IATF 16949:2016 Clause 7.1.5.3 Laboratory requirements

All kinds of Laboratory mechanical, chemical, dimensional, performance, metallurgical, etc. is a center that provides measurement, testing, and calibration services. We must consider two types of laboratories, internal and external laboratories.  The internal laboratory is the laboratory inside the building that belongs to the organization, that is, your company.   The external laboratory is the laboratory where you receive support and service from outside. Laboratories play a crucial role in the automotive industry, supporting various aspects of product development, quality control, and regulatory compliance. Here are some key roles of laboratories in the automotive industry:

1. Product Development and Testing: Laboratories are involved in the testing and evaluation of automotive components, systems, and materials during the product development stage. They conduct performance testing, durability testing, safety testing, and other specialized tests to ensure compliance with industry standards and specifications.
2. Quality Control and Inspection: Laboratories perform quality control inspections to verify the conformity of automotive parts, materials, and finished products. They conduct measurements, inspections, and tests to ensure that products meet the specified requirements and comply with relevant regulations.
3. Calibration and Metrology: Laboratories provide calibration services for measuring equipment and instruments used in automotive manufacturing and testing processes. They ensure that measurement equipment is accurate and reliable, maintaining traceability to national or international standards.
4. Emission Testing and Compliance: Laboratories play a vital role in emission testing to verify compliance with environmental regulations, such as emission standards for vehicles. They perform emission measurements and analysis, including exhaust gas analysis and particulate matter testing.
5. Material Analysis and Validation: Laboratories conduct material analysis and validation to ensure the quality and performance of automotive materials. They perform tests for mechanical properties, chemical composition, thermal properties, and other material characteristics to ensure they meet required specifications.
6. Failure Analysis and Investigations: In case of product failures or issues, laboratories conduct failure analysis and investigations to identify root causes and provide solutions. They use advanced techniques such as microscopy, spectroscopy, and mechanical testing to analyze failed components and identify design or manufacturing issues.
7. Research and Development: Laboratories engage in research and development activities to drive innovation in the automotive industry. They explore new materials, technologies, and testing methodologies to enhance product performance, safety, and efficiency.
8. Regulatory Compliance: Laboratories assist automotive manufacturers in meeting regulatory compliance requirements. They provide testing and certification services to ensure adherence to safety standards, emission regulations, and other applicable industry regulations.
9. Advanced Testing and Simulation: With the growing complexity of automotive systems, laboratories employ advanced testing and simulation techniques. This includes virtual testing, computer-aided engineering, and simulation tools to assess vehicle performance, crashworthiness, aerodynamics, and other critical factors.
10. Training and Education: Laboratories often offer training programs and educational resources to support skill development and knowledge enhancement in the automotive industry. They provide training on testing methodologies, equipment operation, standards compliance, and best practices.

Overall, laboratories play a vital role in ensuring the quality, safety, and performance of automotive products. They contribute to product development, quality control, regulatory compliance, and continuous improvement efforts in the automotive industry.

Clause 7.1.5.3.1 Internal laboratory

An organization’s internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, requirements for: (a) adequacy of the laboratory technical procedures; (b) competency of the laboratory personnel; (c) testing of the product; (d) capability to perform these services correctly traceable to the relevant process standard when no national or international standard(s) is available, a methodology shall be defined to verify measurement system capability; (e) customer requirements, if any; (f) review of the related records. Third-party accreditation to ISO/IEC 17025 or equivalent may be used to demonstrate the organization’s in-house laboratory conformity to this requirement.

