Developing a Quality Management System (QMS) from scratch can require significant time, resources and specialist knowledge.

QMSregs provides professionally developed, editable QMS templates that offer a structured starting point for preparing quality manuals, procedures, policies and supporting documentation.

By adapting our ISO 13485 and ISO 9001 templates to your organisation's requirements, you can reduce the time and resources spent developing documentation while maintaining control over your quality management processes.

Templates can also complement professional consultancy support, allowing specialist resources to be focused on implementation, training and regulatory requirements.

Preparing quality management system documentation can be a time-consuming process, particularly for medical device manufacturers developing an ISO 13485 QMS.

Our editable templates provide pre-structured procedures, forms and records that can be adapted to your organisation's activities.

Rather than creating every document from the beginning, quality and regulatory professionals can focus on reviewing, customising and implementing the documentation to reflect their actual processes.

Organisations reviewing an existing Quality Management System can use relevant QMS templates as a reference when identifying potential documentation gaps.

Our ISO 13485 and ISO 9001 templates provide examples of procedures and records that may be relevant to quality management system requirements.

Templates can support the preparation of a gap assessment, although a complete assessment must consider the applicable standard, regulatory requirements, existing processes and evidence of effective implementation.

Preparing for ISO 13485 or ISO 9001 certification requires organisations to establish, implement and maintain a Quality Management System that meets the applicable standard.

QMSregs templates can support the development of documented procedures, quality policies and records used within a QMS.

However, certification requires more than documentation alone. Organisations must demonstrate that their processes are implemented effectively, supported by appropriate records and maintained through activities such as internal audits and management reviews.

QMSregs was established by the Patient Guard group, drawing on professional experience in medical device regulatory compliance and quality management systems.

Our templates are developed with reference to relevant standards and regulatory frameworks, including ISO 13485, ISO 9001, ISO 14971, EU MDR and IVDR, as applicable to the individual product.

This practical regulatory and quality management experience helps provide organisations with structured documentation that can be customised to their products, processes and regulatory responsibilities.