1 of 19 BUSINESS PROCESS (BP) QUALITY MANAGEMENT SYS NAME SIGNATURE DATE PREPARED BY BILL ATKINSON SIGNATURE ON FILE 12/3/2014 APPROVALS DEPARTMENT NAME SIGNATURE DATE PRESIDENT DANNY ANGEL SIGNATURE ON FILE 12/3/2014 QUALITY BILL ATKINSON SIGNATURE ON FILE 12/3/2014 SALES DREW MULLINAX SIGNATURE ON FILE 12/3/2014 LAB MGR MATHEW COLLIER SIGNATURE ON FILE 12/3/2014 REVISION HISTORY REV DESCRIPTION OF CHANGE CO # DATE 4 CONVERSION TO NEW FORMAT, MINOR GRAMMER AND SPELLING CORRECTIONS,CREATION OF SOPS 4.1 MINOR SPELLING AND GRAMMER ERROR CORRECTION, SECTION 5.9 56 1/8/2014 NA 5/13/14 4.2 TYPO CORRECTED ON TEMP ON 15 NA 6/27/14 5.0 CONVERSION OF SPECIFIC ACCREDITING BODY TO MORE GENERAL DESCRIPTION 6.0 CLARIFICATION OF OWNERSHIP OF CONTROL OF NON CONFORMING MATERIAL CORRECTION BY DOC CONTROL ADMINISTRATOR OF DATA CORRUPTION IN FILE SAVE ERROR NA 11/2/2014 DCR #72 12/3/2014 NA 7/7/2015
2 of 19 Effective as of 22 October 2008: Check the file server for the current revision of this document. If this is the current revision, proceed. If this is NOT the current revision, print out the current revision and use that to proceed. Destroy all outdated and/or obsolete copies of this document. TABLE OF CONTENTS 1. Scope of Registration... 3 2. Angel s Instrumentation Corporate history... 3 3. Angel s Instrumentation Products and definitions... 3 Quality Management Systems... 4 4. Management Requirements... 4 4.1 Organization... 4 4.2 Management System... 6 4.3 Document Control... 10 4.4 Review of Requests, Tenders, and Contracts... 10 4.5 Subcontracting of Calibrations... 11 4.6 Purchasing Services and Supplies... 11 4.7 Service to the Customer... 11 4.8 Complaints... 12 4.9 Control of Nonconforming work... 12 4.10 Improvement... 13 4.11 Corrective Action... 13 4.12 Preventative Action... 13 4.13 Control of Records... 13 4.14 Internal Audits... 13 4.15 Management Review... 13 5. Technical Requirements... 14 5.1 General... 14 5.2 Personnel for Permanent and On-site... 15 5.3 Accommodation and Environmental Conditions... 15 5.4 Test and calibration methods and method validation... 16 5.5 Equipment... 16 5.6 Measurement traceability... 16 5.7 Sampling... 18 5.8 Handling of Test and Calibration Items... 18 5.9 Assuring the quality of calibration results... 18 5.10 Reporting the results... 19
3 of 19 1. SCOPE OF REGISTRATION Angel s Instrumentation Scope of Registration To satisfy our customer s needs, Angel s meets the requirements of ISO/IEC 17025, ANSI/NCSL Z540-3, our accrediting body requirements, and all appropriate regulatory authorities. Note: Throughout this Quality Manual and in other Angel s Instrumentation related documents, the words Angel s Instrumentation or AI refer to the Angel s Instrumentation facility at 928 Canal Drive, Chesapeake, VA. The scope of the Quality Management System (QMS) registration is applicable to this site, onsite Commercial Operations and Shipboard Calibrations only. 2. ANGEL S INSTRUMENTATION CORPORATE HISTORY Angel's Instrumentation, Inc. is registered as a Subchapter S Corporation in the State of Virginia. The administrative headquarters is located at 928 Canal Drive, Chesapeake, VA 23323 3. ANGEL S INSTRUMENTATION PRODUCTS AND DEFINITIONS Angel's Instrumentation, Inc. has been serving high-technology companies by providing state-of-the-art product sales and calibration services. Our experienced personnel ensure that Angel s is constantly improving to meet the advancing calibration, repair, and quality requirements of today s market. In addition to offering Accredited ISO/IEC 17025 and ANSI/NCSL Z540-3, and NIST traceable calibrations our services include providing the following: ISO/IEC 17025 consultation services Asset management Compliance with our accrediting body requirements, guidelines and procedures preventative maintenance on-going service contracts All these services are performed under the quality requirements outlined within this manual. Definitions: Permanent Laboratory: A calibration or testing laboratory erected on a fixed location for a period expected to be greater than three years. Field: Any location where testing or calibration takes place outside of the primary facility Field Test/Calibration: Testing/Calibration (including sampling where it forms part of the documented calibration or test procedure) performed by staff of a laboratory or organization outside of the premises or grounds on which the permanent laboratory or the organization's permanent base or headquarters is located. Field Laboratory: A testing or calibration laboratory facility set up in a dedicated area location or at