In many organizations, the internal laboratory may conduct more technical and comprehensive inspection, testing and calibration using more complex and sensitive equipment, methods and standards. You must have document the internal laboratory scope; You must also specify technical requirements for – adequacy of procedures; personnel training and competency; testing methods; traceability to relevant process standards; control of test specimens; records needed, etc. Your internal laboratory scope must specify the tests, evaluations and calibrations it is qualified to perform; provide a list of the equipment used to perform these activities; and a list of the methods, standards, etc., used. The procedures used in the laboratory could be established practices; MONITORING AND MEASURING DEVICE manufacturer’s reference or user manuals; industry standards, methods and practices; customer specified methods; and regulatory methods and practices. These procedures typically address testing methods and standards; identification and traceability; etc. The need to have a documented laboratory procedure or manual would depend on the scope and complexity of product testing and inspection. OEM customers may have specific competency and training requirements for laboratory personnel.

Scope of Internal Laboratory Facility

An organization’s internal laboratory facility should have a defined scope that outlines its capabilities to perform the required inspection, test, or calibration services. This scope defines the range of activities and services that the laboratory is competent to undertake.The defined scope typically includes the following elements:

1. Testing or Inspection Methods: Specify the specific testing or inspection methods that the laboratory is capable of performing. This may include mechanical testing, chemical analysis, dimensional measurements, electrical testing, environmental testing, and more. The scope should clearly identify the methods that the laboratory is competent in.
2. Equipment and Instrumentation: List the equipment and instrumentation that the laboratory possesses and is qualified to use for the testing, inspection, or calibration services. This includes specifying the range and accuracy of the equipment, as well as any applicable certifications or accreditations.
3. Standards and Specifications: Identify the relevant standards, regulations, or specifications that the laboratory adheres to when conducting testing, inspection, or calibration activities. This ensures that the laboratory is operating in compliance with the necessary requirements.
4. Range of Testing: Define the range of materials, products, or components that the laboratory is qualified to test, inspect, or calibrate. This includes specifying any limitations or exclusions within the laboratory’s scope of services.
5. Accreditation and Certifications: If applicable, mention any accreditations or certifications that the laboratory has obtained. This may include ISO 17025 accreditation or specific industry certifications that validate the laboratory’s competence and adherence to recognized standards.

By having a well-defined scope, an internal laboratory facility can clearly communicate its capabilities, areas of expertise, and limitations to internal stakeholders, customers, and regulatory bodies. This ensures that the laboratory operates within its defined competencies, maintains the necessary resources, and provides accurate and reliable testing, inspection, or calibration services to support organizational quality objectives.

Adequacy of the laboratory technical procedures

The adequacy of laboratory technical procedures is crucial to ensure the accuracy, reliability, and consistency of testing, inspection, or calibration activities. Here are some key aspects to consider in assessing the adequacy of laboratory technical procedures:

1. Documentation and Availability: Technical procedures should be properly documented, easily accessible, and up-to-date. They should provide clear and detailed instructions on how to perform specific tests, inspections, or calibrations. The procedures should be readily available to laboratory personnel and maintained in a controlled manner.
2. Compliance with Standards and Regulations: Laboratory technical procedures should align with applicable standards, regulations, and customer requirements. They should incorporate relevant methods, guidelines, and specifications to ensure compliance with established criteria. Regular review and updates of procedures should be conducted to reflect any changes in standards or requirements.
3. Clarity and Consistency: Technical procedures should be written in a clear and concise manner, using language that is easily understandable by laboratory personnel. They should provide step-by-step instructions, including necessary calculations, equipment setup, sample preparation, and data recording. Consistency in terminology, units of measurement, and data reporting should be maintained throughout the procedures.
4. Method Validation and Verification: Technical procedures should undergo validation and verification to ensure their effectiveness and suitability for the intended purpose. This involves conducting experiments, comparing results with reference methods, and assessing the precision, accuracy, and reliability of the procedures. Method validation and verification should be documented to demonstrate the adequacy of the procedures.
5. Risk Assessment and Mitigation: Technical procedures should include considerations for identifying and managing potential risks associated with the testing, inspection, or calibration activities. Risk assessment should address factors such as equipment limitations, sample handling, potential hazards, and sources of measurement uncertainty. Mitigation measures should be incorporated into the procedures to minimize risks and ensure reliable results.
6. Training and Competence Requirements: Technical procedures should outline the necessary training and competence requirements for laboratory personnel involved in conducting the activities. This includes specifying the qualifications, skills, and knowledge needed to perform the procedures accurately and effectively. Training records and competency assessments should be maintained to demonstrate compliance with these requirements.
7. Continual Improvement: Technical procedures should be subject to continual improvement based on feedback, data analysis, and emerging best practices. Regular review and updates should be conducted to incorporate lessons learned, address identified issues, and enhance the efficiency and effectiveness of the procedures.
8. Document Control and Change Management: Technical procedures should be subject to proper document control and change management processes. This ensures that changes to the procedures are controlled, documented, communicated, and implemented in a systematic and controlled manner.

