NIST Handbook 153 Laboratory Recognition Process for Project 25 Compliance Assessment

NIST HANDBOOK 153
2007 Edition

LABORATORY RECOGNITION PROCESS
FOR PROJECT 25
COMPLIANCE ASSESSMENT
Kurt B. Fischer and Eric D. Nelson, Editors
Office of Law Enforcement Standards
Electronics and Electrical Engineering Laboratory
October 2007

U.S. Department of Commerce
Carlos M. Gutierrez, Secretary
National Institute of Standards and Technology
James M. Turner, Acting Director

Contents
Foreword
1

General Information ............................................................................................................. 1
1.1
1.2
1.3
1.4
1.5
1.6
1.7

2

Organization .......................................................................................................................... 6
2.1
2.2

3

Management of the Project 25 Compliance Assessment Program ................................. 6
Laboratory Assessment Teams ....................................................................................... 7

Management Requirements of Recognized Laboratories ................................................. 9
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15

4

Normative References..................................................................................................... 1
Informative References ................................................................................................... 1
Terms and Definitions..................................................................................................... 1
Purpose and scope ........................................................................................................... 4
Outline of the P25 Compliance Assessment Program .................................................... 4
Confidentiality ................................................................................................................ 5
Complaints ...................................................................................................................... 6

Organization.................................................................................................................... 9
Record keeping requirements. ...................................................................................... 10
Laboratory availability .................................................................................................. 11
Laboratory testing contract requirements review ......................................................... 11
Subcontracting of testing .............................................................................................. 12
Purchasing calibration services ..................................................................................... 12
Access for the P25 CAP Laboratory Assessment Team ............................................... 12
Complaints .................................................................................................................... 12
Control of nonconforming testing work ....................................................................... 12
Improvement ................................................................................................................. 12
Corrective action ........................................................................................................... 13
Preventive action........................................................................................................... 13
Control of records ......................................................................................................... 13
Internal audits................................................................................................................ 13
Management reviews .................................................................................................... 13

Laboratory Assessment Process ........................................................................................ 13
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10

Application for initial recognition ................................................................................ 13
Activities prior to the on-site assessment...................................................................... 14
On-site assessment ........................................................................................................ 16
The post-assessment meeting........................................................................................ 16
The nonconformity reconciliation process.................................................................... 17
The Recognition decision ............................................................................................. 18
Granting recognition ..................................................................................................... 18
Renewal of recognition ................................................................................................. 19
Monitoring visits ........................................................................................................... 20
Changes to Scope of Recognition ................................................................................. 20

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4.11
4.12
4.13
4.14
4.15
5

Suspension of recognition ............................................................................................. 22
Revocation of recognition ............................................................................................. 23
Reinstatement of recognition ........................................................................................ 23
Voluntary termination of recognition ........................................................................... 23
Appeals ......................................................................................................................... 24

Technical Requirements for Recognition ......................................................................... 24
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8

General .......................................................................................................................... 24
Personnel ....................................................................................................................... 24
Accommodation and environmental conditions ........................................................... 25
Test methods and method validation. ........................................................................... 25
Equipment ..................................................................................................................... 25
Handling of test items ................................................................................................... 25
Assuring the quality of test results ................................................................................ 25
Reporting the results ..................................................................................................... 26

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Foreword
Project 25 (P25) is a standards development process for the design, manufacture and evaluation
of interoperable digital two-way wireless communications products created by and for public
safety professionals. The published P25 standards suite is administered by the
Telecommunications Industry Association (TIA Mobile and Personal Private Radio Standards
Committee TR-8). Radio equipment that demonstrates compliance with P25 should be able to
meet a set of minimum requirements to fit certain needs of public safety, including
interoperability, allowing users on different systems to talk via direct radio contact.
The P25 Compliance Assessment Program (CAP) was established on the basis of requests from
the United States Congress 1 and is a voluntary system that provides a mechanism for the
recognition of testing laboratories based on internationally accepted standards This handbook
sets forth the procedures and general requirements under which the P25 CAP operates as a third
party to recognize Project 25 equipment testing laboratories. Although voluntary, the actions of
the P25 CAP and its related laboratory recognition process are emphasized by the use of the
infinitive “will” and the actions of the laboratory by the use of the infinitive “shall” to show that
these actions are obligatory and requirements of the program.
Access to P25 CAP laboratory recognition is available to public and private testing laboratories,
including commercial laboratories, equipment manufacturers’ in-house laboratories, university
laboratories, and federal, state, and local government laboratories from inside or outside the
United States.
This handbook is sponsored by the NIST Office of Law Enforcement Standards (OLES) Public
Safety Communications Systems program, which provides technical expertise to the DHS Office
of Interoperability and Compatibility, which is building a framework for fully interoperable
communications among all first response agencies. It is also developing standards for voice, data
and image transfers, evaluating existing devices and services, and developing a uniform
assessment process for testing the conformity of mobile radio equipment with P25 requirements.
This laboratory recognition process is not part of the NIST National Voluntary Laboratory
Accreditation Program (NVLAP). However, the editors thank NVLAP for providing a model for
the P25 CAP Laboratory Recognition Process.

1

Senate Report 109-088 - DEPARTMENTS OF COMMERCE AND JUSTICE, SCIENCE, AND RELATED
AGENCIES APPROPRIATIONS BILL, 2006 and House Report 109-241 - MAKING APPROPRIATIONS FOR
THE DEPARTMENT OF HOMELAND SECURITY FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2006,
AND FOR OTHER PURPOSES.

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1

General Information
1.1

Normative References

The following references are required for the application of this handbook. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced document applies.

Title 15 United States Code, Section 3710a. Cooperative research and development
agreements
ISO/IEC 17050:2004, Conformity assessment -- Supplier's declaration of conformity
1.2

Informative References

The following references are important for the application of this handbook. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced document applies. The
last two references are to publications not yet available at the time of the publication of this handbook.

ISO/IEC 17000:2004, Conformity assessment—Vocabulary and general principles
ISO/IEC 17011:2004, Conformity assessment - General requirements for accreditation
bodies accrediting conformity assessment bodies
ISO/IEC 17025:2005, General requirements for the competence of testing and
calibration laboratories
NIST Handbook 150:2006, National Voluntary Laboratory Accreditation Program
Procedures and General Requirements
NIST Document, Project 25 Compliance Assessment Program Test Method Review
Summary
Compliance Related Telecommunications Systems Bulletins
1.3

Terms and Definitions

1.3.1

American Association for Laboratory Accreditation (A2LA):
A2LA provides comprehensive services in accreditation and training for testing and
calibration laboratories. See also NVLAP below.