4 of 19 a customer's premises, outside of the organization's Materials laboratory set up at an airport construction site, a calibration laboratory under contract set up in support of a customers manufacturing process) All field laboratories must be identified on the application paperwork, be assessed as part of the permanent laboratory assessment, and be identified on the laboratory's scope of accreditation. Mobile Laboratory: Fully equipped, self-contained, transportable testing or calibration laboratory capable of performing tests or calibrations under controlled environmental conditions. (Note: Mobile laboratories are subject to the same terms of accreditation as a site laboratory. Mobile laboratories left at one site for three yeas or more will be subject to the same terms of accreditation as a permanent laboratory Site Laboratory: A testing or calibration laboratory facility set up in a dedicated area on-site for the duration of the testing or calibration activities but not for periods expected to exceed three years. QUALITY MANAGEMENT SYSTEMS The Angel s Instrumentation quality system documents/procedures that satisfy the clauses and requirements set forth in the ISO/IEC 17025:2005 -General requirements for the competence of testing and calibration laboratories standard, and/or other applicable regional, national or international standards or regulations are referenced at the applicable clause(s) within this document. Copies of a current version of this document are available to all Angel s Instrumentation employees, and those outside Angel s Instrumentation, by request. 4. MANAGEMENT REQUIREMENTS 4.1 Organization Angel's Instrumentation, Inc. is registered as a Subchapter S Corporation in the State of Virginia. The administrative headquarters is located at 928 Canal Drive, Chesapeake, VA 23323 4.1.2 To satisfy our customer s needs, Angel meets the requirements of ISO/IEC17025, our accrediting body, and all appropriate regulatory authorities. 4.1.3 Angel s quality and laboratory Quality Management System is applicable to all work carried out by Angel's personnel both in-house and on site locations. 4.1.4 All personnel, irrespective of other responsibilities, are required to report any nonconforming work by use of non-conformance sheets. This includes but is not limited to, improvements, departures, and preventive departures from the current management system. (See Integrity Policy) 4.1.5 Angel s Instrumentation:
5 of 19 a) has given the Quality Manager the authority and resources needed to carry out his/hers duties and to identify the occurrence of departures from the management system requirements; and has given the Metrology Manager the authority and resources needed to carry out his duties and to identify the occurrence of departures from the procedures for performing calibrations, and to initiate actions to prevent or minimize such departures; This includes the implementation of and improvement of the management system. b) requires that all personnel are free from any undue internal and external commercial, financial, and other pressures and influences that may adversely affect the quality of their work or diminish confidence in their competence, impartiality, judgment or operational integrity (completed Memorandum of Agreements maintained on file); (see Integrity Policy) c) has instructed all personnel of the need to protect the confidential information and proprietary rights of all its customers; to include electronic back-ups (see backup Policy and see Integrity Policy) d) has instructed all personnel and has a policy to avoid involvement in activities that would diminish confidence in our competence, impartiality, judgment, or operation integrity (see Integrity Policy) e) has defined its organization and management structure and the relationships between quality management, technical operations and support using an organizational chart; f) Has specified through job descriptions, policies and procedures, organizational chart, and the QAM the responsibilities, authorities and interrelationships of all personnel who manage, perform, or verify work affecting the quality of the calibrations.