ISO/IEC 17025:2017 Clauses 7.1.2 and 7.1.3

 

ISO/IEC 17025:2017 establishes guidelines for laboratory competence and reliability. Clauses 7.1.2 and 7.1.3 focus on communication between the laboratory and its customers regarding testing methods and decision rules. Proper implementation of these clauses ensures transparency, accuracy, and customer confidence in the laboratory's results.

 

Clause 7.1.2: Informing Customers About Inappropriate or Outdated Methods

If a customer requests a method that is outdated, inappropriate, or does not meet regulatory standards, the laboratory must inform them and suggest a suitable alternative.

Why is This Important?

• Ensures results are scientifically valid and meet current industry standards.
• Prevents misleading results that could impact food safety or compliance.
• Helps customers make informed decisions about testing methodologies.

A food manufacturer requests a moisture content analysis in flour using an old gravimetric method that is slow and less accurate. However, the lab knows that Karl Fischer titration is a more precise and efficient method.

Laboratory Action:

• The lab informs the customer that the requested gravimetric method is outdated.
• The lab explains the advantages of Karl Fischer titration, such as better accuracy and faster results.
• The customer agrees to use the improved method, ensuring compliance with updated standards.

 

Clause 7.1.3: Statement of Conformity to a Specification or Standard

If a customer requests a statement of conformity (e.g., pass/fail, within tolerance/out of tolerance), the lab must clearly define:

1. The specification or standard used.
2. The decision rule applied (i.e., how results are interpreted in relation to the standard).
3. If the decision rule is not inherent in the specification, the lab must communicate it to the customer and obtain agreement.

Why is This Important?

• Ensures clarity in reporting results.
• Prevents misinterpretation of test findings.
• Helps customers understand whether the sample meets regulatory or safety standards.

A beverage company sends a soft drink sample for pH testing and requests a pass/fail result based on an FSSAI standard (pH range: 3.0–4.0).

Laboratory Action:

• The lab confirms the FSSAI standard (3.0–4.0) as the reference.
• The lab explains the decision rule, such as rounding criteria or measurement uncertainty.
• The customer agrees, and the final report states: "pH = 3.8 (Pass, within standard)."

 

Requirement for Compliance

1. Maintain a Database of Valid Methods:

·       Regularly update testing methods based on ISO, AOAC, or regulatory changes.

·       Train staff to identify outdated or inappropriate methods.

2. Communicate Clearly with Customers:

·       Explain why an alternative method is better.

·       Provide references or regulatory guidelines for suggested methods.

3. Define and Document Decision Rules:

·       Clearly specify the criteria used for pass/fail decisions.

·       Ensure agreement with the customer before finalizing results.

4. Maintain Records of Customer Communication:

·       Document discussions regarding method selection and decision rules.

·       Keep records of customer approvals for transparency and audit purposes.

SOP: Procedure for Maintaining the Laboratory Log Book

  

1.0 PURPOSE

1.1 To lay down the procedure for maintaining the laboratory log book.

 

2.0 SCOPE

2.1 This SOP shall be applicable to all personnel working in the laboratory, including scientists and chemists.

 

3.0 RESPONSIBILITY

3.1 Scientists, chemists, and heads of departments shall be responsible for the implementation of this SOP.

 

4.0 DISTRIBUTION

4.1 The Quality Assurance (QA) department is responsible for keeping the SOP ‘Master Copy’ approved by the Quality Manager.

4.2 A ‘Control Copy’ of the SOP shall be distributed within the department and placed near related equipment or instruments as required.

 

5.0 ABBREVIATIONS

5.1 ABBREVIATIONS

5.1.1 SOP: Standard Operating Procedure
5.1.2 Lab: Laboratory

  

6.0 PROCEDURE

6.1 The laboratory log book is a bound data record book used for recording daily activities in the respective laboratory.

6.2 Laboratory record log books shall be issued to Analyst upon request.

6.3 Each page of the log book shall be pre-numbered by the assistant responsible for issuing it.

6.4 In case an incorrect entry is discovered, it shall be struck through with a single horizontal line.

6.5 All activities shall be recorded offline in the sequence they are completed.

6.6 The log book shall be maintained and preserved securely and confidentially; it shall not be taken outside the laboratory.

6.7 All dates shall be written in the format DD/MM/YYYY, where:

• DD: Date in numerical
• MM: Month in numerical
• YYYY: Year in numerical

 6.8   The complete log book shall be reviewed for technical adequacy and safely preserved in the archival area for future reference.