1.3.2

Asia Pacific Laboratory Accreditation Cooperation (APLAC):
APLAC is a group of accreditation bodies in the Asia Pacific region responsible for
accrediting calibration, testing and inspection facilities.

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1.3.3

Authorized Representative:
An individual who is authorized to commit a Laboratory to fulfill the P25 Compliance
Assessment Program’s conditions for recognition.

1.3.4

Certificate of Recognition:
A document presented by the P25 CAP to a laboratory that has demonstrated competence
to conduct a particular Scope of Recognition of testing, that is, all of the test cases or a
subset of test cases defined in the applicable Compliance Related Telecommunications
Systems Bulletin.

1.3.5

Compliance Related Telecommunications Systems Bulletin:
A Telecommunications Systems Bulletin (see below) published by the
Telecommunications Industry Association (TIA) that defines a particular set of test
methods required to demonstrate that equipment built to a particular interface standard is
compliant with those standards.

1.3.6

Equipment Supplier:
The Original Equipment Manufacturer (OEM) or an authorized agent of the OEM.

1.3.7

International Laboratory Accreditation Cooperation (ILAC):
An international cooperation of laboratory and inspection accreditation bodies that
provides a focus for
a) developing and harmonizing laboratory and inspection accreditation practices,
b) promoting laboratory and inspection accreditation to industry, governments, regulators
and consumers, and
c) assisting and supporting developing accreditation systems.
It also provides global recognition of laboratories and inspection facilities via the ILAC
Mutual Recognition Arrangement. (See http://www.ilac.org/)

1.3.8

Invitational Testing Session:
A group testing session hosted by an infrastructure equipment provider for the purposes of
evaluating equipment interoperability.

1.3.9

Laboratory Assessment Team:
One or more individuals possessing knowledge of ISO/IEC 17025 processes and technical
familiarity with a particular Scope of Recognition of testing who travel to a laboratory to
assess its compliance to prescribed standards. Although the term Team is used here, a lead
assessor may possess the competence to also function as the subject matter expert and
thus act as a “single person” Laboratory Assessment Team.

1.3.10 Laboratory Client:
The entity that contracts with the laboratory; usually the laboratory client is the equipment
supplier.
1.3.11 Laboratory Code:
A unique identifier for program management assigned to each laboratory participating in
the P25 Compliance Assessment Program.

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1.3.12 Model Class:
Products defined by the manufacturer as having identical P25 functionality shall constitute
a Model Class.
1.3.13 Monitoring Visit:
An on-site assessment of a laboratory not associated with an initial or renewal recognition
assessment.
1.3.14 Mutual Recognition Arrangement (MRA):
A signed document concluded among governmental and other authorities of different
countries for mutual recognition of accreditations.
1.3.15 National Voluntary Laboratory Accreditation Program (NVLAP):
NIST NVLAP provides third-party accreditation to testing and calibration laboratories.
NVLAP's accreditation programs are established in response to Congressional mandates
or administrative actions by the Federal Government or from requests by private-sector
organizations. See also A2LA above.
1.3.16 P25 Compliance Assessment Program/Laboratory Program Manager (P25 CAP/LPM):
The program manager for the laboratory assessment and recognition portion of the P25
Compliance Assessment Program.
1.3.17 P25 Compliance Test Method:
A normative test procedure defined for compliance testing of a given interface. These test
procedures are typically broken down into the following categories:
a) Performance (e.g., Measurement Methods and Performance Recommendations)
b) Conformance
c) Interoperability
1.3.18 Scope of Recognition:
The type of testing for which a laboratory has demonstrated compliance and competence.
The particular test methods are contained in the relevant definition of compliance related
Telecommunications Systems Bulletins (TSBs) approved by the P25 Steering Committee
and published by TIA. The Scope of Recognition will list the actual test methods for
which the laboratory has demonstrated competency. NOTE: The Scope of Recognition
need not include all of the test methods contained in the aforementioned TSBs.
1.3.19 Supplier’s Declaration of Compliance (SDoC):
A formal declaration of compliance created in accordance with ISO/IEC 17050 for a
particular set of P25 Compliance Test Methods defined within the relevant Compliance
Related Telecommunications Systems Bulletin. The SDoC is signed by an Authorized
Representative of the Equipment Supplier.

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1.3.20 Telecommunications Systems Bulletin (TSB)
Telecommunications Systems Bulletins are published by the Telecommunications
Industry Association (TIA). A TSB is not a standard, but rather contains technical
material that may be valuable to industry and users.
1.3.21 Test Case:
A particular section which defines a unique test procedure within a compliance test
methods document.
1.3.22 Test Method Review Summary:
A document template used by members of a P25 CAP Laboratory Assessment Team to
record their observations of the management system and demonstrations of test
procedures during an on-site assessment.
1.3.23 Test Report Format:
A predefined format for summary test reports required by the P25 CAP for use by
laboratories participating in the recognition program.
1.4

Purpose and scope

1.4.1

This handbook sets forth the procedures and general requirements under which the Project
25 Compliance Assessment Program operates as an unbiased third party to recognize
Project 25 equipment testing laboratories.

1.4.2

The required P25 Compliance Test Methods and Test Cases are defined in TIA standards
and informative Compliance Related TSBs.

1.4.3

This handbook constitutes the collective body of requirements that must be met by a
laboratory seeking P25 CAP recognition for any of the specific test methods (for example,
audio level) provided in the laboratory’s Scope of Recognition. A given laboratory’s
Scope of Recognition may or may not cover all of the TIA-defined needs or
recommendations.
1.5

1.5.1

Outline of the P25 Compliance Assessment Program

The P25 Compliance Assessment Program (CAP) is a voluntary system that provides a
mechanism for the recognition of testing laboratories based on internationally accepted
standards. It identifies competent laboratories through assessments by trained Laboratory
Assessment Teams (see 2.2) and promotes the acceptance of compliant test results from
these laboratories.