(reference SOP: Roles and Responsibilities, doc# 200-17) g) Has identified the Metrology Manager whom is responsible for providing adequate supervision of calibration staff, including trainees by persons familiar with methods and procedures, purpose of each calibration, and with the assessment of the calibration results. (Reference SOP: Training, doc# 700) h) has identified the Metrology Manager as the individual having overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations including compliance with the requirements of ISO/IEC 17025 and ANSI/NCSL Z540-3; i) has given the Quality Manager the responsibility and authority for ensuring that the management system is compliant with the requirements of ISO/IEC 17025 and ANSI/NCSL Z540-3; and is implemented and followed at all times; The Quality Manager has direct access to the President who is responsible for making all decisions on laboratory policy or resources;
6 of 19 j) appoints deputies for key managerial personnel (See Authorization for Representation) k) Ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system via the annual meetings. 4.1.6 Top management (Field Service Manager, Vice President, and President) have an "open door" policy and annual meetings (on the annual meetings form) to facilitate the communication process on objectives and effectiveness of the managements system as required by ISO/IEC 17025 and ANSI/NCSL Z540-1. 4.2 Management System Angel s Instrumentation has established, documented, implemented, and maintains a QMS, and monitors its effectiveness in accordance with the requirements of the standards referred to in Section 4.0 appropriate to the scope of its activities. Angel s documents its policies, procedures, and instructions to the extent necessary to assure the quality of its calibration results. The system s documentation is understood by, available to, and implemented by all personnel as appropriate to their job function. A listing of those test or calibrations that Angel s is capable of performing are listed in Angel s Scope of calibration An up-to-date record of field location and the purpose for which they were used can be found querying calibration records (Query Labeled: "All Calibration Work Done On-Site Query"). Details of the specific test (s) or calibration (s) undertaken at each on-site location can be found by querying calibration records (Query Labeled: "All Calibration Work Done On-Site Query") Details of how the management system is applied to and incorporates field calibration is expressed in Angel s organizational chart. This includes supervision of the site operations. A separate listing of those test or calibrations that Angel s is capable of performing on-site are listed in the Angel s Scope of calibration. Only technicians whom are qualified through Angel s training program to perform tasks for onsite calibrations do so. Details of how the management system is applied to and incorporates site testing/calibration is the same as 4.1.5 (e.g.) Identification of approved signatures, criteria for signatory approval, and limits of signatory authority are provided in 4.1.4 and 5.2. This criterion includes an assessment of the necessary attributes. All Angel s Staff are aware of the requirements and conditions for ISO/IEC 17025 accreditation, particularly those related to calibration/test reports. The Angel s Instrumentation documentation includes: Angel s Instrumentation Statement of Commitment, Quality Policy, & Objectives
7 of 19 Angel s Instrumentation Top Management, and its employees, are committed to compliance with established requirements for Certification and/or other applicable regional, national or international standards or regulations, and maintaining the effectiveness of its Quality Management System. Angel s management system policies and objectives are defined in this Quality Manual. The overall objectives are documented in our quality policy statement below, and the object of the quality policy statement is reviewed periodically during management review meetings for continuing suitability and is issued under the authority of the President is as follows: Quality Policy Statement- Angel aims to provide timely service, quality service and cost savings to our customers. All employees are expected to understand the quality policy as it relates to their specific job responsibilities. To achieve this policy, Angel will ensure its services are provided in compliance with its quality system, documented calibration procedures, and the requirements of ISO/IEC 17025. Supporting Information- Our quality policy statement indicates our commitment