ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes – is the current standard in the field of management system for enterprises providing medical products or related services.
ISO 13485:2016 documentation in editable form
Over 70 files!
You can find here Quality Manual with attachments, procedures, intructions and registers
For who?
If you are an organization in the health or medical sector, the standard will most likely apply to you. The standard is dedicated to companies that are involved in any stage of the life of a medical device. From design, through distribution to service.
Is it worth?
If you care about providing the highest quality product/services, and therefore want to minimize the risk of a non-compliant product, you should seriously consider implementing the above standard. This will certainly affect the quality of your products and increase the company’s competitiveness. It will increase customer trust and reduce complaints. Having a Quality Management System in accordance with ISO 13485:2016 is also often a tender requirement.
What we have got for you?
Having learned from experience, we know perfectly well that preparing and managing system documentation may cause some problems. That’s why we provide you with a set of documentation in an editable form that you can implement in your organization or use as you wish. You can also get inspired and implement selected solutions in your organization.
We have a sample Quality Manual and attachments for you (Quality Policy, Process Map and Organizational Chart). We also provide you with a number of procedures with sample procedures and instructions. You will also receive a collection of forms and registers. A total of over 70 files. The full list can be found below.
Remember that each organization is different and our quality manual, together with procedures and instructions, is a framework. It will be necessary to adapt the presented procedures to the conditions prevailing in a specific organization. Forms and registers are forms used to collect and document the operation of the system.
Use our solutions if you want to save time on creating documentation from scratch or simply want to make your work easier.
List of ISO 13485 documents
STRATEGICAL:
Manual (docx)
Process map (docx)
Quality Policy (docx)
Organizational chart (xlsx)
PROCEDURES:
Procedure for managing documentation and records (xlsx)
Management review procedure (xlsx)
Installation procedure (xlsx)
Service procedure (xlsx)
Internal audit procedure (xlsx)
Complaints procedure (xlsx)
Procedure for corrective and preventive actions (xlsx)
Procedure for supervision of non-compliant products (xlsx)
Purchasing procedure (xlsx)
Design procedure (xlsx)
Production procedure (xlsx)
Sales procedure (xlsx)
GUIDELINES:
Feedback analysis (docx)
Risk analysis for processes (docx)
Incidents (docx)
Withholding and recalling products (docx)
Issuing advisory notes (docx)
FORMS:
FMEA analysis of processes – form (xlsx)
Stock sheet (xlsx)
List of records and documents (xlsx)
Distributor list (xlsx)
Training plan (xlsx)
Infrastructure register (xlsx)
Register of corrective and preventive actions (xlsx)
Internal audit schedule (xlsx)
Audit plan(xlsx)
Internal audit report (xlsx)
Complaint register (xlsx)
Register of qualified suppliers (xlsx)
Customer satisfaction survey (xlsx)
Register of contacts with customers (xlsx)
Production register (xlsx)
Service register (xlsx)
Register of control and measurement equipment (xlsx)
Register of product suspensions and recalls (xlsx)
Incident reporting register (xlsx)
Procedure template – form (xlsx)
Process monitoring worksheet (docx)
Instruction template (docx)
Internal training report (docx)
Management review program (docx)
Register of standards and legal acts (docx)
Management review report (docx)
Position card (docx)
Training evaluation survey (docx)
Non-conforming product card (docx)
List of quality objectives (docx)
Advisory note (docx)
Conversion card (docx)
Software Validation Form (docx)
Measuring instrument card (docx)
Delivery receipt form (docx)
Project input card (docx)
Device installation card (docx)
Quality control card in production (docx)
Production card (docx)
Project card (docx)
Service card (docx)
Device card (docx)
Design Review Note (docx)
Catalog of production components (docx)
Supplier qualification list (docx)
Material list (docx)
Project change card (docx)
Design validation and verification plan (docx)
Production guide (docx)
List of process indicators (docx)
Order to supplier (docx)
Instllation register (xlsx)
Technical informations:
Files packed in ZIP format.
Only open documentation in Microsoft Office 2013 or later.
