NIST Handbook 143
State Weights and Measures Laboratories Program Handbook

5. General Technical Requirements for Calibration Laboratories

This section sets out the general NIST/OWM general technical requirements with which a legal metrology calibration laboratory must comply in order to be recognized to carry out specific calibrations. The requirements of subsections 5.1 through 5.13 are comparable to the requirements of ISO/IEC Guide 25 as they apply to calibration laboratories and as written in the ANSI/NCSL Z540-1-1994 U.S. national standard.

NOTE: Additional sections have been added in the form of "OWM NOTES" to identify how each section will be interpreted for State legal metrology laboratories.

5.1 Organization and Management

5.1.1 The laboratory shall be legally identifiable. It shall be organized and shall operate in such a way that its permanent, temporary, and mobile facilities meet the requirements of this Handbook.

5.1.2 The laboratory shall:

1. have managerial staff with the authority and resources needed to discharge their duties;
2. have policies to ensure that its personnel are free from any commercial, financial, and other pressures which might adversely affect the quality of their work;
3. be organized in such a way that confidence in its independence of judgment and integrity is maintained at all times;
4. specify and document the responsibility, authority, and interrelation of all personnel who manage, perform, or verify work affecting the quality of calibrations and tests;
5. provide supervision by persons familiar with the calibration or test methods and procedures, the objective of the calibration or test, and the assessment of the results. Management practices shall be such as to ensure adequate supervision;
6. have a technical manager (however named) who has overall responsibility for the technical operations;
7. have a quality manager (however named) who has responsibility for the quality system and its implementation. The quality manager shall have direct access to the highest level of management at which decisions are taken on laboratory policy or resources, and to the technical manager. In some laboratories, the quality manager may also be the technical manager or deputy technical manager;

   OWM NOTE: It is recognized that multi-functions may exist in small laboratories whereby it is difficult or impossible to maintain a distinction between a "technical manager" and a "quality manager." In these cases, OWM technical evaluation and assessment will serve as an independent review as needed or required.

8. nominate deputies in case of absence of the technical or quality manager;
9. have documented policy and procedures to ensure the protection of customers' confidential information and proprietary rights;

   NOTE: It is recognized that this is not always a requirement for a laboratory. Where confidentiality and protection of proprietary rights are required by the customer, the laboratory policies and procedures shall be documented in the quality manual.

10. where appropriate, participate in interlaboratory comparisons and proficiency testing programs; and
11. have documented policy and procedures to ensure that its clients are served with impartiality and integrity.

    OWM NOTE: Organizational responsibilities must be defined and identified on an organization chart or similar device. The chart must depict the relation of the laboratory to its parent organization and to other units that report to the same parent. Position descriptions shall be available for each staff member and each shall know his/her responsibilities within the organization.

5.2 Quality System, Audit and Review

5.2.1 The laboratory shall establish and maintain a quality system appropriate to the type, range and volume of calibration activities it undertakes. The elements of this system shall be documented. The quality documentation shall be available for use by the laboratory personnel. The laboratory shall define and document its policies and objectives for, and its commitment to, good laboratory practice and quality of calibration or testing services. The laboratory management shall ensure that these policies and objectives are documented in a quality manual and communicated to, understood, and implemented by all laboratory personnel concerned. The quality manual shall be maintained current under the responsibility of the quality manager.

5.2.2 The quality manual and related documentation, shall state the laboratory's policies and operational procedures established in order to meet the requirements of this Handbook. The quality manual and related documentation shall also contain:

1. a quality policy statement, including objectives and commitments, by top management;
2. the organization and management structure of the laboratory, its place in any parent organization and related organizational charts;
3. the relations between management, technical operations, support services and the quality system;
4. procedures for control and maintenance of documentation;
5. job descriptions of key staff and reference to the job descriptions of other staff;
6. identification of the laboratory's approved signatories;
7. the laboratory's procedures for achieving traceability of measurements;
8. the laboratory's scope of calibrations and/or tests;
9. arrangements for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;
10. reference to the calibration, verification, and/or test procedures used;
11. procedures for handling calibration and verification items;
12. reference to the major equipment and reference measurement standards used;
13. reference to procedures for calibration, verification and maintenance of equipment used;
14. reference to verification practices including interlaboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes;
15. procedures to be followed for feedback and corrective action whenever measurement discrepancies are detected, or departures from documented policies and procedures occur;
16. the laboratory management policies for departures from documented policies and procedures or from standard specifications;
17. procedures for dealing with complaints;
18. procedures for protecting confidentiality and proprietary rights;
19. procedures for audit and review;
20. a statement of the laboratory's policy for establishing and changing calibration intervals for equipment it controls;
21. a statement of the laboratory's policy concerning the technique(s) to be used for determining measurement uncertainty and calibration/verification adequacy; and
22. a description of the laboratory's policy regarding the use of the NIST/OWM Certificate of Traceability (or NVLAP certificate of accreditation and NVLAP logo, if appropriate).

