ISO/IEC 17025:2017 Clause 6.6.3: Communication of Requirements to External Providers

Clause 6.6.3 of ISO/IEC 17025:2017 emphases on the laboratory’s responsibility to clearly communicate its requirements to external providers. This ensures that all products and services obtained from external sources meet the laboratory’s operational, technical, and quality needs.

Key Elements of Clause 6.6.3

1. Products and Services to Be provided

The laboratory must define and inform the exact products or services required.

Example: If a laboratory issue purchase order for a certified reference material (CRM) for testing, it must specify the chemical composition, purity, and certification details needed.

2. Acceptance Criteria

The laboratory must provide the criteria for determining whether the products or services meet its requirements.

Example: For calibration services, the laboratory could specify working range to be calibrated, traceability to international standards, and documentation needs such as calibration certificates and calibration certificate of equipment which is used for equipment under calibration.

3. Competence of External Providers

The laboratory must communicate any requirements related to the competence of the external provider, including personnel qualifications.

Example: A laboratory providing the calibration shall have accreditation with ISO/IEC 17025.

4. Activities Performed at the External Provider’s Premises

The laboratory must inform external providers about any activities the laboratory or its customers intend to perform at the provider's location.

Example: If the laboratory or its customer plans to witness a test or inspect a process at the provider’s premises, this requirement must be communicated in advance.

Practical Steps for Compliance

1. Define Requirements

Prepare a detailed procurement or service specification document.

Include all technical, quality, and delivery requirements.

2. Use Clear Communication Channels

Share the requirements through formal agreements, purchase orders, contracts, or documented correspondence.

3. Set Performance and Acceptance Criteria

Define measurable criteria for acceptance, such as tolerance levels, turnaround times, and certifications. Include these criteria in the contract or agreement.

4. Verify Competence

Request evidence of competence, such as accreditation certificates or personnel qualifications.

5. Document and Monitor Agreements

Maintain records of all communications, agreements, and evaluations.

Monitor compliance during and after the delivery of the products or services.