Ensuring Quality through Design, Development, and External Supplier Control in ISO 9001

In order to get what you need, instructions should leave no doubt as to what it is that you want. Instructions are preferably given as a written order or electronic communication.

Remember that telephoned instructions are open to misunderstanding by your external provider and you should take precautions to ensure that your instructions are understood.

You should keep a record of what was ordered so you can confirm that you got what you asked for.

This part of the requirement outlines the details that should be included, as appropriate, in stating your requirements for the control of externally provided products and services.

The extent to which the details listed in items a) to f) apply depends on the extent to which the products and services being ordered affect the organization and the quality of your products and services.

•  the products and services to be provided or the processes to be performed on behalf of the organization;
•  approval or release of products and services, methods, processes, or equipment;

It is essential that all relevant details of the products and services wanted are clearly stated at the time of ordering. These can include drawing, catalogue or model numbers and required delivery date -and place. In some cases, the complete description could be covered by a catalogue number, or a part number. Other factors that may need to be clearly stated could relate to packaging, labelling. certificates of analysis or test results.

While it is essential to fully describe what you want, unnecessary detail can lead to misunderstanding and incorrect delivery.

The written purchase order should be checked prior to issue. In a small organization, it will probably be the person who does the buying who will do the checking for adequacy. This could simply involve reading the order, initialing and dating it.

In case of outsourcing. Inform the external provider necessary maintenance condition for the equipment, a plan that describes the requirements for the manufacturing process.

•  competence of personnel, including necessary qualification, Necessary skill and/or qualification for instance such as for soldering, welding, sommelier, hygiene control, a cook etc.
•  their interactions with the organization’s quality management system;

For examples, when outsourcing is a part of the manufacturing process, such as assemble process, inspection process etc., to the external provider, the organization has to inform, where these processes positions in the organizations QMS

In addition, what is the process before and what is after the process,what inputs are needed and what outputs are intended to the next process. Moreover, provide information about what controls are necessary

•  the control and monitoring of the external provider’s performance to be applied by the organization. Inform the external providers what performance is to be controlled and to be monitored by the organization.

Then inform how the organization evaluate and re-evaluates the external provider’s performance.

•  Verification activities that the organization, or its customer, intends to perform at the external provider’s premises.

If you order products and services from an external provider, and wish to monitor or measure these at the external provider’s premises, the arrangements for these activities need to be agreed and included in your order.

Some examples of the fulfilment of this requirement are an interior decorator viewing curtain fabrics and monitoring employees being trained at a training facility.

If a customer wants to visit your external provider’s premises to check the product, this needs to be stated in both the customer’s order to you and in your order to the external provider.

Whether or not the customer actually does this, you are still responsible for ensuring that all the products obtained from external providers meet the requirement of