    OWM NOTE: The list of items in this section is not a complete list of all items that must be included in a quality manual. The NIST Office of Weights and Measures provides NIST IR 5802, Quality Manual Template for the State laboratories to use as a baseline which complies with these requirements and must be sufficiently modified to match specific program details. All modifications must be evaluated against these criteria. All updates must be submitted for review.

5.2.3 The laboratory shall arrange for audits of its activities at appropriate intervals to verify that its operations continue to comply with the requirements of the quality system. Such audits shall be carried out by trained and qualified staff who are, wherever possible, independent of the activity to be audited. Where the audit findings cast doubt on the correctness or validity of the laboratory's calibration results, the laboratory shall take immediate corrective action and shall immediately notify, in writing, any client whose work may have been affected.

The audits shall be objective and be conducted internally or on contract. The audits shall include both general criteria (documents, records and policies) and technical compliance (test methods and practices and calibration procedures).

5.2.4 The quality system adopted to satisfy the requirements of this Handbook shall be reviewed at least once a year by the management to ensure its continuing suitability and effectiveness and to introduce any necessary changes or improvements.

OWM NOTE: Appendix C contains an "Internal Assessment and Management Review" form that is to be used for this activity and is to be submitted annually or as circumstances change in the laboratory.

5.2.5 All audit and review findings and any corrective actions that arise from them shall be documented. The person responsible for quality shall ensure that these actions are discharged within the agreed time frame.

5.2.6 In addition to periodic audits the laboratory shall ensure the quality of results provided to clients by implementing checks. These checks shall be reviewed and shall include, as appropriate, but not be limited to:

1. internal quality control using whenever possible statistical techniques;

   NOTE: Measurement assurance techniques are acceptable measures to control the measurement process and consistently produce the highest quality measurements.

2. participation in proficiency testing and other interlaboratory comparisons;
3. regular use of certified reference materials and/or in-house quality control using secondary reference materials;
4. replicate measurements using the same or different methods;
5. retesting of retained items;
6. correlation of results for different characteristics of an item.

   OWM NOTE: The laboratory shall maintain a list of control charts or surveillance activities maintained by the laboratory. Measurement control requirements must be in place for each measurement service provided by the laboratory. The quality manual template contains forms that may be used by the laboratory to list control charts, surveillance activities, and proficiency tests. This documentation must be available during on-site assessments and submitted to the NIST Office of Weights and Measures as requested.

5.3 Personnel

5.3.1 The calibration laboratory shall have sufficient personnel, having the necessary education, training, technical knowledge and experience for their assigned functions.

5.3.2 The calibration laboratory shall ensure that the training of its personnel is kept up-to-date consistent with employee assignments and development.

5.3.3 Records on the relevant qualifications, training, skills and experience of the technical personnel shall be maintained by the laboratory.

OWM NOTE: The NIST Office of Weights and Measures provides training to State legal metrology laboratories. State metrologists are required to complete the appropriate level of training as indicated in Table 2, for the laboratory to be recognized at designated levels. Information regarding the training program is maintained in the Office of Weights and Measures.

5.4 Accommodation and Environment

OWM NOTE: Section 7 of this Handbook contains specific technical requirements for various measurement parameters that will be used for additional guidance in laboratory assessments.

5.4.1 Laboratory accommodation, calibration areas, energy sources, lighting, temperature, humidity, and ventilation shall be such as to facilitate proper performance of calibrations or tests.

NOTE: Laboratory design will be, to the maximum extent practical, in accordance with guidelines found in the NCSL Recommended Practice #7, Laboratory Design, July 25, 1993.

