ISO 9001:2015 Standard – Clause 8

In ISO 9001:2015 standard, Clause 8 – Operation ~ is regarding the Operational Planning and Control, Requirements for products and services, Design and Development Planning, Production Service Provision with control of the non-conforming output, Release of products and services, and Control of nonconformity outputs.

8.1   Operational Planning and Control

Generally, the organization needs to plan, implement and control the processes needed to deliver its products and services.

This means the organization needs to communicate with the customer to get the requirements of the products or services they require and comply with the legal or statutory requirements. The sequence of a proper operation control is:

• Determine requirements for products and services
• Determine the criteria for processes (the way in which its processes are carried out)
• Determine the criteria for acceptance of products and services
• Determine the need for resources
• Implement controls of the processes
• Keep necessary procedures and controls

8.2 Requirements for products and services

The organization needs to communicate with customers including providing information regarding products and services (can include the brochure, catalog, etc), handling contracts or orders and changes, obtaining customer feedback, handling and controlling customer property, and finally establishing specific requirements for contingency actions.

The organization needs to ensure the applicable statutory and regulatory requirements are taken into consideration when determining requirements for the products or services offered. The organization needs to review the requirements for products and services before committing to supply products/services to the customer. 

8.3   Design and development of product and services

Next, design and development of products and services. The process of designing and developing products and services is important since it creates a competitive advantage for the organization. If the organization does not have design and development, then this clause can the excluded.

The steps in design and development are as below:

When doing Planning, the organization needs to determine the stages and control by considering the nature, duration, and complexity of the design and development activities; required process stages and reviews; Verification and validation; responsibilities and authorities; resources; involvement of customers; and control level expected for the design.

Input – consider what criteria need to satisfy by getting inputs from e.g., market research, customer feedback, sales reports, product functionality, previous design issues, statutory/legal requirements and consequences of failure etc.

Control – Apply control to the design and development process through verification, validation, review, and evaluation, corrective action, etc.

Output – Need to ensure design and development output meet the requirements and is documented in either whitepaper, Sketches, blueprints, specifications, manufacturing instructions, packaging/labeling instructions, safety warnings etc.

Changes – if any changes during the design and development, it needs to review, controlled and documented.

8.4   Control of externally provided processes, products, and services

The externally provided products refer to products or services we purchase from other’s companies, like suppliers or Subcon. All these external providers need to be controlled either through evaluation, audit, or pre-qualification. The organization need to provide adequate product/service requirements to the external provider.

8.5 Production and service provision

The organization must control the processes (operation process) that produce their product or services through:

• monitor and measure production processes and resources
• provide sufficient equipment and a suitable environment for the operation
• ensure the competent people in work
• validate and verified the output from the production
• implement action to prevent human error

The organization needs to control the unique identification of its products or services. It is easier for traceability when anything happened. Method of unique identification can thorough, label, barcode, unique job order number, serial number, lot number, etc.

The organization needs to control and safeguard the property from their customer or external provider. If any is damaged or lost, it is required to report to the customer or external provider. 

The organization needs to have a post-delivery service to ensure customer satisfaction and improve customer loyalty. Post-delivery activities can be like a follow-up call, after-sales service, warranty, etc. All the production processes changed need to be controlled and documented.

8.6   Release of products and service

The organization is required to check the acceptance of its product or service before releasing it to customers. The checking might be through a test, verification, validation against customer spec, inspection etc. The criteria of acceptance and the person authorizing the release need to be documented.

8.7   Control of nonconforming outputs

The organization needs to control if found non-conformance products or services to prevent unintended delivery to the customer. The non-conformance output needs to be either corrected or segregated.