For calibration laboratories, ISO/IEC 17025 accreditation is a demonstration of their technical competence and capability to produce valid calibration results.
- What is ISO/IEC 17025:2017 Standard?
- What is Accreditation?
- Why ISO/IEC 17025 is Important for Calibration Laboratories?
- Key Requirements of ISO/IEC 17025:2017 Standards
- Clause 4 General Requirements:
- Clause 5 Structural Requirements:
- CLAUSE 6 RESOURCE REQUIREMENTS:
- Clause 7 Process Requirements
- CLAUSE 7.1 REVIEW OF REQUEST, TENDER & CONTRACTS:
- CLAUSE 7.2 SELECTION, VERIFICATION, AND VALIDATION OF METHODS:
- CLAUSE 7.3 SAMPLING
- CLAUSE 7.4 HANDLING OF TEST AND CALIBRATION ITEMS
- CLAUSE 7.5 TECHNICAL RECORDS:
- CLAUSE 7.6 EVALUATION OF MEASUREMENT UNCERTAINTY
- CLAUSE 7.7 ENSURING THE VALIDITY OF RESULTS
- CLAUSE 7.8 REPORTING OF RESULTS
- CLAUSE 7.9 COMPLAINTS
- CLAUSE 7.10 NON-CONFORMING WORK:
- CLAUSE 7.11 CONTROL OF DATA & INFORMATION MANAGEMENT
- CLAUSE 8 MANAGEMENT SYSTEM REQUIREMENTS
- LIST OF REQUIRED DOCUMENTS AND RECORDS
- Roadmap for Calibration Laboratories to Get ISO/IEC 17025 Accreditation
- CONCLUSION
- Frequently Asked Questions (FAQs)
What is ISO/IEC 17025:2017 Standard?
The ISO/IEC 17025 standard lists the requirements for calibration laboratories to prove their competence and ability to produce valid results. Introduced for the first time in 1999, the 17025 standard has evolved to incorporate modern industry and laboratory practices. The latest revision of the standard was introduced in 2017.
What is Accreditation?
Accreditation against ISO/IEC 17025 is the official recognition that a laboratory has the competence, management systems, and resources to deliver valid and reliable calibration results on a consistent basis. To accomplish this accreditation, an external body, such as UKAS, PJLA, or EIAC, conducts a detailed assessment of the laboratory’s procedures, staff competence, equipment, and laboratory environment. This independent confirmation gives assurance to customers that laboratory operations are aligned with internationally accepted standards and practices.
Why ISO/IEC 17025 is Important for Calibration Laboratories?
ISO/IEC 17025 accreditation means that the calibration results produced by the laboratory are accepted worldwide without the requirement of repeated testing across borders. It assures customers and regulatory bodies that the laboratory meets globally accepted standards and is periodically assessed by an independent body. Accreditation provides a calibration laboratory with a clear advantage over its competitors. For example, a calibration lab providing services to an aerospace company fails to secure its contract because its non-accredited calibrations were not accepted by the company’s clients in Europe.
If an organization has an internal calibration laboratory catering to its calibration requirements, ISO 17025 accreditation of it is equally important for lifting customer confidence in its products.
Key Requirements of ISO/IEC 17025:2017 Standards
ISO/IEC 17025 was updated in 2017 to align with the best industry practices and the latest quality management system principles. Below is a breakdown of the major requirements that laboratories need to understand and implement in order to maintain compliance.
Clause 4 General Requirements:
Clause 4.1 Impartiality:
KEY REQUIREMENTS
- Ensure impartiality in operations through demonstrated actions.
- Identify all risks related to impartiality in your risk management plan.
HOW TO IMPLEMENT
The laboratory shall have:
- An Impartiality Policy.
- An impartiality undertaking signed by all employees.
- Risks related to impartiality identified in the Risk Management Plan.
Clause 4.2 Confidentiality:
KEY REQUIREMENTS
- Ensure confidentiality of customer information through practical measures.
HOW TO IMPLEMENT
The laboratory shall have:
- A legally enforceable confidentiality undertaking signed by all employees, including support functions such as marketing and sales.
- A clause in the contract with the customer binding the laboratory to ensure confidentiality of customer information.
Clause 5 Structural Requirements:
KEY REQUIREMENTS
- The laboratory’s legal status, management/organizational structure, and job descriptions shall be defined and documented.
HOW TO IMPLEMENT
The laboratory shall have:
- An organogram.
