Thunder Scientific Calibration Laboratory Quality Manual

Thunder Scientific Calibration Laboratory

Issue Date 08/28/2012

Document CL-QM-01

Authorized by: Brad Bennewitz PRESIDENT CEO Issue No. 7

of 26 Sub Authorizer: Jarred Crouse QUALITY MANAGER Document Title: Thunder Scientific Calibration Laboratory Quality Manual LIVE

Thunder Scientific Corporation Proprietary Information Printed 8/28/2012 @ 9:00 AM

QUALITY MANUAL FOR CALIBRATION LABORATORY

Document Number: CL-QM-01 Revision: 7

Document Date: 28 August 2012

This document may be released to customers as an uncontrolled document.

Thunder Scientific Corporation 623 Wyoming Blvd., SE Albuquerque, NM 87123

(505) 265-8701 (505) 266-7728 Fax



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Table of Contents 1. Introduction ............................................................................................................................................... 5 2. References ................................................................................................................................................. 6 2.1 External References ................................................................................................................................... 6 2.2 Internal References .................................................................................................................................... 6 3. Definitions ................................................................................................................................................. 7 3.1 Abbreviations ............................................................................................................................................ 7 4. Management Requirements ....................................................................................................................... 8 4.1 Organization .............................................................................................................................................. 8 4.1.1 Legal identity ............................................................................................................................................. 8 4.1.2 Commitment to meet requirements and satisfy needs ............................................................................... 8 4.1.3 Scope of management system .................................................................................................................... 8 4.1.4 Responsibilities of key personnel .............................................................................................................. 8 4.1.5.a Authority and resources ............................................................................................................................. 8 4.1.5.b Undue pressure .......................................................................................................................................... 8 4.1.5.c Confidential information and proprietary rights ........................................................................................ 9 4.1.5.d Independence of judgment and integrity ................................................................................................... 9 4.1.5.e Organization and management structure ................................................................................................... 9 4.1.5.f Responsibility, authority and interrelation of personnel ............................................................................ 9 4.1.5.g Supervision ................................................................................................................................................ 9 4.1.5.h Technical Manager .................................................................................................................................... 9 4.1.5.i Quality Manager ........................................................................................................................................ 9 4.1.5.j Deputies ................................................................................................................................................... 10 4.1.5.k Awareness................................................................................................................................................ 10 4.1.6 Communication ....................................................................................................................................... 10 4.2 Management system ................................................................................................................................ 10 4.2.1 Management system ................................................................................................................................ 10 4.2.2 Quality policy statement .......................................................................................................................... 10 4.2.3 Management commitment ....................................................................................................................... 10 4.2.4 Management communication ................................................................................................................... 10 4.2.5 Structure of quality documentation ......................................................................................................... 10 4.2.6 Roles and responsibilities ........................................................................................................................ 11 4.2.7 Management system integrity .................................................................................................................. 11 4.3 Document control .................................................................................................................................... 11 4.3.1 General .................................................................................................................................................... 11 4.3.2 Document approval and issue .................................................................................................................. 11 4.3.3 Document changes ................................................................................................................................... 12 4.4 Review of requests, tenders and contracts ............................................................................................... 12 4.5 Subcontracting of calibrations ................................................................................................................. 12 4.5.1 Eligible sub-contractors ........................................................................................................................... 12 4.5.2 Advising the customer ............................................................................................................................. 12 4.5.3 Responsibility for sub-contractor work ................................................................................................... 12 4.5.4 Register of sub-contractors ...................................................................................................................... 13 4.6 Purchasing services and supplies ............................................................................................................. 13 4.6.1 Selection and purchasing of services and supplies .................................................................................. 13 4.6.2 Verification of services and supplies ....................................................................................................... 13 4.6.3 Purchasing documents for services and supplies ..................................................................................... 13 4.6.4 Evaluation of suppliers ............................................................................................................................ 13 4.7 Service to the customer ............................................................................................................................ 13



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4.7.1 Customer cooperation .............................................................................................................................. 13 4.7.2 Customer feedback .................................................................................................................................. 14 4.8 Complaints ............................................................................................................................................... 14 4.9 Control of nonconforming testing and/or calibration work ..................................................................... 14 4.9.1 Policy and procedure for nonconforming work ....................................................................................... 14 4.9.2 Nonconforming work corrective action ................................................................................................... 14 4.10 Improvement ............................................................................................................................................ 15 4.11 Corrective action...................................................................................................................................... 15 4.12 Preventive action ..................................................................................................................................... 15 4.13 Control of records .................................................................................................................................... 15 4.13.1 General .................................................................................................................................................... 15 4.13.2 Technical Records ................................................................................................................................... 15 4.14 Internal audits .......................................................................................................................................... 16 4.15 Management reviews ............................................................................................................................... 16 5. Technical Requirements .......................................................................................................................... 17 5.1 General .................................................................................................................................................... 17 5.2 Personnel ................................................................................................................................................. 17 5.2.1 Competence ............................................................................................................................................. 17 5.2.2 Training goals .......................................................................................................................................... 17 5.2.3 Employment relationship ......................................................................................................................... 18 5.2.4 Job descriptions ....................................................................................................................................... 18 5.2.5 Authorizations ......................................................................................................................................... 18 5.3 Accommodations and environmental conditions ..................................................................................... 18 5.3.1 Laboratory accommodations ................................................................................................................... 18 5.3.2 Monitoring and recording of environmental conditions .......................................................................... 18 5.3.3 Separation of incompatible activities ....................................................................................................... 18 5.3.4 Laboratory access .................................................................................................................................... 18 5.3.5 Good Housekeeping ................................................................................................................................ 19 5.4 Calibration methods and method validation ............................................................................................ 19 5.4.1 General .................................................................................................................................................... 19 5.4.2 Selection of methods ............................................................................................................................... 19 5.4.3 In-house developed methods ................................................................................................................... 19 5.4.4 Non-standard methods ............................................................................................................................. 19 5.4.5 Validation of methods ............................................................................................................................. 20 5.4.6 Estimation of uncertainty of measurement .............................................................................................. 20 5.4.7 Control of data ......................................................................................................................................... 20 5.5 Equipment................................................................................................................................................ 21 5.5.1 Equipment inventory ............................................................................................................................... 21 5.5.2 Equipment capability and calibration ...................................................................................................... 21 5.5.3 Operation of equipment ........................................................................................................................... 21 5.5.4 Identification of equipment...................................................................................................................... 21 5.5.5 Equipment records ................................................................................................................................... 21 5.5.6 Equipment procedures ............................................................................................................................. 22 5.5.7 Equipment mishandling ........................................................................................................................... 22 5.5.8 Calibration status ..................................................................................................................................... 22 5.5.9 Equipment going outside TSCL’s control ............................................................................................... 22 5.5.10 Intermediate checks ................................................................................................................................. 22 5.5.11 Correction factors .................................................................................................................................... 22 5.5.12 Safeguard against adjustments ................................................................................................................. 22 5.6 Measurement traceability......................................................................................................................... 22