 

7.0 PRECAUTIONS

7.1 All entries shall be made in clear and simple language without ambiguity.

7.2 All entries and signatures must be legible.

7.3 Overwriting and the use of white correction fluid, black pens, or red pens are prohibited. Mistakes shall not be erased. Instead, draw a line through the error and record the correct information.

7.4 Related references shall be mentioned clearly as required.

 

8.0 REFERENCES

[List any applicable references here]

 

 

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.

 

Standard Operating Procedure (SOP) for Good Documentation Practices (GDP) in a Food Testing Laboratory

1.0 Objective

To establish standardized procedures for documenting, maintaining, and reviewing records in the food testing laboratory to ensure data integrity, traceability, and compliance with regulatory requirements specific to food safety and testing.

 

2.0 Scope

This SOP applies to all laboratory personnel involved in data recording, document preparation, maintenance, and review in compliance with Good laboratory Practices (GLP), ISO 17025, and FSSAI mannula for food testing.

 

3.0 Responsibility

3.1 Laboratory Personnel:

·         Ensure compliance with Good Documentation Practices while recording and handling food testing data.

3.2 Department Heads:

·         Oversee adherence to GDP guidelines and perform periodic audits of food testing records.

3.3 Quality Assurance  (QA):

·         Maintain master copies of documents and review controlled document compliance for food testing processes.

 

4.0 Definitions and Abbreviations

4.1 Definitions:

·         Good Documentation Practices (GDP): Guidelines for creating and maintaining accurate, clear, and complete records specific to food testing procedures.

4.2 Abbreviations:

·         SOP: Standard Operating Procedure.

·         GDP: Good Documentation Practices.

·         QA: Quality Assurance.

·         FSSAI: Food Safety and Standards Authority of India.

 

5.0 Procedure

5.1 General Guidelines

1.      Use of Ink:

Always use indelible blue or black ink for manual entries. Entries must be legible, clear, and without ambiguity.

2.      Date Format:

Record dates as DD/MM/YYYY

3.      Error Correction:

Do not overwrite or erase errors. Draw a single line through the incorrect entry, write the correct information nearby, and initial with the date of correction.

4.      Completeness:

All fields in documents must be filled. If not applicable, write "N/A" or "Not Applicable."

5.      Page numbaer:

Number pages as “Page X of Y” to ensure completeness.

6.      Avoid Blank Spaces:

Cross out any unused space with a diagonal line and note "Cancelled" or "Not Applicable" with initials and date.

 

5.2 Documentation Standards

1.      Headers and Footers:

Include document title, SOP number, version, and effective date on each page.

2.      Signatures and Initials:

Every document must have signatures, initials, and dates of preparation, review, and approval.

3.      Instrument Records:

Record the name, identification number, and calibration status of instruments used in food testing or analysis.

4.      Analytical Data:

Maintain detailed records of reference standards, lot numbers, and method descriptions for food samples.

5.      Sample Identification:

Each food sample must have a unique identification number to ensure traceability.

 

5.3 Handling and Storage

1.      Control Copies:

Use "Controlled Copy" stamps for distributed documents and maintain a log of issued copies.

2.      Master Copies:

Store original documents securely in the Quality Assurance archive.

3.      Document Retention:

Retain documents for the duration specified by regulatory requirements (e.g., FSSAI guidelines).

4.      Access Control:

Restrict access to sensitive documents to authorized personnel only.

 

5.4 Training

1.      Awareness Training:

Conduct regular training for all personnel on GDP principles specific to food testing.

2.      Documentation Updates:

Train employees on changes to documentation formats or requirements related to food safety standards.

 

6.0 Precautions

1.      Do not use correction fluid, tape, or pencil entries in records.

2.      Ensure records are clean, safe, and stored to prevent damage or loss.

3.      Verify data accuracy during entry to minimize errors.

4.      Maintain confidentiality of food testing records.

 

7.0 References

1.      ISO 17025: General requirements for the competence of testing and calibration laboratories.

2.      FSSAI Guidelines for Food Testing Laboratories.

 

8.0 Annexures

1.      Annexure 1: Format for Document Correction Log.

2.      Annexure 2: Training Record Template.

3.      Annexure 3: Document Issuance and Retrieval Log.

4.      Annexure 4: Sample Identification Log Template.

 

9.0 Revision History

Version	Effective Date	Description of Changes	Prepared By	Approved By
1.0	DD/MM/YYYY	Initial Release	QA Officer	Lab Director