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1.5.2

The P25 CAP was established on the basis of requests from the United States Congress 2 .
The specific tests, types of tests, and standards to be included in the program are defined
in Telecommunications Systems Bulletins approved by the Project 25 Steering
Committee. The laboratory assessment part of the program is managed by the Project 25
Compliance Assessment Program Laboratory Program Manager (P25 CAP/LPM) (see
2.1.1) who reports periodically to and receives feedback from government stakeholders.
While the P25 CAP/LPM exercises a great deal of authority and autonomy over the
program, this individual does not unilaterally propose or decide the scope of the program.

1.5.3

The P25 CAP/LPM administers laboratory related policies and procedures in a nondiscriminatory manner. Access to P25 CAP laboratory recognition is not conditioned on
the size of a laboratory or on its membership in any association or group, nor is it
conditioned upon the number of laboratories already recognized. P25 CAP services are
available to public and private testing laboratories, including commercial laboratories,
manufacturers’ in-house laboratories, university laboratories, and federal, state, and local
government laboratories. For laboratories operating outside the United States, the P25
CAP/LPM may accept reports prepared by Laboratory Assessment Teams operating under
ISO/IEC 17011 accreditation bodies that have signed a Mutual Recognition Arrangement
with APLAC and/or ILAC. The provisions of this Handbook shall govern the conduct of
all laboratory assessments irrespective of the composition of Laboratory Assessment
Teams (see 1.4.3).

1.5.4

P25 Compliance Assessment Program laboratory recognition is based on evaluation of a
laboratory’s quality management system and technical competence for conducting
specific test methods and measurements in certain fields or scopes of testing. Recognition
is granted only after an applicant has demonstrated that it has met all P25 CAP laboratory
requirements in this handbook. Recognition is acknowledged by the issuance of a
Certificate and Scope of Recognition, which details the specific test methods,
measurements and services for which a laboratory has been recognized

1.5.5

The P25 CAP/LPM operates a management system that is compliant with ISO/IEC
17011:2004; however, this system does not undergo peer review and is not part of the
APLAC and/or ILAC Mutual Recognition Agreements.

1.5.6

P25 CAP laboratory recognition does not relieve a laboratory from complying with
applicable federal, state, and local laws and regulations.
1.6

1.6.1

Confidentiality

To the extent permitted by applicable laws, the P25 CAP will protect the confidentiality of
all information obtained relating to the application, on-site assessment, evaluation, and
recognition of laboratories.

2

Senate Report 109-088 - DEPARTMENTS OF COMMERCE AND JUSTICE, SCIENCE, AND RELATED
AGENCIES APPROPRIATIONS BILL, 2006 and House Report 109-241 - MAKING APPROPRIATIONS FOR
THE DEPARTMENT OF HOMELAND SECURITY FOR THE FISCAL YEAR ENDING SEPTEMBER 30, 2006,
AND FOR OTHER PURPOSES.

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1.6.2

In addition, P25 CAP and the laboratory further agree that, to the extent permitted by law,
P25 CAP/LPM and Laboratory Assessment Team members will protect information
obtained during application, on-site assessment, evaluation, and recognition from
disclosure pursuant to Title 15 USC 3710a(c)(7)(A) and (7)(B) for a period of 5 years
after such information is obtained.

1.6.3

For the first 5 years that laboratory information is held by the P25 CAP, the provisions of
1.6.1 and 1.6.2 will be in force. Information in the P25 CAP’s possession for more than 5
years will continue to be held in confidence under the provisions of 1.6.1.
1.7

Complaints

The P25 CAP/LPM will employ a formal system to address complaints, which includes
procedures for determining the validity of complaints, taking appropriate and effective actions,
responding to complainants, and record-keeping. A complaint regarding the activities of the P25
CAP or of a P25 CAP-recognized laboratory may be lodged by any person or organization.
Information about the complaint shall be put in writing and mailed, faxed, or e-mailed to the P25
CAP/LPM, along with supporting documentation, if available. A complaint concerning a P25
CAP-recognized laboratory shall first be submitted to the laboratory against which the complaint
is lodged.

2

Organization
2.1

2.1.1

Management of the Project 25 Compliance Assessment Program

P25 Compliance Assessment Program Laboratory Program Manager (P25 CAP/LPM)

2.1.1.1 Responsibilities
The P25 CAP/LPM oversees the day-to-day operations of the program and is responsible for:
a)

Selecting members of Laboratory Assessment Teams;

b)

Recognizing qualified laboratories;

c)

Resolving laboratory- or testing-related disputes between parties to the P25 CAP;

d)

Briefing government stakeholders on a periodic basis;

e)
Adapting the management of the program to address the changing needs of P25
users as communicated by the government stakeholders.
2.1.1.2 Selection
The P25 CAP/LPM is selected by the Director of NIST Office of Law Enforcement Standards.

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2.2

Laboratory Assessment Teams

The P25 CAP/LPM selects assessors on the basis of their professional and academic
achievements, experience in the field of testing, management experience, training, technical
knowledge, assessment skills, and communications skills. Assessors are assigned to conduct an
on-site assessment of a particular laboratory on the basis of how well their experience, training,
and skills match the type of testing to be assessed, as well as the absence of conflicts of interest.
2.2.1

2.2.2

Team functions
a)

Conduct assessments on candidate laboratories

b)

Prepare reports based on assessments

c)

Conduct monitoring visits on existing, recognized laboratories

d)

Investigate and report on circumstances of any disputes

Functions of Assessment Team Members

Assessment team members perform two related functions:
a) The Lead Assessor (Laboratory Quality System Expert) applies detailed
knowledge of the ISO/IEC 17025 standard and this handbook to evaluate a laboratory’s
management (quality) system. (LPG)
b) The Subject Matter Expert assesses the technical competence of a laboratory to the
requirements of the technical standards and the requirements contained in this
handbook.
2.2.2.1 Requirements of Quality System Experts
a) A minimum of 3 days of formal training in the ISO/IEC 17025 laboratory
accreditation assessment processes.
b)

Experience having conducted three or more prior assessments

c) Preference will be given to assessors with experience with a nationally- and
internationally-recognized (that is, signatory to a Mutual Recognition Arrangement)
accreditation body.
2.2.2.2 Requirements of Subject Matter Experts
a)
Familiarity with the test method document(s) including execution method for each
test and the pass/fail criteria for each test.
b)

Familiarity with the necessary test equipment associated with each test.