By evaluating and ensuring the adequacy of laboratory technical procedures, organizations can enhance the consistency, accuracy, and reliability of their testing, inspection, or calibration activities. This contributes to maintaining high-quality standards, meeting customer requirements, and supporting overall organizational objectives.

Competency of the laboratory personnel

The competency of laboratory personnel is critical to ensuring accurate and reliable testing, inspection, or calibration results. Here are some key aspects to consider in assessing the competency of laboratory personnel:

1. Education and Training: Evaluate the educational background and qualifications of laboratory personnel. Look for relevant degrees, certifications, or diplomas in fields related to the laboratory’s activities. Consider the level of formal education and training received by the personnel.
2. Experience and Expertise: Assess the level of experience and expertise of laboratory personnel in conducting the specific testing, inspection, or calibration activities. Consider the number of years of experience and the range of projects or tests they have been involved in. Experience in relevant industries or specific techniques adds value to their competency.
3. Technical Knowledge: Evaluate the depth and breadth of technical knowledge possessed by laboratory personnel. They should have a solid understanding of the principles, theories, and methods related to the laboratory’s activities. Assess their knowledge of relevant standards, regulations, and industry best practices.
4. Skill Proficiency: Assess the practical skills and proficiency of laboratory personnel in performing the required tasks and techniques. Consider their ability to operate laboratory equipment, conduct measurements, perform analyses, interpret results, and troubleshoot issues. Proficiency in using relevant software or data analysis tools is also important.
5. Continuing Professional Development: Evaluate the commitment of laboratory personnel to continuous professional development. Look for evidence of participation in relevant training programs, conferences, seminars, or workshops. Consider their involvement in professional organizations or societies related to their field of expertise.
6. Quality Management Systems Knowledge: Assess the understanding and application of quality management system principles by laboratory personnel. They should be familiar with the requirements of relevant standards (e.g., ISO 17025) and follow established quality procedures and processes. Competency in document control, data integrity, and adherence to standard operating procedures is essential.
7. Communication and Collaboration Skills: Consider the communication and collaboration skills of laboratory personnel. They should be able to effectively communicate with team members, clients, and stakeholders. Strong interpersonal skills, the ability to work in teams, and effective documentation practices contribute to overall competency.
8. External Proficiency Assessments: Evaluate the participation of laboratory personnel in external proficiency testing or inter-laboratory comparison programs. These programs assess the competence of laboratories and provide an external benchmark for performance.
9. Supervision and Oversight: Assess the level of supervision and oversight provided to laboratory personnel. Effective management, mentoring, and quality control practices play a role in maintaining and improving competency levels.
10. Competency Assessment and Records: Establish processes for assessing and documenting the competency of laboratory personnel. This may involve regular performance evaluations, skills assessments, training records, and competency matrices. These records demonstrate that personnel have the necessary skills and knowledge to perform their assigned tasks competently.

By evaluating and ensuring the competency of laboratory personnel, organizations can maintain the quality and reliability of their testing, inspection, or calibration services. It helps instill confidence in the accuracy and reliability of the results, supports compliance with standards, and contributes to overall customer satisfaction.

