Documentationconsultancy.com offers an editable ISO 13485 documentation kit. To achieve ISO 13485 Certification, you must have to implement Quality Management System and prepare ISO 13485 documents that define implemented system well. Documentationconsultancy.com offers an ISO 13485 Documentation Toolkit that contains a complete set of mandatory and supporting ISO 13485 documents. These documents are fully editable as per the system requirements. To know more about the ISO 13485 documents, visit here: https://www.documentationconsultancy.com/iso-13485-documents.html
3. What is ISO 13485:2016 Documentation?
ISO 13485 was published for the first time in 1996. It presents the
requirements for a comprehensive quality management system for
the design and manufacturing of medical devices. To achieve ISO
13485 Certification, you must have to implement Quality
Management System and prepare ISO 13485 documents that
define implemented system well.
5. Quality Manual
• It covers a sample copy of the
quality manual and requirement-
wise details for how ISO
13485:2016 is implemented. It
covers sample policy for all
process areas, Quality policy
and organization structure and
covers 1st tier of ISO
13485:2016 documents.
6. Procedures
• It covers a sample copy of procedures covering all the specific practice areas of
19 processes. This procedures help the organization to make the best system and
quick process improvements. All procedures are listed below.
List of Procedures
• Procedure for Management review
• Procedure for Document and Data Control
• Procedure for Control of records
• Procedure for Internal Audit
• Procedure for Training
• Procedure For Corrective And Preventive Action
• Procedure for Control of Monitoring of work environment
• And Many More...
7. Exhibits
• It covers a sample copy of guidelines covering all the details and for training to the
user to implement the processes and get detail ideas for process implementation
and improvement.
List of Exhibits
• Skill Requirements
• Disposal of Non–conforming Products
• Quality Plan
• Document codification system
8. Formats
• It covers sample copies of forms required to maintain records as well as establish
control and make a system in the organization. The samples given are as a guide
and not compulsory to follow and the organization is free to change the same to
suit its own requirements.
• Purchase Order
• Supplier Registration form
• Open Purchase Order
• Design And Development Plan
• Design Review Minutes Of Meeting
• Preventive Maintenance Schedule
List of Formats
• Validation Of Autoclave By Biological
Indicator
• Differential Pressure Monitoring
Record
• Testing Of Personnel By Finger Dab
• Installation commissioning report
• Internal Audit Non–Conformity Report
9. Standard Operating Procedures
• It covers a sample copy of work instructions to link with significant aspects of
issues in the organization. It takes care of all such issues and is used as a training
guide as well as to establish control and make a system in the organization. The
samples given are as a guide and not compulsory to follow and the organization is
free to change the same to suit its own requirements.
List of SOPs
• Measurement Of Temperature And Humidity
• Validation of Autoclave
• Microbial Monitoring of Production Area
• Temperature Monitoring of Sterility Room and Microbiology Laboratory
• Temperature & Humidity Monitoring
• Clean Room Condition Monitoring
10. • This documents kit contains ISO 13485
manual, procedures, SOPs, sample
templates and formats that comply with
system requirements.
• 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.
How This Documentation is Useful?
11. Features of
Documentation kit
• Written in Plain English
• It will save much time in typing and
preparation of documents alone.
• User-friendly and easy to learn.
• Developed under the guidance of
experienced experts.
• Provides a model of a Management
system that is simple and free from
excessive paperwork.