- Job descriptions of all staff.
CLAUSE 6 RESOURCE REQUIREMENTS:
CLAUSE 6.2 PERSONNEL:
KEY REQUIREMENTS
- Define skills and competencies required to perform each laboratory function.
- Hire people according to a defined criterion.
- Document their competency level.
- Train them to increase their competency level.
- Supervise their work.
- Authorize them to perform laboratory activities once they have achieved the desired level of competence.
- Monitor their competence on an ongoing basis.
- Set goals to improve their competence on an ongoing basis.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- Procedure for Personnel Management covering all requirements of 6.2.5.
- Competence Matrix.
- Authorization Matrix.
- Annual Training Plan.
- Competence gap assessment and Training Needs Analysis.
- Training Attendance Sheet.
- Competence Evaluation Sheet.
CLAUSE 6.3 ENVIRONMENT:
KEY REQUIREMENTS
- Suitable environmental conditions and facilities for performing calibration of equipment.
- These conditions are derived from international standards or published procedures and shall be documented.
- Control, record, and monitor these conditions.
- Ensure compliance while performing on-site calibrations as well.
HOW TO IMPLEMENT
Create the following form(s)/record(s):
- Environment Record Form.
- Environment Control Charts.
CLAUSE 6.4 EQUIPMENT:
KEY REQUIREMENTS
- Appropriate equipment to perform laboratory activities.
- Procedure for transportation, handling, storage, and maintenance of laboratory equipment.
- Intermediate checks to verify the performance of laboratory equipment.
- The accuracy and functional specifications of the equipment are intact before it is used to perform calibration or measurements.
- Calibration program for calibration of equipment at regular intervals.
- Risk assessment for defining calibration intervals of its own equipment.
- Correction factors to be applied in measurements where applicable.
- Regular maintenance of laboratory equipment.
- Measures to prevent adjustments and tampering with equipment.
HOW TO IMPLEMENT:
The laboratory shall create and maintain the following documents and records:
- Procedure for transportation, handling, storage, and maintenance of laboratory equipment.
- Master list of equipment with complete information required in 6.4.13.
- Calibration program for laboratory equipment.
- Calibration records/certificates of the equipment.
- Calibration tags.
- Seal tags pasted on equipment to prevent unintentional adjustment in equipment.
- Intermediate check plan.
- Intermediate check data sheet/graphs.
- Maintenance plan.
- Maintenance sheet.
CLAUSE 6.5 METROLOGICAL TRACEABILITY:
KEY REQUIREMENTS
- Laboratory equipment is calibrated by an accredited laboratory.
- Unbroken calibration traceability chain.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- A traceability chart (optional but recommended).
- Calibration certificates of the laboratory equipment.
CLAUSE 6.6 EXTERNALLY PROVIDED PRODUCTS & SERVICES
KEY REQUIREMENTS
- Ensure quality and suitability of products and services being purchased.
- Define complete specifications and requirements for items or services to be purchased.
- Criteria for selection of suppliers.
- Periodic evaluation of suppliers.
- Take necessary action based on evaluation results.
- Inspection/verification of procured items before use for quality assurance.
- Communicate the following to the supplier:
- Specifications of the required product or service.
- Acceptance criteria.
- Requirements of personnel competence (if required), such as in the case of training services.
- Activities at supplier premises (if required), such as pre-shipment inspection.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- Procedure for purchase of externally provided products and services.
- List of approved suppliers.
- Supplier evaluation form.
Clause 7 Process Requirements
CLAUSE 7.1 REVIEW OF REQUEST, TENDER & CONTRACTS:
KEY REQUIREMENTS
- Customer requirements are clear, documented, and understood.
- Capability to meet these requirements.
- Seek customer consent for selection of calibration method.
- Inform the customer if the method suggested by them is not suitable.
- If a statement of conformity is required by the customer, then:
- Define specification limits.
- Select a suitable decision rule.
- Seek customer consent regarding the decision rule.
- Any differences regarding the contract to be settled before the start of work.
- Any deviation from the agreed terms or amendments in the contract to be communicated to the customer.
- Reasonable access to the customer shall be provided to monitor the laboratory’s work specific to the customer request.
- Record of progress review on customers’ work order and discussion with customers regarding laboratory activities related to their work order shall be documented.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- Procedure for review of requests, tenders, and contracts.
- Customer Contract Form.
- Customer Request Review.