Testing of the product

Testing of the product in an internal laboratory provides organizations with the advantage of having direct control over the testing process and ensuring that products meet specific quality standards. Here is an overview of the testing process in an internal laboratory:

1. Test Planning: Develop a comprehensive test plan that outlines the objectives, scope, and requirements for product testing. Identify the specific tests to be performed, testing methods, acceptance criteria, and any applicable industry standards or regulations.
2. Test Equipment and Facilities: Ensure that the laboratory is equipped with the necessary testing equipment and facilities to perform the required tests. Calibrate and maintain the equipment according to established procedures and schedules to ensure accuracy and reliability.
3. Test Method Development: Develop or adopt appropriate test methods for the specific product being tested. This may involve using industry-standard test methods or developing custom methods tailored to the product’s requirements.
4. Test Execution: Conduct the tests according to the defined test plan and procedures. Follow the established protocols, safety guidelines, and quality control measures during test execution. Record all relevant data and observations during the testing process.
5. Data Analysis and Interpretation: Analyze the test results using appropriate statistical or analytical methods. Compare the results against predefined acceptance criteria or performance specifications. Interpret the data to determine if the product meets the required standards or if further actions are needed.
6. Defect Identification and Reporting: Identify any defects, deviations, or non-conformities discovered during testing. Document and report the findings, including detailed descriptions of the issues, their impact on the product, and recommendations for corrective actions.
7. Test Reporting: Prepare test reports summarizing the testing process, methodology, results, and conclusions. Clearly communicate the product’s performance against specified criteria, highlighting any areas of concern or improvement. Include any relevant graphs, charts, or supporting data to enhance the report’s clarity and accuracy.
8. Test Record keeping: Maintain accurate and organized records of all testing activities, including test plans, protocols, results, and reports. This ensures traceability, facilitates future analysis or audits, and supports ongoing quality control and improvement efforts.
9. Continuous Improvement: Regularly review and evaluate the testing process to identify opportunities for improvement. Incorporate feedback from test results, customer feedback, or changes in industry standards to enhance testing methodologies and practices.
10. Collaboration and Communication: Foster collaboration and effective communication between the laboratory personnel, other departments, and stakeholders involved in the product development and quality control processes. This ensures a shared understanding of testing requirements, facilitates problem-solving, and promotes a culture of quality.

Testing products in an internal laboratory allows organizations to closely monitor and control the quality of their products. It enables timely identification and resolution of any product issues, leading to improved customer satisfaction, compliance with standards, and overall product excellence.

Capability to perform these services correctly traceable to the relevant process standard

The laboratory shall specify and implement capability to perform these services correctly, traceable to the relevant process standard when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability. The laboratory, as part of its quality management system, should specify and implement the capability to perform testing, inspection, or calibration services correctly. This capability should be traceable to relevant process standards or, in the absence of national or international standards, the organization should define and implement a methodology to verify the measurement system capability. Here are the key considerations:

