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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. 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
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) | Plan, implement and control operational processes that generate customer output, e.g. planning, engineering, operations, purchasing, warehousing, and delivery, etc. | 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, and a method for handling customer comments. | 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. | 8.3 Design & Development of Products and Services |
| Customer focus and relationship management | 4.4.1 Risks and opportunities (f) | Ensure that externally provided processes, products or services meet quality requirements and monitor the performance of external providers. | 8.4 Control of Externally Provided Products and Services |
| Customer focus | 4.4.1 Processes (a, b & c) | 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. | 8.5 Product 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. | 8.6 Release of Products and Services |
| Customer focus and Improvement | 4.4.1 Evaluate (g) | Identify products or services that do not conform to their intended requirements. Records of product non-conformity should be periodically reviewed. | 8.7 Non-conforming Outputs |
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