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Supplementary Laboratory Management Review

Reviewed by Laboratory Management:

Names:

Signatures:

Date(s):

Background and Compliance Deadlines:

Information for this Supplementary Management Review may be taken from the 2019 Internal 

Audit and summarized to share during the laboratory management reviews in 2019. The 

information is being requested during the 2019 Annual Submission to assess and summarize 

levels of laboratory compliance with the 2019 NIST Handbook 143, Program Handbook. 

Handbook 143 includes updated recognition requirements to reference and ensure compliance 

with ISO/IEC 17025:2017. Training on the new ISO/IEC 17025 standard has been provided 

via Laboratory Metrology Info Hours, OWM Webinars, and at Regional Measurement 

Assurance Program (RMAP) training each year since 2016 with feedback provided to 

laboratories during the annual review evaluations. Note: This supplementary evaluation is a 

sampling of compliance and not a full assessment; the laboratory is responsible for a complete 

internal audit of the laboratory against the new ISO/IEC 17025:2017 standard, hereafter called 

the standard. 

The deadline for full compliance to the 2019 Handbook 143, Program Handbook and ISO/IEC 

17025:2017 is no later than the submission cycle beginning November 2020 for issuance of 

Recognition certificates in 2021.

Evaluation of Laboratory Policies and Management Systems:

1. Impartiality and Confidentiality (4.1, 4.2).

The standard includes new language regarding the assurance of laboratory impartiality and 

confidentiality of customer information and laboratory data. OWM has observed in many State 

governments the availability of employee handbooks and government policies intended to 

ensure impartiality, including the avoidance of conflict of interest activities. In addition, many 

State government have provided feedback that all information produced by the laboratory is 

considered public information. However, the standard requires that such policies be 

documented and customers notified (as appropriate). 
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Describe how your State policies and guidance have been implemented in your laboratory. 

Describe how any requirements you have for ensuring confidentiality or public availability of 

information are communicated to laboratory customers. What types of risks have been 

considered and/or minimized related to impartiality and confidentiality. 

2. Requirements regarding Risk Management (sections noted below).

The standard includes a number of references to risk based thinking. The Introduction to the 

standard states the following:

This document requires the laboratory to plan and implement actions to address risks and 

opportunities. Addressing both risks and opportunities establishes a basis for increasing 

the effectiveness of the management system, achieving improved results and preventing 

negative effects. The laboratory is responsible for deciding which risks and opportunities 

need to be addressed.

Key sections in the standard that identify risk include the following 1) Section 4.1.4, risks to 

impartiality; 2) Section 7.8.6.1, risks associated with decision rules (related to stating that 

standards meet documentary standards such as the 105-x standards); 3) Section 7.10, 

minimizing risk related to actions of non-conforming work (e.g., continuing to perform 

calibrations outside documented environmental limits, untrained staff performing calibrations, 

use of standards past calibration due dates); 4) identification and actions to address risks and 

opportunities (e.g., identified in the 2018 version of the OWM Management Review form). 

Training was conducted by OWM during the 2016 and 2018 Regional Measurement Assurance 

Program sessions on “risk management” concepts and techniques in anticipation of the 

standard changes. The OWM management review form was updated in 2018 in anticipation 

of these changes as well.

Describe what has been completed to address RISK topics in the laboratory quality 

management system (e.g., inclusion of risk policies in the quality documents and procedures) 

and laboratory management reviews? 

Provide highlights and explanations for the top three actions that have been completed over 

the past three years related to addressing Risk and Opportunities. 

3. Changes and updates needed to the management system (e.g., quality documents) 

(Section 8).

OWM provided training and recommendations during the 2018 RMAP sessions on approaches 

that could be used to ensure compliance in current laboratory quality documents, including the 

inclusion of a cross-walk between the 2007 version of Handbook 143 and the new standard
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and an assessment to compare prior quality manual sections with the new standard. Additional 

discussions at the RMAPs included the level of effort required to completely rewrite and 

update quality manuals that was desired by a number of laboratories (but not required 

according to the standard itself).

Describe the efforts that have been made or will be made to update the laboratory Quality 

Management System so that it is compliant with the 17025:2017 standard or will be compliant 

by the 2020 deadline.

