Introduction: Consultant Engagement and Initial Training   (Duration: 0.5 Month)

Introductory Tasks

1.1 Initial Consultation and Project Kick-off

Task: Schedule Initial Consultation

• Description: Arrange a meeting with the lead implementer and the consultant to discuss the project scope, objectives, timelines, and responsibilities.
• Documentation: Project plan and meeting agenda.
• Meeting: Initial consultation meeting.

Task: Conduct Gap Analysis

• Description: Perform a detailed gap analysis to identify the current state of the laboratory and areas needing improvement to meet ISO/IEC 17025 requirements.
• Documentation: Gap analysis report.
• Meeting: Meeting with the consultant to review gap analysis findings.

1.2 Training

Task: Develop Training Plan

• Description: Create a comprehensive training plan covering all aspects of ISO/IEC 17025 implementation.
• Documentation: Training plan document.
• Meeting: Meeting with the consultant to review and finalize the training plan.

Task: Conduct Staff Training

• Description: Provide training sessions for all relevant staff on ISO/IEC 17025 requirements and the implementation process.
• Documentation: Training materials and attendance records.
• Meeting: Training sessions with the consultant.

Section 1: General Requirements   (Duration: 0.5 Month)

4.1 Impartiality

Task: Develop an Impartiality Policy

• Description: Create and document a policy ensuring that all laboratory activities are conducted impartially.
• Documentation: Impartiality policy document.
• Meeting: Initial meeting with the consultant to discuss and draft the policy.

Task: Conduct Risk Assessment for Impartiality

• Description: Identify and assess risks to impartiality in laboratory activities, and document mitigation strategies.
• Documentation: Risk assessment report.
• Meeting: Periodic meetings with the consultant to review identified risks and mitigation strategies.

Task: Implement Mitigation Measures

• Description: Apply and document measures to eliminate or minimize identified risks to impartiality.
• Documentation: Risk mitigation action plan.
• Meeting: Follow-up meeting with the consultant to evaluate the effectiveness of mitigation strategies.

4.2 Confidentiality

Task: Draft Confidentiality Agreements

• Description: Create legally binding confidentiality agreements for personnel and external parties.
• Documentation: Confidentiality agreements.
• Meeting: Consult with legal and compliance experts to finalize agreements.

Task: Establish Confidentiality Procedures

• Description: Develop procedures to manage information confidentiality in laboratory activities.
• Documentation: Confidentiality management procedures.
• Meeting: Training session with staff and consultant to ensure understanding and compliance.

Section 2: Structural Requirements (Duration: 0.5 Month)

5.1 Legal Entity

Task: Verify Legal Entity Status

• Description: Ensure the laboratory is a legal entity or part of a legal entity, and document the status.
• Documentation: Legal entity documentation (e.g., registration certificates).
• Meeting: Initial meeting with legal advisors to review and confirm the legal structure.

5.2 Management Responsibility

Task: Define Management Responsibilities

• Description: Identify and document the responsibilities of management personnel for laboratory activities.
• Documentation: Organizational chart and management responsibilities document.
• Meeting: Meeting with senior management to confirm responsibilities and authority.

5.3 Scope of Laboratory Activities

Task: Define Scope of Activities

• Description: Document the range of laboratory activities that conform to ISO/IEC 17025 requirements.
• Documentation: Scope of activities document.
• Meeting: Consultation with the consultant to review and validate the defined scope.

5.4 Organizational Structure

Task: Establish Organizational Structure

• Description: Define and document the organizational structure, including relationships between management, technical operations, and support services.
• Documentation: Organizational structure document.
• Meeting: Meeting with all relevant departments to communicate and validate the structure.

5.5 Resource Allocation

Task: Allocate Necessary Resources

• Description: Ensure the allocation of necessary resources (personnel, equipment, facilities) to laboratory activities.
• Documentation: Resource allocation plan.
• Meeting: Periodic meetings with the consultant to assess resource needs and adjustments.

Task: Monitor and Review Resources

• Description: Regularly monitor and review resource allocation to ensure ongoing compliance and effectiveness.
• Documentation: Resource review reports.
• Meeting: Quarterly review meetings with the consultant to discuss resource adjustments and improvements.

Section 3: Resource Requirements (Duration: 1.5 Months)

6.1 General

Task: Review and Identify Resource Requirements

• Description: Assess and document all necessary resources including personnel, facilities, equipment, systems, and support services.
• Documentation: Resource requirement document.
• Meeting: Schedule a meeting with the consultant to verify and validate resource requirements.

