ISO 9001 - Clause 8.2: Requirements For Products And Services
The Structure of ISO9001:2015 Clause 8.2
Requirements for products and services are the needs and expectations that customers have for the products and services that they purchase. The needs and expectations can be functional, perceptual, or emotional.
Functional needs are the basic requirements that the product or service must meet to be able to perform its intended function. Perceptual needs are the needs that customers have for the product or service to have certain sensory characteristics.
Emotional needs are the needs that customers have for the product or service to provide a certain feeling or experience.
To ensure that customers’ needs, and expectations are met, organizations must have a process in place for identifying, understanding, and responding to these requirements. This process is known as requirements management.
Requirements management is a key part of an organization’s quality management system (QMS).
The requirements for products and services are specified in ISO 9001:2015 clause 8.2. This clause also specifies the requirements for the requirements management process.
The requirements management process must be documented, and it must include the following steps:
1.Identifying the requirements for products and services.
2. Analysing and documenting the requirements.
3.Communicating the requirements to relevant stakeholders.
4.Obtaining feedback on the requirements from relevant stakeholders.
5.Validating the requirements.
6.Managing changes to the requirements.
The output of the requirements management process is a set of approved requirements for the product or service. This document forms the basis for all subsequent stages of product or service development, including design, manufacturing, testing, and delivery.
Organisations must have a process in place for managing changes to the requirements. Changes to the requirements can come from internal or external sources. Internal sources of change include new information about customer needs, advances in technology, and changes in organisational objectives.
External sources of change include changes in legislation or regulation, market trends, and competitor activity. Changes to the requirements must be reviewed and approved by relevant stakeholders before they are implemented.
Requirements for products and services are the needs and expectations that customers have for the products and services that they purchase. The needs and expectations can be functional, perceptual, or emotional. Functional needs are the basic requirements that the product or service must meet to be able to perform its intended function.
Perceptual needs are the needs that customers have for the product or service to have certain sensory characteristics. Emotional needs are the needs that customers have for the product or service to provide a certain feeling or experience.
To ensure that customers’ needs, and expectations are met, organisations must have a process in place for identifying, understanding, and responding to these requirements.
This process is known as requirements management.
Requirements management is a key part of an organization’s quality management system (QMS). The requirements for products and services are specified in ISO 9001:2015 clause 8.2. This clause also specifies the requirements for the requirements management process.
The requirements management process must be documented, and it must include the following steps:
1.Identifying the requirements for products and services.
2. Analysing and documenting the requirements.
3.Communicating the requirements to relevant stakeholders.
4.Obtaining feedback on the requirements from relevant stakeholders.
5.Validating the requirements.
6.Managing changes to the requirements.
The output of the requirements management process is a set of approved requirements for the product or service. This document forms the basis for all subsequent stages of product or service development, including design, manufacturing, testing, and delivery.
Organisations must have a process in place for managing changes to the requirements. Changes to the requirements can come from internal or external sources. Internal sources of change include new information about customer needs, advances in technology, and changes in organisational objectives.
External sources of change include changes in legislation or regulation, market trends, and competitor activity. Changes to the requirements must be reviewed and approved by relevant stakeholders before they are implemented.
1. Clause 8.2.1 - Communicate with Your Customer
Organisations should communicate with their customers for products and services. They should provide relevant information to customers about their products and services.
The purpose of this communication is to promote customer satisfaction through the effective exchange of information. The communication should include, as appropriate:
• Product information
• Service Information
• Order Status
• Product changes
• Customer feedback
To ensure that customer communication is effective, organizations should define the methods of communication and who is responsible for each method. Organizations should also establish feedback mechanisms to ensure that customers' needs are being met.
2. Clause 8.2.2 Determining the Requirements for products and services
Clause 8.2.2 of the ISO 9001:2015 standard specifies the requirements for determining the needs and expectations of customers for products and services. The organisation must ensure that these needs and expectations are met.
The clause 8.2.2 requirements are as follows:
- The organisation shall determine the requirements for products and services.
- The organisation shall ensure that the requirements for products and services are determined.
- The organisation shall determine the methods for identifying the requirements for products and services.
- The organisation shall ensure that the methods used to identify the requirements for products and services are appropriate.
The organisation shall ensure that the requirements for products and services are determined when they are needed.
The organisation shall ensure that the requirements for products and services are determined before a product or service is provided. The organisation shall ensure that the requirements for products and services are determined by appropriate methods.
The organisation shall ensure that the requirements for products and services are determined by methods that include:
a) customer communication.
b) market research.
c) trend analysis; and
d) competitor analysis.
3. Clause 8.2.3 Review the Requirements for products and services
The purpose of this clause is to ensure that the organization has a documented process for the review of requirements for products and services. This documented process shall include:
• identification of who will undertake the review.
• the method(s) by which the review will be conducted.
• identification of the review criteria.
• time frame for review.
• identification of the records to be generated from the review process.
Employees who will undertake the requirements review and the method by which reviews shall be conducted shall be identified. The records generated from the review process should be recorded and managed in such a way as to prevent inadvertent or unauthorised change.
4. Clause 8.2.4 Changes to requirements for Products & Services
Clause 8.2.4 of ISO 9001:2015 specifies the requirements for changes to the products and services provided by the organisation. All changes to products and services must be planned and implemented in a controlled manner to ensure that the quality of the products and services is not compromised.
Clause 8.2.4 changes to requirements for products and services specify that the organisation must have a documented procedure for controlling changes to the products and services.
This procedure must ensure that all changes are properly planned, implemented, and tested before being released to the customer.
The main objectives of Clause 8.2.4 changes to requirements for products and services are to ensure that:
• All changes to products and services are controlled.
• The quality of the products and services is not compromised.
• The customer is kept informed of all changes to the products and services.