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5.6.1 General .................................................................................................................................................... 22 5.6.2 Specific Requirements ............................................................................................................................. 23 5.6.3 Reference standards and reference materials ........................................................................................... 23 5.7 Sampling .................................................................................................................................................. 24 5.8 Handling of calibration items .................................................................................................................. 24 5.8.1 General .................................................................................................................................................... 24 5.8.2 Identification of calibration items ............................................................................................................ 24 5.8.3 Condition of calibration items ................................................................................................................. 24 5.8.4 Protection of calibration items ................................................................................................................. 24 5.9 Assuring the quality of calibration results ............................................................................................... 24 5.10 Reporting the results ................................................................................................................................ 25 5.10.1 General .................................................................................................................................................... 25 5.10.2, 5.10.3 and 5.10.4 Calibration certificates and calibration reports ......................................................... 25 5.10.5 Opinions and interpretations .................................................................................................................... 26 5.10.6 Calibration results obtained from subcontractors .................................................................................... 26 5.10.7 Electronic transmission of results ............................................................................................................ 26 5.10.8 Format of certificates ............................................................................................................................... 26 5.10.9 Amendments to calibration certificates ................................................................................................... 26



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1. Introduction Quality Manual CL-QM-01 describes the management system in place at Thunder Scientific’s Calibration Laboratory. It references quality policies and procedures and various other related documents, which together makes up the management system. The layout of the manual for sections 4 and 5 coincides with that of ISO/IEC 17025 for easy identification of the section addressing a specific requirement. In the text, italics are used to identify referenced documents, electronic records, and reports. A list of documents, with their complete title and their document number referenced, can be found in a separate report in the PROQUIS database Titled: Controlled Document Master List. Thunder Scientific’s scope of calibration includes humidity, temperature and pressure calibrations.. Quality Manager Thunder Scientific Corporation Calibration Laboratory



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2. References

2.1 External References

ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”

NIST Handbook 150 “Procedures and General Requirements”

BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML “Guide to the Expression of Uncertainty in Measurement (GUM)”

NIST Technical Note 1297 “Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results”

2.2 Internal References

PROQUIS “Controlled Document Master List”

CL-SCOPE “Laboratory’s Scope of Calibrations and/or Verifications”



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3. Definitions

Major Equipment Equipment owned by TSCL and calibrated in-house.

Reference Measurement Standards Standards or equipment owned by TSCL, some calibrated by NIST or accredited laboratories.

PROQUIS (PROfessional QUality Information System for Business) Quality management information system for control of documentation and records.

Calibration Manager Database for storing information for TSCL reference standards and calibration equipment.

Register Electronic register that keeps and records all quality records in PROQUIS.

PROQUIS Report A generated report from PROQUIS linked to electronic records stored in the PROQUIS Database Register.

Process Report An enhanced flow chart used as a documented procedure or work instruction showing the inputs and outputs, and the measure of a process.

3.1 Abbreviations CL – Calibration Laboratory ILAC MRA – International Laboratory Accreditation Cooperative Mutual Recognition Arrangement MAP – Calibration Measurement Assurance Procedure NIST – National Institute of Standards and Technology ORG – Organization PM – Process Map POL – Policy PRO – Procedure PROQUIS – Professional Quality Information System for Business QM – Quality Manual QMS – Quality Management System SOP – Standard Operating Procedure TSC – Thunder Scientific Corporation TSCL – Thunder Scientific Calibration Laboratory



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4. Management Requirements This section describes the overall management requirements including the legal identity, organization, and management arrangements at TSCL.

4.1 Organization

4.1.1 Legal identity Thunder Scientific Corporation is incorporated in the state of New Mexico, United States of America. Physical address of: 623 Wyoming Blvd. SE, Albuquerque, NM 87123.

4.1.2 Commitment to meet requirements and satisfy needs TSCL is committed to performing its calibration activities in such a way as to meet the requirements of ISO/IEC 17025, to satisfy the needs of its customers, regulatory organizations, and accreditation bodies.

4.1.3 Scope of management system The management system documented in this quality manual and associated documentation applies to work carried out at TSCL’s permanent facilities, at customer sites, and in associated temporary or mobile facilities.

4.1.4 Responsibilities of key personnel TSCL is part of a larger organization (Thunder Scientific Corporation). Key personnel are involved in, influence the calibration activities of TSCL, and have defined responsibilities to ensure that potential conflicts of interest are avoided.

4.1.5.a Authority and resources The authority vested in the Technical Manager is described in the PROQUIS Job/Position Register in the description field as the Technical Manager Job Description and from the Job Skills Required/Position Description Report generated from the PROQUIS Personnel Module. The authority vested in the Quality Manager is described in the PROQUIS Job/Position Register in the description field as the Quality Manager Job Description and from the PROQUIS Job Skills Required/Position Description Report generated from the PROQUIS Personnel Module. Between them, they have the authority and resources needed to carry out their duties and to identify the occurrence of departures from the management system described in this quality manual and related documentation or from the procedures for performing calibrations, and to initiate actions to prevent or minimize such departures.

4.1.5.b Undue pressure The laboratory’s policy for employees accepting gifts and gratuities is documented in the Gifts and Gratuities Policy (QMS/CL-POL-03). Internal complaints or concerns from employees are handled according to the Corrective Action Policy (QMS/CL-POL-05). Employees are never asked to meet productivity goals that will jeopardize the quality of the work.