- Contract Review Form.
CLAUSE 7.2 SELECTION, VERIFICATION, AND VALIDATION OF METHODS:
KEY REQUIREMENTS
For Standard Calibration Method
- Selection of appropriate, latest calibration methods.
- Verify standard methods before implementation.
- You can use techniques such as Type 1 gauge study or Gauge R & R study for method verification.
- Verification shall be repeated if a new revision of the method is published.
For Non-Standard or Laboratory-Developed Method
- Validation shall be planned and performed by competent and qualified personnel.
- Validate non-standard or laboratory-developed methods before use.
- Scope of validation shall be based on the performance output, fit for intended use of the method, and customer requirements.
- If any changes in the validated method are made and these changes affect the results of previous validations, then the method must be re-validated.
- Records of validation, i.e., procedure used, specifications of requirements, performance characteristics, results of validation, and statement of validity of method for its intended use.
- Risk-based approach (such as PDCA—plan, do, check, and act) for method selection and extent of validation.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- SOP for method verification and validation.
- Method Development and Validation Plan.
- Method Validation Sheet and graphs.
- Standard Method Verification Sheet and graphs.
- Calibration Methods/Procedures.
CLAUSE 7.3 SAMPLING
Sampling is generally not applicable to calibration laboratories and is therefore not discussed here.
CLAUSE 7.4 HANDLING OF TEST AND CALIBRATION ITEMS
KEY REQUIREMENTS
- Ensure the integrity of items received from customers for calibration.
- Safe handling of customer equipment as per provided instructions.
- Unique identification of the customer equipment, such as a calibration ID.
- Any anomaly found in the equipment at the time of receiving to be recorded.
- Special storage conditions (if any) shall be maintained, recorded, and monitored.
- If equipment is not fit for calibration, the customer shall be consulted for further course of action, and this consultation shall be recorded.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Procedure for handling of test and calibration items.
- Calibration items register.
- Equipment Receiving and Delivery Note.
CLAUSE 7.5 TECHNICAL RECORDS:
KEY REQUIREMENTS
- Maintain necessary data and information related to laboratory records.
- The said data shall enable repetition of laboratory activity under the same conditions.
- Identity of staff performing each activity.
- Amendments in records are traceable to the original ones.
- Original and amended data shall be retained.
- Amendments are clearly identifiable.
- Identity of the person responsible for the amendment.
HOW TO IMPLEMENT
- Ensure that the above-mentioned requirements are met while generating any type of laboratory record, such as intermediate check records, environmental records, etc.
CLAUSE 7.6 EVALUATION OF MEASUREMENT UNCERTAINTY
Measurement uncertainty represents the doubt regarding the result of a measurement. The standard requires the laboratory to estimate the scale or range of this doubt with a certain level of confidence, e.g., 95% confidence.
KEY REQUIREMENTS
- The lab shall evaluate measurement uncertainty for all measurements (customer’s or internal).
- Identify all significant factors contributing towards uncertainty in measurement.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Develop uncertainty budgets for all types of measurements.
- The standard does not require a procedure for measurement uncertainty. It is recommended to create an SOP on measurement uncertainty estimation for each type of calibration. It can also be made part of calibration procedures.
CLAUSE 7.7 ENSURING THE VALIDITY OF RESULTS
KEY REQUIREMENTS:
- Monitor the validity of calibration results.
- Use techniques such as inter-laboratory comparison, proficiency testing, replicate calibration, recalibration, quality control checks, intermediate checks, etc.
- Detect and observe trends from data of these monitoring activities.
- Monitoring shall be periodic, planned, and reviewed.
- Participate in inter-laboratory comparison and proficiency testing at planned intervals (mandatory requirement of ILAC and accreditation bodies).
- Data from these activities to be used for improvement, and corrective actions to be taken where required.
HOW TO IMPLEMENT:
Laboratories should implement as many monitoring activities as possible. They shall create and maintain the following documents and records:
- Procedure for Quality Assurance.
- Quality Assurance Plan.
- Record for each QA activity, such as intermediate checks, PT/ILC, recalibration, etc.
- Participate in an ILC/PT program in compliance with the policy of ILAC and your accreditation body. Keep PT reports in your records.
- Analyze the data collected from monitoring activities and identify opportunities for improvement.
CLAUSE 7.8 REPORTING OF RESULTS
KEY REQUIREMENTS
- Verify calibration results before issuance.
