ISO 9001 Clause 8.2.2 primarily concerns the establishment and determination of product or service requirements to meet customer needs and organizational objectives.
Breakdown of Clause 8.2.2
Defining Requirements: The organization must clearly define and understand the specific requirements for the products or services offered to customers. This includes statutory and regulatory requirements that are mandatory as well as any other needs that are stated or implied by the organization itself.
Statutory and Regulatory Requirements: These are legal and industry-specific standards and rules that need to be met to ensure the product or service complies with the law.
Organizational Requirements: In addition to the mandatory legal requirements, the organization might also establish its own criteria or additional requirements to meet internal quality or performance standards.
Capability to Meet Claims: The organization must ensure that it possesses the necessary resources, capabilities, and processes to meet the claims it makes about its products or services. This could include performance, functionality, safety standards, or any other promised aspect.
Example of Clause 8.2.2 for an Electronic Devices Manufacturer
Let's consider a company that manufactures electronic devices. When implementing ISO 9001 Clause 8.2.2, the company would:
Regulatory and Statutory Requirements: Identify and comply with the legal standards related to the production of electronic devices, such as electromagnetic compatibility regulations, safety requirements, and disposal regulations for electronic waste.
Organizational Requirements: Define specific quality criteria beyond legal standards, such as using specific grades of materials, ensuring a certain level of durability, and establishing reliability standards that exceed the basic requirements. These criteria might include the use of certain grade components, in-house testing procedures, or additional quality control checks.
Claims Verification: Ensure that the company can meet the marketing claims it makes about its products. For example, if the company markets a device as water-resistant or shockproof, the devices must undergo rigorous testing to verify these claims before they are marketed to the customers.
Documentation: The company should document these requirements and the methods used to comply with them. This documentation might include technical specifications, quality control checklists, testing methodologies, and validation reports, all demonstrating that the product meets the stipulated requirements.
In this way, the company adheres to Clause 8.2.2 of ISO 9001 by clearly defining, meeting, and verifying the requirements for its electronic devices to ensure both compliance with industry standards and meeting the commitments made to its customers.
ISO 9001:2015 Clause 8.2.2 Determining Requirements for Products and Services
In essence, this clause is about understanding, documenting, and meeting the various requirements (legal, regulatory, and internal) necessary for ensuring that the product or service provided meets the specified quality and fulfills the claims made to the customers.