Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 1 of 6 Approved: JMA Effective Date: September 16, 2019

Purpose

The purpose of this Guide is to outline the steps to conduct internal audits and 

management reviews.

Scope

This Guide applies to all activities of the Radiation Physics Division (RPD) that

pertain to the calibration and testing services.

Definitions

N/A

Equipment

N/A

Health & Safety Precautions

N/A

Protocol

Internal audits

1. At least every two years or at the discretion of the Quality Manager and/or 

Division Chief, the Quality Manager will initiate an internal assessment to

verify that the RPD operations continue to comply with the requirements of 

this quality management system and the NIST Quality Management System; 

see QMI 8.8 and Appendix B.

2. The audit activity shall be conducted by qualified Division members assigned 

by the Group Leaders and the Quality Manager and confirmed by the 

Division Chief. The assessors will be knowledgeable of the Division’s 

Quality Management System.

3. Unscheduled audits may be performed at any time at the discretion of the 

Quality Manager, Group Leader or Division Chief.

4. The internal audit shall begin with the drafting of a schedule that includes the 

documentary review of the Quality Manual and associated documents as well 

as a proposed date range for the technical service reviews. 

4.1 The Quality Manager shall prepare the internal assessment schedule and 

be responsible for ensuring its completion in a timely manner.
Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 2 of 6 Approved: JMA Effective Date: September 16, 2019

4.2 The Quality Manager may participate in each technical service area 

review if desired. The Deputy Quality Manager may participate in 

technical service area reviews as schedules permit.

4.3 The Quality Manager shall be responsible for the review of QM-II level 

documents for accuracy and adherence to current policies and 

procedures. These documents include, but are not limited to, the 

Division Quality Manual and all Guides.

4.4 The Quality Manager shall be responsible for the review of the 

administrative records for the Quality Management System maintained 

by the Quality Manager. The review shall include the maintenance of 

records, both written and electronic, for accurate and timely archiving.

4.5 The Quality Manager shall prepare a summary of findings to be 

combined with the internal assessment findings for the technical service 

reviews (see number 11 in this section).

5. Based on the compliance requirements for an activity, the auditor should 

develop a checklist for the audit or use the spreadsheet provided by the 

quality manager. A sample checklist is found in Appendix A. This checklist 

should include:

5.1 A list of objective requirements based on the quality management system 

documentation and the scope of the audit.

5.2 Each finding should be clearly identified using the following four 

categories, taken from the NIST Peer Review/Assessments Report

template:

5.2.1 Nonconformity (NC) – stated with reference to the ISO 

standard, the NIST-QM-I, or to sublevel quality documents –

evidence is described when the requirements are not being met or 

the documentation is silent. Per NIST-QM-I, the RPD has a 

maximum of 90 days to correct the nonconformity or to produce 

its action plan. Cause of the nonconformity will also be 

identified and described.

5.2.2 Comment (C) – when the requirement is met, but opportunities 

for improvement may be present. NIST will consider the costbenefit and consider risks associated in determining whether an

action will be taken. A formal response to the comment will be 

provided. Comments are considered actionable. 

5.2.3 Editorial (E) – often the reviewers find opportunities for

improving and clarifying the information in the documentation

that is under the scope of review. NIST will consider including 

these notations if captured on the findings spreadsheet and will 

leverage the updates if revisions are required in the 

documentation, particularly for the quality manuals and 

procedures. 
Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 3 of 6 Approved: JMA Effective Date: September 16, 2019

5.2.4 Notes (N) - will be included in the spreadsheet, if time permits

for the reviewers. These notations will include complimentary 

observations for the measurement service providers and their 

measurement systems and procedures.

5.3 A section for notes to document the basis for acceptability (or 

unacceptability) of a checklist item.

5.4 Pages numbered to ensure that each page is traceable to the rest of the 

checklist and notes.

5.5 The date of the audit and a place for the signature of the auditor on each 

page.

6. Using the checklist, the auditor may evaluate compliance with requirements 

by observing activities in progress, interviewing personnel, reviewing 

documentation or records, and reviewing procedures.

7. The auditor brings any conditions identified as requiring corrective actions 

during the assessment to the attention of the Quality Manager, Group Leader 

and the individual(s) involved.

8. Appropriate personnel must follow the Change in Disseminated Values and 

Report Amendments Guide (RPD-G-12) to notify any clients if investigations 

show that their results may have been affected.

9. Upon completion of the assessment, the auditor reviews the results with the 

Group Leader and/or the Division Chief as appropriate.

10. The auditor documents any findings (including those corrected during the 

audit) on the spreadsheet provided by the quality manager or the auditor’s 

preferred checcklist and initiates Corrective Action Plans (RPD-G-08) or 

Preventive Actions (RPD-G-09) as appropriate.

