简介：顾问参与和初始培训   (持续时间： 0.5 个月)

入门任务

1.1 初步咨询和项目启动

任务：安排初次咨询

• 说明 安排与主要实施者和顾问会面，讨论项目范围、目标、时间表和责任。
• 文件。 项目计划和会议议程。
• 会议： 首次咨询会议。

任务：进行差距分析

• 说明 Perform a detailed gap analysis to identify the current state of the laboratory and areas needing improvement to meet ISO/IEC 17025 requirements.
• 文件。 差距分析报告。
• 会议： 与顾问会面，审查差距分析结果。

1.2 培训

任务： 制定培训计划制定培训计划

• 说明 Create a comprehensive training plan covering all aspects of ISO/IEC 17025 implementation.
• 文件。 培训计划文件。
• 会议： Meeting with the consultant to review and finalize the training plan.

任务：开展员工培训

• 说明 Provide training sessions for all relevant staff on ISO/IEC 17025 requirements and the implementation process.
• 文件。 培训材料和出勤记录。
• 会议： 顾问培训课程。

Section 1: General Requirements   (持续时间： 0.5 个月)

4.1 公正性

Task: Develop an Impartiality Policy

• 说明 Create and document a policy ensuring that all laboratory activities are conducted impartially.
• 文件。 Impartiality policy document.
• 会议： Initial meeting with the consultant to discuss and draft the policy.

Task: Conduct Risk Assessment for Impartiality

• 说明 Identify and assess risks to impartiality in laboratory activities, and document mitigation strategies.
• 文件。 Risk assessment report.
• 会议： Periodic meetings with the consultant to review identified risks and mitigation strategies.

Task: Implement Mitigation Measures

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

4.2 保密性

Task: Draft Confidentiality Agreements

• 说明 Create legally binding confidentiality agreements for personnel and external parties.
• 文件。 Confidentiality agreements.
• 会议： Consult with legal and compliance experts to finalize agreements.

Task: Establish Confidentiality Procedures

• 说明 Develop procedures to manage information confidentiality in laboratory activities.
• 文件。 Confidentiality management procedures.
• 会议： Training session with staff and consultant to ensure understanding and compliance.

Section 2: Structural Requirements (持续时间： 0.5 个月)

5.1 Legal Entity

Task: Verify Legal Entity Status

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

5.2 Management Responsibility

Task: Define Management Responsibilities

• 说明 Identify and document the responsibilities of management personnel for laboratory activities.
• 文件。 Organizational chart and management responsibilities document.
• 会议： Meeting with senior management to confirm responsibilities and authority.

5.3 Scope of Laboratory Activities

Task: Define Scope of Activities

• 说明 Document the range of laboratory activities that conform to ISO/IEC 17025 requirements.
• 文件。 Scope of activities document.
• 会议： Consultation with the consultant to review and validate the defined scope.

5.4 Organizational Structure

Task: Establish Organizational Structure

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

5.5 Resource Allocation

Task: Allocate Necessary Resources

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

Task: Monitor and Review Resources

• 说明 Regularly monitor and review resource allocation to ensure ongoing compliance and effectiveness.
• 文件。 Resource review reports.
• 会议： Quarterly review meetings with the consultant to discuss resource adjustments and improvements.

Section 3: Resource Requirements (持续时间： 1.5 个月)

6.1 General

Task: Review and Identify Resource Requirements

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

6.2 人员

Task: Define Competence Requirements

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

任务： Develop Training Programs

• 说明 Develop and implement training programs to ensure personnel are competent to perform assigned tasks.
• 文件。 Training program documents.
• 会议： Training session with the consultant to guide staff through the new training programs.

Task: Authorize Personnel

• 说明 Formally authorize personnel to perform specific laboratory activities.
• 文件。 Authorization records.
• 会议： Internal review meeting to approve personnel authorizations.

6.3 设施和环境条件

任务：评估设施要求

• 说明 Evaluate and document the facility and environmental conditions necessary for laboratory activities.
• 文件。 设施评估报告。
• 会议： Consultation with the consultant to review facility requirements.

Task: Monitor Environmental Conditions

• 说明 Implement a system to monitor, control, and record environmental conditions.
• 文件。 Environmental monitoring logs.
• 会议： Regular review meetings to ensure compliance with environmental control measures.

6.4 设备

Task: Inventory and Assess Equipment

• 说明 Create an inventory of all equipment and assess its suitability for laboratory activities.
• 文件。 Equipment inventory list.
• 会议： Review meeting with the consultant to verify equipment suitability.

Task: Implement Equipment Maintenance Procedures

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

6.5 计量学的可追溯性

Task: Establish Calibration Program

• 说明 Develop a calibration program to ensure the metrological traceability of measurement results.
• 文件。 Calibration program document.
• 会议： Periodic review meetings with the consultant to assess the effectiveness of the calibration program.

