Quality Policy

Purpose

This policy states top management’s commitments to quality and provides the framework for setting and reviewing quality objectives.

Scope

It applies to all Critica Solutions services, employees and service providers acting on its behalf.

Responsibilities

• Chief Executive Officer: approves, communicates and reviews the policy.
• Quality Manager: makes employees aware of it and monitors its implementation through the quality objectives.
• All employees: understand it and apply it in their work.

Review

The policy is reviewed annually at management review and upon any significant change in the company’s direction.

Our Quality Policy

Critica Solutions is committed to providing reliable logistics services for healthcare products that preserve their quality and safety until they reach the patient. To achieve this, we are committed to:

• Patient safety first: we accept no compromise on product storage conditions or safety for any commercial reason.
• Compliance: meeting the requirements of the Saudi Food and Drug Authority and other regulatory authorities, Good Distribution Practice, ISO 9001, ISO 13485 for the medical device scope, and our customers’ contractual requirements.
• Customer focus: understanding and meeting our customers’ requirements, communicating with them transparently, and seeking to enhance their satisfaction.
• Risk-based thinking: identifying risks to the product and service, including the impact of extreme heat and climate change, and addressing them before they occur.
• Quality culture and ethical behaviour: encouraging blame-free reporting of errors and maintaining full integrity of records and data.
• Integrity: zero tolerance for bribery, corruption and forced labour, and protection of customer and patient information, in accordance with the Code of Ethics and Conduct Policy POL-QM-02.
• Partnership with service providers: working only with qualified and licensed parties and defining responsibilities with them in written quality agreements.
• Competence: training and qualifying our employees and providing them with a safe working environment.
• Continual improvement: setting and reviewing measurable quality objectives, and learning from deviations, complaints and audits to improve the quality management system.

This policy is communicated to all employees and published on the company website.

References

• ISO 9001:2015 – Clause 5.2: Quality policy.
• ISO 13485:2016 – Clause 5.3 (for the medical device scope).
• EU Guidelines on Good Distribution Practice 2013/C 343/01 – Section 1.2.