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
- 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.
- 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.
- 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.
- 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
- Define Requirements
Prepare a detailed procurement or service
specification document.
Include all technical, quality, and delivery
requirements.
- Use Clear Communication
Channels
Share the requirements through formal agreements,
purchase orders, contracts, or documented correspondence.
- 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.
- Verify Competence
Request evidence of competence, such as accreditation
certificates or personnel qualifications.
- Document and Monitor Agreements
Maintain records of all communications, agreements,
and evaluations.
Monitor compliance during and after the delivery of
the products or services.
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