Author: Parveen K Kohli

The American Petroleum Institute (API) has released Advisory 15, which introduces additional requirements for the Quality Management System (QMS) at facilities that have or are seeking an API Monogram License. These changes will be effective starting April 1, 2025, and will improve audit effectiveness by expanding the scope and range of products and processes covered within the QMS. The requirements specified in this advisory are mandatory and must be followed in addition to all existing Program requirements.

Why was this advisory required?

As per API Q1, 10th edition organizations must implement a QMS for “products provided within the scope defined by the organization”.

In recent API Monogram Audits, it has been observed that some organizations have confined their scope exclusively to products covered under the API Monogram License. However, these organizations also manufacture other products for use in the petroleum and natural gas industry. This limited scope within their Quality Management Systems (QMS) has hindered API’s ability to conduct thorough audits. On occasion, during audits or when collecting samples, an insufficient number of samples were available to perform an effective audit.

Therefore, API has mandated the following requirements shall apply to all API Monogram Licensees.

“When a Monogram Licensed organization defines and documents its scope, in accordance with API Q1, 10th edition clauses 4.1.1 and 4.1.4.1, the scope shall include, at a minimum, all products manufactured at the Licensed facility where the product is for use in the petroleum and natural gas industry. The scope shall also include all manufacturing-related processes performed on products for use in the petroleum and natural gas industry”.

What does this mean?

A Monogram Licensed organization must define and document its scope to include:

  • All products, irrespective of the scope of the Monogram License, manufactured at the licensed facility for use in the petroleum and natural gas industry.
  • All manufacturing-related processes carried out on those products, such as welding, machining, or testing.

This ensures a comprehensive approach to quality management across relevant products and processes.

What actions are required?

Organizations need to update their Quality Manual or other relevant documentation to reflect the revised scope of their Quality Management System (QMS).

  • Example: Previously, the scope might have stated, “Design and Manufacture of Steel Gate Valves as per API 600.”
  • Revised Scope: Following Advisory 15, the updated scope could be “Design and Manufacture of all types of valves, including steel gate valves as per API 600 for use in the petroleum and natural gas industry.”

This adjustment in scope assures compliance with the advisory and aligns the documented scope with the comprehensive requirements of the quality management system.

What is the Impact During Audits?

Enhanced Sample Selection Flexibility

With the implementation of Advisory 15, auditors are granted greater flexibility in selecting samples during audits. This means that auditors can now choose samples from the full range of products manufactured at a facility for use in the petroleum and natural gas industry, rather than being restricted to products covered under the Monogram License.

  • Example: Previously, if a facility held a Monogram License for API 600 Steel Gate Valves, the audit sample selection would typically be limited to these specific valves. However, under the new guidelines, auditors can now also review additional products, such as globe valves, ball valves, check valves or other pipeline components, produced at the same facility, provided they are intended for use in the petroleum and natural gas sector.

This expanded sample pool allows auditors to conduct a more comprehensive evaluation of a facility’s quality management processes across its entire range of operations, not just the Monogram-licensed products.

Overall, these changes aim to strengthen audit effectiveness and support organizations in maintaining robust and consistent QMS across their full product portfolio.

Advisory 15 can be downloaded at this link.

Disclaimer: This interpretation is provided solely for guidance and is based exclusively on the author’s learning experience within the API ecosystem. Before forming any judgments, readers are encouraged to rely on their own understanding in light of their organization’s requirements.

Note: API does not endorse this interpretation, either in part or as a whole