and focus on our priority as an organization; achieving customer satisfaction. Our method to achieve ongoing customer satisfaction is by continually improving processes, products, and services to ensure they consistently meet or exceed stated requirements. Moreover, our quality policy statement acts as a compass in providing the direction and framework for establishing key corporate level performance measures (KPI) and related improvement objectives. Each employee is charged with the responsibility to ensure product quality, continuous reliability, and service improvements as applicable to their respective functions. We ensure that our quality policy is communicated and understood at all levels of the organization through new employee orientation, documented training, periodic communications, and periodic reinforcement. Our quality policy statement is controlled by inclusion in this manual. Quality Objectives-The key quality objectives established are: 5 Day Calibration Turnaround QMS Training for All Employees Semi-annual Quality Update Meetings
8 of 19 A number of other metrics have been established to measure QMS effectiveness that include, but is not limited to: Product & Process Performance, Customer Feedback, and Internal Audit Results The established quality objectives are: 100% QA Final Inspection 5% QVI 100% Pass Increase Calibration throughput by decreasing the time interval between intake to invoice dates. Information relating to the above metrics is collected and analyzed. The resulting performance data, related to these measures, is communicated to the appropriate Angel s Instrumentation management and employees. Where the standards specify that a requirement, procedure, activity, or special arrangement be documented it is documented, implemented, and maintained. Where Angel s Instrumentation chooses to outsource any process that affects calibration requirements, Angel s Instrumentation ensures control over such processes. Control of such outsourced processes is identified within this QMS, and purchasing and supplier control procedures and processes are defined by SOP: Purchase of Cal Services and Supplies, Doc# 600. Angel s Instrumentation shall not outsource any ISO/IEC 17025 accredited work for customer devices. Note: Processes needed for the QMS referred to above include processes for management activities, provision of resources, product realization, and measurement. The QMS is documented in a tiered presentation format, documented in SOP: Procedure for Procedures, Document # 400-6: Figure 1 depicts the structure and hierarchy of Angel s Instrumentation quality documents.
9 of 19 Levels of Documentation Quality Manual Procedures Work Instructions Inspection & Test Calibration & Maintenance Forms and Records Corrective Action Quality Activities Procurement Material Management Production Maintenance Customer Interface Research & Development Servicing Statistical Techniques Business Functions Common Elements Management Responsibility Document Control Quality Records Training Audits Angel s Instrumentation utilizes a customer survey, customer complaints, and customer contact forms as customer feedback mechanisms to determine the effectiveness and continuous improvement of the managements system. Angel s Instrumentation's management review system reviews and ensures the continually improving effectiveness of the management system. Angel s Instrumentation Top Management is committed to meeting customers, statutory, and regulatory requirements. Angel's top management requires all employees to meet those requirements. Those requirements are communicated via our (See Meeting Agendas) annual meetings. When deemed necessary, the quality manual makes reference to supporting administrative and technical procedures. A listing of supporting documentation can be found in the master documentation list along with hyperlinks where necessary. Angel s Instrumentation documentation structure consists of the QAM as the uppermost level, Standard Operating Procedures (SOPs) as may be adopted, and lower level Work Instructions (WIs, Local Calibration Procedures (LCPs), Forms, and calibration certificate records. All roles and responsibilities are defined in Angel s management system as well as how they relate to ISO/IEC 17025, ANSI/NCSL Z540-1, and ANSI/NCSL Z540.3 Angel s Top managers are required to review and sign a QAM Review and Commitment Letter before release of any new QAM or components.