5.4.2 The environment in which these activities are undertaken shall be specified and not invalidate the results or adversely affect the required uncertainty of measurement. Particular care shall be taken when such activities are undertaken at sites other than the permanent laboratory premises.

NOTE: It is expected that environments which do not meet generally accepted norms, such as those found in NCSL Recommended Practice, #7, yet which exhibit the stability required to apply necessary correction factors, will be specified by the laboratory for the purpose of assessment of compliance with its own procedures to achieve its stated uncertainties.

5.4.3 The laboratory shall provide facilities for the effective monitoring, control and recording of environmental conditions as appropriate. Due attention shall be paid, for example, to biological sterility, dust, electromagnetic interference, humidity, line voltage, temperature, and sound and vibration levels, as appropriate to the calibrations concerned.

5.4.4 There shall be effective separation between neighboring areas when the activities therein are incompatible.

5.4.5 Access to and use of all areas affecting the quality of these activities shall be defined and controlled.

5.4.6 Adequate measures shall be taken to ensure good housekeeping in the laboratory.

NOTE: It is the laboratory's responsibility to comply with the relevant health, safety and environmental requirements. This aspect, however, is outside the scope of this Handbook.

5.5 Equipment and Reference Materials

5.5.1 The laboratory shall be furnished with all items of equipment (including reference materials) required for the correct performance of calibrations. In those cases where the laboratory needs to use equipment outside its permanent control it shall ensure that the relevant requirements of this Handbook are met.

5.5.2 All equipment shall be properly maintained. Maintenance procedures shall be documented. Any item of equipment which has been subjected to overloading or mishandling, or which gives suspect results, or has been shown by verification or otherwise to be defective, shall be taken out of service, clearly identified and wherever possible stored at a specified place until it has been repaired and shown by calibration, verification or test to perform satisfactorily. The laboratory shall examine the effect of this defect on previous calibrations or tests.

5.5.3 Each item of equipment including reference materials shall, when appropriate, be labeled, marked or otherwise identified to indicate its calibration status.

>5.5.4 Records shall be maintained of each item of equipment and all reference materials significant to the calibrations performed. The records shall include:

1. the name of the item of equipment;
2. the manufacturer's name, type identification, and serial number or other unique identification;
3. date received and date placed in service;
4. current location, where appropriate;
5. condition when received (e.g., new, used, reconditioned);
6. copy of the manufacturer’s instructions, where available;
7. dates and results of calibrations and/or verifications and date or criteria when the calibration and/or verification expires;
8. details of maintenance carried out to date and planned for the future;
9. history of any damage, malfunction, modification or repair; and
10. measured value observed for each parameter found to be out of tolerance during calibration/verification.

    OWM NOTE: The quality manual template contains a chart to list of equipment and its current performance evaluation. This information will be requested during on-site assessments, and the chart may be requested annually for review with measurement control documents.

5.6 Measurement Traceability and Calibration

5.6.1 All measuring and testing equipment having an effect on the accuracy or validity of calibrations shall be calibrated and/or verified before being put into service. The laboratory shall have an established program for the calibration and verification of its measuring and test equipment to ensure the recall or removal from service of any standard or equipment which has exceeded its calibration interval or is otherwise judged to be unreliable.

5.6.2 The overall program of calibration and/or verification of equipment shall be designed and operated so as to ensure that, wherever applicable, measurements made by the laboratory are traceable to national, international, or intrinsic standards of measurement where available. Calibration certificates and/or reports shall, wherever applicable, state the traceability to national, international, or intrinsic standards of measurement and shall provide the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified metrological specification.

Where applicable, the methodology of the ISO Guide to the Expression of Uncertainty in Measurement: 1993, shall be used as the basis for expression of uncertainty of the measurement. Where detailed procedures are not used to quantify and combine uncertainties (i.e., use of test accuracy ratio concepts), the sources of uncertainty shall be tabulated and demonstrated to be acceptable for the measurement undertaken.

