8.0 Operation

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ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret the fundamentals of ISO 9000:2015 to help understand, and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. The ISO Navigator Pro™ database divides the requirements into four sequential stages; Plan, Do, Check and Act.

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8.2 Requirements for Products and Services

8.2.2 Determining Requirements for Products and Services

This new requirement replaces ISO 9001:2008 Clause 7.2.1 - Determination of Requirements Related to Product Requirements. You should seek and record evidence that your organization has implemented a process to determine the requirements for the products and services that it intends to offer to customers.

This may also include the requirements from interested parties and also statutory and regulatory requirements relating to the product. You should determine how your organization was proactive in evaluating if there were any additional requirements for the product or service’s intended use.

If the organization determined there were not any additional requirements, this should be evident in associated records. If there were additional requirements, then evidence should be present how they were addressed in the affected process i.e. design, purchasing, manufacturing. The objective here is to set up a process to make sure that however an order is accepted, all the requirements for that order are determined. You will need to identify the following:

  1. Customer’s requirements;
  2. Those defined by the product’s purpose;
  3. Legal and statutory obligations;
  4. Organizational objectives;
  5. Appropriate records.

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