6.6 Externally Provided Products and Services
6.6.1 Ensuring Suitability of Externally Provided Products and Services
The laboratory shall ensure that only suitable externally provided products and services that affect laboratory activities are used, when such products and services:
- Are intended for incorporation into the laboratory’s own activities.
- Are provided, in part or in full, directly to the customer by the laboratory, as received from the external provider.
- Are used to support the operation of the laboratory.
Note:
Products can include, for example, measurement standards and equipment, auxiliary equipment, consumable materials, and reference materials. Services can include, for example, calibration services, sampling services, testing services, facility and equipment maintenance services, proficiency testing services, and assessment and auditing services.
6.6.2 Procedure and Records for Externally Provided Products and Services
The laboratory shall have a procedure and retain records for:
- Defining, reviewing, and approving the laboratory’s requirements for externally provided products and services.
- Defining the criteria for evaluation, selection, monitoring of performance, and re-evaluation of the external providers.
- Ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer.
- Taking any actions arising from evaluations, monitoring of performance, and re-evaluations of the external providers.
6.6.3 Communication of Requirements to External Providers
The laboratory shall communicate its requirements to external providers for:
- The products and services to be provided.
- The acceptance criteria.
- Competence, including any required qualification of personnel.
- Activities that the laboratory, or its customer, intends to perform at the external provider's premises.