Skip to product information
1 of 1

Quality Manual Template - ISO 9001

Quality Manual Template - ISO 9001

Regular price £9.99
Regular price Sale price £9.99
Sale Sold out

Template Overview

Develop a structured and fully compliant Quality Management System (QMS) with our ISO 9001:2015 Clause 1.1 Quality Manual Template. A Quality Manual serves as the foundation of your ISO 9001:2015 certification, outlining your organization’s commitment to quality, regulatory compliance, and continuous improvement. This ready-to-use template provides a clear framework for documenting your QMS, ensuring consistency, efficiency, and audit readiness.

Key Features

✔ Pre-Formatted Quality Manual Template – Covers key ISO 9001:2015 Clause 1.1 requirements.

✔ Scope of the Quality Management System – Define the boundaries and applicability of your QMS.

✔ Quality Policy & Objectives Section – Establish clear goals aligned with business strategy and compliance.

✔ Roles & Responsibilities of Key Personnel – Ensure leadership engagement and employee accountability.

✔ Process-Based QMS Structure – Outline workflows, interactions, and controls for quality management.

✔ Risk Management & Continuous Improvement Framework – Integrate ISO 9001’s risk-based approach.

✔ Audit-Ready Documentation & Compliance Tracking – Maintain structured records for certification audits.

✔ Editable Digital Format – Fully customizable for various industries and business models.

Why choose a QMS Template?

This Quality Manual Template is ideal for quality managers, compliance teams, and business leaders, ensuring a structured, compliant, and effective QMS foundation.

Download the ISO 9001:2015 Quality Manual Template today and take the first step toward ISO 9001 certification and operational excellence!

View full details
  • About Patient Guard

    QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.

  • Secure Payment and Document Download

    Our secure system keeps your transaction safe, and the email will be sent promptly to the address you provided. Just click the link to instantly access and download your documents.

  • Contact Us

    For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.