6.6 外部提供的产品和服务

Task: Evaluate Suppliers

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

Section 4: Process Requirements (持续时间： 2 个月)

7.1 对请求、投标和合同的审查

任务：制定审查程序

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

7.2 方法的选择、验证和确认

Task: Document Method Selection Procedures

• 说明 Establish procedures for the selection and verification of methods used in laboratory activities.
• 文件。 Method selection procedures.
• 会议： Review meeting with the consultant to validate method selection procedures

Task: Validate Methods

• 说明 Perform validation of methods to ensure they are fit for intended use.
• 文件。 Method validation reports.
• 会议： Periodic meetings to review validation results and approve methods.

7.3 取样

Task: Develop Sampling Plans

• 说明 Create sampling plans and methods to ensure the validity of subsequent testing or calibration results.
• 文件。 Sampling plans and methods.
• 会议： Review sampling plans with the consultant to ensure they meet laboratory requirements.

7.4 Handling of Test or Calibration Items

Task: Establish Handling Procedures

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

7.5 技术记录

Task: Implement Record Keeping System

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

7.6 测量不确定性的评估

Task: Establish Measurement Uncertainty Evaluation Procedures

• 说明 Develop procedures to evaluate measurement uncertainty for relevant laboratory activities.
• 文件。 Measurement uncertainty evaluation procedures.
• 会议： Review meeting with the consultant to validate and approve the evaluation procedures.

7.7 确保结果的有效性

Task: Implement Quality Control Procedures

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

7.8 结果报告

Task: Develop Reporting Procedures

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

7.9 投诉

Task: Establish Complaints Handling Procedures

• 说明 Develop and document procedures for handling complaints from customers and other stakeholders.
• 文件。 Complaints handling procedures.
• 会议： 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

• 说明 Create procedures to manage nonconforming work, including identification, documentation, evaluation, and corrective action.
• 文件。 Nonconforming work procedures.
• 会议： Training session with staff to ensure understanding and compliance.
• 7.11 对数据和信息管理的控制

Task: Implement Data Management System 

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

Section 5: Management System Requirements (持续时间： 1.5 个月)

8.1 Options

Task: Choose Management System Option

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

8.2 Management System Documentation

Task: Document Management System

• 说明 Develop and maintain documentation for the management system, including policies, procedures, and records.
• 文件。 Management system documentation.
• 会议： Review meeting with the consultant to ensure completeness and compliance.

8.3 Control of Management System Documents

Task: Implement Document Control Procedures

• 说明 Establish procedures for controlling management system documents, ensuring they are reviewed, approved, and accessible.
• 文件。 文件控制程序。
• 会议： Training session with staff to ensure proper document control.

8.4 Control of Records

Task: Develop Record Control Procedures

• 说明 Create procedures for controlling records, ensuring they are maintained, protected, and retrievable.
• 文件。 Record control procedures.
• 会议： Internal meeting to train staff on record control procedures.

8.5 Actions to Address Risks and Opportunities

Task: Conduct Risk and Opportunity Assessment

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

8.6 Improvement

Task: Implement Improvement Actions

• 说明 Develop and document actions to improve the effectiveness of the management system.
• 文件。 Improvement action plan.
• 会议： Periodic meetings to review progress and effectiveness of improvement actions.

8.7 Corrective Actions

Task: Establish Corrective Action Procedures

• 说明 Create procedures to identify, document, and address nonconformities and implement corrective actions.
• 文件。 Corrective action procedures.
• 会议： Training session with staff to ensure proper implementation of corrective actions.

8.8 Internal Audits

Task: Plan and Conduct Internal Audits

• 说明 Develop an internal audit program to evaluate the effectiveness of the management system.
• 文件。 Internal audit plan and reports.
• 会议： Audit planning and review meetings with the consultant.

8.9 Management Reviews

Task: Conduct Management Reviews

• 说明 Plan and conduct management reviews to ensure the continuing suitability, adequacy, and effectiveness of the management system.
• 文件。 Management review meeting minutes and reports.
• 会议： Periodic management review meetings.

Final Assessment and Accreditation Preparation (持续时间： 1 个月)

9.1 Final Assessment Preparation

Task: Conduct Final Pre-Assessment

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

9.2 Internal Audit

Task: Conduct Internal Audit

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

9.3 Management Review Preparation

Task: Prepare for Management Review

• 说明 Organize and document the management review process, ensuring all aspects of the management system are evaluated.
• 文件。 Management review documents.
• 会议： Management review meeting to finalize the review process.

9.4 Accreditation Body Selection 4.

Task: Select Accreditation Body

• 说明 Research and select a suitable accreditation body for ISO/IEC 17025 certification.
• 文件。 Accreditation body selection report.
• 会议： 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.