1. Specification of Service Capability: The laboratory should define and document its service capabilities, including the specific tests, inspections, or calibrations it can perform accurately and reliably. This may involve specifying the range of parameters, materials, or components that the laboratory is competent to handle.
2. Traceability to Process Standards: When relevant national or international standards exist for the testing, inspection, or calibration services, the laboratory should ensure that its procedures and methods are traceable to these standards. This involves establishing a clear chain of traceability from the laboratory’s measurements to the specified standards.
3. Methodology Development: In cases where no national or international standards are available, the organization should develop and implement a methodology to verify the measurement system capability. This methodology should include procedures, techniques, and acceptance criteria to ensure accurate and reliable measurements.
4. Measurement System Analysis: The laboratory should conduct measurement system analysis to assess the capability and performance of its measurement systems. This analysis helps identify sources of measurement error, variability, and bias within the laboratory’s processes and equipment.
5. Calibration and Equipment Verification: The laboratory should calibrate and verify its measurement equipment to ensure accurate and reliable results. Calibration activities should be performed using traceable reference standards and documented in calibration certificates or records.
6. Measurement Uncertainty: The laboratory should estimate and document the measurement uncertainty associated with its test, inspection, or calibration services. This provides an indication of the range of potential measurement errors and helps ensure the reliability and accuracy of the reported results.
7. Proficiency Testing and Inter laboratory Comparisons: The laboratory should participate in proficiency testing or inter laboratory comparisons to assess its measurement system capability against other laboratories. These external assessments provide a valuable benchmark for evaluating the laboratory’s performance and identifying areas for improvement.
8. Quality Control and Assurance: The laboratory should establish robust quality control and assurance processes to monitor and control the accuracy and reliability of its testing, inspection, or calibration services. This includes implementing regular checks, audits, and reviews of procedures, methods, and equipment to ensure compliance with established standards and requirements.
9. Continuous Improvement: The laboratory should continuously strive for improvement in its measurement system capability. This involves analyzing measurement data, identifying trends or patterns, and implementing corrective and preventive actions to enhance the accuracy and reliability of measurements.
10. Documentation and Records: The laboratory should maintain comprehensive documentation and records of its measurement system capability verification activities. This includes records of equipment calibration, measurement system analysis results, proficiency testing reports, and any corrective actions taken.

By specifying and implementing the capability to perform services correctly and establishing a methodology to verify measurement system capability, laboratories can ensure the accuracy, reliability, and traceability of their testing, inspection, or calibration services. This contributes to overall quality assurance, customer satisfaction, and compliance with relevant standards and requirements.

Customer Requirement

As part of the laboratory’s quality management system, it is essential to specify and implement customer requirements effectively. This includes understanding, documenting, and reviewing customer requirements, as well as maintaining records related to these requirements. Here are the key considerations:

1. Understanding Customer Requirements: The laboratory should have a process in place to clearly understand and document customer requirements. This involves actively engaging with customers to gather information about their specific needs, expectations, and any relevant standards or specifications.
2. Documentation of Customer Requirements: The laboratory should document customer requirements in a clear and organized manner. This can be done through the use of contracts, purchase orders, specifications, or other appropriate forms of documentation. The documented customer requirements should include relevant details such as test parameters, acceptance criteria, deadlines, and any special instructions or considerations.
3. Implementation of Customer Requirements: The laboratory should ensure that customer requirements are effectively implemented in its testing, inspection, or calibration processes. This involves communicating the requirements to relevant personnel, providing necessary instructions, and allocating resources to meet customer expectations.
4. Review of Customer Requirements: Regularly review and verify customer requirements to ensure their completeness, accuracy, and alignment with the laboratory’s capabilities. This includes reviewing contracts, purchase orders, or any other relevant documents to confirm that the laboratory can fulfill the specified requirements.
5. Risk Assessment and Mitigation: Consider conducting a risk assessment of customer requirements to identify any potential risks or challenges associated with meeting those requirements. Develop appropriate mitigation measures to address identified risks and ensure successful compliance with customer expectations.
6. Records of Customer Requirements: Maintain records of customer requirements and related communications. This includes keeping copies of contracts, purchase orders, specifications, or any other documents provided by the customer. Record any changes or updates to the requirements and maintain a documented trail of customer interactions.
7. Communication with Customers: Establish effective communication channels with customers to address any queries, clarifications, or changes to requirements. Maintain open lines of communication to ensure that both parties have a clear understanding of expectations and can address any issues or concerns in a timely manner.
8. Customer Feedback and Satisfaction: Seek customer feedback on the laboratory’s performance in meeting their requirements. This feedback can be gathered through surveys, feedback forms, or other appropriate means. Act upon customer feedback to continuously improve the laboratory’s processes and enhance customer satisfaction.
9. Continuous Improvement: Continuously strive to improve the laboratory’s understanding and implementation of customer requirements. This can be achieved through regular internal reviews, lessons learned from customer interactions, and ongoing process improvement initiatives.
10. Compliance with Confidentiality: Ensure that customer requirements and related information are handled with confidentiality and in accordance with applicable privacy and data protection regulations.

