Radiation Physics Division Quality Management System Guide RPD-G-01

GUIDE AND PROCEDURE WRITING

Version: 3.11 Page 1 of 6 Approval: JMA Effective Date: 11/15/2021

Purpose

This protocol provides an outline of elements necessary to write or revise Guides,

Procedures, and the RPD-QM-II, within the Radiation Physics Division (RPD).

Scope

This protocol applies to Guides, Procedures, and the RPD-QM-II, all of which are

written and maintained in support of the RPD calibration, measurement quality 

assurance, and standard reference material programs.

Definitions

Guide – Information and instructions for the operational aspects of the RPD

Quality Management System.

Procedure – A set of principles and practices that describe the requirements for

calibrations, certifications, measurement quality assurance, or standard reference 

material production.

RPD-QM-II - A document stating the quality policy, quality management system, 

and quality practices of an organization.

Protocol

Part 1 - RPD Guides

1. The Guide templates are obtained from the Quality Manager.

2. The obligatory sections to be included are as follows: Purpose, Scope, 

Protocol, Acceptance Criteria, Records, Filing and Retention. If any of these 

sections do not apply, a “N/A” must be entered. 

3. Optional sections may include: Definitions, Equipment, Health & Safety 

Precautions, References, and Appendices. If these do not apply, they may be 

omitted from the Guide.

4. Additional sections may be added as needed.

5. Specific guidelines may be obtained from the Quality Manager.
Radiation Physics Division Quality Management System Guide RPD-G-01

GUIDE AND PROCEDURE WRITING

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Review of RPD Guides

1. The Guide may be distributed to RPD staff for review for consistency with 

common practices. Comments should be directed to the Quality Manager.

2. The Guide is reviewed by each of the Group Leaders to ensure that it does not 

conflict with the operational aspects of RPD services. Comments should be 

directed to the Quality Manager.

3. The Quality Manager reviews the Guide to ensure that all items dealing with 

quality (documents, records, etc.) are handled in the correct manner.

4. The RPD Division Chief reviews the Guide to ensure that it adheres to

Division policy.

5. The Division Chief approves the Guide by email or written notification to the 

Quality Manager.

Distribution

Once a Guide is approved, the Quality Manager will assign it a number and will 

add it to the master list of controlled documents. The master list of controlled 

documents will be updated to reflect any revisions. The Quality Manager will 

notify the RPD staff of the Guide’s status and availability.

The Quality Manager is under no obligation to provide updated Guides to bearers 

of uncontrolled quality management system documentation.

Guide Revision

1. The Quality Manager will initiate the review process, as needed, at the 

discretion of the Quality Manager or the Division Chief.

2. Guides are to be revised when a change is warranted.

3. The Guide revision review and approval process is identical to that described 

above in Review of RPD Guides.

4. The Quality Manager is responsible for updating all controlled documents. 

5. The Quality Manager has the option of issuing errata notifications rather than 

revised protocols in the interim between official revisions.
Radiation Physics Division Quality Management System Guide RPD-G-01

GUIDE AND PROCEDURE WRITING

Version: 3.11 Page 3 of 6 Approval: JMA Effective Date: 11/15/2021

Deleted Guides

1. A Guide will be deleted when:

• it is no longer in effect

• there is a change of name and/or number

2. The Quality Manager shall remove the deleted Guide from the RPD files and 

place it in the Deleted Documents file. 

Part 2 – Technical Service Procedures

1. There is no set format for calibration service Procedures. They should be 

written in an easy-to-understand format appropriate to the particular service.

2. The obligatory section headings to be included are: Purpose, Scope, 

Definitions, Equipment, Safety, Procedures, Uncertainty Analysis, Records,

References, Filing and Retention. Other sections may be added as deemed 

appropriate.

3. Authors are strongly encouraged to consider the NIST-QM-I and RPD-QM-II 

as guidance in preparing the content of their (calibration or SRM) service 

Procedure. The following list of sections from NIST-QM-I are of particular 

relevance: (6.0) Resource requirements, (7.0) Process requirements and (8.4) 

Control of records.

4. The Procedure shall be consistent with all requirements of the NIST Quality 

Management System.

Review of Procedures

1. An independent reviewer shall be named by the relevant Group Leader.

2. The independent reviewer reviews the Procedure.

2.1 This person should be familiar, but not necessarily intimately involved, 

with the calibration/testing program in the Procedure.

2.2 If possible, the independent reviewer should visit the measurement 

facility to either perform the Procedure or simulate the steps involved.