10 of 19 4.3 Document Control Angel s Instrumentation controls, through its master list and SOP: Document Control, doc # 100, all documents that form part of its management system including the Management System manual, calibration methods, software, specifications, instructions and manuals. Job-related documents such as contracts and specifications, unique calibration procedures, repair instructions, calibration reports and certificates are controlled within each project file by a unique service report number. The control of data related to calibration is covered in Section 5.4.7. The control of records is covered in section 4.13, which calls out SOP: Record Control and Retention, Document # 100-4. Angel's Instrumentation's official document control policy is listed in the SOP: Document Control, (Document number 200) and associated documents. 4.4 Review of Requests, Tenders, and Contracts All requests for quotes, contracts, and amendments received by Angel s Instrumentation are reviewed to assure that customer requirements are adequately defined and documented. This review activity confirms Angel s Instrumentation ability to meet contract requirements and identifies if there are differences between quotation/proposal and contract. Any differences are resolved before critical work is initiated. Angel s Instrumentation assures its capability to meet contractual requirements. Records of contract review are maintained. Angel s Instrumentation will ensure the requirements are met for contract review by the following: a. The requirements including the methods to be used, are defined, documented, and understood. b. The Metrology Manager, or designate will ensure the laboratory has the capability and resources to meet customer's requirements. c. The Metrology Manager, or designate will ensure the appropriate test and/or calibration method is selected and capable of meeting the customer's requirements. Note: The Metrology Manager, or designate will ensure that any difference between the quote/contract will be resolved before any work commences. The Metrology Manager will further ensure that each Quote/Contract will be acceptable both to the laboratory and the customer. Reference SOP: Contract Review, Document # 600-2
11 of 19 4.5 Subcontracting of Calibrations Angel s Instrumentation, Inc shall not subcontract any ISO/IEC 17025 accredited calibrations. Where non-accredited work is subcontracted Angel s Instrumentation will advise the customer of the arrangement in writing, and when appropriate, gain the approval of the customer in writing where possible. All equipment Angel s Instrumentation subcontracts is noted as such on the quotation provided to the customer. Angel s Instrumentation maintains responsibility to the customer for any subcontractor s work, except where the customer has specified which subcontractor is to be used. Angel s Instrumentation will maintain a list of all subcontractors that it uses and a record of the evidence used to determine their competence. Reference SOP: Purchase of Calibration Services and Supplies, Document # 600 4.6 Purchasing Services and Supplies Reference: SOP: Purchase of Calibration Services and Supplies, Document # 600 SOP: Purchasing, Document # 600-3 4.7 Service to the Customer Angel s Instrumentation affords its customers, or their representatives, cooperation to clarify the customer's request and to monitor Angel s performance in relation to the work performed to the extent in which Angel s can ensure confidentiality to other customers. Such cooperation includes providing the customer or the customer's representative reasonable access to relevant areas of Angel s Instrumentation facilities for the witnessing of calibrations performed for the customer. Communication with the customer is maintained throughout the work performed for the customer. Angel s Instrumentation will inform the customer of any delays or major deviations in the performance of their calibrations. Angel s uses customer surveys, provided to the customer upon completion of work performed, to obtain feedback. The feedback is reviewed during management review and is used to improve the management system, calibration activities, and customer service. Reference: SOP: Contract Review, Document # 600-2 SOP: Customer Complaint, Document # 400-8
12 of 19 4.8 Complaints Angel s Instrumentation maintains a log of all complaints and of the associated corrective actions taken though the use of nonconformance reports. When necessary, immediate action is taken to resolve the customer issue until the nonconformance is addressed in its entirety. All customer complaints are promptly resolved. Reference: SOP: Customer Complaint, Document # 400-8 4.9 Control of Nonconforming work Angel s Instrumentation utilizes a Nonconformance report to document when any aspect of its work, or the results of this work, does not conform to its own procedures or the agreed requirements of the customer. Policies and procedures ensure that: a) The responsibilities and authorities for the management of nonconforming work are designated and actions are defined and taken when nonconforming work is identified b) An evaluation of the significance of the nonconforming work is made c) Correction is taken immediately, together with any decision about the acceptability of the nonconforming work. d) Where necessary, the customer is notified and work is recalled e) The responsibility for authorizing the resumption of work is identified All employees of Angel s Instrumentation are responsible for detecting and reporting non-conformant products, services, and processes. It is the responsibility of the Quality Manger, and the Calibration Lab Manager in the absence of the Quality Manager, to determine the severity of the non-conformance and execute appropriate responses, which may include but are not limited to production halts, process changes, and recalls. Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of Angel s Instrumentation operations with its own policies and procedures, the corrective action procedures given in SOP: Corrective Action and Preventive Action (CAPA), Document #400-7 shall be promptly followed. Reference: SOP: Corrective Action and Preventive Action (CAPA), Document #400-7
