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Quality management system guidance
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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. Control planned changes and review the consequences of unintended changes.
- Establish arrangements to provide the customer with product information, enquiry handling and orders, a method for handling customer feedback, and information on contingency actions, including those related to disruptions.
- Implement and maintain a design and development process, appropriate to the types of products or services provided, involving customers and other relevant interested parties where appropriate.
- 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. Keep evidence of each nonconformity, the action taken and who decided it, and review trends periodically.
How to apply the latest quality management principles
Apply the quality management principles (QMPs) in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle. The ISO 9000 quality management principles are embodied with in the individual requirements of ISO 9001 and the table below relates these principles to the applicable clauses and requirements:
| ISO 9000 Principles | ISO 9001 Base Clauses | Action & Compliance Summary | ISO 9001 Clauses |
| Process approach | 4.4.1 Processes (a, b, c, d & e) | Plan, implement and control operational processes that generate customer output, e.g. planning, engineering, operations, purchasing, warehousing, and delivery. Control planned changes and review the consequences of unintended changes. | 8.1 Operational Planning and Control |
| Customer focus | 4.4.1 Processes (a, b & c) | Establish arrangements to provide the customer with product information, enquiry handling and orders, feedback and complaints handling, and information on contingency actions, including those related to disruptions. Review requirements before committing to supply. | 8.2 Requirements for Products and Services |
| Customer focus | 4.4.1 Processes (a, b & c) | Implement and maintain a design and development process appropriate to the types of products or services provided, involving customers and other relevant interested parties where appropriate. | 8.3 Design & Development of Products and Services |
| Customer focus and relationship management | 4.4.1 Risks and opportunities (g) | Ensure that externally provided processes, products or services meet requirements, communicate your requirements to external providers, and monitor their performance. | 8.4 Control of Externally Provided Processes, Products and Services |
| Customer focus | 4.4.1 Processes (a, b & c) | Control the way your products are produced and services provided, including identification and traceability, customer and external provider property, preservation, post-delivery activities and control of changes. | 8.5 Production and Service Provision |
| Customer focus and evidence-based decision making | 4.4.1 Processes (a, b & c) | Ensure planned arrangements are completed prior to the release of the product or service. Verify that product or service requirements have been met and keep evidence of who authorized release. | 8.6 Release of Products and Services |
| Customer focus and improvement | 4.4.1 Evaluate (h) | Identify and control outputs that do not conform to requirements to prevent their unintended use or delivery. Take suitable action and keep evidence of the nonconformity, the action taken and who decided it. | 8.7 Nonconforming Outputs |
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