Management system guidance
8.0 Operation
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8.1 Operational Planning and Control
Clause 8.1 is the starting point for the operational part of your quality management system. Your organization must plan, implement and keep control of the processes it uses to provide its products and services, and of the processes it uses to carry out the actions it decided on under Clause 6 (risks, opportunities, quality objectives and planned changes). The clause broadly corresponds to ISO 9001:2008 Clause 7.1 – Planning of Product Realization, but it covers implementation and control as well as planning.
ISO 9001:2026 sets out five planning activities. In plain terms, your organization should:
- Work out what each product or service has to achieve, using the requirements determined under clause 8.2;
- Set the criteria a product or service has to meet before it is accepted (e.g. tolerances, inspection limits, service levels);
- Set criteria for how each process should be run (e.g. machine settings, methods, response times);
- Control the processes against those criteria;
- Decide what resources are needed for the product or service to conform.
Keep documented information available, to the extent your organization needs, for two purposes: to give confidence that processes have been carried out as planned, and as evidence that products and services conform. Typical examples are job cards, travellers, inspection and test records, service reports and signed-off checklists.
Planned changes to operations must be controlled. When something changes that was not planned, review what the change has caused and take action to limit any adverse effects where needed. Any outsourced processes, products or services that are relevant to the QMS must also be kept under control (see 8.4).
What changed in ISO 9001:2026: the planning activities have been re-ordered as a) to e). The 2015 item that combined process criteria and acceptance criteria is now split into two items (b and c), and determining resources has moved to e). The 2015 item on determining, maintaining and retaining documented information has been replaced by two separate statements that documented information is available – one to show processes ran as planned and one as evidence that products and services conform. The 2015 sentence requiring the output of planning to suit the organization’s operations no longer appears. The requirements on controlling changes and outsourced processes are carried over.
In practice, your organization needs to plan in advance how it will manufacture its products or deliver its services. The plans need to take into account the product or service requirements and any relevant quality objectives, the resources and documents that may be necessary, the monitoring and inspection activities needed to confirm that the product or service will meet requirements, and the documented information that should be kept.
There should be a process for developing work instructions that set out standard practice for performing tasks in line with customer and QMS requirements, including how non-routine or one-off tasks are planned and controlled.
You should seek and record evidence that your organization has determined the processes needed to meet the requirements of its customers and of its QMS. Look for evidence that process inputs, outputs, resources, controls, criteria, and process measures and performance indicators have been planned. Operational planning includes the following elements:
- Developing process plans that include clear, concise and detailed work instructions;
- Defining quality objectives and requirements (tolerances, surface finish, workmanship standards, etc.) for the product or service;
- Defining how quality objectives and requirements are documented; e.g. drawings, specifications, models, etc., and communicated, e.g. instructions, pre-production samples, operator training, etc.
- Ensuring that product and service inspection and testing methods and procedures are defined and documented, along with their respective acceptance criteria;
- Ensuring that each specified inspection, test and monitoring activity is recorded through work orders, tags, tickets, forms, electronic data collection systems, etc.;
- Undertaking risk analysis studies of key manufacturing processes and ensuring mitigations arising from risk management are incorporated into key product and/or process designs;
- Developing the capabilities, training, qualifications, procedures and work instructions necessary to execute the requirements to ensure product compliance to contract/customer requirements;
- Developing training and procedures to ensure general workmanship, equipment maintenance and qualification, and material handling standards are maintained in a manner consistent with contract/customer requirements and sound business practices;
- Designating and maintaining an adequate number of personnel trained and qualified to support both new product development and continuous process improvement;
- Implementing production and purchasing control systems capable of managing all phases of manufacturing and service delivery, from scheduling of customer needs, to the delivery of finished goods. The system employed should account for every part entered into the manufacturing process and provide for lot/batch tracking, traceability and integrity of process, including documentation of delays and interruptions;
- Ensuring suitable production facilities, equipment, inspection and servicing capabilities are available to achieve contract/customer requirements.
- Ensuring that process environment conditions (see 7.1.4) such as lighting, housekeeping, contamination, handling equipment, temperature compensation and process licencing are managed in such a way as to comply with contract/customer and regulatory agency requirements.
- Controlling conditions such as utilities and supplies including water, compressed air, electricity and chemical products to the extent they affect product quality.
Department Managers must ensure that work practices and instructions are developed as necessary to support the execution of process and production plans, while supervisors at every level must ensure that training is implemented and that qualifications are maintained to support the requirements of process and production plans.
Operational personnel must carry out the process and production plans as per instructions and in the sequence presented to them. When required, they must stop work if they identify any discrepancies in product, planning or instructions to their immediate supervisor, and make input into process improvement or corrective action.
Process and production plan verification
All other customer defined criteria for control or monitoring of quality must have been established (e.g. process mapping, statistical process control, third party verification, etc.) and customer approval must have been obtained as necessary. A new process is deemed qualified for release to production when the following criteria are met:
- An approved First Article is produced to the Process Plan to verify that all dimensions, features, and product attributes meet specified requirements;
- Key/Critical features are identified for in-process monitoring of machined product through pre-control or other specified means;
- All machine set-up, operating instructions and operator qualifications are in place and operating;
- Inspection plans are in place for quality control verification at both In-Process and Final Inspection steps;
- Special processes have been verified through the approved supplier list or other specified means;
- Product and/or component purchases have been verified through the approved supplier list and end item Quality Control or specified functional test.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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