Step 1 – Initial Consultation

Understand your medical-device activities, products, quality objectives, regulatory responsibilities, and certification requirements.

Step 2 – Gap Assessment

Evaluate your existing Medical Device Quality Management System against ISO 13485 requirements and identify gaps.

Step 3 – Define QMS Scope

Determine the products, processes, locations, departments, activities, and medical-device lifecycle stages covered by the QMS.

Step 4 – Regulatory Assessment

Identify applicable Palestinian regulatory requirements and other requirements relevant to your medical devices and target markets.

Step 5 – Documentation

Develop quality policies, procedures, work instructions, risk-management documentation, forms, records, and supporting QMS documents.

Step 6 – Implementation

Implement the Medical Device Quality Management System throughout the defined scope.

Step 7 – Employee Training

Train employees on ISO 13485 requirements, regulatory responsibilities, quality procedures, risk management, and medical-device processes.

Step 8 – Internal Audit

Conduct internal audits to evaluate QMS conformity and identify nonconformities.

Step 9 – Management Review

Review QMS performance, quality objectives, regulatory requirements, audit results, product performance, customer feedback, corrective actions, and improvement opportunities.

Step 10 – Corrective Actions

Address identified nonconformities and verify that corrective actions are effective.

Step 11 – Certification Audit

An independent certification body conducts the external assessment of your Medical Device Quality Management System.

Step 12 – Certification Decision

The certification body reviews the assessment results and independently makes the certification decision.

Step 13 – Continual Improvement

Maintain the QMS, monitor product and process performance, address nonconformities, review regulatory requirements, and continually improve the quality management system.