FM-198 Q1_ISO 9001

Audit Report Revision: 9.0

Effective Date: 11/21/23

API MONOGRAM / APIQR PROGRAM

API Spec Q1 10th Edition and ISO 9001:2015
AUDIT REPORT

Scope of the document:

This audit report shall be used when auditing organization claiming conformity to API Spec Q1 10th
Edition as a Quality Management System. Also, it is applicable to those organizations that in addition to
API Q1 are claiming conformity to ISO 9001:2015 and/or API product specifications included in the
Monogram Program.

Requirements specific to ISO 9001:2015 are highlighted with GRAY shading and they are not applicable
when conducting audits that do not include ISO 9001:2015 within the scope.

This report is not applicable to audits with a scope limited only to ISO 9001:2015.

For audits including Monogram Licenses:

The designated API auditor shall fill out the relevant section of this document and all applicable FM-199
supplementary audit reports associated with the API product specifications under the scope of the audit.

For Surveillance and Recertification audits of APIQR and Dual Facilities:

An audit of the full quality management system must be performed. All sections of this report must be
completed.

For Surveillance Audits of Monogram-only Facilities:

Section headings with an asterisk (*) are the mandatory sections that must be filled out during
surveillance audits of Monogram-only facilities. Applicable FM-199 audit reports shall be filled out entirely.

The mandatory sections are:

1. Audit Information, Audit Scope & License Scope

2. Use of API Monogram, APIQR and ANAB Marks
3. Alternative Marking Agreement (AMA)
4. Product Realization (with the exception of 5.3 Risk Management and 5.10 Management of
Change)
5. Internal Audit (API Spec Q1 clause 6.2.2)
6. Audit Summary, Audit Time Summary & Auditor Conclusion/Recommendation

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Audit Information*
Facility ID:
Audit ID:

Company Name/ Document any changes in the space below:

Facility Name:

Facility Address:

Primary Account
Manager(s):

Lead Auditor:
Audit Team Members:
Audit Start Date: Audit End Date:
Audit Type: Number of Employees Verified Number of
(per myCerts): Employees:
Duration: *Assigned Audit Days: *Actual Audit Days:

Justification: *Justification required if different from required audit days – Notify API of any changes and update Audit Plan

Shifts: Start Time End Time No. of Employees Audited? (Y/N)

Shift 1

Shift 2

Shift 3

Explanation (required for shifts not audited or if sum of employees does not equal verified number of employees):

Audit Scope*
API Spec Q1:10th ed. ISO 9001:2015

Audit Criteria: API Spec(s):

Other criteria:

License(s)/Certificate(s) Scope*
--Mark all changes to the scope on this section–
License Cert # Status Expiration Date

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Verification of Scope of Registration / Monogram License(s) and Exclusions

Verify each of the following: Select One: Finding #:

Yes – Scope is Accurate / Appropriate

Scope of Registration (as currently identified on
Application/Certificate) is accurate for the activities and No – Mark all changes on registration scope above
processes performed by the facility.
N/A – No Certificates of Registration
Monogram – product scope of Monogram License (as Yes
currently identified on Application/Certificate) is
accurate for the activities and processes performed by No – Mark all changes on license scope above
the facility and facility has the manufacturing capability
for each product within the scope of the license(s). N/A – No Monogram License(s)

Yes – Exclusions, if any, are Accurate/Appropriate

Exclusions (as currently identified on
Application/Certificate) taken are allowable, applicable
No - Exclusions are not Accurate/Appropriate – Mark all
and justified. Document any discrepancies.
changes on the scope section above
Note: Please see Advisory 6 for allowable Monogram
Program design exclusions.
N/A – No exclusions identified

Significant changes to the QMS since previous audit (if applicable):

Use of API Monogram, APIQR and ANAB Marks*

Control of the Application and Removal of the API Monogram (API Spec Q1, Annex A.5)
Requirements: Objective Evidence / Comments: Finding #:

Marking/monogramming procedure addresses all

requirements of Annex A.5, including application and
removal of the Monogram.
Identify evidence of implementation, if applicable.

