ISO/IEC 17025:2017 Clause 7.1.1: Review of Requests, Tenders, and Contracts

 

Clause 7.1.1 of ISO/IEC 17025:2017 emphasizes the importance of systematically reviewing customer requests, tenders, and contracts. This ensures that the laboratory can meet customer requirements effectively, while maintaining compliance with the standard’s principles of quality and competence.

Key Definition

The terms requests, tenders, and contracts refer to the following:

1. Requests:

These are inquiries or orders received from customers for specific laboratory services

 

2. Tenders:

Formal offers or proposals made by a laboratory in response to an inquiry from a customer. Tenders usually outline the scope, methods, costs, and timelines.

 

3. Contracts:

Agreements between the laboratory and the customer defining the terms and conditions of the work to be performed. Contracts specify details like testing scope, timelines, methods, and fees.

This clause emphasis that the laboratories to review requests, tenders, and contracts to ensure:

• Customer requirements are clearly defined and understood.
• The laboratory has the capability, resources, and competence to fulfil the requirements.
• If external providers are involved, the laboratory informs the customer and gains approval.
• Appropriate methods and procedures are selected to meet customer expectations.

 

  

Documented Procedure

Laboratories must establish a documented procedure for reviewing all requests, tenders, and contracts. This procedure should ensure consistency in how requirements are evaluated, recorded, and communicated.

 

1. Requirement Definition (7.1.1a)

The laboratory must ensure that customer requirements are adequately defined, documented, and understood. This includes:

• Scope of testing or analysis
• Applicable standards or methods
• Turnaround times and reporting formats

 

2. Capability Assessment (7.1.1b)

The laboratory must evaluate its ability to fulfil the requirements. This includes:

• Availability of trained personnel
• Suitability and availability of equipment
• Time and resources needed to meet deadlines

 

3. Use of External Providers (7.1.1c)

If external providers (e.g., subcontractors) are involved, the laboratory must:

• Apply the requirements of Clause 6.6
• Inform the customer about the involvement of external providers
• Obtain the customer’s approval before proceeding
•  

External providers may be engaged in cases where:

• The laboratory lacks the resources or competence to perform certain activities
• The laboratory has the competence but cannot perform the work due to unforeseen circumstances

 

  

4. Selection of Methods (7.1.1d)

 

Appropriate methods and procedures must be selected to ensure the results meet customer requirements. These methods should:

• Be validated or verified
• Align with applicable standards or regulatory guidelines

 

5.     Simplified Reviews 

For internal or routine customers, reviews of requests, tenders, and contracts can be simplified. For example, predefined agreements or established workflows may be used for repeat customers.

  

Implementation in Food Testing Laboratories

Food testing laboratories play a crucial role in ensuring the safety, quality of food products. Clause 7.1’s requirements are particularly relevant to customer needs, regulatory requirements.

 Clause 7.1.1 can be applied :

1.     Requirement Definition

A food manufacturer approaches a laboratory to test pesticide residues in fruits and vegetables. The lab:

§  Discusses the scope of testing, identifying specific pesticides and regulatory limits (e.g., FSSAI).

§  Confirms the required turnaround time and parameter to be report.

§  Documents these requirements clearly in the contract and record it.

 

2. Capability Assessment

The lab reviews its internal resources to ensure:

• Availability of trained analysts.
• Properly calibrated equipment, such as GC-MS or LC-MS/MS, for pesticide residue analysis.
• Availability of Certified Reference Material (CRM)
• Sufficient time and material resources to meet the deadline.

 

3.     Use of External Providers

If a specific parameter, need to be to be subcontracted these parameter shall be in the accredited scope of the lab

§  Informs the customer about the subcontracting arrangement.

§   Ensures that the subcontractor complies with ISO/IEC 17025 and other applicable standards.

4.     Selection of Methods:                                                                                                                                                                                                                                                                                  The lab selects AOAC or validated methods for pesticide analysis. For example:

§  Multi-residue pesticide analysis using GC-MS.

§  Ensures the method meets detection limits and regulatory requirements.

 

5. Simplified Reviews

For routine customers, such as a customer sending regular batches of spices for aflatoxin testing, the lab:

• Uses a predefined service agreement.
• Skips detailed reviews for each batch, relying on established workflows.

 

Practical Steps for Compliance

1. Develop a Comprehensive Review Procedure

Create a documented procedure outlining the steps for reviewing requests, tenders, and contracts. Include templates or checklists for consistency.

2. Train Staff

Ensure staff understand the review process and their responsibilities. Training should cover:

• Identifying and defining customer requirements
• Assessing laboratory capabilities
• Communicating with customers and external provider
•  
2. Maintain Records

Keep detailed records of:

• Initial customer communications
• Defined requirements and agreed terms
• Capability assessments and subcontracting approvals
• Methods selected and justifications

 

4. Monitor and Review

Periodically review the effectiveness of the procedure. Identify and address any gaps or inefficiencies.

 

 

Importance of Clause 7.1.1

1. Customer Satisfaction

Clear reviews ensure that the lab understands and meets customer needs, building trust and confidence.

2. Operational Efficiency

Assessing capabilities beforehand helps the lab avoid overcommitting or delays.

3. Risk Mitigation

Ensures the lab only accepts work within its scope and capacity, reducing the risk of non-compliance or errors.

4. Transparency

Keeps customers informed about subcontracting arrangements and method selection, enhancing accountability.

5. Regulatory Compliance

Aligns laboratory operations with regulatory requirements and standards, ensuring reliable and defensible results.