Evaluation of Laboratory Resources:

4. Staffing Requirements (Section 6.2).

Little has changed in the new standard regarding personnel requirements. The standard

addresses requirements for impartiality; documentation of competence for each laboratory 

function including requirements for education, qualification, training, technical knowledge, 

skills and experience; ensuring competence and evaluation of the significance of any 

deviations; communication to personnel duties, responsibilities, and authority; and 

authorization for laboratory functions, including validation of methods, analysis, reporting, 

reviewing, and releasing measurement results. Handbook 143, Program Handbook lists 

specific training requirements for State laboratories to ensure compliance with the standard

and to ensure uniformity in calibration practices and measurement results in support of the 

United States weights and measures system. OWM recognizes laboratory staff as Authorized 

Signatories once training requirements have successfully been met.

 

Describe your laboratory challenges and efforts to ensure compliance with Handbook 143 

requirements and support for hiring competence staff, completing on-the-job training,

preparing staff to attend the required OWM training seminars, ensuring staff complete the 

required Laboratory Auditing Program problems, and to ensure succession planning. Address 

related risk considerations as well.

5. Facility Maintenance and Operational Support (Section 6.3). 

Little has changed in the new standard regarding facility requirements. The standard addresses 

requirements for 1) suitability and ensuring no adverse effects to measurement results; 2) 

documented environmental conditions; 3) monitoring, recording, and controlling 

environmental conditions, and measures to control the facilities including access/use, 

prevention of contamination, and effective separation of incompatible areas; and 4) activities 

performed at sites or facilities outside of permanent laboratory control. OWM has regularly 

provided guidance, training, and feedback to laboratories regarding designing, validating, 

monitoring and controlling laboratory conditions. OWM calibration procedures all include 

environmental requirements for each measurement area. In addition, OWM has provided 

guidance, feedback, and restrictions in recognition for calibrations that are performed in 
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locations outside of permanent laboratory control.

Describe your laboratory challenges and efforts to ensure compliance with Handbook 143 and 

ISO/IEC 17025:2017 requirements and support for ensuring suitable facilities, control, and 

monitoring.

6. Calibration and Maintenance Requirements for Standards and Equipment (Sections 

6.4, 6.5, 6.6).

These three sections of the standard include metrological traceability for laboratory standards 

and equipment, as well as evaluation of calibration providers to ensuring metrological 

traceability. 

OWM publishes Good Measurement Practice (GMP) 11 and GMP 13, as well as associated 

job aids (Excel tools) that define suitable baseline calibration intervals, document traceability 

hierarchies, maintain records of calibration history, evaluate suitable calibration and service 

providers. Implementation of these GMPs requires detailed maintenance and records of 

calibrations of standards and service to laboratory equipment. Maintenance of the laboratory 

equipment and standards is a significant cost for most laboratories and generally requires longterm thinking as a planned effort. Language in many of the State regulations/statutes directs 

the laboratory to ensure traceability of laboratory standards to NIST or the International System 

of Units (SI). The OWM 2017 Annual Submission provided the opportunity to summarize and 

evaluate the status and assurance of laboratory metrological traceability. Long-term balance 

replacement plans have been recommended to State laboratories and “obsolete balance” lists 

obtained from balance manufacturers have been provided to States to support planning efforts. 

Summarize a LIST of actions taken in the last three years to ensure that laboratory standards 

have up-to-date calibrations, that equipment such as balances have suitable maintenance, 

repair, evaluation, and replacement, and that standards and equipment are cared for properly.

Describe the challenges your laboratory has addressed to ensure ongoing measurement 

traceability is assured to support your program.

Evaluation of Laboratory Processes

7. Selection, Verification, and Validated of Methods (7.2)

The standard specifies that the laboratory shall use appropriate and validated procedures for 

measurements and uncertainty evaluations. OWM publishes standard operating procedures, 

good laboratory practices, good measurement practices, and a good laboratory practice for 

validating laboratory-developed procedures. OWM training seminars and webinars cover 

application of OWM procedures. Laboratory Auditing Program (LAP) problems assess the 

compliance and implementation of OWM-published procedures. In general, if the laboratory 

applies, and does not deviate from, OWM published procedures, the criteria in this section are 

met. Laboratory developed methods and deviation from OWM procedures will require special 
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assessments, records of evaluation, and special record retention policies (records must be 

retained as long as the procedure is in use). 

