYYY

XXXXX YYYYY

dd/mm/yyyy

Page 15 of 18

Type 4A - Accredited Quantitative Calibration to Manufacturers Defined Methods. These calibrations and related certificates will be the same as the Quantitative Calibration to Manufacturers Defined Methods (i.e. Type 5NA) with the effort in full compliance with accredited calibration lab duties, subject to contract satisfaction for the scope of test point calibration defined. The application of the Accreditation Body Reference and Certification indication attests to this and makes the certificates subject to Accreditation Body assessment. Type 5A - Accredited Quantitative Calibration to Industry Defined Reference Defined Standard Methods. These calibrations and related certificates will include an NMI (e.g. NIST traceability in US), calibration labels, full test documentation of "AsFound" and "As-Left" calibration or test points, pass-fail or allowable tolerance values, completion of full required data per Defined Industry Reference Defined Standard Methods (e.g. ASME B89.1.9-2002 for Gage Blocks with reduced tolerance of GGG-G-15C ). The application of the Accreditation Body Reference and Certification indication attests to this and makes the certificates subject to Accreditation Body assessment.

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

Division/Location

Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

Specific Modifier/Preparer Checked and Approved Date (dd/mm/yyyy)

User Identification:

ISG #

Rev

Doc. # ISG-RD1001-R12

XXXXX YYYYY

XXXXX YYYYY

dd/mm/yyyy

Page 16 of 18

Annex B Special EMC/EMI Calibration Requirements

EMI/EMC Measurement and Test Equipment often require special calibration. This annex provides discussion for such equipment: B-1 EMI Receivers and/or Spectrum Analyzers with appropriate peripherals EMI Receivers and/or Spectrum Analyzers with appropriate peripherals are the instruments found in various standards for EMI/EMC testing. The specifications that envelope the instrument measurement functions are ANSI 63.2-1996, CISPR 16-1-2002, and MIL Standard 461E. CISPR 16-1 provides the most comprehensive coverage of the EMI receiver characteristics, auxiliary equipment and the test environment The actual test standards may have differing instrument requirements as a function of actual test requirements (spectrum analyzers may be used above 1 GHz in certain test standards). Consistent with ANSI C63.4-2001, Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz clause 4.4, these instruments shall meet the following requirements. These instruments shall be calibrated in accordance with the manufacturers recommendations and the instrument requirements of ANSI C63.2-1996. The instruments shall be maintained as a system to ensure measurement accuracy traceable to SI units of measurement via national (NIST) or international standards, as specified in ANSVNCSL 2540-l-1994 or IS0 10012-1:1992. : Example Models enveloped that are typically used in CISPR 16-1 receiver compliant measurements: Rohde & Schwarz Instrument Model Numbers ESIB 7 / 26.5 / 40 ESCS 30 ESVP ESH3 ESAI, ESBI, ESMI ESVB AFJ International ESR Series 55

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

Division/Location

Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

Specific Modifier/Preparer Checked and Approved Date (dd/mm/yyyy)

User Identification:

ISG #

Rev

Doc. # ISG-RD1001-R12

XXXXX YYYYY

XXXXX YYYYY

dd/mm/yyyy

Page 17 of 18

Example Models Enveloped that are typically used in CISPR 16-1 receiver compliant measurements: Hewlett Packard (or Agilent) Model Numbers HP 8566B or HP 8568B plus option 462 plus HP 85650A plus HP 85685A HP 8542E or HP 8546A Schwarzbeck Mess - Elektronik FCKL 1528 (9 kHz - 30 MHz) FCVU 1534 (20 MHz - 1050 MHz) Schaffner EMC SMR 4503 SMR4518 ARNELLAB NM-7/60A EMI/RFI Receiver Dynamic Sciences International DI 660 Series

General Requirements for Specialized EMI/EMC Equipment In paragraph B-1 above some specifics of specialized EMI/EMC equipment is discussed. Similar specialization exists for tests for Harmonics (e.g. EN 61000-3-3) and other tests. Consequently, no calibration of the M&TE that follows is acceptable that is not per the controlling industry standard or major manufacturer full calibration methods. In addition the methods shall be based on specific approval of the Customer in writing. Antennas, EMI Receivers, Spectrum Analyzers, EMC Analyzers, Harmonic Analyzers, Coupling/Decoupling Networks, Artificial Mains Networks, Line Impedance Stabilization Networks, Surge and Electric Fast Transient and Burst Generators, Signal Generators, RF Current Probes and Current Transformers, Quasi-Peak Adaptor units, Tracking Generators. Presentation of calibration laboratory accreditation is not an acceptable substitute of the requirements to meet this specification.

Integrity Solutions Group, Inc. Procurement Specification for Calibration Services Laboratory:

Division/Location

Original Author, Revision, Date : L. P. Gradin, R12, 2004/02/06

Specific Modifier/Preparer Checked and Approved Date (dd/mm/yyyy)

User Identification:

ISG #

Rev

Doc. # ISG-RD1001-R12

XXXXX YYYYY

XXXXX YYYYY

dd/mm/yyyy

Page 18 of 18

The following shall be the basis of any deviation request from standard methods: Consistent with ISO/IEC 17025-1999 clause 5.4.4: "When it is necessary to use methods not covered by standard methods, these shall be subject to agreement with the client and shall include a clear specification of the client's requirements and the purpose of the test and/or calibration. The method developed shall have been validated appropriately before use." Consistent with ISO/IEC 17025-1999 clause 5.5.4.2 "The laboratory shall validate non-standard methods, laboratory-designed/developed methods, standard methods used outside their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the intended use. The validation shall be as extensive as is necessary to meet the needs of the given application or field of application"

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