13 of 19 4.10 Improvement Angel s Instrumentation continuously improves the management system through the use of quality policies and procedures, quality objectives, audit results, analysis of data, corrective and preventive actions, and management reviews. 4.11 Corrective Action Reference SOP: Corrective Action and Preventive Action (CAPA), Document #400-7 4.12 Preventative Action Reference SOP: Corrective Action and Preventive Action (CAPA), Document #400-7 4.13 Control of Records Reference SOP: Record Control and Retention, Document # 100-4 4.14 Internal Audits Reference SOP: Internal Audits, Document # 300 4.15 Management Review Angel s Instrumentation top management reviews the QMS, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. The review includes assessing opportunities for improvement, the need for changes to the QMS and/or the quality policy and quality objectives. A formal management review (Upper Management forms the team) is conducted at least once annually. The President & CEO, the COO, or designate has the option to call for additional reviews as he deems necessary. (Reference Management review Schedule, Document # 200-4) 4.15.1 Review Input (Reference Management review Agenda, Document # 200-5) The input to the Angel s Instrumentation management review includes, as a minimum, information on: The suitability of policies and procedures; Reports from management and supervisory personnel; Results of interlaboratory comparison or proficiency tests; Changes to the volume and type of work; Results of audits, Customer feedback and Complaints, Process performance and product conformity analyses,
14 of 19 Status of preventive and corrective actions, Follow-up actions from previous management reviews, Changes that could affect the QMS, Recommendations for improvement, Resource needs, Training needs, Supplier concerns, and New or revised regulatory requirements. 4.15.2 Review Output (Reference Management review Outcome, Document # 200-6) The output from the Angel s Instrumentation management review includes, at a minimum, decisions and actions related to: Improvements needed to maintain the effectiveness of the QMS and its processes, Improvement of product related to customer requirements, Statement regarding the effectiveness of the QMS; Assessment of the QMS processes and achievement against the quality policy, and objectives, Changes needed to the quality policy and/or objectives, Resource needs, and Assessment of the QMS ability to prevent and, where applicable, control product nonconformance. 5. TECHNICAL REQUIREMENTS 5.1 General Factors affecting the correctness and reliability of calibrations performed by Angel s Instrumentation include: Human Factors, Accommodation and environmental conditions, Calibration methods, Equipment, Measurement traceability, Handling of calibration items. 5.1.1 Angel s Instrumentation takes these factors into account when developing calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.
15 of 19 5.2 Personnel for Permanent and On-site Angel s Instrumentation management ensures the competence of all who perform calibrations, evaluate results, and sign calibration certificates. Personnel performing specific tasks are qualified on the basis of appropriate education, training, experience, and/or demonstrated skills, as required. Personnel in task training are supervised at all times. Records of qualifications are maintained for all technical personnel in the form of resumes and other training records, as appropriate. Reference: Mobile Database Training Manual, Document # 700-2 Service Data Base Software Manuel, Document # 700-3 Training Record, Document # 700-4 Service Database Training Records Form: Employee Quarterly Evaluation Report, Document # 200-14 Form: Employee Year-end Performance Report, Document # 200-15 Form: Employee Professional Development Plan, Document # 200-16 Reference: SOP: Roles and Responsibilities, Document # 200-17 5.3 Accommodation and Environmental Conditions 5.3.1 The Metrology Manager is responsible for ensuring facilities for calibration including but not limited to: energy sources and environmental conditions: temperature 22.8 +/- 5 C [73 F +/-9 ] in the general labs, and 20.0 C +/- 1.0 [68 F +/- 1.8 ] in the physical dimensional lab and humidity 20% RH and 60% RH [35% is optimal]. These are controlled and suitable for the performance of calibrations. When onsite calibrations/tests are performed, particular care shall be taken (as well as documented) to ensure environmental conditions do not invalidate the results or adversely affect the required quality of any measurement. a. Technical requirements for accommodations and environmental conditions that can affect the results of calibrations are documented in calibration procedures, as appropriate. 5.3.2 Angel s Instrumentation monitors, controls, and records environmental conditions as required by calibration procedures and where they may influence the quality of the calibration results. Calibrations are stopped when the environmental conditions may jeopardize the results of the calibrations. 5.3.3 Angel s Instrumentation performs no activities, which are incompatible with each other; as such no need has been identified for separation of activities.