3. The Group Leader shall review the Procedure to ensure that it meets Group 

policy and operational requirements.
Radiation Physics Division Quality Management System Guide RPD-G-01

GUIDE AND PROCEDURE WRITING

Version: 3.11 Page 4 of 6 Approval: JMA Effective Date: 11/15/2021

4. The Quality Manager shall review the Procedure to ensure that quality 

requirements are being met.

5. The RPD Division Chief reviews the Procedure to ensure that it adheres to 

Division policy.

6. The Division Chief approves the Procedure by email or written notification to 

the Quality Manager.

Distribution

Once a Procedure is approved, it shall be given to the Quality Manager who will 

assign it a unique number and will add it to the master list of controlled 

documents. The Quality Manager will notify the RPD staff of the Procedure’s 

status and availability.

The Quality Manager is under no obligation to provide updated Procedures to 

bearers of uncontrolled quality management system documentation. 

Procedure Revision 

1. The Quality Manager will initiate the review process, as needed, at the 

discretion of the Quality Manager or the Division Chief.

2. Procedures are to be revised when a change is warranted.

3. The Procedure revision review and approval process is identical to that 

described above in Review of RPD Procedures with the exception that steps 1 

& 2 are optional.

4. The Quality Manager is responsible for updating all controlled documents.

Deleted Procedures

3. A Procedure will be deleted when:

• it is no longer in effect

• there is a change of name and/or revision number

4. The Quality Manager shall remove the deleted Procedure from the RPD files 

and place it in the Deleted Documents file. 
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Part 3 - RPD QMII

1. There is no set format for the RPD-QM-II but following the format of the 

QMI provides clarity.

2. The RPD-QM-II must be consistent with the NIST-QMI. 

Review of RPD-QM-II

1. A draft version (with changes identified) of the Quality Manual is prepared by 

the Quality Manager and distributed to the RPD Group Leaders, Deputy 

Division Chief and the Division Chief. 

2. The draft version is reviewed for consistency with common practices, 

services, and policy by management.

3. The RPD Division Chief reviews the RPD-QM-II to ensure that it adheres to

Division policy.

4. The Division Chief approves the Quality Manual by email or written 

notification to the Quality Manager.

Distribution

After a revision of RPD-QM-II is approved as the official version, the RPD Division 

Quality Manager will have it posted on the RPD Quality Management System website as 

the official version. Notice of the revised RPD-QM-II will be posted on the Document 

Revisions page of the RPD Quality Management System website. 

RPD-QM-II Revision

1. The Quality Manager will initiate the review process, as needed, at the 

discretion of the Quality Manager, RPD staff request or RPD management.

2. The RPD-QM-II will have a completed documentary review during internal 

audits during which the staff are requested to review the RPD-QM-II.

3. The RPD-QM-II will be revised when a change is warranted.

4. The RPD-QM-II revision review and approval process is identical to that 

described above in Review of RPD RPD-QM-II.

5. The Quality Manager is responsible for updating all controlled documents. 

6. The Quality Manager has the option of issuing errata notifications in the 

interim between official revisions.
Radiation Physics Division Quality Management System Guide RPD-G-01

GUIDE AND PROCEDURE WRITING

Version: 3.11 Page 6 of 6 Approval: JMA Effective Date: 11/15/2021

Deleted RPD-QM-II

5. An old version of the RPD-QM-II will be deleted when a new version is 

created.

6. The Quality Manager shall remove the deleted RPD-QM-II from the RPD

files and place it in the Deleted Documents file. 

Acceptance Criteria

The Division Chief approves the RPD-QM-II, Guide, or Procedure by email or 

written notification to the Quality Manager.

Schedule

Guides and Procedures will be reviewed at least every two years. The RPD-QM-II

will be reviewed whenever changes are made.

Records

Master list of controlled documents

RPD Guides 

RPD Procedures

RPD-QM-II

Deleted Documents file

Filing and Retention

The master list of controlled documents is available on the RPD Quality

Management System website and shall be retained only until the next list is 

prepared.

The official versions of the RPD-QM-II, and its Guides, Procedures, forms and 

supporting documents, are maintained by the RPD Quality Manager. The 

controlled versions of these quality documents are stored as portable document 

format (PDF) electronic files located on the NIST servers and disseminated

through the external website by a hypertext link on the RPD home page

{http://www.nist.gov/pml/div682/qualitysystem.cfm}. Printed versions or 

electronic versions residing elsewhere (i.e., other physical locations or storage 

media) are uncontrolled. 

All deleted RPD-QM-II, Guides, and Procedures (including old revisions) shall be 

placed in the Deleted Documents file. The Quality Manager shall maintain this 

file. All old revisions shall be maintained until it is decided to delete the Guide or 

Procedure altogether. Once the decision has been made to delete the Guide or 

Procedure, only the last revision must be maintained in the Deleted Documents 

file.