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4.1.5.c Confidential information and proprietary rights For TSCL’s policy regarding customer confidential information and proprietary rights, see the Confidentiality Policy (QMS/CL-POL-02). The procedure for instructing new employees in the management system and requiring them to sign TSC’s Confidentiality Agreement is found in the New Hire Introduction Agenda. A signed copy of TSC’s Confidentiality Agreement can be found in each employee’s personnel file. The procedure for protecting the electronic storage of results is given in the Data Protection and Backup Procedure (QMS/CL-PRO-13). The procedure for protecting customer confidential information during electronic transmission of results is given in the Electronic Transmission Procedure (QMS/CL-PRO-15).

4.1.5.d Independence of judgment and integrity TSCL’s policy for acceptable activities is documented in the Acceptable Activities Policy (QMS/CL -POL-09). TSCL’s procedure to avoid involvement in unacceptable activities is documented in the Activity Evaluation Procedure (QMS/CL-PRO-06).

4.1.5.e Organization and management structure The organization and management structure for TSCL is defined by the Organizational Chart (CL-ORG-01).

4.1.5.f Responsibility, authority and interrelation of personnel The responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of calibrations and tests are defined in the following documents:

- Organizational Chart (CL-ORG-01) - Technical Manager Job Description (PROQUIS Job/Position Table in the description field) - Quality Manager Job Description (PROQUIS Job/Position Table in the description field) - Calibration Technician Job Description (PROQUIS Job/Position Table in the description field)

4.1.5.g Supervision The technical manager and the quality manager provide supervision. For details of the education, experience and training of the technical manager and the quality manager, see their skill table in the Personnel Register and the PROQUIS Job/Position Details Report.

4.1.5.h Technical Manager The Technical Manager has overall responsibility for the technical operations, see the Technical Manager Job Description in the PROQUIS Job/Position Table and the Job Skills Required/Position Description Report. The Technical Manager has the resources needed to ensure the required quality of laboratory operations.

4.1.5.i Quality Manager The Quality Manager has responsibility for the quality management system and its implementation; see the Quality Manager Job Description in the PROQUIS Job/Position Table and the Job Skills Required/Position Description Report. The quality manager has direct access to the technical manager and highest level of management controlling the laboratory policies and/or resources.



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4.1.5.j Deputies When appropriate, deputies shall be assigned in the absence of the technical manager and/or the quality manager. Refer to TSC Organization Chart (QMS-ORG-01).

4.1.5.k Awareness TSCL personnel are made aware of the relevance and importance of their activities by business priorities, objectives and regular communication with management.

4.1.6 Communication Top management assures that appropriate communication venues are established within the laboratory to ensure the effectiveness of the management system.

4.2 Management system

4.2.1 Management system TSCL has established, implemented and maintains the management system documented in this quality manual and related documentation. TSCL has documented its policies, systems, programs, procedures, and instructions to the extent necessary to assure the quality of calibration results. The system’s documentation has been communicated to, understood by, is available to and implemented by all personnel. For documentation, see the Control of Documents Procedure (QMS/CL-PM-17) and the Document Change History Report generated from PROQUIS Document Register.

4.2.2 Quality policy statement TSCL’s quality policy statement is documented in the Calibration Laboratory Quality Policy (CL-POL-01), which is issued under the authority of the Chief Executive.

4.2.3 Management commitment TSCL has established a management system that is administered at the highest level within this group. This quality manual, its supporting documentation, annual internal audits and management reviews, demonstrate management’s commitment to the implementation of the requirements of ISO/IEC 17025 and to the continual improvement of the effectiveness of the management system that it describes.

4.2.4 Management communication TSCL’s management communicates to the organization the importance of meeting customer, as well as statutory and regulatory requirements, through several methods including, but not limited to, meetings and direct presentations. Through these methods, all employees are made familiar with TSCL Calibration Laboratory Quality Policy (CL-POL-01). The management of TSCL will ensure that customer requirements are identified and met with the intent of achieving customer satisfaction and exceeding customer expectations.

4.2.5 Structure of quality documentation TSCL’s internally generated quality documentation is made up of this quality manual, quality policies and quality procedures as well as calibration procedures, work instructions and a number of supporting documents.



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References to documents within the management system are made in italic throughout the internally generated quality documentation. References to documents are reported as shown as a linked document to the Quality Manual through the PROQUIS Document Register. In addition, TSCL’s management system encompasses a number of externally generated documents by reference from internally generated quality documents. A list of these documents that are part of the Quality Management System viewed on the Controlled Document Master List Report as documents of external origin. The Controlled Document Master List Report generated from the PROQUIS Document Register outlines the structure of the documentation and lists all the quality documents, both internal and external, that make up the management system. It also gives the current issue/revision number and issue/approval date of each document. The quality documentation also refers to various files and logs (also in italic) throughout the text. The PROQUIS Document Listing Report refers to these files and logs, as they are updated as part of normal laboratory operations without necessitating a revision change. However, they are considered part of the management system.

4.2.6 Roles and responsibilities The roles and responsibilities of the Technical Manager and Quality Manager, including their responsibility for ensuring compliance with ISO/IEC 17025 and NIST Handbook 150 is documented in the QMS-ORG-01 and a PROQUIS Job Skills Required/Position Description Report for the Technical Manager Job Description and Quality Manager Job Description, respectively.

4.2.7 Management system integrity TSC’s top management shall ensure that:

a) Planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives.

b) Integrity of the quality management system is maintained when changes to the quality management system

are planned and implemented through the Control of Documents Procedure (QMS/CL-PM-17), the Management Review Process (QMS/CL-PM-12), and the Internal Audit Process (QMS/CL-PM-10).

4.3 Document control

4.3.1 General TSCL has established and maintains the Control of Documents Procedure (QMS/CL-PM-17) for controlling all internally generated documents and documents of external origin that form part of this management system. Refer to Control of Records Procedure (QMS/CL-PM-22) for storage, retention, and disposition.

4.3.2 Document approval and issue All documents issued to personnel at TSCL as part of the management system are reviewed and approved by authorized personnel in accordance with Control of Documents Procedure (QMS/CL-PM-17) prior to issue. The PROQUIS Controlled Document Master List identifies the current revision status and distribution of documents in the management system. The PROQUIS Controlled Document Master List is readily available to all staff in order to preclude the use of invalid and/or obsolete documents.



