This month’s first question

Under ISO 9001:2015, how specific must you be when stating your interested parties? Can you simply put "customers, stakeholders, employees and suppliers," for example? Or is it better to list the names of organizations and individuals? What is the most effective way of obtaining this information? How should it be diagrammed?

Our response

Identifying interested parties, or stakeholders, is a new requirement in ISO 9001:2015. The requirement is included in clauses of the standard that address: 

  • Understanding the needs and expectations of interested parties (clause 4.2).
  • Quality management system (QMS) scope (clause 4.3).
  • Quality policy (clause 5.2.2).
  • Measurement traceability (clause 7.1.6).
  • Requirements for products and services (clause 8.2.3).
  • Design and development planning (clause 8.3.2).
  • Management review (clause 9.3.2).

Clause 6.1.1 (risks and opportunities) indirectly includes interested parties by referring to clause 4.2.

Understanding the needs and expectations of interested parties can be accomplished through several approaches such as brainstorming and expert judgement. Analyzing contractual documents can reveal useful information, and so can meetings and focus groups. 

Where to start

The first step to addressing the interested parties requirement is to identify groups that may be relevant to your QMS. Also consider regulatory agencies, shareholders, distributors, retailers, business partners, financial institutions, business owners and the general public. 

Within these groups, there may be specific organizations or even individuals that are more relevant to your QMS than others. Because needs and expectations may differ from one organization to another, you should go beyond identifying groups and identify specific organizations that are relevant to your QMS. 

Review contracts and purchase orders, and brainstorm with your corporate legal, corporate communications, purchasing, regulatory compliance and quality departments to identify additional organizations. Your HR and quality departments also may be helpful in identifying relevant internal groups. This list can become long—the key is to keep it manageable.

To identify the most relevant interested parties, consider using 2x2 matrixes such as power/interest, power/influence or influence/impact. After you have your list, it’s helpful to associate each interested party with the specific ISO 9001 clause (listed earlier) it may influence.


Additional guidance can be found in resources such as Quality Progress, Nancy R. Tague’s The Quality Toolbox and the Project Management Institute’s A Guide to the Project Management Body of Knowledge (PMBOK Guide). Online searches that include "ISO 9001:2015 interested parties" and "stakeholder analysis" will yield additional guidance.

Information management

The information obtained during this effort can be managed with spreadsheets or tables. Understand who will use the information and determine the best way to summarize and share it. Although ISO 9001:2015 does not require a procedure for addressing interested parties, it may be beneficial to document the process so it can be repeated later when information regarding the needs and expectations of interested parties is updated.

Finally, consult with your ISO 9001 registrar. A registrar can provide information about how it will assess compliance to the interested parties requirement. Ultimately, you should design an approach that makes good business sense and provides value to your QMS.

This response was written by Ken Cogan, project manager, Maxtena Inc., Rockville, MD.

This month’s second question

Regarding ISO 9001:2015, Clause 4.2—Understanding the needs and expectations of interested parties: What tools can be used to monitor and review information about interested parties and their relevant requirements? Is there a monitoring tool that can be adopted to fill the requirements of this clause?

Our response

There are proactive and reactive approaches to monitoring and reviewing information about interested parties and their relevant requirements. There also are appropriate tools that can be used to analyze and review the information. 

The first step is to identify all relevant interested parties. This is effectively done by brainstorming with the heads of various functions of the organization and top management. Review the list as a team to determine whether any other parties should be added. 

If in doubt, consult ISO 9001:2015, which defines "interested party" as a "person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity."1

While interested parties—such as customers, external providers and employees—are obvious, other interested parties—such as the society and community, opposing pressure groups and the competition—sometimes are ignored because an organization thinks they are irrelevant. 

In some cases, new interested parties emerge due to shifts in an organization’s strategy. If an organization decides to close one of its manufacturing locations or reduce headcount, for example, this can have a negative effect on a community’s unemployment rate and the local economy. On the other hand, opening a new office or factory can positively affect a community by bringing more jobs. Monitoring societal impact is important in this situation. 

A competitor’s approach to a breakthrough technology in product and service offerings could make your organization’s offerings less competitive, so monitoring market intelligence is important for the organization’s survival. 

Your industry may be levied a higher tariff by the government, but monitoring the information through the appropriate political action committee may help in taking proactive measures. 

Online Table 1 provides an example of a comprehensive review of interested parties, sources of information, frequency of monitoring and monitoring tools. It is important to note that information may be a compilation of numerical and textual data from various sources.

Online Table 1


  1. International Organization for Standardization (ISO), ISO 9001:2015—Quality management systems—Fundamentals and vocabulary.


Ramu, Govind, "Ready or Not," Quality Progress, January 2018, pp. 16-21.

Tague, Nancy R., The Quality Toolbox, second edition, ASQ Quality Press, 2005.

This response was written by Govind Ramu, ASQ fellow and quality management professional, Fremont, CA.

It is one thing for mid-level quality personnel to do this, how do we get top management involved? They are likely to have different assessments than I do.
--John Elwer, 02-07-2018

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