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c)
Familiarity with the normative reference document(s) (TIA TSBs and
Compliance-Related TSBs) behind the pass/fail criteria for each test.
d)
Familiarity with the parameters and methods for configuring and programming the
device under test so as to generally discern whether the test operator has satisfactorily
configured it.

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e)
Familiarity with potential P25 feature interactions impacting the execution of a test
or interpretation of the results of a test.
f)
2.2.3

A minimum of 1 day of formal training in ISO/IEC 17025 processes.

Role of Lead Assessor
Each assessment team will have a Lead Assessor who acts as the single point of contact
between the assessment team and the laboratory, and the assessment team and the P25
CAP/LPM. The Lead Assessor shall be, at a minimum, a Quality System Expert per
2.2.2.1. The Lead Assessor may also be a Subject Matter Expert per 2.2.2.2.

2.2.4

3

The P25 CAP/LPM will provide the laboratory with a short biographical sketch of each
assessor. If a conflict of interest or prior business relationship exists, a laboratory may
request, and will be provided, an alternate assessor.

Management Requirements of Recognized Laboratories
3.1

Organization

3.1.1

The laboratory shall carry out its testing activities in such a way as to meet the
requirements of this handbook.

3.1.2

The management system shall cover work carried out in the laboratory’s permanent
facilities, at sites away from its permanent facilities, or in associated temporary or mobile
facilities.

3.1.3

The laboratory shall
a) have managerial and technical personnel who, irrespective of other responsibilities,
have the authority and resources needed to carry out their duties, including the
implementation, maintenance and improvement of the management system, and to
identify the occurrence of departures from the management system or from the procedures
for performing tests and/or calibrations, and to initiate actions to prevent or minimize such
departures (see also 5.2);
b) have arrangements to ensure that its management and personnel are free from any
undue internal and/or external commercial, financial and other pressures and influences
that may adversely affect the quality of their work;
c) have policies, procedures, and equipment to ensure the protection of the laboratory
client’s confidential information and proprietary rights, including procedures for
protecting the electronic storage and transmission of results;

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d) have policies and procedures to avoid involvement in any activities that would
diminish confidence in its competence, impartiality, judgment or operational integrity;
e) define the organization and management structure of the laboratory, its place in any
parent organization, and the relationships between quality management, technical
operations and support services;
f) specify the responsibility, authority and interrelationships of all personnel who
manage, perform or verify work affecting the quality of the tests;
g) provide adequate supervision of testing staff, including trainees, by persons familiar
with laboratory methods and procedures, test methods, and the assessment of the test
results;
h) have technical management which has overall responsibility for the technical
operations and the provision of the resources needed to ensure the required quality of
laboratory operations;
i) appoint a member of staff as Quality Manager (however named) who, irrespective of
other duties and responsibilities, shall have defined responsibility and authority for
ensuring that the management system related to quality is implemented and followed at all
times; the Quality Manager shall have direct access to the highest level of management at
which decisions are made on laboratory policy or resources;
j) appoint personnel to act in the absence of key managerial personnel (see Note);
k) ensure 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.
NOTE: Individuals may have more than one function and it may be impractical to appoint
acting personnel for every function.
3.1.4

Top management shall ensure that appropriate communication processes are established
within the laboratory and that communication takes place regarding the effectiveness of
the management system.
3.2

3.2.1

Record keeping requirements.

Test item related documents: The following documentation is required for each item
tested at the laboratory:
a)

A detailed description of the item including hardware, software, and firmware;

b)

A copy of the test procedure(s) used;

c) Identification of the test operator, the date of the test, and unambiguous identification
of the unit tested (including the firmware version) and the infrastructure environment; and

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d) A copy of the detailed test report including any applicable laboratory notes,
intermediate computations, and analysis.
3.2.2 Laboratory related documents: The following documentation is required to substantiate
the competence of the laboratory which conducted the tests.
3.2.2.1 A descriptive biography for each laboratory employee detailing, for example, their years
of experience, pertinent training or certifications, academic background, etc.
3.2.2.2 Equipment records:
a) Complete records on the latest calibrations for all test equipment in the laboratory;
and
b) Configuration records for any radio infrastructure equipment used in the laboratory
indicating the dates of any hardware, software, and/or firmware configuration changes on
the equipment.
3.2.3

Retention requirements:
All documents related to a particular test object shall be held by the laboratory for as long
as the particular model of equipment is available for sale by the Equipment Supplier,
including models whose software or firmware version numbers change over time, but at
least for a period of five years. Records may be stored in hard copy or electronic format.
3.3

Laboratory availability

Laboratories are advised to develop formal policies that are available to stakeholders describing
the facilities’ availability. Such policies might contain, for example, minimum requirements or
expectations for invitational testing sessions, provisions for quick turnaround testing sessions,
terms for minimum intervals between announced testing sessions, and periods of time for
advance notice of testing. Any limitations to these policies should also be available for review by
stakeholders.
3.4

Laboratory testing contract requirements review

The requirements that identify the system or units that will be tested should be carefully reviewed
by Laboratory Technical Management. The test report(s) and the associated Supplier’s
Declaration of Compliance (SDoC) which the test report(s) support shall apply only to the Model
Class tested. Other configurations or variants that have not been tested shall not be included in the
SDoC. It is recommended that the Equipment Supplier’s Design and Development Engineering as
well as Product Marketing document a test plan that includes the normal sales/marketing
variations of the product.