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Documents are periodically reviewed and a record of document review is retained in the PROQUIS database. Obsolete documents of external origin are retained for either legal or knowledge preservation purposes and they are suitably marked as OBSOLETE with reference to the document that supersedes it. Electronic documents are archived by PROQUIS when that document is revised. All internally generated management system documents are uniquely identified. The identification includes the revision level, date of issue, page numbering, and total number of pages, as well as the authority approving the document.

4.3.3 Document changes Changes to documents are reviewed and approved by the same function that performed the original review, unless specifically designated otherwise; see the Control of Documents Procedure (QMS/CL-PM-17). The designated personnel have access to pertinent background information upon which to base their review and approval. Previous revisions of documents are stored in the PROQUIS Document Register as archived documents. Revised documents that are external to the PROQUIS database are stamped as a document of external origin with a document number (issue number or letter) and with identification of the document that superseded it. TSCL’s documentation control system does not allow for the amendment of documents by hand. The maintenance, and control of electronic documents in the Document Control system are described in the Control of Documents Procedure (QMS/CL-PM-17).

4.4 Review of requests, tenders and contracts TSCL’s procedure for the review of requests, tenders and contracts is given in the Customer Quote Process (QMS /CL-PM-02) and the Customer Order Process (QMS /CL-PM-03). Reviews are entered and records are retained in the PROQUIS Customer Care Register. The customer is informed of any deviation from the contractual requirements. If the contract needs to be amended after work has commenced, the Customer Order Process (QMS/CL-PM-03) spells out that the same contract review process is repeated and that any amendments are communicated to all affected personnel.

4.5 Subcontracting of calibrations This section describes the arrangements in place at TSCL for ensuring the quality of calibrations placed with sub-contractors. Note: Currently TSCL does not subcontract its calibration service.

4.5.1 Eligible sub-contractors The policy of TSCL is to only use accredited laboratories to perform calibrations as sub-contractors. The calibrations have to be within the scope of accreditation of the sub-contracting laboratory.

4.5.2 Advising the customer TSCL shall advise the customer in writing in advance of any intention to sub-contract calibrations. When appropriate, TSCL will gain the approval of the customer in writing, when possible.

4.5.3 Responsibility for sub-contractor work TSCL considers itself responsible to the customer for the sub-contractor’s work, except in the case where the customer or a regulatory authority specifies which sub-contractor is to be used.



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4.5.4 Register of sub-contractors TSCL maintains a Vendor List on each subcontractor that it uses for calibrations. This file contains the record of the evidence of the sub-contractor’s accreditation to ISO/IEC 17025 by an ILAC MRA recognized accrediting body.

4.6 Purchasing services and supplies The purchasing Vendor List defines the scope of services and supplies covered by the provisions in this section.

4.6.1 Selection and purchasing of services and supplies The Purchasing of Products or Services Policy (QMS/CL-POL-25) defines the measures put in place for selection and purchasing of services and supplies to ensure that the quality of these services and supplies is adequate to sustain confidence in TSCL’s calibrations. The Purchase, Reception and Storage of Consumable Materials Procedure (QMS/CL-PM-11) provides details of how reagents and consumable materials relevant for TSCL’s tests and calibrations are purchased, received and stored.

4.6.2 Verification of services and supplies It is the policy of TSCL to require purchased equipment, materials, and services to comply with the specified requirements. TSCL will, wherever possible, ensure that purchased equipment and consumable material are not used until they have been inspected, calibrated or otherwise verified as complying with all standard specifications relevant to the calibrations concerned.

4.6.3 Purchasing documents for services and supplies The Control of Purchased Product or Services Procedure (QMS/CL-PM-25) provides details of how the purchasing documents are issued, reviewed, and approved for technical content.

4.6.4 Evaluation of suppliers The purchasing Vendor List contains records of all approved suppliers from whom TSCL obtains support services or supplies required for calibration, including records of evaluations of the suppliers.

4.7 Service to the customer

4.7.1 Customer cooperation TSCL affords customers and their representatives cooperation to clarify the customer’s request and to monitor TSCL’s performance in relation to the work performed, provided that this can be done while ensuring the confidentiality of other customers.

Such cooperation shall include: a) Providing the customer or the customer’s representative reasonable access to relevant areas of the

laboratory for the witnessing of tests and/or calibrations performed for the customer. b) Preparation, packaging, and dispatch of test and/or calibration items needed by the customer for

verification purposes.



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TSCL shall maintain good communication with the customer throughout the job process and shall inform the customer of any delays or major deviations in the performance of the tests and/or calibrations via fax, email, or phone call (with record of contact with customer).

4.7.2 Customer feedback TSCL actively strives to obtain feedback, both positive and negative, from its customers (i.e. customer surveys, website link, etc.). The feedback is used to analyze and improve the management system, testing and calibration activities, and customer service. The process for acquiring/analyzing feedback is documented in Feedback Process (QMS/CL-PM-08).

4.8 Complaints This section defines the policies and procedures put in place by TSCL to resolve complaints from customers and other parties about the laboratory’s activities. The policy adopted by TSCL for the resolution of complaints from customers and other parties about the laboratory’s activities is documented in the Corrective Action Policy (QMS/CL-POL-05). The procedure for resolving complaints is documented in the Corrective Action Procedure (QMS/CL-PM-05). Records of all complaints and the actions taken by TSCL to resolve them are contained in the PROQUIS Customer Care Register and the PROQUIS Nonconformity Log.

4.9 Control of nonconforming testing and/or calibration work

4.9.1 Policy and procedure for nonconforming work TSCL’s policy regarding nonconforming calibration work is documented in the Control of Nonconforming Material/Services Policy (QMS/CL-POL-11) and the Control of Nonconforming Product and Services Procedure (QMS/CL-PM-09). The procedure for feedback and corrective action, which is used whenever nonconforming calibration work is detected or departures from documented policies and procedures occur, is documented in the PROQUIS Nonconformity Log in accordance with the Corrective Action Procedure (QMS/CL-PM-05). TSCL notifies customers promptly, in writing, fax, email, or phone call (with record of customer contact), of:

- Any event such as the identification of defective calibration equipment that casts doubt on the validity of results given in any calibration certificate or report, or amendment to a calibration certificate or report. The notification will quantify the magnitude of the error created in the calibration result.

