Einleitung: Projektauftakt und Lückenanalyse  

Einführende Aufgaben

1.1 ISO 15189 Kick-off and Awareness

Aufgabe: Organisation eines Kick-off-Meetings

• Beschreibung: Hold a kick-off meeting to introduce the ISO 15189 project, explaining the objectives, scope, timelines, and resource requirements to key stakeholders.
• Liefergegenstände: Projektplan, Tagesordnung und Sitzungsprotokolle.
• Treffen: Initial consultation with senior management and the implementation team.

1.2 Lückenanalyse durchführen

Task: Conduct Gap Analysis Against ISO 15189 2012 Requirements

• Beschreibung: Assess the current laboratory processes, management system, and technical operations against the requirements of ISO 15189:2012 to identify gaps.
• Liefergegenstände: Bericht über die Lückenanalyse mit den festgestellten Nichtkonformitäten.
• Treffen: Review findings with management, laboratory heads, and quality teams.

Section 1: QMS Documentation and Quality Policy 

2.1 Develop and Document Quality Policy and Objectives

Aufgabe: Definition von Qualitätspolitik und -zielen

• Beschreibung: Establish the laboratory’s quality policy and measurable quality objectives, aligning them with ISO 15189:2012 and the organization’s strategic direction.
• Liefergegenstände: Documented quality policy and objectives.
• Treffen: Review and approve with senior management.

2.2 Develop Quality Management System Documentation

Task: Create QMS Documentation (Procedures, Work Instructions)

• Beschreibung: Develop the necessary documentation for the quality management system, including a quality manual, process procedures, and work instructions that meet ISO 15189 requirements.
• Liefergegenstände: Qualitätshandbuch, Verfahren, Arbeitsanweisungen.
• Treffen: Review documentation with the QMS team.

Section 2: Laboratory Operations and Risk Management 

3.1 Implement Laboratory Operations Procedures (ISO 15189 Clauses 5.4, 5.5, 5.6)

Task: Establish Procedures for Laboratory Operations

• Beschreibung: Document and implement procedures for pre-examination (sample collection), examination (testing), and post-examination (reporting) phases of laboratory work, ensuring compliance with ISO 15189:2012.
• Liefergegenstände: Standard operating procedures (SOPs) for laboratory operations.
• Treffen: Review and validate procedures with laboratory staff and technical teams.

3.2 Develop Risk Management Procedures

Task: Implement Risk Management in Laboratory Activities

• Beschreibung: Develop procedures to identify, assess, and control risks associated with laboratory activities, including patient safety risks and equipment malfunctions.
• Liefergegenstände: Risk management plan and procedure.
• Treffen: Review risk management process with the technical and quality teams.

Section 3: Competence and Training  

4.1 Competence of Laboratory Personnel (ISO 15189 Clause 5.1)

Task: Define Competence Requirements for Laboratory Staff

• Beschreibung: Establish criteria for the competence of laboratory personnel, including qualifications, skills, and training required for each role within the laboratory.
• Liefergegenstände: Competence matrix and job descriptions.
• Treffen: Review with HR and department heads to finalize staff roles and competence requirements.

4.2 Develop Training and Competency Assessment Program

Task: Create and Implement a Training Program

• Beschreibung: Develop a training program to ensure that all laboratory personnel are competent to perform their assigned tasks, and establish procedures for ongoing competency assessments.
• Liefergegenstände: Training program documents and records of completed training.
• Treffen: Training sessions with staff on new processes and assessments.

Section 4: Equipment Management and Traceability 

5.1 Equipment Management (ISO 15189 Clause 5.3)

Task: Implement Equipment Calibration and Maintenance Procedures

• Beschreibung: Establish procedures for the calibration, maintenance, and qualification of laboratory equipment to ensure accuracy and reliability.
• Liefergegenstände: Equipment management procedure, calibration schedule, maintenance logs.
• Treffen: Review and implement equipment management with the technical team.

5.2 Ensure Traceability of Measurement Results

Task: Develop and Implement Traceability Systems

• Beschreibung: Ensure traceability of all measurement results, from sample collection to the final report, to ensure the reliability and reproducibility of test results.
• Liefergegenstände: Traceability procedure and records.
• Treffen: Review traceability systems with the laboratory and quality teams.

Section 5: Document Control and Non-Conforming Work 

6.1 Implement Document Control System (ISO 15189 Clause 4.3)

Aufgabe: Festlegung von Verfahren für die Dokumentenkontrolle

• Beschreibung: Develop a document control system to manage all QMS-related documentation, ensuring that all documents are reviewed, approved, and updated regularly.
• Liefergegenstände: Document control procedure, document registers.
• Treffen: Schulung des Personals in Bezug auf das Dokumentenkontrollsystem.

6.2 Non-Conforming Work and Corrective Actions (ISO 15189 Clause 4.9)

Task: Establish Procedures for Handling Non-Conforming Work

• Beschreibung: Implement a process to identify, document, and resolve non-conforming work (e.g., erroneous test results), ensuring appropriate corrective actions are taken to prevent recurrence.
• Liefergegenstände: Non-conformance reports, corrective action logs.
• Treffen: Post-audit review to discuss non-conforming work and corrective actions.

Section 6: Internal Audits and Continuous Improvement 

7.1 Develop Internal Audit Program (ISO 15189 Clause 4.14)

Task: Create an Internal Audit Plan

• Beschreibung: Establish an internal audit program to evaluate the effectiveness of the QMS, covering all critical laboratory processes and ISO 15189 requirements.
• Liefergegenstände: Internal audit plan, audit checklist.
• Treffen: Review audit plan with the audit team and quality manager.

7.2 Interne Audits durchführen

Aufgabe: Interne Audits durchführen

• Beschreibung: Conduct internal audits to verify compliance with ISO 15189 and QMS requirements. Identify areas for improvement and implement corrective actions.
• Liefergegenstände: Interne Auditberichte, Berichte über Nichtkonformität.
• Treffen: Post-audit review meeting with the management team to discuss findings and corrective actions.

Abschließende Bewertung: Vorbereitung der Zertifizierung und externes Audit 

8.1 Durchführung eines internen Audits vor der Zertifikation

Task: Perform a Pre-Certification Internal Audit

• Beschreibung: Conduct a full internal audit to assess the laboratory’s readiness for the ISO 15189 accreditation audit, ensuring that all identified gaps have been addressed.
• Liefergegenstände: Pre-certification audit report.
• Treffen: Review audit findings with management and finalize corrective actions.

8.2 Auswahl der Zertifizierungsstelle und externes Audit

Aufgabe: Auswahl der Zertifizierungsstelle und Planung des Zertifizierungsaudits

• Beschreibung: Research and select an accredited certification body for ISO 15189. Schedule the external audit and ensure the laboratory is fully prepared.
• Liefergegenstände: Bericht über die Auswahl der Zertifizierungsstelle, Zeitplan für das externe Audit.
• Treffen: Final meeting with management and quality team to confirm readiness for the certification audit.

Dieser 8-monatige Projektplan für ISO 15189:2012 implementation ensures a structured approach to achieving accreditation for medical laboratories. It covers all key areas, including quality management, laboratory operations, equipment management, non-conformance handling, internal audits, and certification preparation, ensuring compliance with ISO 15189 by the end of the project.