API Monogram Marks sampled (on products, letterhead, business cards or any API Verify each of the following:
other medium): Spec:
Note: Identify the API Specification and observed evidence
Applied by licensee only

Includes mark and

license number
Applied to product at
licensed facility location

Verify conformance of the following requirements. Enter N/A if mark is not used. Verified Finding #:
APIQR Marks are only on correspondence, advertising, and promotional materials that are related to the
goods and services referenced in the scope of the Organization’s registration.

The APIQR / ANAB Mark has not been used on a product or product packaging, related documentation, or
in such a way as to suggest that APIQR / ANAB have certified or approved any product, process or service
of the registered organization.

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The APIQR and ANAB Marks are used in conjunction with the organization’s name, location and
registration certificate numbers.

The ANAB Mark is used in conjunction with the APIQR Mark, and the size of the ANAB Mark does not
exceed the size of the APIQR Mark.
The APIQR and ANAB Marks are reproduced:
1. in black, its original colors or the predominant color of the letterhead or printing,
2. on a clearly contrasting background, and
3. In a size which makes the mark’s features clearly distinguishable and without distortion of its dimensions.
If applicable - Upon written notification, the organization immediately ceased and desisted in the use of the
APIQR/ANAB Marks and/or API Monogram:
1) upon suspension or cancellation, or
2) In any manner that is determined misleading by API / APIQR.
Applicant organization – APIQR, ANAB Marks and/or API Monogram have not been identified in
promotional materials or other company documentation.

Additional comments:

Alternative Marking Agreement (AMA)*

Refer to FM-011 API Monogram Program Alternative Marking of Products License Agreement

AMA Locations – Identify all AMA locations and mark any changes

Scenarios applicable
(See FM-011, Table 1. Select all that apply) ☐Scenario 1 ☐Scenario 2 ☐Scenario 3

Requirement: Objective Evidence/Comments: Finding #

Scenarios 1 & 2 only:
• Subcontracted processes and API Monogram marking
planned and documented as part of QMS
• Maintains ownership of the product and sufficient
inspection procedures
• Processes and controls to verify conformance identified
• Subcontractor (Marking Party) is an authorized API
Marker
• Mill test reports or certificates of compliance issued by
either the Licensee or Marking Party include a statement
identifying that processing, product conformance
verification, and API Monogram application were
performed at the facility by an authorized API Marker
• Licensee remains responsible for all failures to meet the
API specification, through delivery of the final product
Scenario 3 only:
• Subdivision of bulk items and API Monogram marking
planned and documented as part of QMS
• Maintains ownership of the product and sufficient
inspection procedures
• Processes and controls to verify conformance identified

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• Subcontractor (Marking Party) is an authorized API

Marker
• Licensee remains responsible for all failures to meet the
API specification, through delivery of the final product

Quality Management System Requirements

In the space provided below, detail the objective evidence (documentation reviewed, records reviewed and personnel interviewed) to
ensure conformance to the identified QMS requirements. Detail any discrepancies / nonconformance identified.

API Spec Q1, Section 4.1 Quality Management System

Requirement: Objective Evidence/Comments: Finding #:

• QMS Scope
• Quality Policy
• Quality Objectives
• QMS Planning and Exclusions
• Internal and External Communication

• When determining scope, organization considers

external and internal issues - ISO 9001, 4.3 a)
• When determining scope, organization considers
requirements of interested parties – ISO 9001,
4.3 b)
• Quality Objectives relevant to enhancement of
customer satisfaction - ISO 9001, 6.2.1 d)

API Spec Q1, Section 4.2 Management Responsibility

Requirement: Objective Evidence/Comments: Finding #:

