ISO 9001 Navigator Pro™

Quality management system guidance

ISO Navigator Pro

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8.0 Operations

For those risks and opportunities that your organization has identified, you should seek evidence that these actions have been integrated into the management system; as such, these actions should be verifiable at process level – for example, evidence of controls, acceptance criteria and resources to address the risks and opportunities. Review the acceptability criteria; this may include targets, measures, values, KPIs, specifications and other criteria as relevant to the output.

  • Plan, implement and control operational processes that generate customer output, e.g. planning, engineering, operations, purchasing, warehousing, and delivery, etc. Implement the hierachy of controls to mitigate impacts and hazards.
  • Establish arrangements to provide the customer with product information, enquiry handling and orders, and a method for handling customer comments.
  • Implement and maintain a design and development process, appropriate to the types of products or services provided.
  • Ensure that externally provided processes, products or services meet quality requirements and monitor the performance of external providers.
  • Control the manner by which your products are produced and services provided. This also relates to clauses 5.2, 7.1, 7.2, 7.4 and 8.2.
  • Ensure planned arrangements are completed prior to the release of the product or service. Verify that product or service requirements have been met.
  • Identify products or services that do not conform to their intended requirements. Records of product nonconformities should be periodically reviewed.

How to apply the latest quality management principles

The latest and current quality management principles (QMPs), stated in ISO 9000:2015, are intended to provide the foundation by which any organization can continually improve its performance.

You can learn to apply the latest quality management principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle.

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Free PDCA guidance

ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.