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Key Steps for ISO Implementation:

1. Project Planning Phase:

• Allocate resources and establish project proponents, roles, and responsibilities.
• Identify and mitigate project risks.
• Plan for trainings, personnel development, and set deliverables and milestones.

2. Gap Analysis:

• Analyze current practices against system requirements, stakeholders’ needs, and regulatory compliance.
• Assess risks and opportunities and prepare mitigation strategies.
• Define roles, authorities, and responsibilities within the organizational structure.
• Establish timelines and milestones for documentation and implementation.

3. Documentation & Trainings:

• Establish operational controls and objectives using the process approach.
• Develop management and operational documentation, SOPs, procedures, and guidelines.
• Conduct trainings on processes, documentation, and data collection.
• Provide awareness trainings on certification requirements and standards.
• Conduct specialized trainings as needed.

4. Internal Audit & Management Review:

• Plan and organize internal audits based on ISO 19011 requirements.
• Conduct a shadow audit to ensure readiness for certification.
• Address and close any non-conformities identified during audits.
• Conduct Management Reviews with key stakeholders to review deliverables and requirements.