- Any customer’s measuring or test equipment found to be out-of-tolerance, or found to be nonfunctional during the calibration/verification process will be reported to the customer. Measurement data will be reported to the customer so that appropriate action can be taken.

4.9.2 Nonconforming work corrective action Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of TSCL’s operations with its own policies and procedures, the corrective action procedures given in section 4.11 are promptly followed.



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4.10 Improvement TSCL monitors the effectiveness of its management system using the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, management review, and by complying with the requirements of ISO/IEC 17025. The combined activities sustain the improvement effort within TSCL.

4.11 Corrective action TSCL’s policy regarding corrective action is documented in the Corrective Action Policy (QMS/CL-POL-05). The procedure for feedback and corrective action, documented in the Corrective Action Procedure (QMS/CL-PM-05), is used whenever nonconforming calibration work is detected, or departures from documented policies and procedures occur. When the identification of nonconformance or departures from policies and procedures cast doubt on TSCL’s compliance with its policies and procedures or its compliance with ISO/IEC 17025, the appropriate areas of activity are audited in accordance with section 4.14 as soon as possible.

4.12 Preventive action TSCL strives to identify needed improvements and potential sources of nonconformance concerning the management system and/or technical requirements. When opportunities are identified for improvement, or if preventive action is required, action plans are developed, implemented, and monitored to reduce the likelihood of the occurrence of such nonconformance and to take advantage of the opportunities for improvement. Preventive action is implemented and the effectiveness of such actions is documented in accordance with the Preventive Action Procedure (QMS/CL-PM-06).

4.13 Control of records

4.13.1 General TSCL’s procedure for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records is documented in the Control of Records Procedure (QMS/CL-PM-22). Data protection and backup is documented in the Data Protection and Backup Procedure (QMS/CL-PRO-13).

4.13.2 Technical Records TSCL retains records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records, and a copy of each calibration certificate issued, for 5 years. The records for each calibration contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the calibration to be repeated under conditions as close as possible to the original. The records include the identity of personnel responsible for the sampling, performance of each calibration and checking of results. Observations, data, and calculations are recorded at the time they are made and are identifiable to the specific task. When a mistake occurs in a record the mistake is crossed out and the correct value is then entered alongside. Mistakes are not erased, made illegible or deleted. All such alterations to records are signed or initialed by the person making the correction. In the case of records stored electronically, equivalent measures are taken to



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avoid loss or change of original data. All records stored electronically through PROQUIS are access controlled and a running audit trail is generated for all changes in the database.

4.14 Internal audits TSCL periodically conducts internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and ISO/IEC 17025, see Internal Audit Process (QMS/CL-PM-10). Planned audits are documented in the PROQUIS Audit Register. Audits are planned such that all elements of the management system, including the calibration activities are audited at least once per year. It is the responsibility of the Quality Manager to plan and organize audits as required by the Internal Audit Plan and as requested by management. Wherever possible, the audits are carried out by trained and qualified staff that is independent of the activities being audited. The audits are designed to determine:

- Whether procedures described in the management system are being followed; - Whether management system objectives are being achieved; - Whether designated duties are being carried out satisfactorily; and - Whether there are opportunities for improvement.

When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of TSCL’s calibration results, TSCL will take timely corrective action, and notify customers in writing, fax, email or phone call (with record of the contact with customer and the contents of discussion), if investigations show the laboratory results may have been affected. Completed audits are documented in the PROQUIS Audit Register. The documentation includes the area of activity audited, the audit findings and corrective actions that arise from them. See PROQUIS Internal Audit Details Report. Corrective action requests initiated because of the audits are documented in the PROQUIS Nonconformity Register. Follow-up audit activities verify and record the implementation and effectiveness of the corrective action taken.

4.15 Management reviews A management review of the management system is conducted at a minimum once every year to ensure the management system continues to be suitable and effective and to introduce any necessary changes or improvements. See Management Review Process (QMS/CL-PM-12) The management review follows a set agenda that is maintained in the PROQUIS Management Review Register. The minutes of completed management reviews are documented in the PROQUIS Management Review Register Corrective action requests initiated because of the management reviews are documented in the PROQUIS Management Review Report and the Management Review Nonconformity Register. Follow-up audit activities verify and record the implementation of the corrective action within an appropriate and agreed timescale, as well as the effectiveness of the corrective action taken. See PROQUIS Internal Audit Process Detail Report.



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5. Technical Requirements This section describes the technical system implemented at TSCL.

5.1 General Appropriate factors affecting the correctness and reliability of the calibrations and/or tests performed at TSCL are accounted for which include contributions from:

- Personnel (5.2) - Accommodation and environmental conditions (5.3) - Calibration and test procedures (5.4) - Laboratory equipment (5.5) - Measurement traceability (5.6) - Sampling (5.7) - Handling calibration items (5.8)

The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) calibrations. TSCL takes account of these factors in developing calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

5.2 Personnel

5.2.1 Competence The management at TSCL ensures the competence of all who operate specific equipment, perform calibrations, evaluate results, and sign calibration certificates by documenting the necessary education, training, technical knowledge and experience for each job function at TSCL. See the Personal Skills Training Register. The adequacy of the personnel is evaluated on an on-going basis as well as during the annual management review. The evaluation covers qualifications, training, skills and experience requirements, as well as manpower requirements. Appropriate supervision is provided for staff that is undergoing training. Personnel performing specific tasks shall be qualified based on appropriate education, training, experience and/or demonstrated skills, as required. See the calibration technician’s individual training records for specific training information.

5.2.2 Training goals The management of TSCL formulates the goals with respect to the education, training, and skills of the laboratory personnel. The training needs of the personnel at TSCL are evaluated on an on-going basis. For new employees a New Hire Introduction is conducted to familiarize the new employee with the systems and procedures employed by TSCL. For new employees, and employees who change jobs, Training Records are prepared and filed. The training records identify the training needs for the employee as the difference between the required skills for the position and the skills the employee already has. The training records are updated whenever new task training has occurred and/or at the employee’s annual review. When any new training is conducted, the effectiveness of the training is evaluated to ensure competence. TSCL’s procedure for skills training is described in Training Procedure (QMS/CL-PM-07).



