ISO 9001 – 4.2 Understanding the Needs and Expectations of Interested Parties

In the last blog we discussed 4.1 Understanding the Organization and Its Context. In this blog we will be diving deeper into 4.2 Understanding the Needs and Expectations of Interested Parties. This clause requires organizations to first identify and then monitor the needs, expectations and requirements of the interested parties.

In this blog posts we will be discussing:

1. Identifying Interested Parties

2. Understanding their needs and expectations

3. Relevance to the QMS

4. Monitoring, Review & Alignment

5. How to Implement Clause 4.2

4.2 Standard Requirement (ISO 9001:2015):

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

a) the interested parties that are relevant to the quality management system;

b) the requirements of these interested parties that are relevant to the quality management system.

The organization shall monitor and review information about these interested parties and their relevant requirements.

Identifying Interested Parties

Interested Parties of your organization are groups or individuals that have an active interest in the success or performance of the organization’s QMS. These interested parties can influence the ability of the organization to meet customer needs or quality objectives. Some examples of relevant interested parties may include:

· Customers

· Employees

· Investors & Owners

· Competitors

· Suppliers and Partners

· Local Communities

· Regulators & Authorities

Understanding their needs and expectations

The second part of clause 4.2 is understanding the interested parties’ needs and expectations. This comes after all interested parties are identified, the organization must determine the needs and expectations. Not all interested parties will have the same effect on the QMS, the organization should focus on ones that affect quality and compliance. Some examples of this include:

· Customers

· Regulators

· Suppliers

· Employees

· Local Community

The table below

Relevance to the QMS

Determining the relevance to the QMS means the organization must determine which needs and expectations are most applicable and should be immediately addressed by the QMS. As not all of the needs and expectations are relevant to the QMS and need to be addressed quickly.

Relevant needs are things that could have an impact on the organization’s ability to meet certain customer requirements or needs. Such things could impact the ability to provide certain products and services.

Examples of these would be proper training for employees to maintain consistency and avoid errors. Also, a regulatory requirement to adhere to certain environmental laws in the manufacturing process.

In some cases, these relevant needs and expectations of interested parties may be best addressed by pulling them into the QMS’s quality objectives program. This will be discussed in section 6.2.2 of the ISO 9001:2015 standard which allows for the organization to systematically plan out how to effectively address these needs and expectations. But, more to come on this issue in future blog posts.

Monitoring, Review & Alignment

In order to maintain the effectiveness of the QMS the organization must continually monitor and review the expectations and the needs of all interested parties. This monitoring and review process involves adapting to the internal or external factors that could influence these needs.

Having regular management review meetings with the discussion being centered around how these needs and expectations of interested parties are evolving and what their impacts are on quality of the organization.

Alignment with the overall strategic direction of the organization is directly linked with the needs and expectations of interested parties. Identifying and addressing these interested parties' requirements ensures that its quality management efforts are aligned with its overall business goals and long-term sustainability.

How to Implement Clause 4.2

Stakeholder Analysis

Perform a stakeholder analysis to identify all interested parties and prioritize the parties based on the influence on the organizations QMS and business operations.

Needs and Expectations

Identify expectations of all Interested parties with engagement through surveys, reviews or meetings. This also includes any contractual, legal or regulatory requirements that may be relevant.

Document Requirements

Recording and maintaining the needs and expectations of interested parties and ensuring that these requirements are incorporated into the QMS through objectives, process improvements and risk assessments.

Monitoring

Establish a way to regularly update and review the interested parties’ needs whether it’s through internal audits or management review meetings.

Integration with QMS

Incorporate requirements into organizations QMS by aligning them with quality policies, objectives and processes.

In conclusion, as 4.2 wraps up clause 4.2 is about understanding and managing the needs and expectations of interested parties. Forming a foundation of a QMS that is responsive to its environment around it. Improving the effectiveness of the QMS and achieving long-term success is important through meeting customer expectations and needs while better complying with regulatory requirements and mitigating risks. In the next blog post we will be diving deeper into 4.3 Determining the scope of the quality management system.

Related Blog Posts:

ISO 9001 – 4.1 Understanding the Organization and its Context

ISO 9001 – 4.1 Understanding the Organization and its Context (wilkshireconsulting.com)

Context of the Organization

https://www.wilkshireconsulting.com/single-post/iso-9001-context-of-the-organization-overview