Interested Parties

‍Interested Parties (or stakeholders) are individuals or organizations that are relevant to the quality management system and whose needs and expectations the organization must determine, monitor, and review.

The concept of Interested Parties is a fundamental component of the Quality Management System (QMS) framework, particularly as defined and implemented under the ISO 9001:2015 standard. It emphasizes that quality management must consider all relevant external and internal factors that influence an organization's purpose and ability to deliver conforming products and services.

The existence of an organization depends on these parties, both direct and indirect.

Frequently Asked Questions (FAQs) Associated with Interested Parties

The sources primarily address interested parties in the context of organizational planning, strategy, risk-based thinking, and quality management implementation.

1. What role do Interested Parties play in Quality Management Systems (QMS)?

The ISO 9000 family of standards explicitly recognizes that organizations should understand their customers' and other stakeholders' current and future needs and strive to exceed their expectations.

Under the ISO 9001:2015 framework, understanding the needs and expectations of interested parties is mandatory and forms part of the requirements for "Context of the organization" (Section 4).

Specifically, the organization shall determine:

The interested parties that are relevant to the QMS.
The requirements of these interested parties that are relevant to the QMS.

2. What are examples of relevant Interested Parties?

While the sources emphasize that the organization must determine who its relevant interested parties are, explicit examples of parties mentioned across quality systems and regulations include:

Customers: Organizations depend on them. They know the quality of products and services best, and incorporating their feedback helps maintain loyalty and satisfaction.
External Providers/Suppliers: These parties are often interdependent with the organization, and a mutually beneficial relationship enhances the ability of both to create value. Implementing a QMS may require input from suppliers.
Employees/People at all levels: Their full involvement is the essence of an organization and enables their abilities to be used for the organization's benefit.
Auditing Registrars/Certification Bodies: These third-party entities audit organizations and issue ISO 9001 compliance certificates.
Statutory and Regulatory Bodies/Government Agencies: The ISO 9000 family helps organizations ensure they meet customer and statutory and regulatory requirements. For medical devices, the FDA, Notified Bodies, and other Regulatory Agencies are interested parties.

3. How does the organization use the information gathered from Interested Parties?

The requirements of relevant interested parties, determined in Clause 4.2 of ISO 9001:2015, must be considered during the following activities:

Determining the scope of the QMS (Clause 4.3): The requirements of relevant interested parties are inputs for defining the boundaries and applicability of the quality management system.
Risk and Opportunity Planning (Clause 6.1): The organization must consider the requirements of interested parties when determining the risks and opportunities that need to be addressed in the QMS.
Design and Development Planning (Clause 8.3.2): The need for involvement of customers and users in the design and development process, as well as the needs of other relevant interested parties, must be considered when determining design controls.
Monitoring Customer Satisfaction (Clause 9.1.2): Organizations must monitor customers' perceptions regarding the degree to which their needs and expectations have been fulfilled. Customer feedback is explicitly mentioned as a required input for management review.

4. What challenges can arise from Interested Parties during QMS implementation?

One of the identified challenges in implementing a QMS is external resistance.

Supply Chain Demands: Implementation may require input from suppliers and other stakeholders. A challenge is the demand for the supply chain to adopt similar quality management standards, which can harm existing relationships if changes are not effectively communicated.
General Disruption: If interested parties (suppliers and customers) are unhappy with changes resulting from QMS implementation, existing relationships could be harmed.

5. Is there a specific ISO requirement for defining procedures related to Interested Parties?

While not mandatory, a non-mandatory document that can be used for ISO 9001 implementation is a Procedure for determining the context of the organization and interested parties (referencing Clauses 4.1 and 4.2).

6. Is every interested party relevant to the QMS?

No, there is no requirement in ISO 9001 for the organization to consider interested parties that are not relevant to its quality management system. If an organization decides that a particular requirement of a relevant interested party is not relevant to its QMS, there is no requirement to include that specific requirement in the QMS.

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