11. After completion of the audit, the auditor prepares a summary, which can be 

accomplished on the provided checklist, that includes:

11.1 The inclusive dates of the audit.

11.2 The scope of the audit.

11.3 The auditor’s name.

11.4 Key persons contacted during the course of the audit.
Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 4 of 6 Approved: JMA Effective Date: September 16, 2019

11.5 If necessary, a summary of the results of the audit may be prepared, 

including any exemplary practices, and any findings noted including 

corrective or preventive actions taken.

12. The Division Chief is notified of any findings through a report generated by 

the quality mananger using a format resembling the NIST Corrective Action 

Log, an example of which is found in Appendix B. The document(s) are filed 

appropriately for later use in the 5-year audit

Management reviews

Management review requirements are set by the NIST-QM-I 8.9.

Follow-up audits and reviews

1. Follow-up actions on audit and review findings shall begin in a timely 

fashion.

2. If neither a corrective action plan nor preventive action form were initiated,

the individual involved shall respond in writing to all findings that require 

additional information.

3. The auditor will check the response to ensure that the finding is addressed 

properly. A follow-up audit or review may be conducted if necessary.

4. Once the auditor is satisfied, the response is given to the Division Chief and 

the Quality Manager to file appropriately.

Acceptance Criteria

N/A

References

RPD Quality Management System Documentation

Documentation

Audit or review checklist

Internal audit or management review report

Filing and Retention

The Quality Manager shall file all documents by date of audit. The retention time 

for audit files will be indefinite.
Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 5 of 6 Approved: JMA Effective Date: September 16, 2019

Appendix RPD-G-10. A

CHECKLIST FOR AUDITOR

This is an example of a spreadsheet that can be used for the internal audit, provided by 

the quality manager at the commencement of the audit. The auditor can use a preferred

checklist, providing the required items from RPD-G-10 section 5 are included.

NIST QS INTERNAL AUDIT CHECKLIST AND SUMMARY

(see RPD QMII Guide 10 section 5 and 11)

Procedure number (Scope of Audit): Use Procedure number 1 

through 18.

Inclusive Dates of 

Audit:

NIST ID: Use the Calibration Service Identifier

Auditor(s) and 

signature(s): Use an 

electronic signature 

or initials. 

Objective requirements (RPD QMII Guide 10 section 5.3 & 11.5): 

technical review of the procedure ( add to this if necessary or specify 

the approach taken). 

Key persons 

contacted during 

audit: 

Item 

No.

Section Guide # & 

Page

Procedure # 

& Page

NC,C,E 

or N

Findings (Notes) 

(RPD QMII 

Guide 10 section 

5.3 & 11.5)

Corrections (RPD 

QMII Guide 10 

section 11.5)

1

2

3

Add rows as necessary.

From RPDG-10 5.5.2

5.5.2.1 Nonconformity (NC) – stated with reference to the ISO standard, the NIST-QM-I, or to 

sublevel quality documents – evidence is described when the requirements are not being met or the 

documentation is silent. Per NIST-QM-I, the RPD has a maximum of 90 days to correct the 

nonconformity or to produce its action plan. Cause of the nonconformity will also be identified and 

described.

5.5.2.2 Comment (C) – when the requirement is met, but opportunities for improvement may be 

present. NIST will consider the cost-benefit and consider risks associated in determining whether 

an action will be taken. A formal response to the comment will be provided.

5.5.2.3 Editorial (E) – often the reviewers find opportunities for improving and clarifying the 

information in the documentation that is under the scope of review. NIST will consider including 

these notations if captured on the findings spreadsheet and will leverage the updates if revisions are 

required in the documentation, particularly for the quality manuals and procedures.

5.5.2.3 Notes (N) - will be included in the spreadsheet, if time permits for the reviewers. These 

notations will include complimentary observations for the measurement service providers and their 

measurement systems and procedures.
Radiation Physics Division Quality Management System Guide RPD-G-10

INTERNAL AUDITS AND MANAGEMENT REVIEWS

Version:3.35 Page 1 of 6 Approved: JMA Effective Date: September 16, 2019

Appendix RPD-G-10. B

Example of a NIST CORRECTIVE ACTION LOG FY 20

CAR 

#

Date

Issued

Assigned

to

Requirement

Reference

Brief

Description Risk1 and Impact2

Reply

Request 

Date

Expect 

Comp.

Date

Reply

OK?

Y/N

Status and 

Comments

Date 

Closed

1 19 

August 

2019 –

Carry 

over 

from 

FY19

Sally 

Bruce

NIST-QM-I, 

8.3

Comment 4 

from the 

Internal audit: 

review of the 

NIST Quality 

Manager 

handbook is 

needed.

In the event a backup 

NIST Quality 

Manager is needed, 

the Handbook is a 

guide to the duties 

and responsibilities –

Medium impact

19 

August, 

2019

31 

December 

2019

Agreed, schedule 

for FY20

Format 2017-11-22 provide by Sally Bruce and implemented in August of 2019.

1 Risk can be positive or negative effect of the nature of the action item/finding, consider the probability of this happening.

2

Impact is a consideration of what is at stake to the QMS, the operations, or the services (high or low impact).