Introduction: Project Kick-off and Gap Analysis  (Duration: 1 Month)

Introductory Tasks

1.1 ISO 13485 Kick-off and Awareness

Task: Organize Kick-off Meeting

• Description: Conduct a kick-off meeting to introduce the ISO 13485:2016 project to key stakeholders, discussing objectives, scope, timelines, and responsibilities.
• Deliverables: Project plan, meeting agenda, and minutes.
• Meeting: Initial consultation with senior management and implementation team.

1.2 Perform Gap Analysis

Task: Conduct Gap Analysis Against ISO 13485:2016 Requirements

• Description: Assess the organization’s current QMS and processes against ISO 13485:2016 requirements to identify gaps.
• Deliverables: Gap analysis report with identified non-conformities.
• Meeting: Review findings with management and the quality team.

Section 1: Quality Management System (QMS) Planning  (Duration: 2 Months)

2.1 Develop and Document Quality Policy and Objectives

Task: Define Quality Policy and Objectives

• Description: Develop a quality policy and measurable quality objectives that align with ISO 13485:2016 and the organization’s strategic direction.
• Deliverables: Documented quality policy and objectives.
• Meeting: Review with senior management for approval.

2.2 Develop QMS Documentation

Task: Create QMS Documentation (Procedures, Work Instructions)

• Description: Document all key processes required by ISO 13485, including production, design, risk management, document control, and training.
• Deliverables: QMS manual, procedures, work instructions.
• Meeting: Review documented procedures with the QMS team.

Section 2: Risk Management and Regulatory Compliance (Duration: 2 Months)

3.1 Implement Risk Management Processes (ISO 14971 Integration)

Task: Identify and Document Risk Management Procedures

• Description: Develop and implement risk management procedures based on ISO 14971 (Application of Risk Management to Medical Devices) to ensure the identification, analysis, and control of risks associated with medical devices.
• Deliverables: Risk management plan and procedure.
• Meeting: Review risk management plan with the design and production teams.

3.2 Ensure Regulatory Compliance (ISO 13485 Clause 7.2)

Task: Define Regulatory Requirements for Medical Devices

• Description: Identify all applicable regulatory requirements related to medical devices in the relevant markets (e.g., FDA, CE marking) and ensure they are integrated into the QMS.
• Deliverables: Regulatory compliance matrix.
• Meeting: Review regulatory requirements with the regulatory affairs and quality assurance teams.

Section 3: Product Realization and Design Controls  (Duration: 1 Month)

4.1 Establish Product Design and Development Processes (ISO 13485 Clause 7.3)

Task: Develop Design and Development Procedures

• Description: Establish procedures for the design and development of medical devices, including design planning, inputs, outputs, verification, validation, and design reviews.
• Deliverables: Design and development procedure, design review templates.
• Meeting: Review with engineering and design teams.

4.2 Implement Design Change Controls

Task: Establish a Design Change Management Process

• Description: Create a design change control process to ensure that all changes are documented, validated, and reviewed for their impact on product safety, performance, and regulatory compliance.
• Deliverables: Design change control procedure.
• Meeting: Review with design, production, and quality teams.

Section 4: Supplier Management and Traceability (Duration: 1 Month)

5.1 Supplier Evaluation and Approval (ISO 13485 Clause 7.4)

Task: Develop Supplier Evaluation Procedures

• Description: Implement a supplier evaluation and approval process to ensure that suppliers meet the required quality standards and regulatory requirements.
• Deliverables: Supplier evaluation criteria, approved supplier list.
• Meeting: Review supplier performance and approval criteria with procurement.

5.2 Implement Traceability and Control of Medical Devices

Task: Develop Traceability Procedures (ISO 13485 Clause 7.5)

• Description: Establish a traceability system to ensure that the history, application, and location of medical devices can be traced throughout production, delivery, and installation.
• Deliverables: Traceability procedure, traceability records.
• Meeting: Train staff on traceability procedures and conduct system testing.

Section 5: Control of Non-Conforming Product and Corrective Actions (Duration: 1 Month)

6.1 Control of Non-Conforming Product (ISO 13485 Clause 8.3)

Task: Establish Procedures for Handling Non-Conforming Products

• Description: Develop procedures to identify, document, segregate, and dispose of non-conforming products, ensuring they do not reach customers or patients.
• Deliverables: Non-conformance reports, corrective action logs.
• Meeting: Review non-conformance procedures with production and quality teams.

6.2 Implement Corrective and Preventive Actions (ISO 13485 Clause 8.5)

Task: Develop Corrective Action Procedures

• Description: Implement a corrective and preventive action (CAPA) process to investigate the root cause of non-conformities and take preventive actions to avoid recurrence.
• Deliverables: CAPA reports, root cause analysis documentation.
• Meeting: CAPA review meeting with senior management and department heads.

Section 6: Internal Audits and Management Review (Duration: 2 Months)

7.1 Internal Audit Program (ISO 13485 Clause 8.2.4)

Task: Develop an Internal Audit Plan

• Description: Create an internal audit program to evaluate the effectiveness of the QMS, covering all areas required by ISO 13485:2016, including design, production, supplier management, and regulatory compliance.
• Deliverables: Internal audit plan, audit checklist.
• Meeting: Audit planning meeting with the audit team and quality manager.

7.2 Conduct Internal Audits

Task: Perform Internal Audits

• Description: Conduct internal audits to verify compliance with the QMS and ISO 13485 requirements. Identify any non-conformities and areas for improvement.
• Deliverables: Internal audit reports, non-conformance reports.
• Meeting: Post-audit review meeting with the management team to discuss findings and corrective actions.

7.3 Conduct Management Review (ISO 13485 Clause 5.6)

Task: Schedule and Conduct a Management Review

• Description: Conduct a management review to assess the effectiveness of the QMS and its alignment with business objectives. Ensure top management evaluates QMS performance and opportunities for improvement.
• Deliverables: Management review meeting minutes, action plans.
• Meeting: Present results and discuss strategic improvement actions with senior management.

Final Assessment: Certification Audit Preparation and External Audit (Duration: 1 Month)

8.1 Pre-Certification Audit

Task: Perform a Pre-Certification Internal Audit

• Description: Conduct a pre-certification audit to verify that the QMS meets ISO 13485:2016 requirements and is ready for the certification audit. Address any remaining non-conformities.
• Deliverables: Pre-certification audit report, corrective action plan.
• Meeting: Final review with senior management to confirm readiness for the external audit.

8.2 Certification Body Selection and External Audit

Task: Select Certification Body and Schedule Certification Audit

• Description: Select an accredited certification body for the ISO 13485 audit. Coordinate the external audit schedule and ensure the organization is fully prepared.
• Deliverables: Certification body selection report, external audit schedule.
• Meeting: Final meeting with management and quality team to confirm readiness for the certification audit.

This 8-month project plan for ISO 13485:2016 implementation provides a structured approach to achieving certification. The plan covers the key areas of quality management, risk management, design and development controls, supplier management, non-conformance handling, and internal audits, culminating in the final certification audit.