This section discusses the need for companies to carry out production and service provision under controlled conditions. It lists common controlled conditions such as documented information, suitable monitoring equipment, infrastructure, competent staff, validation of results, error prevention, and controlling product release, delivery, and post-delivery activities. While these should be used if applicable, documented procedures are not required for every activity unless needed to prevent non-conformances.
This section discusses the need for companies to carry out production and service provision under controlled conditions. It lists common controlled conditions such as documented information, suitable monitoring equipment, infrastructure, competent staff, validation of results, error prevention, and controlling product release, delivery, and post-delivery activities. While these should be used if applicable, documented procedures are not required for every activity unless needed to prevent non-conformances.
This section discusses the need for companies to carry out production and service provision under controlled conditions. It lists common controlled conditions such as documented information, suitable monitoring equipment, infrastructure, competent staff, validation of results, error prevention, and controlling product release, delivery, and post-delivery activities. While these should be used if applicable, documented procedures are not required for every activity unless needed to prevent non-conformances.
This section discusses the need for companies to carry out production and service provision under controlled conditions. It lists common controlled conditions such as documented information, suitable monitoring equipment, infrastructure, competent staff, validation of results, error prevention, and controlling product release, delivery, and post-delivery activities. While these should be used if applicable, documented procedures are not required for every activity unless needed to prevent non-conformances.
Control of production and service provision (section 8.5.1).
The overall statement from the section
is that your company must carry out the activities to provide your product or service under controlled conditions. The standard then includes a listing of common controlled conditions that should be used if they are applicable to your product or service. These include documented information for your products and services, suitable monitoring and measurement resources (including equipment), suitable infrastructure and environment, competent persons, validation of the ability to achieve results, actions to prevent human error, and activities controlling product release, delivery, and post- delivery. As with all other processes, these do not need to be documented procedures unless non- conformances would occur if the procedure was not written down.