• Leadership and Commitment

• Responsibility and Authority
• Management Representative

• Demonstrate leadership and commitment by

promoting use of process approach and risk-
based thinking – ISO 9001, 5.1.1 d)

API Spec Q1, Section 4.3 Organization Capability

Requirement: Objective Evidence/Comments: Finding #:

• Provision of resources
• Organizational Knowledge
• Personnel Competence
• Training
• Work Environment

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Personnel Sampled for Competency, Awareness and Training

Defined Competency Competency Records
Name Job Title Finding#:
Requirement(s)

• Defined Competency Requirement: Organization’s required qualification/competency requirements for the specific position.
• Competency Records: Sampled employee records (e.g. education, experience, certificate, training, etc.)

API Spec Q1, Section 4.4 Documentation Requirements

Requirement: Objective Evidence/Comments: Finding #:

• QMS Documentation
• Procedures
• Control of Internal Documents
• Control and Use of External Documents

Procedures required by API Spec Q1

Verify that procedures required by the standard are established, documented, implemented, and maintained for continual suitability.
(Please complete the Identification of QMS Procedures table and identify any nonconformities as applicable)

Mark Mark
API API
with “X” with “X”
Spec Q1 Requirement Finding# Spec Q1 Requirement Finding#
if if
Clause Clause
available available

4.3.2.1 Personnel Competence 5.6.7 Externally Owned Property

4.3.2.2 Training 5.6.8 Preservation of Product

4.4.3 Control of Internal Documents 5.6.9 Inspection, Testing, and Verification

Control and Use of External

4.4.4 5.6.10 Preventive Maintenance
Documents

4.5 Control of Records 5.7 Product Release

5.1 Contract Review 5.8 TMMDE

5.3 Risk Management 5.9 Control of Nonconforming Product

5.4 Design 5.10 Management of Change (MOC)

5.5.1 Purchasing Control 6.2.1 Customer Satisfaction

Verification of Purchased
5.5.3 Products, Components or 6.2.2 Internal Audit
Activities

5.6 Control of Product Realization 6.3 Analysis of Data

5.6.4 Validation of Processes 6.4.2 Corrective Action

Annex Control of the Application and Removal

5.6.5 Identification & Traceability
A.5 of the API Monogram (if applicable)

5.6.6 Inspection/Test Status

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API Spec Q1, Section 4.5 Control of Records

Requirement Objective Evidence/Comments: Finding #:

• Records established and controlled

• Procedure
• Records retention

Product Realization*
Audit Conditions
Audit sampling priority should be established according to the conditions outlined below.
Category Category Definition
1 Monogram product currently being manufactured and available for review
Monogrammable (product meeting all requirements but not marked) product currently being
2
manufactured and available for review
3 Non-monogrammable product currently being manufactured and available for review
4 Monogram product manufactured since the last API audit but not available for review (records review)
Monogrammable product manufactured since the last API audit but not available for review (records
5
review)
Non-monogrammable product manufactured since the last API audit but not available for review
6
(records review)
Complete the table below based on the above classifications:
Category Product/Service Identification Specification (as applicable)

In the space provided below, detail the objective evidence (documentation reviewed, records reviewed and personnel interviewed) to
ensure conformance to the identified QMS requirements. Detail any discrepancies / nonconformance identified.

API Spec Q1, Section 5.1 Contract Review *

List Contracts reviewed / sampled (Include contract number, customer name, date of API Spec / Product:
contract and any other pertinent details below):

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Requirement: Objective Evidence/Comments: Finding #:

• Determination of Requirements
• Review of Requirements
• Changes to Requirements

API Spec Q1, Section 5.2 Planning *

Requirement: Objective Evidence/Comments: Finding #:

• Planning of Product Realization

• Output of Planning

API Spec Q1, Section 5.3 Risk Management

Requirement: Objective Evidence/Comments: Finding #:

• Risk Assessment Procedure

• Impact on Delivery
• Impact on Quality of Product
• Changes Impacting Product Quality
• Contingency Planning
• Records