16 of 19 5.3.4 Access to and use of areas affecting the quality of calibrations is controlled. Special care must be taken to control access to areas affecting the quality of calibrations while on-site. Reference SOP: On-Site Policies and Procedures, Document # 800. Angel s practices good housekeeping in the laboratory, I.A.W Angel s Reference: SOP: Roles and Responsibilities, doc# 200-17 5.4 Test and calibration methods and method validation 5.5 Equipment Angel s Instrumentation uses appropriate methods and procedures for all tests and/or calibrations within its ISO/IEC 17025 accredited scope as appropriate. This includes sampling (where applicable), handling, transport, storage, and preparation of items to be tested and or calibrated. All test equipment data (in which not having could jeopardize the results) will have instructions for the use and operation of and/or handling/preparation instructions, prior to calibration. All instructions, standards, manuals, and reference data will be up to date, readily available, and validated before calibration/testing begins. Any deviation from test and calibration methods will occur only if the deviation has been documented, technically justified, and authorized by the customer. (Reference SOP: On-Site Policies and Procedures, Document # 800) 5.5.1 Angel s Instrumentation is furnished with all items of sampling, measurement and test equipment required for the correct performance of the tests and/or calibrations (including sampling, preparation of test and/or calibration items, processing and analysis of test and/or calibration data). In cases where Angel s Instrumentation needs to use equipment outside its permanent control, the Metrology Manager will ensure that the requirements of this International Standard are met. 5.6 Measurement traceability Reference SOP: Equipment and Handling and Storage of TMDE, Doc #: 900-2 All equipment used for calibrations having a significant effect on the accuracy or validity of the result of calibrations performed will be calibrated before being put into service. Angel s Instrumentation calibrations utilize the same procedures and policies for customer equipment. The Metrology Manager is responsible for ensuring equipment is calibrated in the same manner. Reference Roles and Responsibilities, Doc # 200-17. 5.6.S.1 When it is necessary to utilize reference standards on-site, adequate measures shall be taken to ensure that the necessary calibration status is maintained during transportation and while on-site. The response of such reference standards to environmental changes or other relevant
17 of 19 5.6.2 Specific requirements 5.6.2.1 Calibration parameters shall be known and documented. 5.6.2.1.1 The Calibration Manger will ensure calibrations and measurements performed by Angel s are traceable to the SI (System International) units of measurement. 5.6.2.S.1 Angel s establishes traceability of its own measurement standards and measuring instruments to the SI by means of an unbroken chain of calibrations to NIST or a mutual recognition agreement, such as the Comite International des Poids et Mesures (CIPM) Mutual Recognition Arrangement (MRA), is in effect with the National Institute of Standards and Technology and sufficient equivalence of applicable calibration service exists or when the calibration service of the NIST is not available or does not meet the measurement performance requirements. When using external calibration services traceability of measurement is assured by the use of calibration services from laboratories that can demonstrate competence, measurement capability, and traceability (i.e. ISO/IEC 17025). The calibration certificates issued by these laboratories contain the measurement uncertainty and/or a statement of compliance with an identified metrological specification. When providing ISO 17025 and/or ANSI Z540 accredited calibrations, all measurements Angel s provides must be within our accredited scope. 5.6.2.2 Testing 5.6.2.1.2 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: 1. Use of certified reference materials provided by a competent supplier to give a reliable physical or chemical characterization of a material; 2. Use of specified methods and/or consensus standards that are clearly described and agreed by all parties concerned. 5.6.2.1.3 Where traceability to SI units through national metrology institutes are not available, or SI units are not established, a consensus standard including a reference standard and related calibration procedure, which are clearly specified and mutually agreed upon by all parties concerned, will be applied. 5.6.2.2.1 Angel s currently provides no testing 5.6.3 Reference standards and reference materials 5.6.3.1 The Metrology Manager will ensure reference standards are calibrated by a body that can provide traceability as described in 5.6.2.1. Reference standards of measurement held by Angel s will be used for calibration only and for no other purpose, unless it can be shown that their performance as reference standards would not be invalidated. Reference standards will be calibrated before and after any adjustment.
