Introduction: Project Kick-off and Gap Analysis 

Introductory Tasks

1.1 ISO/IEC 17043 Kick-off and Awareness

Task: Organize Kick-off Meeting

• Description: Conduct a kick-off meeting to introduce the ISO/IEC 17043:2023 project to key stakeholders. Discuss objectives, scope, timelines, and responsibilities.
• Deliverables: Project plan, meeting agenda, and minutes.
• Meeting: Initial consultation with senior management, proficiency testing coordinators, and the implementation team.

1.2 Perform Gap Analysis

Task: Conduct Gap Analysis Against ISO/IEC 17024:2012 Requirements

• Description: Assess current proficiency testing processes, management systems, and technical operations against ISO/IEC 17043:2023 requirements to identify gaps.
• Deliverables: Gap analysis report with identified non-conformities.
• Meeting: Present findings to senior management and technical teams.

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Section 1: Quality Management System (QMS) Documentation and Policy Development 

2.1 Develop and Document Quality Policy and Objectives (ISO 17043 Clause 4.1)

Task: Define Quality Policy and Objectives

• Description: Develop the PT provider’s quality policy and measurable objectives, ensuring alignment with ISO/IEC 17043:2023 requirements.
• Deliverables: Quality policy and objectives document.
• Meeting: Review and approve the policy with senior management.

2.2 Develop Quality Management System (QMS) Documentation

Task: Create QMS Documentation (Manual, Procedures, Work Instructions)

• Description: Develop necessary documentation for the QMS, including a quality manual, process procedures, and work instructions that cover all key areas of proficiency testing activities.
• Deliverables: Quality manual, procedures, work instructions.
• Meeting: Review QMS documentation with the quality and technical teams.

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Section 2: Design and Planning of Proficiency Testing Schemes 

3.1 Develop and Document PT Scheme Design Process (ISO 17043 Clause 5)

Task: Define Proficiency Testing Scheme Requirements

• Description: Establish processes for designing proficiency testing schemes, including test item selection, statistical analysis, and evaluation criteria.
• Deliverables: PT scheme design documents, test item specifications, and performance evaluation methods.
• Meeting: Review PT scheme design with technical teams.

3.2 Develop PT Program Documentation (ISO 17043 Clause 5)

Task: Document Proficiency Testing Programs and Instructions

• Description: Develop documentation for the PT programs, including participant instructions, procedures for test item distribution, and reporting protocols.
• Deliverables: PT program documentation, participant guides, and result reporting templates.
• Meeting: Review PT program documents with technical and operational teams.

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Section 3: Impartiality, Confidentiality, and Competence 

4.1 Establish Policies for Impartiality and Confidentiality (ISO 17043 Clause 4

Task: Develop Impartiality and Confidentiality Policies

• Description: Establish policies to ensure impartiality and confidentiality in proficiency testing activities, ensuring that results are handled objectively and securely.
• Deliverables: Impartiality and confidentiality policies.
• Meeting: Review policies with senior management and relevant stakeholders.

4.2 Define Competence Requirements for PT Personnel (ISO 17043 Clause 6)

Task: Establish Competence Criteria for PT Personnel

• Description: Define the qualifications, experience, and skills required for personnel involved in PT schemes, including coordinators and evaluators.
• Deliverables: Competence matrix, job descriptions, and training plans.
• Meeting: Review competence criteria with HR and program heads.

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Section 4: Proficiency Testing Process Implementation 

5.1 Implement PT Scheme Procedures (ISO 17043 Clauses 7.1 – 7.5)

Task: Implement Procedures for PT Scheme Management

• Description: Roll out PT scheme procedures for planning, conducting, and reporting proficiency tests, ensuring that the defined process is followed consistently.
• Deliverables: PT scheme process documents, result reporting forms.
• Meeting: Review the implementation of PT processes with the technical team and ensure staff is trained on PT procedures.

5.2 Implement PT Evaluation Methods (ISO 17043 Clause 7.6)

Task: Roll Out Evaluation and Statistical Analysis Procedures

• Description: Implement evaluation methods and statistical analysis for assessing PT results and determine participant performance.
• Deliverables: Statistical analysis templates, performance evaluation reports.
• Meeting: Train PT coordinators on evaluation and statistical analysis methods.

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Section 5:Control of Documents and Records  

6.1 Implement Document Control System (ISO 17043 Clause 8)

Task: Establish Procedures for Document Control

• Description: Implement a document control system to ensure all PT-related documents, policies, and records are reviewed, updated, and managed according to ISO 17043.
• Deliverables: Document control procedures and document register.
• Meeting: Train staff on the document control system.

6.2 Implement Record Keeping and Traceability (ISO 17043 Clause 8.5)

Task: Establish Procedures for PT Record Control

• Description: Develop procedures to securely manage and retain records of PT activities, ensuring traceability of evaluations and results.
• Deliverables: Record control procedures, record retention schedules.
• Meeting: Review procedures with the quality team and train staff on record management.

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Section 6: Internal Audits and Management Review 

7.1 Develop Internal Audit Program (ISO 17043 Clause 8.6)

Task: Create Internal Audit Plan

• Description: Develop an internal audit program to regularly assess the effectiveness of the PT provider’s processes and compliance with ISO/IEC 17043:2023 requirements.
• Deliverables: Internal audit plan, audit schedule, and checklist.
• Meeting: Review audit plan with internal auditors and senior management.

7.2 Conduct Internal Audits

Task: Perform Internal Audits

• Description: Conduct internal audits to evaluate the PT provider’s adherence to ISO/IEC 17043 standards, including impartiality, confidentiality, and competence requirements.
• Deliverables: Internal audit reports, non-conformance reports.
• Meeting: Post-audit review meeting to discuss findings and corrective actions.

7.3 Conduct Management Review (ISO 17043 Clause 8.7)

Task: Perform Management Review of the PT Provider’s QMS

• Description: Conduct a management review to evaluate the performance of the PT provider, including an analysis of audit results, customer feedback, and opportunities for improvement.
• Deliverables: Management review minutes and action plans.
• Meeting: Present findings and improvement plans to senior management.

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Final Assessment: Certification Preparation and External Audit 

8.1 Conduct Pre-Certification Internal Audit

Task: Perform Pre-Certification Internal Audit

• Description: Conduct a final internal audit to ensure the PT provider meets ISO/IEC 17043:2023 requirements and is ready for external accreditation.
• Deliverables: Pre-certification audit report, corrective action plans.
• Meeting: Final review meeting with senior management and the certification team.

8.2 Certification Body Selection and External Audit

Task: Select Certification Body and Schedule Certification Audit

• Description: Research and select an accredited certification body for ISO/IEC 17043. Schedule the external audit and ensure the organization is fully prepared.
• Deliverables: Certification body selection report, external audit schedule.
• Meeting: Final meeting with management and certification teams to confirm readiness for accreditation.

This 8-month project plan for ISO/IEC 17043:2023 implementation provides a structured approach to achieving accreditation for proficiency testing providers. It covers key areas such as PT scheme development, impartiality, competence, documentation, internal audits, and continual improvement, aligning the organization with ISO/IEC 17043 requirements for proficiency testing activities.