NOTE: A significant number of intrinsic standards such as the Josephson Array Voltage Standard and the Iodine-Stabilized Helium-Neon Laser Length Standard have been developed and are now being used by many national standards laboratories and some industrial laboratories. These standards are based on well characterized laws of physics, fundamental constants of nature, or invariant properties of materials and make ideal stable, precise, and accurate measurement standards if properly designed, characterized, operated, monitored and maintained. Where intrinsic standards are used, the laboratory should demonstrate by measurement assurance techniques, interlaboratory comparisons, or other suitable means that its intrinsic standard measurement results are correlated with those of national or international standards.

5.6.3 Where traceability to national, international or intrinsic standards of measurement is not available, traceability requirements may be satisfied by:

1. participation in a suitable program of interlaboratory comparisons or proficiency testing;
2. internationally accepted standards in the field concerned;
3. suitable reference materials;
4. ratio or reciprocity-type measurements; or
5. mutual consent standards which are clearly specified and mutually agreed upon by all parties concerned.

5.6.4 Reference standards of measurement held by the laboratory shall be used for calibration or verification only and for no other purpose, unless it can be demonstrated that their performance as reference standards has not been invalidated.

5.6.5 Reference standards of measurement shall be calibrated by a competent body that can provide traceability to a national, international, or intrinsic standard of measurement. There shall be a program of calibration and verification for reference standards.

OWM NOTE: A competent body will generally be interpreted as NIST, or a State laboratory with a Certificate of Traceability, or other laboratory for formal accreditation from a recognized accreditation body.

5.6.6 Where relevant, reference standards and measuring and testing equipment shall be subject to in-service checks between calibrations and verifications

5.6.7 Reference materials shall, where possible, be traceable to national or international standards of measurement, or to national or international standard reference materials.

OWM NOTE: Copies of calibration reports for primary standards used in the laboratory are maintained in the NIST Office of Weights and Measures. The laboratory must submit updated calibration reports as available. If reports are not from NIST, they should be from another NIST-recognized or another laboratory with formal accreditation from a recognized accreditation body.

5.7 Calibration Methods

5.7.1 The laboratory shall have documented instructions on the use and operation of all relevant equipment, on the handling and preparation of items and for calibration, where the absence of such instructions could jeopardize the calibrations. All instructions, standards, manuals, and reference data relevant to the work of the laboratory shall be maintained up-to-date and be readily available to the staff.

5.7.2 The laboratory shall use appropriate methods and procedures for all calibrations/verifications and related activities within its responsibility (including, but not limited to, sampling, handling, transport and storage, preparation of items, estimation of uncertainty of measurement and analysis of calibration data).

1. Calibration procedures shall contain the required range and tolerance or uncertainty of each item or unit parameter being calibrated or verified. In addition, the procedures shall contain the generic description of the measurement standards and equipment needed with the required parameter, range, tolerances or uncertainties, and specifications for performing the measurement of the calibration or verification, and/or representative types (manufacturer, model, option) that are capable of meeting the generic description for the measurement standards. The procedures shall be consistent with the accuracy required, and with any standard specifications relevant to the calibrations/ verifications concerned.
2. The laboratory shall ensure that the calibration uncertainties are sufficiently small so that the adequacy of the measurement is not affected. Well defined and documented measurement assurance techniques or uncertainty analyses may be used to verify the adequacy of a measurement process. If such techniques or analyses are not used, then the uncertainty of calibration or verification shall not exceed 25 percent of the acceptable tolerance (e.g., manufacturer's specification) for each characteristic of the measuring and test equipment being calibrated or verified.

5.7.3 Where methods are not specified, the laboratory shall, wherever practical, select methods that have been published in international or national standards, those published by reputable technical organizations or in relevant scientific texts or journals.

5.7.4 Where it is necessary to employ methods that have not been established as standard, these shall be subject to agreement with the client, be fully documented and validated, and be available to the client and other recipients of the relevant reports.

5.7.5 Where sampling is carried out as part of the calibration or test method, the laboratory shall use documented procedures and appropriate statistical techniques to select samples.

5.7.6 Calculations and data transfers shall be subject to appropriate checks.

5.7.7 Where computers or automated equipment are used for the capture, processing, manipulation, recording, reporting, storage, or retrieval of calibration data, the laboratory shall ensure that:

1. the requirements of this Handbook are complied with;
2. computer software is documented and adequate for use;
3. procedures are established and implemented for protecting the integrity of data; such procedures shall include, but not be limited to, integrity of data entry or capture, data storage, data transmission, and data processing;
4. computer and automated equipment is maintained to ensure proper functioning and provided with the environmental and operating conditions necessary to maintain the integrity of calibration data;
5. it establishes and implements appropriate procedures for the maintenance of security of data including the prevention of unauthorized access to, and the unauthorized amendment of computer records.