• Actions to address opportunities – ISO 9001,

6.1.1
• Planning how to evaluate effectiveness of
action to address opportunities – ISO 9001,
6.1.2(b)(2)
• Actions are proportionate to potential impact –
ISO 9001, 6.1.2

API Spec Q1, Section 5.4 Design*

Select all that apply:
Performed in-house Performed at a different location within the same organization
Outsourced Excluded (For Monogram licenses, confirm with Advisory 6)
List design packages sampled / verified:
Select a representative sampling of the applicable products (API Specifications and/or Scope of Registration)
• Any Monogram license in “Applicant” status requires verification of all product designs within the application scope.
• Any newly added product requires verification of design, if design is required.

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Design Package Verify that the licensee/applicant has all required design packages available for each product under the
Requirements (Annex scope of each Monogram License (Yes/No. If no, provide details/identify NC):
A, A.6 – Monogram
Only)

Requirement: Objective Evidence/Comments: Finding #:

• Planning
• Inputs
• Outputs
• Review
• Verification and Final Review
• Validation and Approval
• Changes

• D&D Planning considers nature, duration and

complexity of design activities – ISO 9001,
8.3.2 a)
• D&D planning considers the level of control
expected by customers and other interested
parties – ISO 9001, 8.3.2 i)

API Spec Q1, Section 5.5 Purchasing *

Requirements: Objective Evidence / Comments: Finding #:

• Purchasing Control
o Procedure
o Initial Supplier Evaluation—Critical Purchases
o Initial Supplier Evaluation – Critical
Purchases – Customer Specified, Proprietary,
and/or Legal Limited
o Initial Supplier Evaluation—Noncritical
Purchases
o Supplier Reevaluation
o Records
o Outsourcing
• Purchasing Information
• Verification of Purchased Products,
Components or Activities
o Procedure
o Critical Purchases
o Noncritical Purchases
o Records

• Organization communicates requirements for

external provider’s interaction with organization
– ISO 9001, 8.4.3d
• Organization communicates requirements for

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control and monitoring of external provider’s

performance – ISO 9001, 8.4.3e

Suppliers Sampled – Critical Product / Component / Activity Performed:

Purchases: (identify if limitation per 5.5.1.3 has been claimed)

Suppliers Sampled – Noncritical

Product / Component / Activity Performed:
Purchases:

List all outsourced activities and processes (if applicable):

API Spec Q1, Section 5.6 Control of Product Realization*

Description of Production/Service Capabilities
• Describe the organization’s capability, including available machinery and test equipment, required for manufacturing
of products within the scope of certification.
• Identify products, monogrammable and nonmonogrammable, the organization is capable of providing.

Description of Production Processes (describe what manufacturing/service processes take place at the facility and
interactions):
Processes must be described in specific detail to provide information regarding the capabilities of the facility being audited.
For example: machining > fit-up > welding > heat treatment > ultrasonic testing > assembly > hydrotest, etc.

Production and Servicing Processes reviewed / sampled:

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Personnel Work Inspection Process control

Product/service/
Process/Area: interviewed: Product/Service: status
Instruction part identified? documents:
(Name and position) identified?

Control of Production Finding

Objective Evidence / Comments: #:
Requirements:

• Procedure

• Quality Plan

• Process Control Documents

• Prevention of human error – ISO 9001, 8.5.1g

• Post-delivery activities – ISO 9001, 8.5.5

API Spec Q1, Section 5.6.4 Validation of Processes*

Records reviewed for processes requiring validation (Y/N/NA) (select all that apply):
NDE Welding Heat Treatment Coating and Plating Other
Personnel Qualification WPS / PQR Personnel Qualification Personnel Qualification

Equipment Qualification WPQ Procedure/Wis Procedure/Wis

Work Environment Welder Continuity Log Furnace Surveys Equipment

Procedure Qualification Personnel Qualification Work Environment

Equipment Qualification

Finding
Requirements: Objective Evidence / Comments: #:

• Procedure
• Equipment
• Personnel
• Specific Methods
• Acceptance Criteria
• Records
• Revalidation
• Evidence of meeting requirements when
outsourced

API Spec Q1, Section 5.6 Control of Product Realization *

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Requirements: Objective Evidence / Comments: Finding #:

• Identification and Traceability

• Product Inspection / Test Status

• Externally Owned Property

• Preservation of Product
Inspection, Testing, and Verification
• In-process Inspection, Testing, and Verification
• Final Inspection, Testing, and Verification
• Records

• Preventive Maintenance

API Spec Q1, Section 5.7 Product Release *

Requirements: Objective Evidence / Comments: Finding #:

• Procedure
• Release upon satisfactory completion of
planned arrangements
• Release of conforming products or authorized
under concession
• Identification of individual releasing product
• Records maintained

API Spec Q1, Section 5.8 Testing, Measuring, Monitoring, and Detection Equipment (TMMDE) *
Requirements: Objective Evidence / Comments: Finding #:

• Procedure
• Equipment
• TMMDE Equipment from Other Sources
• Records

Equipment observed / sampled (minimum of 3):

Note: Ensure that all inspection and testing requirements of the applicable product specification are addressed
Equipment
Description Frequency Due Date
Unique ID

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API Spec Q1, Section 5.9 Control of Nonconforming Product *

Requirements: Objective Evidence / Comments: Finding #:

• Procedure
• Nonconforming Product During Product
Realization
• Nonconforming Product After Delivery
• Addressing Nonconforming Product
• Release of Nonconforming Product Under
Concession
• Customer Notification of Nonconforming
Product
• Records

Management of Change
API Spec Q1, Section 5.10 Management of Change
Requirements: Objective Evidence / Comments: Finding #:

• Procedure
• MOC Application
• MOC Notification
• Records

QMS Monitoring, Measurement, Analysis, and Improvement

In the space provided below, detail the objective evidence (documentation reviewed, records reviewed and personnel interviewed) to
ensure conformance to the identified QMS requirements. Detail any discrepancies / nonconformance identified.

API Spec Q1, Section 6.1 General

Requirements: Objective Evidence / Comments: Finding #:

• Monitoring, measurement, analysis, and

improvement processes needed to ensure
conformity to requirements are planned and
implemented.
• Determination of the applicable methods,
techniques of analysis of data and extent of use.

API Spec Q1, Section 6.2 Monitoring, Measuring and Improving

Requirements: Objective Evidence / Comments: Finding #:

• Customer Satisfaction
• *Internal Audits:
o Performance of Internal Audit

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o Audit Review and Closure

API Spec Q1, Section 6.3 Analysis of Data

Requirements: Objective Evidence / Comments: Finding #:

The Analysis should include data generated from

the following activities, for example:
- Data generated from monitoring and
measurement,
- internal audits.
- audits of the organization by external parties,
- management reviews.
- other relevant sources.
• Evaluate if planning has been implemented
effectively – ISO 9001, 9.1.3 d)
• Evaluate effectiveness of actions to address
risks and opportunities – ISO 9001, 9.1.3 e)

API Spec Q1, Section 6.4 Improvement

Requirements: Objective Evidence / Comments: Finding #:

• Organization shall continually improve the

effectiveness of the QMS
• Corrective Action

API Spec Q1, Section 6.5 Management Review

Finding #:
Requirements: Objective Evidence / Comments:

• Management reviews are conducted at least

every 12 months.
• Input Requirements
• Output Requirements

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Audit Summary*
The API audit is based on a sampling process of the available information

Number of Findings: Major Nonconformities Minor Nonconformities

Concerns:
(Systemic): (Isolated):
Comments:

Strengths:

Opportunities for Improvement (OFIs):