6.2 Personnel

Task: Define Competence Requirements

• Description: Document the competence requirements for each function influencing laboratory activities, including education, qualification, training, technical knowledge, skills, and experience.
• Documentation: Competence requirements matrix.
• Meeting: Initial meeting with HR and the consultant to discuss competence criteria.

Task: Develop Training Programs

• Description: Develop and implement training programs to ensure personnel are competent to perform assigned tasks.
• Documentation: Training program documents.
• Meeting: Training session with the consultant to guide staff through the new training programs.

Task: Authorize Personnel

• Description: Formally authorize personnel to perform specific laboratory activities.
• Documentation: Authorization records.
• Meeting: Internal review meeting to approve personnel authorizations.

6.3 Facilities and Environmental Conditions

Task: Assess Facility Requirements

• Description: Evaluate and document the facility and environmental conditions necessary for laboratory activities.
• Documentation: Facility assessment report.
• Meeting: Consultation with the consultant to review facility requirements.

Task: Monitor Environmental Conditions

• Description: Implement a system to monitor, control, and record environmental conditions.
• Documentation: Environmental monitoring logs.
• Meeting: Regular review meetings to ensure compliance with environmental control measures.

6.4 Equipment

Task: Inventory and Assess Equipment

• Description: Create an inventory of all equipment and assess its suitability for laboratory activities.
• Documentation: Equipment inventory list.
• Meeting: Review meeting with the consultant to verify equipment suitability.

Task: Implement Equipment Maintenance Procedures

• Description: Develop and document procedures for handling, transport, storage, use, and planned maintenance of equipment.
• Documentation: Equipment maintenance procedures.
• Meeting: Training session with the consultant to ensure all personnel are aware of equipment handling procedures.

6.5 Metrological Traceability

Task: Establish Calibration Program

• Description: Develop a calibration program to ensure the metrological traceability of measurement results.
• Documentation: Calibration program document.
• Meeting: Periodic review meetings with the consultant to assess the effectiveness of the calibration program.

6.6 Externally Provided Products and Services

Task: Evaluate Suppliers

• Description: Assess and approve suppliers of externally provided products and services to ensure they meet laboratory requirements.
• Documentation: Approved supplier list.
• Meeting: Initial and periodic meetings with the consultant to review supplier evaluations.

Section 4: Process Requirements (Duration: 2 Months)

7.1 Review of Requests, Tenders, and Contracts

Task: Develop Review Procedures

• Description: Create procedures to review requests, tenders, and contracts to ensure the laboratory has the capability to meet requirements.
• Documentation: Review procedure document.
• Meeting: Training session with staff to ensure understanding of review procedures.

7.2 Selection, Verification, and Validation of Methods

Task: Document Method Selection Procedures

• Description: Establish procedures for the selection and verification of methods used in laboratory activities.
• Documentation: Method selection procedures.
• Meeting: Review meeting with the consultant to validate method selection procedures

Task: Validate Methods

• Description: Perform validation of methods to ensure they are fit for intended use.
• Documentation: Method validation reports.
• Meeting: Periodic meetings to review validation results and approve methods.

7.3 Sampling

Task: Develop Sampling Plans

• Description: Create sampling plans and methods to ensure the validity of subsequent testing or calibration results.
• Documentation: Sampling plans and methods.
• Meeting: Review sampling plans with the consultant to ensure they meet laboratory requirements.

7.4 Handling of Test or Calibration Items

Task: Establish Handling Procedures

• Description: Develop procedures for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items.
• Documentation: Handling procedures document.
• Meeting: Training session with staff to ensure proper handling of items.

7.5 Technical Records

Task: Implement Record Keeping System

• Description: Create and maintain a system for managing technical records, including procedures for record retention and retrieval.
• Documentation: Technical records management procedures.
• Meeting: Internal meeting to train staff on the new record-keeping system.

7.6 Evaluation of Measurement Uncertainty

Task: Establish Measurement Uncertainty Evaluation Procedures

• Description: Develop procedures to evaluate measurement uncertainty for relevant laboratory activities.
• Documentation: Measurement uncertainty evaluation procedures.
• Meeting: Review meeting with the consultant to validate and approve the evaluation procedures.

7.7 Ensuring the Validity of Results

Task: Implement Quality Control Procedures

• Description: Establish procedures for ensuring the validity of results, including the use of control charts, proficiency testing, and inter-laboratory comparisons.
• Documentation: Quality control procedures document.
• Meeting: Regular review meetings with the consultant to discuss quality control measures.

7.8 Reporting of Results

Task: Develop Reporting Procedures

• Description: Create procedures for reporting test and calibration results, ensuring they meet customer and regulatory requirements.
• Documentation: Reporting procedures document.
• Meeting: Training session with staff to ensure understanding of reporting procedures.