- Ensure correctness and clarity in the results.
- Calibration certificates shall fulfill all common requirements mentioned in clause 7.8.2.
- Calibration certificates shall include explicit requirements related to calibration labs, such as:
- Measurement uncertainty reported in the unit of measured quantity.
- Environmental conditions influencing the measurements.
- Statement of traceability.
- If an adjustment has been carried out, state results before and after adjustment.
- Statement of conformity if agreed with the customer.
- No mention of calibration interval unless agreed with the customer.
- Document decision rule for statement of conformity.
- A decision rule is selected based on the risk assessment for false acceptance and rejection.
- Decision rule and statement of conformity to be mentioned on the calibration certificate.
- Opinions and interpretations (if any) in the calibration certificate to be given by authorized persons, clearly marked on the certificate, and the basis to be documented.
- Amendments (if required) in certificates shall be clearly identified. The reason to be recorded.
- If an amendment is to be made in an already issued certificate, it should be in the form of a separate document traceable to the original certificate with an explicit statement clarifying its type as an amendment to the original.
- If a completely new certificate is to be issued, add a reference to the original one.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Template of calibration certificate conforming to the requirements of clauses 7.8.2 and 7.8.4.
- SOP related to the statement of conformity and decision rule.
- SOP for amendments to calibration certificates.
CLAUSE 7.9 COMPLAINTS
KEY REQUIREMENTS
- Documented process for complaint handling.
- Each complaint received from the customer to be recorded.
- It should be validated before proceeding further.
- If the complaint is genuine, it should be investigated and resolved by taking appropriate action.
- The customer shall be kept in the loop regarding the progress of the complaint and be informed about the outcome.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Procedure or process flow for complaint handling.
- Log register for complaints.
- Complaint form for the customer to file a complaint (optional but recommended).
CLAUSE 7.10 NON-CONFORMING WORK:
KEY REQUIREMENTS
- Procedure for handling any deviations in laboratory activities from its own procedures and requirements of this standard, defining the following:
- Responsibilities and authorities for handling non-conforming work.
- Risk-based decision-making, such as suspension of calibrations, repetition of calibrations.
- Evaluation of the significance of reported nonconformance.
- Acceptability of non-conforming work.
- Recall of calibrated items if required.
- Actions related to non-conforming work to be recorded.
- Root cause analysis and corrective action to be taken if there is a probability of recurrence of non-conforming work.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- Procedure for control of non-conforming work.
- Non-Conformance Form.
CLAUSE 7.11 CONTROL OF DATA & INFORMATION MANAGEMENT
KEY REQUIREMENTS
- All relevant data must be accessible to the laboratory.
- Calibration Management System or Software must be validated before implementation.
- Calibration management software must be protected from unauthorized access, data tampering, and loss.
- If the calibration management system is managed by an external service provider, then the service provider must comply with the requirements of the standard.
HOW TO IMPLEMENT
- Create a work instruction or SOP for data handling and information management. This can be covered in the Quality Manual or as a separate document.
CLAUSE 8 MANAGEMENT SYSTEM REQUIREMENTS
CLAUSE 8.1 OPTIONS
The standard gives the laboratories the following options:
- Option A: The laboratory management system shall fulfill the requirements of this standard from clauses 8.2 to 8.9.
- Option B: If the laboratory management system is certified to ISO 9001 and this system can support the implementation of the requirements of ISO 17025, then the laboratory can use this already implemented management system.
Option A is a widely used approach by laboratories, and in the coming parts of this article, we have covered the requirements for Option A.
CLAUSE 8.2 MANAGEMENT SYSTEM DOCUMENTATION
KEY REQUIREMENTS
- Develop laboratory policies and objectives.
- The policies and objectives shall complement impartiality, technical proficiency of the lab, and stable operations.
- Commitment from top management for the implementation of the management system and its continual improvement.
- All documents and records generated in compliance with this standard to be made part of the management system.
- All documentation shall be accessible to laboratory staff.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Quality Manual.
- Quality and Impartiality Policies. Make them part of your Quality Manual.
- Commitment from top management for the implementation of the management system to be made part of the Quality Policy.
CLAUSE 8.3 CONTROL OF MANAGEMENT SYSTEM DOCUMENTATION
KEY REQUIREMENTS
- Necessary documents to conform to the requirements of the standard.
- Documents shall be:
- Distinctively identified.
- Approved prior to issuance.