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5.2.3 Employment relationship TSCL only uses personnel who are employed by, or under contract to, TSC. Where contracted and/or additional technical key support personnel are used, TSCL ensures such personnel are supervised and competent and that they work in accordance with TSCL’s management system.

5.2.4 Job descriptions TSCL maintains current job descriptions for managerial, technical, and key support personnel involved in calibrations. See PROQUIS Personnel Module. A report of the job descriptions is contained in the PROQUIS Skills Required/Position Description Report.

5.2.5 Authorizations The Technical Manager authorizes specific personnel to perform particular types of calibration, to issue calibration certificates, to give opinions and interpretations and to operate particular types of equipment. Records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel are maintained in the appropriate PROQUIS Personnel Module. This information includes the date on which authorization and/or competence was confirmed and kept readily available.

5.3 Accommodations and environmental conditions

5.3.1 Laboratory accommodations TSCL’s facilities for calibration, including but not limited to energy sources, lighting and environmental conditions, are designed to facilitate correct performance of the tests and/or calibrations. TSCL ensures that the environmental conditions do not invalidate the results or adversely affect the required quality of any measurement by taking into account the uncertainty budgets for each particular measurement. Particular care is taken when calibrations are undertaken at sites other than a permanent laboratory facility. The technical requirements for accommodation and environmental conditions that can affect the results of calibrations are documented in the applicable uncertainty budgets.

5.3.2 Monitoring and recording of environmental conditions TSCL uses temperature and humidity recorders to monitor and record the environmental conditions in the laboratory, see the Laboratory Environment Control Procedure (CL-PRO-08). The placement of each recorder is designed to accurately represent the calibration area. Calibrations are stopped when the environmental conditions jeopardize the results of the calibrations and corrective action is taken in accordance with the Corrective Action Procedure (QMS/CL-PM-05). All temperature and humidity records are maintained for 5 years or per customer requirements.

5.3.3 Separation of incompatible activities All activities that are incompatible with the performance of the calibrations offered by TSCL are banned from the laboratory. See the Laboratory Access Policy (CL-POL-06).

5.3.4 Laboratory access Access to the laboratory is described in the Laboratory Access Policy (CL-POL-06). The laboratory is secure when no authorized personnel are on duty.



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5.3.5 Good Housekeeping All employees are required to comply with the Good Housekeeping Policy (QMS/CL-POL-07). No special procedures are necessary.

5.4 Calibration methods and method validation

5.4.1 General TSCL uses appropriate methods and procedures for all calibrations within its scope. Refer to the individual equipment Calibration Standard Operating Procedure (CL-SOPs). All instructions on the use and operation of all relevant equipment are contained in or referenced from the individual equipment operating manuals. Special instructions for handling, transport, storage, and preparation of items for calibration are documented in the individual equipment Calibration Standard Operating Procedure. All instructions, standards, manuals, and reference data relevant to the work of TSCL are kept up to date and made readily available to personnel (see section 4.3). Deviation from calibration methods is only allowed if the deviation has been documented, technically justified, authorized by the Technical Manager, and accepted by the customer.

5.4.2 Selection of methods TSCL uses calibration methods, which meet the needs of the customer and which are appropriate for the calibrations it undertakes. Methods published in international, regional, or national standards are preferably used. TSCL ensures it uses the latest valid edition of a standard (see section 4.3) unless it is not appropriate or possible to do so. When necessary, the standards are supplemented with additional details to ensure consistent application (Refer to Calibration Measurement Assurance Procedures, CL-MAPs). When the customer does not specify the method to be used, TSCL selects appropriate methods that have been published either in international, regional or national standards, or by reputable technical organizations, or in relevant scientific texts or journals, or as specified by the manufacturer of the equipment. TSCL informs the customer when the method proposed by the customer is considered inappropriate or out of date. In-house developed methods or methods adopted by TSCL may also be used if they are appropriate for the intended use and if they are validated and approved by the Technical Manager TSCL confirms it can properly operate standard methods before introducing the calibrations. If the standard method changes, the confirmation is repeated.

5.4.3 In-house developed methods The introduction of calibration methods developed in-house is a planned activity that is assigned to qualified personnel equipped with adequate resources. In-house methods are updated as development proceeds. Communication is ensured amongst all personnel involved by using the PROQUIS Document Control Register and training sessions, as applicable (See Control of Documents Procedure QMS/CL-PM-17).

5.4.4 Non-standard methods When it is necessary to use methods not covered by standard methods, the non-standard methods are subject to agreement with the customer and shall include a clear specification of the customer's requirements. It is the responsibility of the Quality Management to ensure that the method developed has been validated appropriately before use.



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5.4.5 Validation of methods TSCL validates non-standard methods, in-house designed/developed methods, standard methods used outside their intended scope, 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. It is the responsibility of the Technical Management to ensure the results obtained, the procedure used for the validation, and a statement as to whether the method is fit for the intended use is recorded. The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences and/or cross-sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, shall be relevant to the customers' needs.

5.4.6 Estimation of uncertainty of measurement TSCL determines measurement uncertainty in accordance with the “Guide to the Expression of Uncertainty in Measurement” and “NIST Technical Note 1297”, taking into account all uncertainty components, which are of importance in the given situation. TSCL states the uncertainty of the measurements and calibrations it performs using a coverage factor of k=2 providing a level of confidence of approximately 95%. TSCL requires its calibration suppliers to provide actual values and uncertainties for the attributes of the equipment and standards calibrated. When this is not achievable, for technical or economical reasons, the Technical Management must approve the deviation from this policy before the calibration is performed. For the calibrations TSCL provides to its customers, TSCL shall provide actual values and uncertainties for all attributes calibrated,.

5.4.7 Control of data Calculations and data transfer are subject to checks, see Calibration Certificate Preparation and Approval Procedure (CL-PRO-12). When using computers and automated equipment, TSCL ensures all relevant requirements of ISO/IEC 17025 are taken into account. TSCL ensures that computer software is documented and validated as being adequate for use by either:

- Using commercially available software, where significant resources have been expended to validate and document the software, or;

- Validate and document software developed in-house or specifically for TSCL. TSCL ensures the integrity of data entry and capture by comparing handwritten data (if applicable) to the data entered into computer systems as documented in the Calibration Certificate Preparation and Approval Procedure (CL-PRO-12). Data transmission and processing is verified by evaluating the measured results compared to expected results, charts, graphs etc. as documented in the Calibration Certificate Preparation and Approval Procedure (CL-PRO-12). Data storage is protected as documented in the Data Protection and Backup Procedure (QMS/CL-PRO-13). Unauthorized access to computer records is prevented and confidentiality is preserved by password protecting computers and keeping the laboratory premises secure when no personnel are present.