7.9 Complaints

Task: Establish Complaints Handling Procedures

• Description: Develop and document procedures for handling complaints from customers and other stakeholders.
• Documentation: Complaints handling procedures.
• Meeting: Periodic review meetings with the consultant to assess the effectiveness of the complaints handling process.

7.10 Nonconforming Work

Task: Develop Procedures for Nonconforming Work

• Description: Create procedures to manage nonconforming work, including identification, documentation, evaluation, and corrective action.
• Documentation: Nonconforming work procedures.
• Meeting: Training session with staff to ensure understanding and compliance.
• 7.11 Control of Data and Information Management

Task: Implement Data Management System 

• Description: Establish a system for managing data and information, ensuring accuracy, security, and confidentiality. –
• Documentation: Data management procedures. –
• Meeting: Training session with staff to ensure proper data management practices.

Section 5: Management System Requirements (Duration: 1.5 Months)

8.1 Options

Task: Choose Management System Option

• Description: Decide whether to adopt Option A or Option B for the management system.
• Documentation: Decision document.
• Meeting: Meeting with the consultant to discuss options and make a decision.

8.2 Management System Documentation

Task: Document Management System

• Description: Develop and maintain documentation for the management system, including policies, procedures, and records.
• Documentation: Management system documentation.
• Meeting: Review meeting with the consultant to ensure completeness and compliance.

8.3 Control of Management System Documents

Task: Implement Document Control Procedures

• Description: Establish procedures for controlling management system documents, ensuring they are reviewed, approved, and accessible.
• Documentation: Document control procedures.
• Meeting: Training session with staff to ensure proper document control.

8.4 Control of Records

Task: Develop Record Control Procedures

• Description: Create procedures for controlling records, ensuring they are maintained, protected, and retrievable.
• Documentation: Record control procedures.
• Meeting: Internal meeting to train staff on record control procedures.

8.5 Actions to Address Risks and Opportunities

Task: Conduct Risk and Opportunity Assessment

• Description: Identify and assess risks and opportunities related to the laboratory’s activities, and develop action plans.
• Documentation: Risk and opportunity assessment report.
• Meeting: Regular review meetings with the consultant to discuss and update action plans.

8.6 Improvement

Task: Implement Improvement Actions

• Description: Develop and document actions to improve the effectiveness of the management system.
• Documentation: Improvement action plan.
• Meeting: Periodic meetings to review progress and effectiveness of improvement actions.

8.7 Corrective Actions

Task: Establish Corrective Action Procedures

• Description: Create procedures to identify, document, and address nonconformities and implement corrective actions.
• Documentation: Corrective action procedures.
• Meeting: Training session with staff to ensure proper implementation of corrective actions.

8.8 Internal Audits

Task: Plan and Conduct Internal Audits

• Description: Develop an internal audit program to evaluate the effectiveness of the management system.
• Documentation: Internal audit plan and reports.
• Meeting: Audit planning and review meetings with the consultant.

8.9 Management Reviews

Task: Conduct Management Reviews

• Description: Plan and conduct management reviews to ensure the continuing suitability, adequacy, and effectiveness of the management system.
• Documentation: Management review meeting minutes and reports.
• Meeting: Periodic management review meetings.

Final Assessment and Accreditation Preparation (Duration: 1 Month)

9.1 Final Assessment Preparation

Task: Conduct Final Pre-Assessment

• Description: Perform a final assessment to ensure all ISO/IEC 17025 requirements are met and identify any remaining gaps.
• Documentation: Pre-assessment report.
• Meeting: Meeting with the consultant to review the final assessment findings.

9.2 Internal Audit

Task: Conduct Internal Audit

• Description: Perform a comprehensive internal audit to verify compliance with ISO/IEC 17025 standards.
• Documentation: Internal audit report.
• Meeting: Post-audit meeting with the consultant to discuss findings and corrective actions.

9.3 Management Review Preparation

Task: Prepare for Management Review

• Description: Organize and document the management review process, ensuring all aspects of the management system are evaluated.
• Documentation: Management review documents.
• Meeting: Management review meeting to finalize the review process.

9.4 Accreditation Body Selection 4.

Task: Select Accreditation Body

• Description: Research and select a suitable accreditation body for ISO/IEC 17025 certification.
• Documentation: Accreditation body selection report.
• Meeting: Consultation with the consultant to finalize the selection of the accreditation body.

These tasks ensure a thorough and organized approach to implementing ISO/IEC 17025 2017, promoting competence, impartiality, and consistent operation within the laboratory.