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3.5

Subcontracting of testing

Testing within the Scope of Recognition may not be subcontracted except to another P25recognized compliance assessment laboratory with the same or complementary Scope of
Recognition. Exceptions are FCC tests and other RF physical tests that may be subcontracted to
an EMC test laboratory accredited by an ILAC signatory recognized by the FCC.
3.6

Purchasing calibration services

Purchasing of calibration services shall be controlled and specified by the laboratory to ensure
that the order for services meets its specific requirements. The technical records from the
calibration laboratory will be reviewed by the Laboratory Assessment Team to ensure they are
traceable to NIST or the local National Metrology Institute. Reference NIST Handbook 150:2006
Annex B for further details on demonstrating traceability. As a minimum, the laboratory shall be
traceable for the fundamental parameters of voltage, time, frequency, and RF power.
3.7

Access for the P25 CAP Laboratory Assessment Team

Upon request, the laboratory shall demonstrate to the P25 CAP Laboratory Assessment Team any
of the procedures defined within the applicable Scope of Recognition for the laboratory.
3.8

Complaints

The laboratory shall record all complaints (from either internal or external sources) and process
them using the corrective action and preventive action systems of the laboratory management
system.
3.9

Control of nonconforming testing work

If nonconforming work resulting in invalid test data are detected, the laboratory client and the
P25 CAP/LPM shall be alerted and test methods repeated, as necessary, by the laboratory. If the
nonconforming work is detected after either the test report and/or SDoC has been issued, the P25
CAP/LPM will investigate the nature of the nonconformity and will provide a written
recommendation for corrective action to the laboratory and the laboratory’s client. These parties
shall have 30 days to respond to the proposed corrective action.
3.10 Improvement
The laboratory shall continually improve the effectiveness of its management system through the
use of a quality policy, quality objectives, audit results, analysis of data, corrective and preventive
actions and management review. Refer to ISO/IEC 17025:2005 Section 4.10 for further details.

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3.11 Corrective action
When departures from the laboratory’s established policies and procedures are encountered, the
laboratory shall have a defined process with clearly delineated responsibilities to implement
corrective actions. Refer to ISO/IEC 17025:2005 Section 4.11 for further details.
3.12 Preventive action
The laboratory shall have in place a system for identifying potential nonconformities and
developing action plans to resolve such issues before their occurrence. Refer to ISO/IEC
17025:2005 Section 4.12 for further details.
3.13 Control of records
The laboratory shall have in place documented processes for collecting, retaining, and accessing
records related to the laboratory and the equipment tested. The laboratory shall retain test records
for at least five years. Refer to ISO/IEC 17025:2005 Section 4.13 for further details.
3.14 Internal audits
The laboratory shall periodically conduct internal audits of its own processes that shall include
the management system, its past performance, compliance with this handbook, and laboratory
processes that supports P25 Compliance. Refer to ISO/IEC 17025:2005 Section 4.14 for further
details.
3.15 Management reviews
Laboratory management shall periodically conduct reviews of the management system. Refer to
ISO/IEC 17025:2005 Section 4.15 for further details.

4

Laboratory Assessment Process
4.1

4.1.1

Application for initial recognition

General
To initiate the laboratory recognition process, the applicant laboratory shall submit an
application, a Quality Manual and relevant associated documentation specified within
the application, and shall agree to conditions for recognition stipulated in the
application.

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4.1.2

Required information
An applicant laboratory shall complete an application for recognition that includes, but is
not limited to, the following information:
a)

the legal name and full address of the laboratory;

b)

the Authorized Representative’s name and contact information;

c)

the names, titles and contact information for laboratory staff nominated to serve as
Approved Signatories of test reports;

d)
an organizational chart defining relationships that are relevant to performing
testing covered in the application;
e)
a general description of the laboratory, including its facilities and scope of
operation;
f)
the requested Scope of Recognition as defined by the applicable relevant
Compliance Related Telecommunications Systems Bulletin(s);
Along with the application, the applicant shall provide a Quality Manual, applicable
quality related documents, and other documents as may be required in future scope
definition bulletins.
4.1.3

By submitting the application, the laboratory’s Authorized Representative commits the
laboratory to fulfill the conditions for recognition listed in the P25 CAP Application
Form. The Authorized Representative shall review all documents provided with the
application package and become familiar with P25 CAP requirements before submitting
the application.

4.1.4

Fees for recognition
Reserved for future use.

4.1.5

Review of application
Upon receipt of a laboratory’s application for recognition, the P25 CAP/LPM assigns a
Laboratory Code to the applicant laboratory; acknowledges receipt of the application in
writing; reviews the information supplied by the laboratory for adequacy; requests further
information, if necessary; and specifies the next step(s) in the recognition process.
4.2

4.2.1

Activities prior to the on-site assessment

Assignment of assessor(s)
A pool of assessors is selected by the P25 CAP/LPM based on their qualifications per

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2.2.2.1 and 2.2.2.2. The P25 CAP/LPM then draws from this pool to create prospective
Laboratory Assessment Teams. These teams are proposed to the laboratory’s
Authorized Representative for review per 2.2.4. The laboratory may request alternative
assessor(s). The P25 CAP/LPM will recommend replacement assessors for the
Laboratory Assessment Team to satisfy the Authorized Representative’s concerns per
2.2.4.
4.2.2

Document review

4.2.2.1 The P25 Laboratory Assessment Team will review the laboratory’s Quality Manual and
related management system documentation submitted with the application to ensure they
cover all aspects of the management system related to quality and, if followed, satisfy
the requirements in this handbook. The Lead Assessor on behalf of the assessment team
may ask for additional documentation pertaining, for example, to the management
system, test processes or procedures, other supporting information (e.g., test
configurations, list of test instruments used), and/or records in order to facilitate the
review.
4.2.2.2 The P25 CAP Laboratory Assessment Team may identify suspected documentation
nonconformities. These nonconformities are discussed with the Authorized
Representative, and the laboratory is given the opportunity to address them prior to the
on-site assessment. In some instances, based on the document review, the P25 CAP
Laboratory Assessment Team may request that the laboratory address the
nonconformities before the on-site assessment is scheduled. In such cases, the assessor
will provide a list of the nonconformities to the laboratory in writing. Where the
management system documentation requires significant revision, the P25 CAP
Laboratory Assessment Team may require that the laboratory improve its documentation
and submit it for further review prior to proceeding with the recognition process.
4.2.3

Scheduling of on-site assessment

4.2.3.1 The laboratory is contacted by the Lead Assessor of the P25 CAP Laboratory
Assessment Team to schedule a mutually acceptable date for the on-site assessment. An
assessment normally takes two to five days depending on the proposed Scope of
Recognition. However, laboratory management should apprise the Lead Assessor of the
laboratory’s prior quality system experience and applicable qualifications, since this may
affect the scheduled duration of the assessment. Every effort will be made to conduct an
assessment with as little disruption as possible to the normal operations of the
laboratory.
4.2.3.2 If a laboratory requires that its established assessment date be changed, it shall contact
the Lead Assessor of the P25 CAP Laboratory Assessment Team.
4.2.3.3 An on-site assessment will be conducted as a part of the initial recognition process and
every three years thereafter (based on the date of initial recognition). Delay of
assessments beyond these frequencies may affect a laboratory’s recognition status.
4.2.3.4 If a laboratory has a corrective action plan in place that includes corrective action to be
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taken within one year (as agreed upon by the P25 CAP/LPM) at the time of initial
recognition, it shall have an additional on-site assessment within one year of initial
recognition.
Recognition may not be granted if any corrective action is not completed in an appropriate
amount of time.
4.3
4.3.1