- Reviewed and updated periodically.
- Changes in documents are traceable.
- Obsolete documents to be prevented from unintentional use, and if retained for any purpose, they shall be identified.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Procedure for document control. The procedure shall cover:
- Document identification.
- Approval (authority to be defined).
- Document review mechanism and frequency.
- Document change mechanism.
- Handling of obsolete documents, such as:
- Unique marking.
- Retention period to be defined.
- Master list of documents.
- Master list of external origin documents (manuals, guides, and standards).
- Master list of records.
- Form for document issue, change, and distribution.
- Register for obsolete documents.
CLAUSE 8.4 CONTROL OF RECORDS
KEY REQUIREMENTS
- Build all necessary records required by the ISO 17025 standard.
- Implement a mechanism for records:
- Identification.
- Storage.
- Protection.
- Retrieval.
- Retention.
- Disposal.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Procedure for control of records.
- Master list of records.
CLAUSE 8.5 RISK AND OPPORTUNITIES:
KEY REQUIREMENTS
- Risks and opportunities linked with laboratory operations to be identified.
- Action plan to address these risks and opportunities.
- Implementation of actions and review of their effectiveness.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- SOP for risk and opportunities management.
- Risk Register.
- Risk and opportunity assessment sheet.
CLAUSE 8.6 IMPROVEMENT
KEY REQUIREMENTS
- Identify prospects for improvement in your system. Get help from audits, records, management reviews, and data analysis.
- Take customer feedback.
HOW TO IMPLEMENT
- Customer Feedback Form.
CLAUSE 8.7 CORRECTIVE ACTIONS
KEY REQUIREMENTS
- Identify any non-conformities in your system.
- Take measures for control and correction.
- Do root cause analysis using scientific tools and take corrective action to avoid recurrence.
- Update your risk management plan if required.
- Maintain records of non-conformities and corrective actions taken.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- RCA/Corrective Action Sheet.
- Corrective Action Form.
CLAUSE 8.8 INTERNAL AUDIT
KEY REQUIREMENTS
- Internal audits to be arranged at scheduled intervals to maintain the integrity of your system.
- Create and implement an audit program.
- Establish audit scope.
- Report the findings to management.
- Take corrective actions against non-conformities.
- Review the effectiveness of actions taken.
- Ensure the competence of internal auditors.
HOW TO IMPLEMENT
The laboratory shall create and maintain the following documents and records:
- Internal Audit SOP (not mandatory but recommended).
- Internal Audit Program (a long-term plan, e.g., for 3 years, and can be made part of your QA plan).
- Internal Audit Plan (audit date, auditors’ names, and audit scope).
- Internal Audit Report.
- Competence records of internal auditors (trainings, work experience, etc.).
- Non-conformance form.
CLAUSE 8.9 MANAGEMENT REVIEW
KEY REQUIREMENTS
- Management review meetings to be held at scheduled intervals.
- Requirements mentioned in clause 8.9.2 shall be on the agenda of the meeting.
- Proceedings of the meeting to be recorded, particularly decisions related to the efficiency of the management system and any required changes, improvements in operations, and providing the necessary resources.
- All stakeholders, including top management and people from support functions (marketing, finance, and logistics teams), should be part of the meeting.
HOW TO IMPLEMENT
The laboratory shall create the following documents and records:
- Agenda and plan for the management review meeting (can be issued via email or letter to all stakeholders).
- Conduct meetings as per the plan.
- Minutes of Meeting mentioning decisions taken and responsibilities of individuals to implement these decisions.
LIST OF REQUIRED DOCUMENTS AND RECORDS
Based on the above discussion, the following is a complete list of documents, procedures, SOPs, and records required by a calibration laboratory to meet the requirements of the standard. A few key points to note are:
- A Quality Manual is not mandatory, but having it makes your work much easier.