18 of 19 5.6.3.2 Reference materials, where possible, will be traceable to SI units of measurement, or to certified reference materials. 5.6.3.3 Intermediate checks will be performed on reference, primary, transfer or working standards and reference material shall be carried out according to Angel s procedures and schedules The same procedures for the transportation and storage of TMDE will apply to reference standards/procedures.the Calibration Manager is responsible for ensuring accepted industry practices are followed to ensure the safe handling, transport, storage, and use of reference standards and reference materials to ensure proper functioning and in order to prevent contamination or deterioration. Reference: SOP: On-Site Policies and Procedures, Document # 800. SOP: Measurement Traceability, Document #900-3 5.7 Sampling 5.7.1 Angel s Instrumentation currently performs no sampling in the performance of its calibration services 5.8 Handling of Test and Calibration Items Reference: SOP: Equipment and Handling and Storage of TMDE, Document # 900-2 5.9 Assuring the quality of calibration results 5.7.1 Angel s will monitor the validity of calibrations performed through internal audits, QA Program, and through participation in proficiency tests / inter-laboratory comparisons (NPT/ILC). Participation yearly in a minimum of two complete NPT/ILC(s) will occur and the results will be discussed during Management Reviews as a minimum. The proficiency testing program is documented via a schedule. This schedule covers all disciplines on our scope of accreditation within a four year period. The resulting data will be recorded so that trends are detectable and, where practical, statistical techniques will be applied to the reviewing of the results. Additional monitoring may also include, but not be limited to, the following: a) Regular use of certified reference standards and/or materials; b) Participation in inter-laboratory comparison or proficiency-testing program. c) Replicate calibrations using the same or different methods; d) Re-calibration of retained items; e) Correlation of results for different characteristic of an item f) All quality control data shall be analyzed and, where they are found to be outside pre-defined criteria, a non-conformance is generated and immediate action is required to prevent incorrect results from being reported. All proficiency test and internal audits will be submitted to
19 of 19 Angel s Instrumentation s accrediting body promptly along with corrective action results where applicable. 5.10 Reporting the results The results of each calibration, or series of calibrations carried out by Angel s will be reported accurately, clearly, and objectively, and in accordance with any specific instructions in the calibration procedures. The results shall be reported on a calibration certificate and will include all the information requested by the customer and necessary for the interpretation of the calibration results and all information required by the procedure used. Where a written agreement has been established with the customer, the results may be reported in a simplified way. However, all calibration information, which is not reported to the customer, will be readily available in the Angel s records. Results obtained from on-site calibrations shall be identified as such on issued certificates/reports, whether they form part or all of the information presented. Procedures to fulfill the requirements of ISO 17025 Sections 5.10.1 Section 5.10.9 in reference to the requirements for data documented on the calibration Certificate are contained in Reference: SOP: Calibration Quality and Results, Document #900-4.