ISO 13485 Manual | ISO 13485 Documents
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ISO 13485 Manual Total Documentation for Quick Certification

We offer ISO 13485 certification consultancy and total documentation for quality management system of companies involved in design, manufacture, supply and service of medical devices. So far many companies globally have taken our services and successfully developed quality management system with our help. We have a team of highly-experienced quality management system (QMS) consultants to guide medical device manufacturing companies on quality system documentation, implementation and training process. We also help medical device companies to establish effective and good quality system and get quick ISO 13485 certification. The ISO 13485 certification audit is done by accredited certifying body auditors. Our QMS consultants can develop a management system for medical device companies in compliance with the requirements of customers and pre-eminently-of various global regulators and most importantly, the requirements of ISO 13485:2016.

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

We offer ISO 13485:2016 Documentation Kit for Quality Management System of Medical Devices throughout their lifecycle. This kit is a ready-to-use solution for quick documentation process and easy certification for organizations involved in the design, production, installation and servicing of medical devices and related services. Our documentation kit will help them to build a quality system that consistently meets customer requirements. There are several requirements in ISO 13485: 2016 standard for medical devices and related services. Our documentation kit has been prepared keeping in view all the requirements of this international standard. During implementation of ISO 13485, documents including quality manual, procedures, policies, operating instructions and formats need to be prepared by the companies to establish a good working system. Our experienced Quality system consultants have designed sample documents to help medical device companies prepare all these essential documents for system implementation and quick certification.

Contents of ISO 13485 Documentation Kit

Readymade templates included in our ISO 13485 documentation kit for medical device companies are as below:
ISO 13485 Documents Manual
  • Sample ISO 13485 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.
The entire ISO 13485 documents are well-written in English and provided in editable .doc format, so that your documents will be ready just with minimal editing. You can purchase the total documentation kit for Medical Device QMS with easy editing features and compatible with system requirements. It is a very effective tool to learn and implement QMS documentation, completely meeting the demands of the updated system requirements.

Benefits of ISO 13485 Manual and Documents for Certification

Many medical device companies are implementing ISO 13485 quality management system requirements and getting certification using our sample documents. The key benefits of using this ISO 13485:2016 documentation kit are summarized below:
  • Users can easily amend and change the ISO 13485 manual and other document templates as per their working system and create their own quality documents quickly.
  • Saves much time and cost of document preparation. Our kit gives 100% value for money to customer.
  • Procedures and formats provided in the documentation kit can help in fine-tuning the processes and establishing better control over quality management system.
  • Ready-to-use documents in .doc format reduce your time in documentation process.
  • Documents are useful in training of staff on QMS system requirements.
  • Takes care for all the sections and sub-sections of ISO 13485:2016, which gives better confidence as well as improves the quality system.
  • Effective tool to create ISO 13485 manual, procedures, records and audit checklists for quick certification.

Why ISO 13485 Manual and Procedures are Important?

Though all documents given in this kit are needed for ISO 13485 medical devices quality management system documentation and certification, ISO 13485 Manual and procedures are considered as the most important and basic documents for quality management system of companies involved in design, manufacture, supply and service of medical devices. These two types of documents constitute the top two tiers of ISO 13485 documentation. ISO 13485 Manual, also called Quality Manual, describes about the scope of quality management system of the organization, company profile, organization structure as well as details of each applicable element of ISO 13485:2016 standard. ISO 13485 Manual describes the system at macro level and also provides an overview of processes followed in order to meet the requirements of ISO 13485:2016 standard.
ISO 13485 Procedures provide detailed method of meeting requirements of relevant sections or clauses of the ISO 13485:2016 standard for QMS of medical device companies. These procedures are vital because they support operation of processes and hence establish confidence in the asset management system of an organization. All of these procedures cover the details, such as purpose, scope, responsibility, how procedure is followed, etc.

Method of Online Delivery of Our Documents

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