- We have referred to SOPs as those documents that are not mandatory requirements of the standard but are recommended for effective implementation of the standard. These SOPs can be created as separate documents or incorporated into the Quality Manual.
| Clause | Required Documents | Required Records |
| 4.1 Impartiality | Impartiality Policy Impartiality Undertaking | – |
| 4.2 Confidentiality | – | Confidentiality Undertaking |
| 5 Structural Requirements | Organizational Structure Chart Management Structure Chart Job Descriptions | Notification of Functional Appointments |
| 6.2 Personnel | Procedure for Personnel Management | Competence Matrix Authorization Matrix Annual Training Plan Competence Gap Assessment and Training Needs Analysis Training Attendance Sheet Competence Evaluation Sheet |
| 6.3 Facilities & Environment | Environmental Conditions defined in calibration procedures | Environment Record Form Environment Control Charts |
| 6.4 Equipment | Procedure for transportation, handling, storage, and maintenance of laboratory equipment | Master List of Equipment with complete information required in 6.4.13 Calibration Program for laboratory equipment Calibration Records of the equipment Calibration tags Seal tags pasted on equipment to prevent unintentional adjustment in equipment Intermediate check plan Intermediate check data sheet/graphs Maintenance Plan Maintenance sheet |
| 6.5 Metrological Traceability | Traceability chart | Calibration Certificates of laboratory equipment |
| 6.6 Externally Provided Products & Services | Procedure for purchase of externally provided products and services List of approved suppliers Supplier evaluation form | – |
| 7.1 Review of Requests, Tenders, Contracts | Procedure for review of requests, tenders, and contracts | Customer Contract Form Customer Request Review Contract Review Form |
| 7.2 Selection, Verification, Validation of Methods | SOP for method verification and validation Calibration Methods/Procedures | Method Development and Validation Plan Method Validation Sheet and Graphs Method Verification Sheet and Graphs |
| 7.4 Handling of Test/Calibration Items | Procedure for handling of test and calibration items | Calibration items register Equipment Receiving/Delivery Note |
| 7.5 Technical Records | SOP for Technical Records | Raw data sheet, uncertainty budget, calculations, reports |
| 7.6 Evaluation of Measurement Uncertainty | SOP for Estimation of Uncertainty of Measurement | Uncertainty budgets for all types of measurements |
| 7.7 Ensuring Validity of Results | Procedure for Quality Assurance | Quality Assurance Plan Records of each QA activity PT Report |
| 7.8 Reporting of Results | – | Calibration Certificate |
| 7.9 Complaints | Procedure for complaint handling | Complaint log register Complaint form |
| 7.10 Nonconforming Work | Procedure for control of non-conformances and corrective actions | NCR Form |
| 7.11 Control of Data & Information Management | Policy for control of data and information management covered in Quality Manual | – |
| 8.2 Management System Documentation | Quality Manual Quality and Impartiality Policy Quality Objectives | – |
| 8.3 Control of Management System Documents | Procedure for control of documents Master list of documents Master list of external origin documents Master list of records | Form for document issue, change, and distribution Register for obsolete documents |
| 8.4 Control of Records | Procedure for control of records Master list of records | – |
| 8.5 Actions to Address Risks & Opportunities | SOP for risk management | Risk Register Risk assessment sheet |
| 8.6 Improvement | – | Customer feedback form Data Analysis such as analysis of NCs in past audit reports |
| 8.7 Corrective Actions | Procedure for control of non-conformances and corrective actions | RCA/Corrective Action Sheet |
| 8.8 Internal Audits | Internal Audit Procedure | Internal audit program Internal audit report Competence records of internal auditors (trainings, work experience, etc.) NCR form |
| 8.9 Management Reviews | SOP for management review | Agenda and plan for management review meeting Minutes of Meeting |
Roadmap for Calibration Laboratories to Get ISO/IEC 17025 Accreditation
A step-by-step roadmap for calibration laboratories to get ISO 17025 accreditation is mentioned below:
- Get approval from top management.
- Arrange training for the staff regarding awareness of the standard.
- Create a project plan.
- Identify the accreditation scope, i.e., on which calibration parameters (length, temperature, pressure, etc.) you want to get accredited.
- Write Quality Manual and Job Descriptions.
- Identify risks and opportunities in your system and make a risk management plan.
- Define Quality Objectives.
- Define processes and procedures.
- Start implementing the processes and procedures.
- Maintain all records.
- Participate in an Inter-Laboratory Comparison or Proficiency Testing Program.
- Select an accreditation body.
- Conduct an internal audit.
- Conduct a management review meeting.
- Apply for accreditation.
CONCLUSION
Accreditation to the ISO 17025 standard is fundamental for calibration laboratories to ensure the validity of their calibrations and enhance customer confidence. It provides them with a clear competitive advantage, resulting in improved operational efficiency and increased profits. Laboratories desiring this accreditation shall demonstrate top management commitment, personnel competence, training, and a robust laboratory management system.

