Medical Devices - Quality Management System ISO 13485 :2016 Documentation Kit
ISO 13485:2016 documentation kit includes 100+ editable MS Word files covering all key requirements of the Medical Device Quality Management System (QMS). It provides ready-to-use ISO 13485 documents, manual, procedures, audit checklist forms, templates, and supporting documents to simplify documentation and support effective ISO 13485:2016 implementation.
Content of Medical Devices - Quality Management System ISO 13485:2016 Documentation Kit
Our ISO 13485:2016 manual documentation kit consists of the following documents in editable .docx format.
- ISO 13485 2016 Manual: An ISO 13485 2016 manual to establish a quality system in accordance with the clause wise requirements for system implementation (40 pages in MS-word format)
- ISO 13485 Procedures: A list of mandatory iso 13485 procedures to follow during ISO 13485 certification procedure (19 procedures - 54 pages in MS-word format)
- Exhibits: Sample copies of mandatory exhibits (04 exhibits - 4 pages in MS-Word format)
- Sample Formats / Templates: Ready-to-use verified QMS forms for quick documentation (61 blank formats in MS-Word and MS-Excel format)
- Quality SOP: A set of sample standard operating procedures (06 SOPs - 19 pages in MS-word format)
- Filled forms: Asset register, risk assessment, risk treatment, scope document for quick record keeping.
- ISO 13485 Audit Checklist: It covers more than 900 ISO 13485 audit checklists based on ISO 13485:2016 clause wise and department wise requirements. You can customize this iso 13485 checklist to make your own internal audit checklist.
- Medical Device File: A set of sample technical documents for medical devices in accordance with ISO 134852016 certification requirements (21 files in MS-Word format)
Features of ISO 13485:2016 Documentation Kit
- Easy-to-Understand Documentation: All ISO 13485:2016 documents are written in simple, clear, and easy-to-understand language, making them convenient for implementation and training.
- Editable MS Word Format: The complete documentation kit is provided in editable .docx format, compatible with Microsoft Word 2007 and later versions, allowing organizations to customize documents according to their requirements.
- Complete Documentation & Audit Checklist: The kit includes a comprehensive ISO 13485 Quality Manual, procedures, SOPs, forms, formats, templates, and ISO 13485 audit checklist required for establishing and implementing a Medical Device Quality Management System (QMS).
- Free DEMO Available: A free sample DEMO is available to help users, organizations, and ISO 13485 consultants understand the document structure, contents, and coverage before purchasing.
- Developed by Quality Experts: The ISO 13485 Manual and supporting QMS documentation have been developed under the guidance of experienced quality management professionals and ISO consultants.
- Saves Time and Effort: Ready-to-use templates significantly reduce the time and effort required for preparing, formatting, and maintaining ISO 13485:2016 documentation.
- User-Friendly Documentation: The documents are designed to be simple, practical, easy to understand, and convenient to customize and implement.
- Baseline ISO 13485 QMS: The documentation provides a practical baseline system aligned with ISO 13485:2016 requirements and includes an ISO 13485 audit checklist to support gap assessment, internal audits, and implementation.
- Flexible & Customizable: Templates can be modified according to the organization's products, processes, regulatory requirements, operational activities, and specific quality objectives.
- Simple Documentation Approach: The kit promotes a practical quality management system with clear documentation and helps avoid unnecessary or excessive paperwork.
How the ISO 13485 Documentation Kit is Useful
- Complete QMS Documentation: The kit provides an ISO 13485 Manual, procedures, SOPs, sample forms, formats, templates, and audit checklists to support effective Medical Device Quality Management System implementation.
- Useful for Training & Learning: The documentation kit is suitable for individual learning, employee training, consultant-led training, and group sessions focused on ISO 13485:2016 implementation.
- Valuable for ISO 13485 Consultants: Ready-to-use ISO 13485 documents and customizable templates provide practical support to consultants implementing ISO 13485:2016 Quality Management Systems for medical device organizations.
- Supports Effective Implementation: Sample documentation and the ISO 13485:2016 audit checklist help organizations understand standard requirements, identify documentation needs, and systematically implement their QMS.
- Saves Time and Cost: Editable, ready-made ISO 13485 documents help reduce the time, effort, and cost involved in developing quality manuals, procedures, SOPs, forms, and other QMS documentation from scratch.
- Supports Employee Awareness:The documentation can be used as a training and reference resource to educate employees about quality processes, responsibilities, regulatory requirements, and effective Medical Device QMS practices.
More Details
ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes specifies quality management system requirements for organizations involved in the design, development, production, installation, servicing, and other activities related to medical devices. This 2026 edition was last reviewed and confirmed in 2025. Implementing an ISO 13485:2016-compliant QMS helps organizations establish controlled and consistent processes while supporting applicable regulatory and customer requirements. ISO 13485 certification demonstrates that an organization has established a structured Quality Management System for medical device-related activities. A properly implemented QMS helps improve process control, documentation, risk-based thinking, product quality, traceability, and compliance with applicable regulatory requirements.
Ready-to-Use ISO 13485:2016 Documents by Global Manager Group
Global Manager Group has developed a ready-to-use ISO 13485:2016 documentation kit to support organizations in establishing and implementing a Medical Device Quality Management System. The kit includes an ISO 13485 Quality Manual, procedures, SOPs, forms, formats, templates, work instructions, and ISO 13485 audit checklist.
All documents are provided in an editable .docx format, allowing users to easily customize the content according to their organization's products, processes, responsibilities, and specific requirements. The documentation is designed to provide a practical starting point for organizations preparing for ISO 13485 certification.
The ISO 13485:2016 documentation kit can also serve as a valuable resource for ISO consultants, quality professionals, trainers, and medical device organizations involved in QMS implementation and employee training. By using ready-made and customizable documents, organizations can reduce documentation preparation time and focus more effectively on implementing and maintaining their Medical Device Quality Management System.
Method of Delivery of ISO 13485:2016 Documentation Kit
By downloading the Free DEMO, a user can understand the content of the documentation kit, which helps them to easily take the decision to purchase our products. The user can purchase it online via a secured third party payment gateway or via Bank wire transfer as mentioned in the Payment Option on each page. Once a user purchases the Medical device - QMS iso 13485 documentation kit, we provide a username and password within 12 working hours for online E-delivery of our products via our FTP server.
This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.
For more details on ISO Certification, Contact Us or to see demo of our products, visit our E-Shop.