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TSCL provides electronic transmission of calibration results only upon specific request of the customer. The Electronic Transmission Procedure (QMS/CL-PRO-15) gives the details of the precautions taken to ensure confidentiality is preserved. Computer and automated equipment is maintained to ensure proper functioning, detailed information is contained in the PROQUIS Equipment Maintenance Procedure (CL-PRO-04) and is provided with the environmental and operating conditions necessary to maintain the integrity of calibration data.

5.5 Equipment This section describes the equipment and reference materials used by TSCL for calibrations within its scope.

5.5.1 Equipment inventory TSCL is equipped with instrumentation that is required for the correct performance of calibrations and verifications. TSCL does not use equipment that is outside its permanent control. The required equipment is documented in each calibration procedure in the Individual Equipment Calibration Standard Operating Procedures (CL-SOPs). The inventory of equipment is documented in the Calibration Manager Database.

5.5.2 Equipment capability and calibration TSCL ensures equipment and software used for calibration are capable of achieving the required accuracy by requiring they comply with specifications relevant to the calibrations concerned. Refer to Measurement Assurance Procedures (CL-MAPs). Calibration programs are established for key quantities or values of the instruments where these properties have a significant effect on the results (see Traceability of Calibration Equipment Procedure CL-PRO-02). Before being placed into service, equipment is calibrated or checked to establish that it meets TSCL’s specification requirements and complies with the relevant standard specifications (see Traceability of Calibration Equipment Procedure CL-PRO-02).

5.5.3 Operation of equipment Only laboratory personnel qualified according to their individual training records, as recorded in the PROQUIS Personnel Register, are authorized to operate a given piece of equipment. Up-to-date instructions on the use and maintenance of equipment (including any relevant manuals provided by the manufacturer of the equipment) are readily available for use by laboratory personnel.

5.5.4 Identification of equipment Each piece of major equipment and each reference standard (see Calibration Manager Database) are uniquely identified.

5.5.5 Equipment records A record is maintained in the Calibration Manager Database for each piece of major equipment and each reference standard.



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5.5.6 Equipment procedures Procedures for safe handling, transport, storage, use and planned maintenance of each piece of measuring equipment to ensure proper functioning and in order to prevent contamination or deterioration, as applicable, are called out in the Handling of Reference Standards and Calibration Items (CL-PRO-21).

5.5.7 Equipment mishandling Measuring and test equipment that has been subjected to overloading or mishandling, is unstable, has intermittent problems, or has been shown to be defective, is removed from service. Such equipment is isolated to prevent its use and clearly labeled in accordance with the Control of Nonconforming Product and Services Procedure (QMS/CL-PM-09) as being out of service until it has been repaired and shown by calibration or verification to perform correctly. Details of the suspect non-conformance are entered in the PROQUIS Nonconformity Log (See Control of Nonconforming Product and Services Procedure QMS/CL-PM-09). TSCL examines the effect of defects on previous calibrations and if applicable according to the Control of Nonconforming Material and Services Policy (QMS/CL-POL-11), the Corrective Action Procedure (QMS/CL-PM-05) is initiated.

5.5.8 Calibration status The calibration status of equipment owned by TSCL is recorded in the Calibration Manager database and provided through the Calibration Manager Calibration Recall Report. All of the equipment under control of the laboratory is labeled per Calibration Status and Safeguarding of Calibration Equipment (CL-PRO-23).

5.5.9 Equipment going outside TSCL’s control When, for whatever reason, equipment goes outside the direct control of TSCL, the function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to service.

5.5.10 Intermediate checks When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks are carried out according to the Calibration Standard Operating Procedures (CL-SOPs).

5.5.11 Correction factors Where calibrations give rise to a set of correction factors, TSCL ensures all copies (e.g. in computer software) are correctly updated. Affected calibration procedures contained in the PROQUIS Document Control System give details of how this is accomplished in each case.

5.5.12 Safeguard against adjustments Where relevant, the Calibration Status and Safeguarding of Calibration Equipment (CL-PRO-23) outlines how calibration equipment is safeguarded from adjustments, which would invalidate the calibration results.

5.6 Measurement traceability

5.6.1 General All equipment used for calibrations, including equipment for subsidiary measurements (e.g. for environmental conditions) having a significant effect on the accuracy or validity of the result of the calibrations, is calibrated before being put into service. TSCL’s program and procedures for the calibration of its equipment is given in the Traceability of Calibration Equipment Procedure (CL-PRO-02).



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5.6.2 Specific Requirements The program for calibration of equipment is designed and operated to ensure calibrations and measurements made by TSCL are traceable to the International System of Units (SI). It is the policy of TSCL to use National Metrology Institutes (i.e. NIST) or laboratories accredited by ILAC MRA recognized accrediting bodies to provide metrological traceability. Where no accredited laboratory is available to provide traceability as described above, TSCL will investigate the adequacy of the calibrations by requesting documentation of the laboratory’s procedures, uncertainty analysis, and proof of traceability. It is the policy of TSCL to require its calibration suppliers to document calibration results in a calibration certificate (however named) that, wherever applicable:

- Indicate the traceability to national standards of measurement and/or SI; - Provide the measurement results and associated uncertainty of measurement; and/or - Provide a statement of compliance with an identified metrological specification.

There are certain calibrations that currently cannot be strictly made in SI units. In these cases, calibration shall provide confidence in measurements by establishing traceability to appropriate measurement standards such as:

- The use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterization of a material;

- The use of specified methods and/or consensus standards are clearly described and agreed by all parties concerned.

In these cases, TSCL participates in suitable programs of interlaboratory comparisons, where possible.

5.6.3 Reference standards and reference materials

Reference standards TSCL’s program and procedure for the calibration of its reference standards is given in the Traceability of Calibration Equipment Procedure (CL-PRO-02). Laboratories that can provide traceability as described in 5.6.2 calibrate TSCL’s reference standards. The reference standards of measurement held by TSCL are used for calibration only and for no other purpose, unless it can be shown that performance as reference standards are not invalidated. Reference standards are calibrated before and after any adjustment.

