ISO 13485:2016 Documentation - Manual, Procedures, Checklist
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Medical Devices Quality System ISO 13485:2016 Documentation

We are offering certification consultancy for quality management system for the design and manufacture of medical devices. So far many companies globally have taken our services and successfully developed quality management system with our help. We have experienced quality consulting team, who guide you in system implementation, documentation and training process, which will help medical device manufacturing companies to establish effective good quality system and quick certification. The ISO 13485:2016 certification audit is done by accredited certifying body auditors. Our QMS Consultants develop and produce a management system that facilitates compliance to the requirements of customer and-preeminently-various global regulators.

D126 - ISO 13485:2016 Documentation Kit - Manual, Procedures, Checklists - $ 399

Our company is introduced Quality system for Medical Device - ISO 13485:2016 Documentation, which is ready to use solution of quick documentation process for easy certification. We have developed readymade documentation kit for Medical Devices certification that organization needs to demonstrate its ability to provide medical devices quality system certification and that consistently meet customer requirements. there is requirements applicable to medical devices and related services to establish quality system. During implementation of ISO 13485 documentation, including manual, procedures, policies, operating instructions and forms are prepared by many companies to establish good working system. Our experienced Quality system consultants have designed such quality documents to help medical device manufacturing companies to establish effective documentation.

Content of Readymade Templates included in our Documentation Kit

ISO 13485 Documents Manual
  • Sample quality manual (40 pages in Word document).
  • Procedures for quality management system (19 procedures)
  • Exhibits and Operating Procedures to follow while implementing quality system (04 Exhibits and 06 SOPs).
  • Set of formats and templates for maintaining records (61 sample forms).
  • Process flow chart, which guides to establish good process approach.
  • Medical device technical files (total 21 files in Word document).
  • Audit Checklist - to verify implemented quality management system for medical device.
Entire QMS documentation kit is well written in English and provided in editable .doc format, so just with minimum editing your documents will be ready. The total documents for QMS can be purchase with easy editing features and compatible with system requirements. It is very effective tool to learn and implement QMS documentation completely meet the demands of the updated system requirements.

Benefits of Using Our Documents in QMS - Medical Devices Certification:

  • Many companies are implementing ISO 13485 system as per 2016 requirements and getting benefits of certification as improved QMS for medical devices in day to day life.
  • User can easily amend & change the templates as per their working system and create own quality documents quickly.
  • Saves much time and cost in document preparation. It gives 100% value for money to customer.
  • Procedures and formats provided in document kit can help in fine-tuning the processes and establish better control over quality management system.
  • Ready to use documents in .doc format reduce your time in documentation process.
  • Documents are useful in training to staff for learning QMS system requirements.
  • Takes care for all the section and sub sections, which gives better confidence as well as improve the system.
  • Effective tool to create manual, procedures, records and audit checklists for quick certification.

Method of online Delivery of Our Documents:

On successfully completion of payment process, we will provide username and password to download the product from our ftp server. So the delivery of our products will be within 12 to 24 hours of payment confirmation.
Visit free Demo of Documentation Kit and Purchase it with secure online transaction.