By specifying and implementing customer requirements effectively and maintaining records related to these requirements, laboratories can ensure that customer expectations are met, improve customer satisfaction, and strengthen their relationships with clients. This contributes to the overall success and reputation of the laboratory.

7.1.5.3.2 External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required inspection, test or calibration, either (a) accredited to ISO/IEC 17025 or national equivalent (b) evidence that the external laboratory is acceptable to the customer. Such evidence can be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment provided it meets the requirements of internal laboratory as given above. Use of calibration services, other than by qualified (or customer accepted) laboratories, may be subject to government regulatory confirmation, if required

If you use an external laboratory, you must have evidence that it is ISO/IEC 17025 (or national equivalent) accredited or acceptable to the customer. Ensure that the external laboratory’s ISO/IEC 17025 accreditation is not out of date and its scope includes the activities you have contracted it to perform.When an organization utilizes external, commercial, or independent laboratory facilities for inspection, testing, or calibration services, it is crucial that these facilities have a defined laboratory scope. This scope should include the capability to perform the required services accurately and effectively. Here are key considerations:

1. Defined Laboratory Scope: The external laboratory should clearly define its laboratory scope, specifying the types of inspection, testing, or calibration services it can provide. This includes identifying the specific tests, measurements, or evaluations the laboratory is qualified to perform.
2. Applicable Standards and Specifications: The laboratory scope should align with applicable standards, regulations, and specifications relevant to the organization’s industry or specific requirements. It should demonstrate the laboratory’s competence and compliance with these standards.
3. Accreditation and Certifications: Evaluate the laboratory’s accreditation and certifications, such as ISO/IEC 17025, which demonstrate the laboratory’s adherence to recognized quality management system requirements. These accreditations indicate that the laboratory has undergone rigorous assessment and is competent to provide reliable services.
4. Equipment and Facilities: Ensure that the external laboratory has the necessary equipment, instruments, and facilities to support the required inspection, testing, or calibration services. The laboratory should maintain its equipment in proper working condition and calibrate it regularly.
5. Personnel Competence: Assess the competence and qualifications of the laboratory personnel who will be performing the services. The laboratory should have qualified and experienced staff who are trained in the relevant methods and techniques and possess the necessary skills to carry out the required tasks accurately.
6. Quality Management System: Evaluate the laboratory’s quality management system to ensure that it has appropriate processes and procedures in place for ensuring the quality, traceability, and reliability of the inspection, testing, or calibration services. This includes document control, records management, corrective actions, and proficiency testing.
7. Traceability and Metrological Traceability: The laboratory should have a robust system to ensure traceability of measurements and results to national or international standards. This demonstrates that the laboratory’s measurements are reliable, accurate, and comparable.
8. Reporting and Deliverables: Confirm that the external laboratory provides clear and comprehensive reports or deliverables that meet the organization’s requirements. The reports should include all relevant information, such as test results, measurements, observations, and any applicable uncertainties.
9. Audit and Monitoring: Regularly assess and monitor the performance of the external laboratory to ensure ongoing compliance with the defined laboratory scope. This may involve conducting audits, evaluating performance metrics, or reviewing customer feedback.
10. Confidentiality and Data Security: Ensure that the external laboratory has appropriate measures in place to protect the confidentiality and security of sensitive information, test results, and proprietary data shared by the organization.

By ensuring that external, commercial, or independent laboratory facilities have a defined laboratory scope that aligns with the organization’s requirements, the organization can have confidence in the capabilities and reliability of the services provided by these facilities.

