ISO 9001 Clause 8.2 Requirements for Products and Services

In ISO 9001 8.2 Requirements for Products and Services focuses on how organizations determine, review, and communicate requirements related to their products and services. Additionally, this clause ensures that organizations fully understand and meet customer expectations, legal and regulatory requirements, and internal quality objectives.

In this blog post we will be discussing the following:

8.2 Consist of 4 sections –

· 8.2.1 Customer Communication

· 8.2.2 Determining Requirements for Products and Services

· 8.2.3 Review of Requirements for Products and Services

· 8.2.4 Changes to requirements for Products and Services

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements:

8.2 Requirements for products and services

8.2.1 Customer communication

Communication with customers shall include:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relating to products and services, including customer complaints;

d) handling or controlling customer property;

e) establishing specific requirements for contingency actions, when relevant.

8.2.2 Determining the requirements for products and services

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

a) the requirements for the products and services are defined, including:

1) any applicable statutory and regulatory requirements;

2) those considered necessary by the organization;

b) the organization can meet the claims for the products and services it offers.

8.2.3 Review of the requirements for products and services

8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities;

b) requirements not stated by the customer, but necessary for the specified or intended use, when known;

c) requirements specified by the organization;

d) statutory and regulatory requirements applicable to the products and services;

e) contract or order requirements differing from those previously expressed.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.

8.2.3.2 The organization shall retain documented information, as applicable:

a) on the results of the review;

b) on any new requirements for the products and services.

8.2.4 Changes to requirements for products and services

The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

8.2.1 Customer Communication

Organizations must establish effective communication with customers to ensure clarity on:

· Product and service information – which includes features, specifications and intended use.

· Handling inquires, contracts, and orders – which includes ensuring feasibility before commitment.

· Feedback and complaints – which includes mechanisms to address customer concerns.

· Handling changes and updates – such as notifying customers of modifications to products/ services.

An example of this would be if you are a manufacturing company, you should maintain clear communication with clients regarding order status, delivery timelines, and any product modifications.

8.2.2 Determining Requirements for Products and Services

Before committing to supply, organizations must ensure they understand:

1. Customer-Specified Requirements

o Specifications, performance criteria, and intended use.

2. Legal and Regulatory Requirements

o Compliance with industry standards and safety regulations.

3. Internal Requirements

o Quality objectives, operational constraints, and best practices.

4. Additional requirements identified by the organization

o Special handling, packaging, labeling, or warranty considerations.

An example of this would be if you were a food processing company, you must comply with FDA regulations while also meeting customer requests organic certification.

8.2.3 Review of Requirements for Products and Services

Before accepting orders, organizations must review all requirements to ensure:

· Feasibility – can the organization deliver as per the specified requirements?

· Availability of necessary resources – Raw materials, workforce and technology.

· Alignment with legal, regulatory, and contractual obligations.

What are some key aspects of the review process?

· Clarification of requirements – To prevent misunderstandings before finalizing agreements.

· Identification of Conflicts – To resolve mismatches between customer requests and feasibility.

· Records of Review Results – To maintain documented information for traceability.

How to handle changes in requirements

For any reason if there are any modifications such as customer updates or regulatory changes, organizations must do these things:

· Communicate with relevant departments to assess the impact.

· Update documents and records to reflect all new requirements.

· Ensure affected employees are informed about the new changes.

An example of this would be if you were a software development company and you must review new feature requests from s client to ensure they align with system capabilities before committing.

8.2.4 Changes to requirements for Products and Services

When customer requirements change, organizations must:

· Assess the impact on operations, costs, and timelines.

· Document the changes and communicate them to relevant stakeholders.

· Update work instructions, production plans, and quality control measures accordingly.

An example of this would be you are a construction company and you must assess the feasibility of a design change request before incorporating it into the project plan.

In conclusion, implementing Clause 8.2 Requirements for Products and Services ensures that organizations can enhance operational efficiency, reduce errors, and maintain strong customer relationships. In the next blog post we will be diving deeper into Clause 8.3 Design and development of products and services.