- The production and service provision process needs to be performed under controlled conditions
- One of the methods you can use to control the production of products or services is identification and traceability.
- In case of changes in the production and service provision process, you must review and control the changes to ensure continuing conformity with the requirements.
Control of Production and service provision
Standard ISO 9001 wants to say that you need to set up control by applying and enforcing a set of principles and conditions that will lead the realization process. Control will allow you to monitor various parameters during the product realization that may affect QMS performance and the quality of the product. When determining the parameters for control, it is important to correlate the inputs with the outputs.
This part of the ISO 9001 standard describes the different requirements and suggests practical ways to implement them in your QMS.
Identification and Traceability
Implementing identification and traceability allows you to trace back the activities, operations, processes, and process outputs from both sides of the supply chain (customer and supplier) and enables the identification of all elements that took part in the product's realization or provision of the service. Traceability alludes to the development of a method for collecting data related to the use, history, and location of an object and following it based on a recorded identifier.
Identification refers to the establishment of a method or an activity with means for identifying an object and providing evidence for its identification and status.
Property Belonging to Customers or External Providers
Property that belongs to customers or external providers refers to objects that were provided to your company without charges and you have to use it in the realization of the end product. Those objects can be things like property, goods, authorization to use premises, or data.
Preservation refers to the conformity and integrity of the product. ISO 9001 expects you to act in such a way to preserve process outputs during the realization of the service provision.
Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.
Post Delivery Activities
Post Delivery Activities is as the name suggests, all about how you support your customers after they get their hands on your products or services. Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.
Control of Changes
Control of changes are changes that may occur in the controlled conditions of the realization of service provision and which the organization is committed to providing. We recommend managing the traceability of changes. The traceability will allow you to take one step back when a change does not achieve its goals or create a quality problem. To deploy a change effectively, identify the relationships between its processes and activities and the sequence and interactions of the processes. Also, you can identify the risks that associate with the change and plan the controls.