On-site assessment

Conduct of on-site assessment

4.3.1.1 An on-site assessment may be conducted at all laboratory locations where P25 CAP tests
will be performed.
4.3.1.2 At the beginning of the assessment, an opening meeting will be conducted with
management and laboratory personnel to explain the purpose of the on-site assessment
and to discuss the schedule for the assessment activities.
4.3.1.3 During the assessment, the Laboratory Assessment Team may examine equipment and
facilities, observe demonstrations of testing, examine test reports, examine the
management system, review quality and/or technical records and/or procedures, and
review the biographies of staff to determine their competency in their particular area of
expertise.
4.3.1.4 Laboratory Assessment Team members will use a common Test Method Review
Summary, so each laboratory receives an assessment comparable to that received by
others.
4.4

The post-assessment meeting

The post assessment meeting will provide a summary of all the activities of the assessment as
detailed in 4.3. The nonconformities will be documented and presented to the laboratory. The
laboratory will be given an opportunity to ask questions and clarify any of the nonconformities
received. The laboratory shall have the right to object to any of the nonconformities. These
objections will be handled by the P25 CAP/LPM.
4.4.1

On-site assessment report

The assessment report will consist of evaluations of the quality system (in accordance with the
applicable provisions of this Handbook) and of the technical assessment components. The
technical assessment components will be contained in a Test Method Review Summary which
details which tests were observed, what equipment was used, and the staff member(s) that
conducted the test(s). In addition, the report will contain a listing of any observed
nonconformities.
4.4.1.1 At the conclusion of the assessment, the Lead Assessor will conduct a closing meeting

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a)

the date(s) of assessment;

b)

the names of the assessor(s) responsible for the report;

c)

the names and addresses of all the laboratory sites assessed;

d)

the assessed Scope of Recognition;

e)

comments and/or nonconformities cited by the assessor(s) on the compliance of
the laboratory with the recognition requirements; and

f)

a copy of completed Test Method Review Summaries.

4.4.1.2 The Authorized Representative shall sign the report to acknowledge that the assessor has
discussed its contents. See Section 4.5 regarding further steps in the recognition process.
4.4.1.3 The Lead Assessor will leave a copy of the report with the laboratory and forward the
original report to the P25 CAP/LPM within 5 business days.
4.4.1.4 The Lead Assessor is responsible for the content of the on-site assessment report,
including the statement of any nonconformities.
4.5
4.5.1

The nonconformity reconciliation process

Laboratory response to the on-site assessment report
If there are nonconformities listed in the on-site assessment report, the laboratory’s
Authorized Representative shall respond to the P25 CAP/LPM in writing within 30 days.
In the event that nonconformities require more than 30 days to investigate, the Authorized
Representative and P25 CAP/LPM will agree upon an appropriate response date.

4.5.2

P25 CAP Laboratory Program Manager response
The P25 CAP/LPM will respond to written communications from the Authorized
Representative within 30 days.

4.5.3

Ongoing nonconformity resolution
The Authorized Representative and P25 CAP/LPM will communicate with one another
until a corrective action plan has been accepted by the P25 CAP/LPM or until all
nonconformities are resolved to the satisfaction of the P25 CAP/LPM. Unless otherwise
negotiated in advance, each party shall respond to the other’s communications within 30
days or else the laboratory shall withdraw from the recognition process.

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4.5.4

Disputes
The Authorized Representative may appeal a finding or raise a dispute regarding this
process in accordance with Section 4.16.
4.6

The Recognition decision

4.6.1

The P25 CAP/LPM may appoint a committee to assist in the decisions required for all
actions related to granting, renewing, suspending, and revoking any P25 CAP recognition.

4.6.2

The recognition decision process will consider the laboratory’s record as a whole,
including:
a)

information provided on the application;

b)

results of management system documentation review;

c)

on-site assessment reports;

d)

actions taken by the laboratory to correct nonconformities; and

e) if applicable, the adequacy of the corrective action plan(s) and preventive action plan(s)
submitted by the laboratory.

4.6.3

All nonconformities shall be either resolved or adequately addressed in a corrective action
plan to the P25 CAP/LPM’s satisfaction before recognition will be granted.
NOTE 1: Only management system -related nonconformities (e.g., policies, systems,
program, procedures, and instructions as described in Section 3 of this handbook will be
accepted with only a corrective action plan as agreed by the P25 PAC/LPM. Technical
(i.e., TIA-102) related nonconformities must be resolved to gain recognition. Laboratories
recognized with a corrective action plan must provide quarterly corrective action reports
which show significant milestones and continued progress in resolving identified
nonconformities.
NOTE 2: Laboratories recognized with corrective action plans in place will be subject to
an additional on-site assessment approximately 12 months after the initial recognition
decision.
4.7

Granting recognition

4.7.1

Recognition is granted when a laboratory has met all P25 CAP requirements. The renewal
period is three years; recognition expires and must be renewed within 3 years of the
recognition date (See 4.8).

4.7.2

Renewal dates which provide mutual benefit to both parties may be reassigned by the P25

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CAP/LPM or upon written request from the laboratory. If a renewal date is changed, the
laboratory will be notified in writing of the change.
4.7.3

When recognition is granted, the P25 CAP/LPM will provide the laboratory a Certificate
and Scope of Recognition identified by its Laboratory Code, which includes:
a)

the name and address of the laboratory that has been recognized;

b)

the Scope of the Recognition listing the test methods for which the laboratory has
demonstrated competence;

c)

the laboratory’s Authorized Representative; and

d)

the effective dates of the recognition.
4.8

4.8.1

Renewal of recognition

Each recognized laboratory will receive a renewal package containing an updated
application form approximately 6 months before the expiration date of its recognition, to
allow sufficient time to complete the renewal process.