Accredation to ISO/IEC 17025 or national equivalent

According to ISO/IEC 17025, the external laboratory used for inspection, testing, or calibration services by an organization should be accredited to ISO/IEC 17025 or the national equivalent standard. The accreditation should specifically include the relevant inspection, test, or calibration service in the laboratory’s scope of accreditation. Here are the key points to consider:

1. Accreditation to ISO/IEC 17025: The external laboratory should have achieved accreditation to ISO/IEC 17025, which is the international standard for the competence of testing and calibration laboratories. This accreditation demonstrates that the laboratory has been assessed and deemed competent to perform specific inspection, testing, or calibration services.
2. Inclusion of Services in Scope: The laboratory’s accreditation should specifically include the relevant inspection, test, or calibration service within its scope. The scope of accreditation defines the types of services for which the laboratory is accredited and verifies its competence in performing those services.
3. Certificate of Accreditation: The external laboratory should possess a valid certificate of accreditation issued by an accreditation body. The certificate should clearly state the scope of accreditation, including the specific inspection, test, or calibration service covered by the accreditation.
4. Mark of National Accreditation Body: The certificate of calibration or test report provided by the accredited external laboratory should include the mark or logo of the national accreditation body that has issued the accreditation. This mark serves as a symbol of the laboratory’s recognized competence and compliance with the required standards.
5. Compliance with Accreditation Requirements: The external laboratory should demonstrate ongoing compliance with the requirements of its accreditation. This involves adhering to the technical criteria, quality management system requirements, proficiency testing, and any other obligations specified by the accreditation body.
6. Traceability and Metrological Traceability: The accredited laboratory should ensure traceability of measurements to national or international standards as part of its accreditation. This verifies that the laboratory’s measurements are reliable, accurate, and traceable to recognized reference standards.
7. Review of Accreditation Status: It is essential to periodically review the accreditation status of the external laboratory to ensure it remains valid and up to date. This includes confirming that the accreditation is still active, verifying the scope of accreditation, and checking for any limitations or conditions imposed by the accreditation body.

By utilizing an accredited external laboratory, organizations can have confidence in the laboratory’s competence, reliability, and adherence to recognized standards. The inclusion of the mark of a national accreditation body on the certificate of calibration or test report further supports the credibility and traceability of the laboratory’s services.

Evidence that the external laboratory is acceptable to the customer

Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second-party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. The second-party assessment may be performed by the organization assessing the laboratory using a customer-approved method of assessment. This assessment provides an independent evaluation of the laboratory’s compliance with ISO/IEC 17025 or the national equivalent standard. Here’s how it can be accomplished:

1. Selection of the Second Party: The customer selects a qualified and independent second party to assess the external laboratory. This second party could be the customer’s internal quality team, a third-party auditing organization, or an industry expert familiar with laboratory accreditation and compliance.
2. Assessment Scope and Objectives: Define the scope and objectives of the second-party assessment in collaboration with the customer and the laboratory. This includes identifying the specific areas to be evaluated, such as management systems, technical competence, equipment calibration, documentation, and adherence to relevant standards.
3. Assessment Plan: Develop an assessment plan that outlines the assessment process, timeline, criteria for evaluation, and required documentation. This plan should be agreed upon by all parties involved, including the customer, the laboratory, and the second party conducting the assessment.
4. On-Site Assessment: Conduct an on-site assessment of the external laboratory. The second party assesses the laboratory’s compliance with ISO/IEC 17025 or the national equivalent standard by reviewing relevant documentation, interviewing personnel, observing processes, and verifying adherence to quality management procedures.
5. Compliance Evaluation: Evaluate the laboratory’s compliance with the standard’s requirements, focusing on key aspects such as technical competence, personnel qualifications, equipment calibration, quality control, documentation control, and traceability of measurements.
6. Findings and Recommendations: Document the findings of the assessment, including any areas of non-compliance or opportunities for improvement. Provide recommendations to address identified gaps or deficiencies, along with suggestions for enhancing the laboratory’s compliance with the standard.
7. Customer Approval: The customer reviews the assessment findings and recommendations. Once satisfied with the assessment results, the customer provides formal approval, acknowledging that the laboratory meets the intent of ISO/IEC 17025 or the national equivalent standard.
8. Ongoing Monitoring: Periodically monitor the laboratory’s compliance with the standard to ensure continued conformance and quality performance. This can include periodic assessments, audits, or surveillance visits to verify that the laboratory maintains its compliance.
9. Communication and Reporting: Communicate the results of the second-party assessment to all relevant stakeholders. This includes sharing the assessment report, findings, recommendations, and the customer’s approval of the laboratory’s compliance with the standard.
10. Continuous Improvement: Encourage the laboratory to take corrective actions and implement the recommended improvements identified during the assessment. Foster a culture of continuous improvement to enhance the laboratory’s performance and maintain customer confidence.