5.7.8 Documented procedures shall exist for the purchase, reception and storage of consumable materials used for the technical operations of the laboratory that can affect the results of calibrations.

OWM NOTE: The NIST Office of Weights and Measures maintains NIST Handbook 145, Handbook for the Quality Assurance of Metrological Measurements. States must reference this handbook and use it for all applicable measurement procedures unless data or other evidence is available to support acceptable results using another procedure. Other procedures must be submitted to OWM for review and approval by the NIST Office of Weights and Measures. Use of uniform procedures is critical for maintaining the integrity of the legal measurement system.

5.8 Handling of Calibration Items

5.8.1 The laboratory shall have a documented system for uniquely identifying the items to be calibrated, to ensure that there can be no confusion regarding the identity of such items at any time.

5.8.2 Upon receipt of the calibration item, any abnormalities or departures from standard condition as prescribed in the relevant calibration method shall be recorded. 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, the laboratory shall consult the client for further instruction before proceeding. The laboratory shall establish whether the item has received all necessary preparation, or whether the client requires preparation to be undertaken or arranged by the laboratory.

5.8.3 The laboratory shall have documented procedures and appropriate facilities to avoid deterioration or damage to the calibration item, during storage, handling, preparation, and calibration; any relevant instructions provided with the item shall be followed. Where items have to be stored or conditioned under specific environmental conditions, these conditions shall be maintained, monitored and recorded where necessary. Where a calibration item or portion of an item is to be held secure (for example, for reasons of record, safety or value, or to enable check calibrations to be performed later), the laboratory shall have storage and security arrangements that protect the condition and integrity of the secured items or portions concerned.

5.8.4 The laboratory shall have documented procedures for the receipt, retention or safe disposal of calibration items, including all provisions necessary to protect the integrity of the laboratory.

5.8.4 Tamper-resistant seals shall be affixed to operator accessible controls or adjustments on measurement standards or measuring and test equipment which, if moved, will invalidate the calibration. The laboratory’s calibration system shall provide instructions for the use of such seals and for the disposition of equipment with damaged or broken seals.

NOTE: Tamper-resistant seals are sometimes affixed to equipment to prevent unauthorized access to areas where adjustments or critical components are located.

5.9 Records

5.9.1 The laboratory shall maintain a record system to suit its particular circumstances and comply with any applicable regulations. It shall retain on record all original observations, calculations, and derived data, calibration records and a copy of the calibration certificate, test certificate, or test report for an appropriate period. The records for each calibration shall contain sufficient information to permit repetition of the calibration. The records shall include the identity of personnel involved in sampling, preparation, calibration, or testing.

EXCEPTION: The retention of all original observations, calculations, and derived data in the calibration record system is not a mandatory requirement for calibration laboratories, although it is encouraged as good laboratory practice.

5.9.2 All records (including those listed in 5.5.4 pertaining to calibration equipment), certificates and reports shall be safely stored, held secure and in confidence to the client for the period specified in the quality manual (to the extent allowable by law).

5.10 Certificates and Reports

5.10.1 When a certificate or report is issued, the results of the calibration, or series of calibrations carried out by the laboratory shall be accurate, clear, unambiguous and objective, in accordance with any instructions in the calibration methods. The results should normally be reported in a calibration report or certificate and shall include all the information necessary for the interpretation of the calibration results and all information required by the method used.