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4.8.2

The application for renewal shall be received by the P25 CAP/LPM prior to expiration of
the laboratory’s current recognition to avoid a lapse in recognition. If a laboratory allows
its recognition to expire, the P25 CAP/LPM may at his or her discretion require a new
initial assessment.

4.8.3

On-site assessments of currently recognized laboratories will be performed in accordance
with sections 4.3 through 4.7. If nonconformities are found during the assessment of a
recognized laboratory, the laboratory shall submit a satisfactory response to the P25
CAP/LPM concerning resolution of nonconformities within 30 days of notification or face
possible suspension of recognition.
NOTE: The on-site assessment associated with a renewal may occur at any time during
the three year renewal period. However, it will normally occur within six months of
receipt of the updated application. Renewed recognition is good for three years following
review and acceptance of the application.

4.8.4

Undue delay in the resolution of nonconformities may necessitate another on-site
assessment.
4.9

Monitoring visits

4.9.1

In addition to regularly scheduled assessments, monitoring visits may be conducted by a
P25 CAP/LPM authorized Laboratory Assessment Team at any time during the
recognition period. The need for such visits will be determined by the P25 CAP/LPM.
Monitoring visits will be scheduled in advance with the laboratory so that they do not
interfere with scheduled or unscheduled interoperability testing events.

4.9.2

The scope of a monitoring visit may range from checking a few designated items to a
complete review. The Laboratory Assessment Team may review nonconformity
resolutions, and/or verify reported changes in the laboratory’s personnel, facilities, or
operations.

4.9.3

Laboratories are not assessed any fees for the cost of a monitoring visit.
4.10 Changes to Scope of Recognition

4.10.1 A laboratory's Scope of Recognition may be expanded to include additional performance,
conformance or interoperability Compliance Test Methods, including methods for
additional P25 standard interfaces without the need for an immediate on-site assessment.
If the laboratory requests additions to its Scope of Recognition, it must meet all the
requirements defined in the applicable Compliance Related TSB for which recognition is
sought. Laboratories may also make requests to reduce their Scope of Recognition.
4.10.2 A laboratory wishing to change to its Scope of Recognition must make a request in
writing. When requesting a reduction in its Scope of Recognition, a laboratory shall
identify the relationship between the current and proposed Scopes of Recognition. When

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requesting an expansion of its Scope of Recognition, a recognized laboratory shall provide
the following detailed information to the P25 CAP/LPM:
a) Identify the relationship between the current and proposed Scopes of Recognition.
b) Identify and evaluate the differences between the previously assessed Compliance
Test TSB and the Compliance Test Method(s) to be added under the proposed new
Scope of Recognition.
c) Summarize the critical parameters of the proposed new Compliance Test Methods.
d) Document special considerations contained in the proposed new Compliance Test
Methods.
e) Identify any unique or new test equipment requirements.
f) Describe how staff competence with respect to the added Compliance Test Method(s)
has been achieved.

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4.10.3 This procedure is NOT intended to allow a laboratory to increase its Scope of Recognition
to include Compliance Test Methods for which performance, conformance or
interoperability testing recognition has not been granted through an on-site assessment.
The need for an additional on-site assessment will be determined by the P25 CAP/LPM
on a case-by-case basis. A laboratory may also request deletions from its Scope of
Recognition. The deletions may be temporary or permanent.
4.10.4 Compliance with the requirements of the standards identified in the Compliance Related
TSB will be verified by a Laboratory Assessment Team at the next regularly scheduled
on-site assessment of the recognized laboratory which occurs upon renewal of
recognition.
4.10.5 When a change to the Scope of Recognition is granted, the P25 CAP/LPM will provide
the laboratory a revised Certificate and Scope of Recognition (see 4.7.3).
4.11 Suspension of recognition
4.11.1 If it is determined that a recognized laboratory does not comply with the conditions of this
Handbook established during the current assessment period, the laboratory will be notified
in writing and given 30 days to respond. If the laboratory does not respond within 30
days, the P25 CAP/LPM will suspend the laboratory’s recognition. That determination
may be made by the P25 CAP/LPM (e.g., based on evidence obtained during the
assessment process) or by the laboratory (e.g., by notifying the P25 CAP/LPM of a major
change in accordance with the application instructions). Suspension can be for all or part
of a laboratory’s recognition. If a laboratory’s recognition is suspended for an extended
period of time, the P25 CAP/LPM may also propose to revoke recognition (see 4.12).
4.11.2 If a laboratory’s recognition is suspended, the P25 CAP/LPM notifies the laboratory of
that action, stating the reasons for and conditions of the suspension and specifying the
action(s) the laboratory shall take to have its recognition reinstated. A reassessment of the
laboratory may also be required for reinstatement.
4.11.3 A laboratory whose recognition has been suspended shall not reference P25 CAP
recognition on its test or calibration reports, correspondence, and advertising during the
suspension period in the area(s) affected by the suspension. The P25 CAP will not require
a suspended laboratory to return its Certificate and Scope of Recognition.
4.11.4 A suspended laboratory may be reinstated by satisfactorily addressing the written
concerns raised by the P25 CAP/LPM. When recognition is reinstated, the P25 CAP/LPM
will authorize the laboratory to resume testing activities in the previously suspended
area(s) as a recognized laboratory.
4.11.5 During the suspension period, test reports generated by the laboratory shall not be used to
substantiate a Supplier’s Declaration of Compliance for any products.