Reference materials Reference materials held by TSCL are, wherever possible, traceable to SI units of measurement, or to certified reference materials. Internal reference materials are checked as far as is technically and economically practicable.

Intermediate checks Intermediate checks, needed to maintain confidence in the calibration status of primary, transfer or working standards and reference materials, are carried out according to procedures and schedules linked to the Calibration Manager Database.



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Transport and storage TSCL’s procedures for safe handling, transport, storage and use of reference standards and reference materials in order to prevent contamination or deterioration and in order to protect their integrity are given in the Handling of Reference Standards and Calibration Items (CL-PRO-21).

5.7 Sampling TSCL does not perform sampling.

5.8 Handling of calibration items

5.8.1 General TSCL’s procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of calibration items, including all provisions necessary to protect the integrity of the calibration item, and to protect the interests of the laboratory and the customer are outlined in this section.

5.8.2 Identification of calibration items Calibration items are identified as documented in the Control of Customer Furnished Product Procedure (QMS/CL-PM-28).

5.8.3 Condition of calibration items Upon receipt, the condition of the calibration item is recorded, including any abnormalities or departures from normal or specified conditions as prescribed in the relevant calibration method, as documented in the Control of Nonconforming Product and Services Procedure (QMS/CL-PM-09) and Control of Customer Furnished Product Procedure (QMS/CL-PM-28). Where there is any doubt as to the item’s suitability for calibration, where the item does not conform to the description provided, or where the calibration required is not fully specified, TSCL will consult with the customer for further instructions before proceeding and record the discussion in the PROQUIS Customer Care Register. At this time, TSCL also establishes whether the item to be calibrated has received all the necessary preparation or whether the customer requires special preparation of the calibration item to be undertaken or arranged by TSCL.

5.8.4 Protection of calibration items Calibration items are handled, stored, protected, and when necessary held secure per Handling of Reference Standards and Calibration Items (CL-PRO-21) and Control of Customer Furnished Product Procedure (QMS/CL-PM-28) ensuring no deterioration, loss or damage takes place. When items must be stored or conditioned under specified environmental conditions, these conditions will be maintained, monitored, and recorded.

5.9 Assuring the quality of calibration results TSCL’s Proficiency Testing Procedure (CL-PRO-20) provides information about its policy and practices towards NVLAP’s Proficiency Testing (PT) requirements. Calibration Measurement Assurance Procedure for Humidity (CL-MAP-008), Calibration Measurement Assurance Procedure for Temperature (CL-MAP-003) and Calibration Measurement Assurance Procedure for Pressure (CL-MAP-001), are procedures used for monitoring the validity of calibrations.



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Data from interlaboratory comparison and equipment calibrations is recorded in such a way that trends are detectable and, where practicable, statistical techniques are applied to analyze the results. The monitoring is comprised of:

- Internal quality control schemes, replicate testing, re-testing and correlation of results as documented in the Calibration Records (See Cross Reference for Records (CL-QM-ANNEX-B).

- Participation in interlaboratory comparisons and proficiency-testing programs.

5.10 Reporting the results

5.10.1 General The results of each calibration or series of calibrations carried out by TSCL is reported accurately, clearly, unambiguously and objectively, and in accordance with any specific calibration instructions or method. The results are reported in a calibration report, including all information requested by the customer necessary for the interpretation of the calibration results and all information required by the method used. In the case of calibrations or tests performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified manner. Any information normally included in calibration certificates, which is not reported to the customer, will be kept readily available at TSCL.

5.10.2, 5.10.3 and 5.10.4 Calibration certificates and calibration reports Refer to Calibration Certificate Preparation and Approval Procedure (CL-PRO-12). For use of the term NVLAP and NVLAP Logo refer to NVLAP Term and Logo Control Policy (QMS/CL-POL-08) and NVLAP Term and Logo Control Procedure (QMS/CL-PRO-08). 5.10.4.1 Calibration data The calibration certificates issued by TSCL relate only to quantities and the results of functional tests. If a statement of compliance with a specification is made, it will identify which clauses of the specification are met or not met.

5.10.4.2 Statement of Compliance When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, TSCL will record those results and maintain them for possible future reference. When statements of compliance are made, the uncertainty of measurement is taken into account, refer to the Calibration Certificate Preparation and Approval Procedure (CL-PRO-12). 5.10.4.3 Adjustment or repair When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment or repair are reported, if available. 5.10.4.4 Calibration intervals Calibration certificates and calibration labels issued by TSCL will not contain any recommendation on the calibration interval except where this has been agreed with the customer. Refer to Determining Calibration Intervals Procedure (QMS/CL-PRO-07) for TSCL equipment.



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5.10.5 Opinions and interpretations When opinions and interpretations are included in calibration certificates, TSCL documents the basis upon which the opinions and interpretations have been made. Opinions and interpretations are clearly marked as such in the calibration certificate; refer to the Calibration Certificate Preparation and Approval Procedure (CL-PRO-12).

5.10.6 Calibration results obtained from subcontractors When a calibration has been subcontracted, the laboratory performing the work shall issue the calibration certificate to TSCL. Note: TSCL does not subcontract its calibration services without consulting the customer.

5.10.7 Electronic transmission of results The Electronic Transmission Procedure (QMS/CL-PRO-15) is used in the case of transmission of calibration results by telephone, facsimile, PDF or other electronic means.

5.10.8 Format of certificates The certificate format is designed to accommodate each type of calibration carried out and to minimize the possibility of misunderstanding or misuse. Refer to Calibration Certificate Preparation and Approval Procedure (CL-PRO-12).

5.10.9 Amendments to calibration certificates Material amendments to a calibration certificate or report after issue is made only in the form of a further document or data transfer including the statement “Supplement to Certificate of Calibration” or “Supplement to Report of Calibration.” When it is necessary to issue a complete new calibration certificate, the new Certificate of Calibration is uniquely identified and referenced to the original it replaces; refer to the Calibration Certificate Preparation and Approval Procedure (CL-PRO-12).

Thunder Scientific Calibration Laboratory Quality Manual

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