Quality Policy Statement Example
It’s often tricky to define a simple quality policy statement.
Organisations tend to overcomplicate this, so here is a simple and basic place to start that aligns with the requirements of ISO 9001 as well as your quality management system for medical devices:
The organisation is committed to:
• to understanding and meeting our Customers needs and ensuring our <products/services> satisfy customer requirements
• To achieving Customer satisfaction,
• Continual improvement of its products, processes and services
• Satisfying applicable requirements
<insert company> aims to achieve the above:
• by implementing a single Quality Management System currently conforming to ISO 9001
• by designing, where applicable, the products to meet regulatory requirements to the countries in which the products are intended to be offered for sale.
The Company is also committed to continual development of the Quality Management System and helping to ensure it remains effective in achieving the Quality Objectives. The effectiveness of the QMS is monitored by planned external and internal audits, management reviews and effective corrective and preventative action.
All personnel within the company are responsible for the quality of their work. All employees are aware of the management commitment to the Quality policy and delivering quality in general and are encouraged to support the system through continuous participation.
<insert company> provides training and has established systems to assist all personnel to achieve the standards required. The Company provides support resources and encouragement to all employees to ensure they realise their full potential in meeting the Quality Policy and its objectives.
The Company is committed to investigating customer feedback and complaints and will address all justified issues raised. Post market surveillance process contributes to achieving continuous improvement in achieving high quality for products and customer service.
This policy will be reviewed in accordance with the Document Control Procedure and notified to all employees to ensure it is understood, implemented and maintained.
Insert Date
Insert Signature of CEO
Insert Version