Select the applicable laboratory policy and practice(s) from the following:

___ Our laboratory only uses OWM or internationally/nationally published procedures and 

has demonstrated competency with proficiency testing for each procedure;

___ Our laboratory uses OWM or internationally/nationally published procedures, and the 

following list of laboratory-developed procedures with suitable validation and record 

retention policies, and has demonstrated competency with proficiency testing for each 

procedure: {insert list of procedures};

___ Our laboratory uses OWM or internationally/nationally published procedures, and the 

following list of laboratory-developed procedures and exceptions (e.g., have NOT been 

validated, do NOT have special record retention policies, or have NOT demonstrated 

competency with proficiency testing): {insert list of procedures}; 

___ Objective evidence of software verification and validation is available for all calibration 

procedures where software is used in our laboratory (7.11).

Describe any unique issues or action items for your laboratory regarding the selection, 

verification, and validation of calibration procedures and software verification and validation. 

Describe any situations that did not meet one of the prior selection statements and list 

associated action items as appropriate.

8. Evaluation of Measurement Uncertainty (7.6)

The standard specifies that each laboratory shall identify contributions to measurement 

uncertainty, evaluate significance of each component, and evaluate uncertainties for all 

calibrations, including those performed for the laboratory equipment and standards. This is not 

a new requirement. OWM and accreditation bodies also require the inclusion of uncertainty on 

calibration certificates with an uncertainty statement that describes compliance with suitable 

methods for determining the uncertainty. This is not a new practice or requirement. 

OWM has published a standard operating procedure for performing uncertainty identification 

to reporting, and includes sample uncertainty budget tables and practices within each 

calibration procedure. Further, OWM evaluates laboratory compliance with uncertainty 

identification, calculations, and reporting each year during the annual submission process and 

includes policy requirements that include reporting actual calibration uncertainties for 

calibrations and proficiency testing. OWM believes that this ISO/IEC 17025:2017 requirement 

is fully met for State laboratories.

Describe any unique issues or action items for your laboratory regarding uncertainty 

evaluations and reporting. 
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9. Ensuring Validity of Results (7.7)

The standard specifies that each laboratory shall have a procedure for monitoring the validity 

of results, record results to detect trends, and apply statistical techniques where possible. This 

is not a new requirement. 

State laboratories have implemented measurement assurance practices for many years. OWM 

has published good laboratory practices and standard operating procedures for applying 

measurement assurance methods, which include activities such as training, use of check 

standards, replicate measurements, proficiency testing, and evaluating calibration certificates 

prior to release. Each measurement procedure includes a section on measurement assurance. 

The procedures and practices for ensuring validity of measurement results is covered in all 

OWM seminars. OWM also coordinates proficiency testing through the Regional 

Measurement Assurance Programs and requires participation in PTs for each measurement 

area on the laboratory Scope where possible. In 2018, OWM requested submission of 

measurement assurance evaluations and control charts and provided review and feedback to 

all State laboratories. Where PTs or measurement assurance systems were absent, the 

laboratory Scope was modified for the 2019 recognition cycle. OWM believes that this 

ISO/IEC 17025:2017 requirement is fully met for State laboratories; as long as it is supported 

through internal auditing and as long as OWM-provided feedback and corrective actions have 

been implemented. 

Describe any unique issues or action items for your laboratory regarding measurement 

assurance and control chart evaluations. List specific corrective action(s) that were completed 

since the last OWM assessment of your laboratory measurement assurance system.

10. Calibration Certificates (7.8)

The standard specifies requirements for calibration certificates and reporting of measurement 

results. In general, requirements for calibration certificates are not a new, however there are 

some additional reporting requirements regarding conformity assessment that are important. 

SOP 1, for preparing and reporting calibration data was updated in 2018 to comply with the 

standard. All SOPs were updated in 2019 to address Conformity Assessment requirements to 

ensure decision rules were documented for ensuring uncertainties are less than specified limits 

in documentary standards (e.g., uncertainty must be less than one-third of the applicable 

tolerances for all mass calibrations). OWM provided training on conformity assessment 

statements during the 2018 RMAP and 2019 C-RMAP training sessions.

Describe the assessments your laboratory has performed in the past year to evaluate your 

calibration certificate templates or calibration certificates against SOP 1 (as updated to 

comply with ISO/IEC 17025:2017). List specific corrective action(s) that have been made in 

the past year to update your calibration certificates.