By conducting a customer-approved second-party assessment, the external laboratory can provide additional assurance to the customer that it meets the intent of ISO/IEC 17025 or the national equivalent standard. This assessment serves as an independent validation of the laboratory’s compliance and strengthens the customer’s confidence in the laboratory’s capabilities and reliability.

Calibration service Performed by Equipment Manufacturer

In situations where a qualified laboratory is not available for a particular piece of equipment, calibration services may be performed by the equipment manufacturer. This can be a viable option to ensure that the equipment remains calibrated and accurate. Here are some key points to consider:

1. Manufacturer’s Expertise: The equipment manufacturer is typically the entity with in-depth knowledge of the equipment’s design, specifications, and calibration requirements. They understand the intricacies of the equipment and have access to the necessary technical documentation and resources.
2. Calibration Procedures: The manufacturer will have established calibration procedures specific to their equipment. These procedures are designed to ensure accurate and reliable calibration based on the equipment’s intended use and performance specifications.
3. OEM Calibration Standards: The manufacturer is likely to have access to original equipment manufacturer (OEM) calibration standards, which are specifically developed for their equipment. These standards provide traceability to recognized measurement standards and help maintain the accuracy and reliability of the equipment’s measurements.
4. Equipment-Specific Considerations: Certain equipment may have unique calibration requirements or specialized calibration methods that are best addressed by the manufacturer. This can be due to proprietary technologies, complex functionality, or specific calibration techniques that require specialized knowledge and expertise.
5. Equipment Warranty: In some cases, the manufacturer’s calibration services may be part of the equipment’s warranty or support agreement. Availing calibration services from the manufacturer can ensure compliance with warranty terms and conditions.
6. Equipment Updates and Recalibration: The manufacturer can also provide updates or modifications to the equipment’s firmware, software, or hardware components during the calibration process. This helps maintain the equipment’s performance and accuracy in line with the latest advancements and specifications.
7. Technical Support: Engaging with the manufacturer for calibration services can provide access to technical support and expertise in case any issues or questions arise during the calibration process. This can be particularly valuable when dealing with complex equipment or intricate calibration requirements.
8. Equipment-Specific Certifications: Some equipment may require specific certifications or approvals that can only be provided by the manufacturer. Availing calibration services from the manufacturer ensures compliance with these equipment-specific certifications, ensuring regulatory or industry compliance.
9. Documentation and Records: The manufacturer’s calibration services typically provide comprehensive documentation and calibration certificates specific to the equipment. These records serve as evidence of calibration and can be important for quality control, regulatory compliance, and audits.
10. Availability and Cost: It is important to consider the availability and cost of calibration services provided by the manufacturer. In some cases, the manufacturer may have limitations on their calibration services due to capacity or geographic constraints. Additionally, the cost of calibration services provided by the manufacturer should be evaluated in comparison to other available options.

While availing calibration services from the equipment manufacturer can be a practical solution in the absence of a qualified laboratory, it is important to ensure that the manufacturer has the necessary expertise, resources, and calibration capabilities to perform the required services accurately and reliably.