8.0 Operation

ISO Navigator Pro

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.

Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and OHSAS 18001:2007, and offer an easy way to implement and document your organization's quality management system or integrated management system.

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.

Free internal audit checklists

Check out our free internal audit checklists. The audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements.

Client list

Over 8,000 companies and globally recognized brands have relied on our templates to provide a path to improve, collaborate, and to enhance their operations to achieve certification, please see our client list for more information.