Understanding Clause 7.1.1 of ISO/IEC 17025:2017

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 laboratories can meet customer requirements effectively while maintaining compliance with the standard's core principles of quality and competence.

Key Definitions

Requests
Inquiries or orders received from customers for specific laboratory services.

Tenders
Formal offers or proposals made by a laboratory in response to customer inquiries. These typically outline the scope, methods, costs, and timelines.

Contracts
Agreements between the laboratory and customer defining the terms and conditions of work. These include testing scope, timelines, methodologies, and fees.

Purpose of the Clause

Clause 7.1.1 mandates laboratories to review all requests, tenders, and contracts to ensure that:

a) Customer requirements are clearly defined and understood.

b) The laboratory has the capability, resources, and competence to fulfill them.

c) If external providers are involved, the customer is informed and approval is obtained.

d) Suitable methods and procedures are selected to meet expectations.

Documented Procedure

Laboratories must establish a documented procedure for reviewing all requests, tenders, and contracts. This procedure should promote consistency in evaluating, recording, and communicating customer requirements.

Detailed Requirements of Clause 7.1.1

1. Requirement Definition (7.1.1a)

The laboratory must ensure that customer requirements are adequately defined, documented, and understood, including:

a) Scope of testing or analysis

b) Applicable standards or methods

c) Turnaround times and reporting formats

2. Capability Assessment (7.1.1b)

The laboratory must assess its ability to meet the defined requirements, considering:

a) Availability of trained personnel

b) Suitability and availability of equipment

c) Time and resources required to meet deadlines

3. Use of External Providers (7.1.1c)

When subcontracting is involved, the laboratory must:

a) Apply the requirements of Clause 6.6

b) Inform the customer about the involvement of external providers

c) Obtain customer approval before proceeding

Subcontracting may be necessary when:

a) The laboratory lacks the resources or competence for specific activities

b) The laboratory is competent but unable to perform the work due to temporary constraints

4. Selection of Methods (7.1.1d)

Methods and procedures selected must:

a) Be validated or verified

b) Comply with relevant standards or regulatory requirements

5. Simplified Reviews

For routine or internal customers, the review process can be simplified. For example:

a) Using predefined agreements

b) Relying on established workflows for repeat testing

Application in Food Testing Laboratories

Clause 7.1.1 is especially relevant in food testing labs, which play a key role in ensuring food safety and compliance with regulatory requirements.

1. Requirement Definition

A food manufacturer approaches a lab for pesticide residue testing in fruits and vegetables. The lab:

a) Identifies specific pesticides and relevant regulatory limits (e.g., FSSAI)

b) Confirms turnaround time and reporting parameters

c) Documents the requirements in a contract

2. Capability Assessment

The lab evaluates:

a) Availability of trained analysts

b) Equipment like GC-MS or LC-MS/MS

c) Availability of Certified Reference Materials (CRMs)

d) Sufficient time and materials to meet deadlines

3. Use of External Providers

If a parameter must be subcontracted:

a) The lab ensures the subcontractor is within its accredited scope

b) The customer is informed

c) Compliance with ISO/IEC 17025 is maintained

4. Selection of Methods

The lab selects appropriate validated methods, such as:

a) AOAC methods for pesticide residues

b) Multi-residue analysis using GC-MS

c) Ensuring regulatory compliance and detection limits are met

5. Simplified Reviews for Routine Clients

For example, a spice exporter regularly sends samples for aflatoxin testing:

a) A predefined service agreement is used

b) Detailed reviews are skipped for each batch

Practical Steps for Compliance

1. Develop a Review Procedure

Document a clear procedure for reviewing requests, tenders, and contracts. Use templates or checklists for consistency.

2. Train Staff

Ensure staff are trained to:

a) Identify and define customer requirements

b) Assess laboratory capabilities

c) Communicate effectively with customers and external providers

3. Maintain Records

Maintain comprehensive records of:

a) Customer communications

b) Defined requirements and agreed terms

c) Capability assessments

d) Subcontracting approvals

e) Selected methods and their justifications

4. Monitor and Review

Regularly assess the effectiveness of the procedure and address gaps or inefficiencies.

Importance of Clause 7.1.1