The Quality Manual is available in both hard copy and electronic format, and is controlled under our document control procedure. All revisions are tracked, approved by top management, and distributed according to our internal document control system. Employees are trained on how to access and refer to the manual when needed.
Structure of the Quality Manual:
Our Quality Manual is structured to reflect the clauses of ISO 13485:2016 and includes the following main sections:
- Scope of the QMS:
This section defines the boundaries of our QMS. It explains the type of medical devices we manufacture, including design, development,ISO 13485 Certification process in Kuwait and distribution activities. It also details any clauses that are not applicable (with justification), such as design and development (if excluded).
- Normative References:
This section references ISO 13485:2016 and any relevant supporting standards such as ISO 14971 for risk management.
- Terms and Definitions:
To ensure clarity, we provide definitions aligned with ISO standards and company-specific terminology used throughout the QMS.
- Context of the Organization:
This includes identification of internal and external issues, interested parties (e.g., customers, regulators, suppliers), ISO 13485 Certification services in Kuwait and our approach to risk-based thinking.
- Leadership and Commitment:
We describe top management's responsibility for the QMS, including setting the quality policy and objectives, and demonstrating leadership through active participation in management reviews and audits.
- Quality Policy and Objectives:
Our quality policy is clearly stated in the manual and is aligned with our strategic direction. Objectives are measurable and reviewed regularly.
- Process-Based Approach:
The manual includes a high-level process map showing key processes such as customer service, design, purchasing, production, and quality control. Interactions and dependencies between these processes are described.
- QMS Clauses and Implementation:
Each clause of ISO 13485 is addressed with a summary of how we comply, and references are provided to detailed procedures, forms, and work instructions that are maintained separately.
- Documented Procedures:
A list of required and supporting procedures is included, ISO 13485 Implementation in Kuwait such as document control, internal audits, control of nonconforming product, corrective actions, risk management, and traceability.