5.10.2 Each certificate or report shall include at least the following information:

1. a title, e.g., "Calibration Report" or "Calibration Certificate";
2. name and address of laboratory, and location where the calibration was carried out if different from the address of the laboratory;
3. unique identification of the certificate or report (such as serial number) and of each page, and the total number of pages;
4. name and address of client, where appropriate;
5. description and unambiguous identification of the item calibrated;
6. characterization and condition of the calibration item;
7. date(s) of performance of calibration, where appropriate;
8. identification of the calibration method used, or unambiguous description of any non-standard method used;
9. reference to sampling procedure, where relevant;
10. any deviation from, additions to or exclusions from the calibration method, and any other information relevant to a specific calibration, such as environmental conditions;
11. measurements, examinations and derived results, supported by tables, graphs, sketches and photographs as appropriate, and any failures identified;
12. a statement of the estimated uncertainty of the calibration result (where relevant);
13. a signature and title, or an equivalent identification of the person(s) accepting responsibility for the content of the certificate or report (however produced), and date of issue;
14. where relevant, a statement to the effect that the results relate only to the items calibrated;
15. a statement that the certificate or report shall not be reproduced except in full, without the written approval of the laboratory;
16. a statement that the report must not be used by the client to claim product endorsement by NIST, OWM, NVLAP, or any agency of the U.S. Government;
17. the signature of an Approved Signatory for all calibration reports endorsed with the NIST recognition or accreditation status (or NVLAP logo), if appropriate;
18. special limitations of use; and
19. traceability statement.

5.10.3 Where the certificate or report contains results of calibrations performed by subcontractors, these results shall be clearly identified.

5.10.4 Particular care and attention shall be paid to the arrangement of the certificate or report, especially with regard to presentation of the calibration data and ease of assimilation by the reader. The format shall be carefully and specifically designed for each type of calibration carried out, but the headings shall be standardized as far as possible.

5.10.5 Material amendments to a calibration report or calibration certificate after issue shall be made only in the form of a further document, or data transfer including the statement "Supplement to Calibration Report [or Calibration Certificate], serial number... [or as otherwise identified]," or equivalent form of wording. Such amendments shall meet all the relevant requirements of subsection 5.9 of this Handbook.

5.10.6 The laboratory shall notify customers promptly, in writing, of:

1. any event such as the identification of defective calibration equipment that casts doubt on the validity of results given in any calibration report or certificate, or amendment to a report or certificate. Such notification shall quantify the magnitude of error created in the calibration results.
2. any customer's measuring and test equipment found significantly out-of-tolerance during the calibration/verification process. Measurement data shall be reported so that appropriate action can be taken.

5.10.7 The laboratory shall ensure that, where clients require transmission of calibration results by telephone, telex, facsimile or other electronic or electromagnetic means, staff will follow documented procedures that ensure that the requirements of this Handbook are met and that confidentiality is preserved.

5.11 Subcontracting of Calibration

5.11.1 Where a laboratory subcontracts any part of the calibration, this work shall be placed with a laboratory complying with the requirements of this Handbook. The laboratory shall ensure and be able to demonstrate that its subcontractor is competent to perform the activities in question and complies with the same competence criteria as the laboratory with respect to the work being subcontracted. The laboratory shall advise the client, in writing, of its intention to subcontract any portion of the calibration to another party.

5.11.2 The laboratory shall record and retain details of its investigation of the competence and compliance of its subcontractors and maintain a register of all subcontracting.

5.11.3 The laboratory shall maintain subcontracting policy and procedures and shall clearly identify in the report to the client the subcontractor and exactly which data were obtained by the laboratory and which data were obtained by the subcontractor.

5.12 Outside Support Services and Supplies

5.12.1 Where the laboratory procures outside services and supplies in support of calibrations, the laboratory shall use only those outside support services and supplies that are of adequate quality to sustain confidence in the laboratory's calibrations.

5.12.2 Where no independent assurance of the quality of outside support services or supplies is available, the laboratory shall have procedures to ensure that purchased equipment, materials and services comply with specified requirements. The laboratory should, wherever possible, ensure that purchased equipment and consumable materials are not used until they have been inspected, calibrated or otherwise verified as complying with any standard specifications relevant to the calibrations concerned.

5.12.3 The laboratory shall maintain records of all suppliers from whom it obtains support services or supplies required for calibrations.

5.13 Complaints

5.13.1 The laboratory shall have documented policies and procedures for the resolution of complaints received from clients or other parties about the laboratory's activities. A record shall be maintained of all complaints and of the actions taken by the laboratory.

5.13.2 Where a complaint, or any other circumstance, raises a concern regarding the laboratory's compliance with the laboratory's policies or procedures, or with the requirements of this Handbook or otherwise concerning the quality of the laboratory's calibrations, the laboratory shall ensure that complaints in those areas of activity and responsibility involved are promptly investigated and resolved.