Summary of the closure and verification of corrective actions for previous findings, if any:

Overall assessment of the capability of the facility to manufacture product(s) (Monogram), the effectiveness of the
management system, and the facility’s ability to perform activities/provide products within the scope of registration:

Were audit objectives achieved (Y/N)? Comments:

(See Audit Plan document for description of objectives. If audit objectives
were not achieved, provide detailed explanation and notify API immediately)

Were there significant deviations from the audit plan (Y/N)? Comments:
(If any deviations from audit plan, identify reasons and upload an as-
performed revision of the audit plan to myCerts)

Audit Time Summary*

Date Start Time End Time Facility Rep Initials
Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7
If audit duration is longer than 7 days, please add additional daily start/stop time.
Time spent auditing offsite or at other locations, such as subcontractors, must be identified and noted in the audit report.

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Auditor Conclusion / Recommendation*

NOTE: API makes the final determination of certification status and shall be the sole
judge of whether licensing/registration will be granted/maintained

Registration and / or Licensing may be granted / continued / reinstated based on satisfactory implementation of a Management
System and / or demonstrated capability to meet applicable specification requirements with no nonconformities identified.*
Registration and / or Licensing may be granted / continued / reinstated subject to the review of the nonconformance(s)
identified and acceptance of appropriate corrective action(s) by the API Licensing and Registration Committee. *
Registration and / or Licensing may be subject to the review of the audit results and nonconformance(s) identified, acceptance
of appropriate corrective action(s) and additional actions as defined by the API Licensing & Registration Committee. This
decision may include a re-audit to verify the required corrective actions, withdrawal, suspension and or cancelation.*
* Note: Audits may result in suspension or cancellation of the organization’s license(s) and/or registration(s) or withdrawal of application
for licensing/registration. API makes the final determination of certification status and shall be the sole judge of whether
licensing/registration will be granted/maintained. You will be notified by API if your license/registration is adversely affected by the results
of this audit.
If any part of this audit was performed remotely, please specify (to be completed by Lead Auditor):
• Which processes were audited remotely?

• Whether the remote auditing techniques were effective in achieving the audit objectives?

• Areas that require special attention during the next on-site audit, if applicable. Please provide a detailed
explanation.

Final Auditor / Audit Team Remarks:

Organization’s Representative Comments:

By signing below, I (we) attest that the information above is accurate and has been collected by the audit team during the
performance of the audit that was assigned to me (us) by API and that audit recommendations and conclusions were
communicated to the organization. (Digital Signatures are acceptable)
Audit Team Leader: Date:
Audit Team Member: Date:
Audit Team Member: Date:
By signing this document, it is not an admission of the acceptance of any nonconformities/concerns identified by the audit
team. The signature only confirms that the audit was performed and the audit recommendations and audit conclusions were

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communicated by the auditor. API reserves the right to have final determination of the level of nonconformity identified in the
audit report. (Digital Signatures are acceptable)
Organization Representative (optional): Date:
Enter the next audit date below :
• Initial 1st Surveillance audit after stage 2 initial audit – 9 months after the last day of the initial stage 2 audit
• 1st surveillance audits – 30 months before expiration date
• 2nd surveillance audits – 18 months before expiration date
• Recertification/Renewal audits – 6 months before expiration date
Next Audit Target Date:
Next Audit Type:
(Preliminary date subject to change)

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Opening / Closing Meeting Attendance Sheet

When performing the opening and closing meeting, please refer to the Opening and Closing meeting guidelines
Facility ID: Audit ID:
Audit Team Leader:
Audit Team Members:
Audit Observer(s):
Opening Meeting Date: Time:
Closing Meeting
Date: Time:

Participants (Name & Position) - Initial/check the meetings attended Opening Closing

The information contained in this report is confidential and subject to the confidentiality agreement between the Audit
Team/Auditor(s) and API. Details of the assessment results are found in the succeeding pages of this report.

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