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 .doc format.

1. 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)
2. 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)
3. Exhibits: Sample copies of mandatory exhibits (04 exhibits - 4 pages in MS-Word format)
4. Sample Formats / Templates: Ready-to-use verified QMS forms for quick documentation (61 blank formats in MS-Word and MS-Excel format)
5. Quality SOP: A set of sample standard operating procedures (06 SOPs - 19 pages in MS-word format)
6. Filled forms: Asset register, risk assessment, risk treatment, scope document for quick record keeping.
7. 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.
8. 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 the Product

• The entire iso 13485 documents are written in easy to understand language.
• Hand-outs are written in MS-Word 2007 and Windows 2000.
• The soft copy of the documentation kit and audit iso 13485 checklists also forms a part of this kit.
• Free Download of sample DEMO is available, which guide users and ISO 13485 consultants to understand the content of documentation included in the product.
• ISO 13485 Manual and other quality system documents are developed under the guidance of the experienced quality experts.
• The kit is designed to save much of your time in typing and preparing a presentation as well as documentation.
• It is user-friendly and easy to learn.
• The set of ISO 13485 documents defines the baseline system with ISO 13485 audit checklist that satisfies standard requirements, which can be customized to suit your requirements.
• It provides a model of quality system documentation that is natural, simple and free from excessive paperwork.

How This Product is Useful

• Our documents kit contains ISO 13485 manual, procedures, SOPs, sample templates and formats that comply with system requirements.
• Our ISO 13485 2016 documentation kit is ideal for individual learning as well as group training to ensure the successful implementation of the quality management system for medical devices.
• This set of readymade documents is extremely useful to ISO 13485 consultants for complying with requirements.
• This documentation kit provides you with sample templates and ISO 13485 2016 audit checklist that you need for effective quality documentation and system implementation.
• By using our globally used editable ISO 13485 2016 documents, you can save a lot of your precious time and money while preparing the course materials for in-house documents and SOPs to create cultural change in the organization.
• It is a perfect tool to educate all employees to achieve better performance of Medical devices in the pharma sector.

PRICE – Rs. 26,500/-

HOW TO BUY

To buy ISO 13485 Documentation you can call us on +91 96672 69214 or mail us at joinconsultant123@gmail.com