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4.12 Revocation of recognition
4.12.1 A laboratory that has had its recognition suspended for more than 6 months may be
considered for revocation. If the P25 CAP/LPM proposes to revoke recognition of a
laboratory, he/she will inform the laboratory of the reasons for the proposed revocation
and the procedure for appealing such a decision. Revocation can be for all or part of a
laboratory’s Scope of Recognition.
4.12.2 The laboratory has 30 days from the date of receipt of the proposed revocation letter to
appeal the decision. If the laboratory appeals the decision (see 4.15), the proposed
revocation will be stayed pending the outcome of the appeal. The proposed revocation
will become final through the issuance of a written decision to the laboratory, in the event
that the laboratory does not appeal the proposed revocation within the 30-day period.
4.12.3 If recognition is revoked, the laboratory may be given the option of voluntarily
terminating the recognition (see 4.14).
4.12.4 A laboratory whose recognition has been revoked shall return its Certificate and Scope of
Recognition and shall cease to reference recognition by the P25 CAP in any of its reports,
correspondence, or advertising related to the area(s) affected by the revocation.
4.12.5 At the P25 CAP/LPM’s discretion, the laboratory’s clients may be required to
demonstrate that existing SDoCs are valid. Accordingly, the P25 CAP/LPM will work
with the affected laboratory to identify whether any test cases must be re-run.
4.12.6 If the revocation affects only some, but not all of the items listed on a laboratory’s Scope
of Recognition, the P25 CAP/LPM will issue a revised Certificate and Scope of
Recognition that excludes the revoked area(s) in order that the laboratory might continue
operations in recognized areas.
4.13 Reinstatement of recognition
4.13.1 A laboratory whose recognition has been revoked may reapply (using the same
procedures described in section 4.1) and be recognized if the laboratory:
a) completes the assessment process;
b) meets the P25 CAP conditions for recognition.
4.14 Voluntary termination of recognition
4.14.1 A laboratory may at any time terminate its participation and responsibilities as a
recognized laboratory by advising the P25 CAP/LPM in writing of its desire to do so.
4.14.2 Upon receipt of a request for termination, the P25 CAP/LPM will terminate the
laboratory’s recognition, notify the laboratory that its recognition has been terminated,
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instruct the laboratory to return its Certificate and Scope of Recognition, and to remove
references to the P25 CAP from all subsequent test reports, correspondence, and
advertising.
4.14.3 A laboratory whose recognition has been voluntarily terminated may reapply per section
4.1.
4.15 Appeals
4.15.1 A laboratory has the right to appeal any adverse decision made by the P25 CAP/LPM.
Such decisions include refusal to accept an application; refusal to proceed with an
assessment; corrective action requests; changes in Scope of Recognition; decision to
suspend or revoke recognition; and any other action that impedes the attainment or
sustenance of recognition.
4.15.2 Appeals of decisions made by the P25 CAP/LPM are handled by the Director of NIST’s
Office of Law Enforcement Standards (OLES) or designee. Appeals of decisions made by
the OLES Director are handled by the Director of NIST.
4.15.3 An advisory panel of experts selected by the P25 CAP/LPM may be called to address
appeals of a technical nature.
4.15.4 The party assigned to handle the appeal decides on the validity of the appeal and, if
appropriate, renders a decision. The P25 CAP/LPM advises the appellant of the outcome
of these deliberations and any recourse for further appeal.

5

Technical Requirements for Recognition
5.1

General

All of the test methods that are required within a particular Scope of Recognition shall be
available at the laboratory.
5.2

Personnel

Staff shall be adequately trained for each test method or Test Case that they are responsible for or
perform. Staff shall demonstrate proper programming, configuration, understanding and
operation of the equipment under test and test equipment.
NOTE: Laboratory personnel may rely upon engineering support from the equipment supplier to
demonstrate proper programming of equipment under test.

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5.3

Accommodation and environmental conditions

The facility shall meet the minimum facility requirements specified in the test method standard.
When specified in the standards, environmental conditions such as temperature, humidity, and
barometric pressure shall be recorded at the time of the test. These records (measurements) shall
be traceable to NIST or the local National Metrology Institute.
5.4

Test methods and method validation.

It is the responsibility of each laboratory to validate each test method or Test Case in their own
laboratory using the applicable equipment contained in that lab.
5.5

Equipment

5.5.1

Test equipment shall be available that can adequately perform the test case or test method.

5.5.2

All test equipment shall meet the requirements of the selected test method, including the
normative standards referenced therein. This shall be demonstrated through product
literature or actual measurements.

5.5.3

The laboratory shall have procedures for determining the proper operating condition of
the test equipment.

5.5.4

All test equipment and equipment under test shall be configured in accordance with the
selected test method standard unless an alternative method is employed, in which case,
laboratory personnel shall provide the rationale for its use and explain how the results
obtained using the alternative method compare with the method specified by the standard.
If a test method has optional procedures, the laboratory shall indicate which option was
used.

5.5.5

If modifications to the equipment under test setup are required to achieve a pass verdict,
they shall be clearly indicated in the test report.
5.6

Handling of test items

All test items shall be suitably identified and stored in an appropriate place as required by the
Equipment Supplier. The laboratory shall have a procedure for determining the proper operating
condition of the equipment under test.
5.7

Assuring the quality of test results

To the extent possible, each test method and test case shall have a regular check to determine the
validity of the indicated results.

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5.8
5.8.1

Reporting the results

If available, the laboratory shall furnish one or more previously prepared detailed test
reports or partial report samples prior to on-site assessment. The detailed test report shall
provide:
a)

The date and time that the tests were performed;

b)
The location of the test facility (facilities that have received prior recognition from
other conformity assessment bodies shall use the same address as was previously reported
to the other body);
c)

A list of all equipment tested;

d)
Clear documentation of compliance with the applicable standard, including user
information or labeling requirements;
e)
The product identification and marketing name, installed software and firmware
packages with revision numbers, version numbers, and serial numbers where applicable;
f)
A list of the ancillary equipment and software required to configure the equipment
under test, including revision numbers and serial numbers where applicable (this includes
both equipment and software supplied by the Equipment Supplier and those created by the
laboratory);
g)
A complete list of test equipment used showing the arrangement of equipment and
cables (drawings, photographs or block diagrams showing the interconnections between
components are appropriate for this purpose);
h)
Test equipment lists with manufacturer’s model and serial numbers as well as date
of last calibration and calibration interval;
i)
All equipment set-up conditions and/or test equipment settings, so the tests could
be repeated and give results within the tolerances defined for that measurement;
j)
The measurement data in accordance with the standard in a clear and concise
manner such as in tabular or graphical form (alternatively, chart data, instrument display
captures or photographs may be used provided that the information is clearly presented
and performance requirements are clearly indicated);
k)

A summary which clearly indicates the test case verdict; and

l)
The signature of the person(s) performing the test and the Authorized
Representative.
5.8.2

All test reports shall follow the guidance given in the standard. If the test equipment for a
particular test method is not configured in full conformance with the test setups described

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5.8.3

If a measurement procedure has multiple methods, the test report shall indicate which
method was employed. Any and all deviations from test method procedures in the
standards shall be recorded in the test report.

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