Way to purchase ISO 13485 total document by Global Manager Group

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Overview ISO 134852012 Documents By Global
Manager Group
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What is ISO 13485?
ISO 134852003 critical requirements for a high
quality management system (QMS) wherever a
company must demonstrate its ability to supply
medical devices and connected services that
systematically meet client needs and regulative
needs applicable to medical devices and connected
services.
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Why is ISO 13485?
The aim of ISO 134852012 is to harmonize
international regulations in the field of medical
devices into one quality management system. ISO
13485 2003 is not sufficient to comply with
applicable law and regulations. Implementation of
additional requirements based on local law and
regulations is often required.
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Requirements of ISO 13485
ISO 13485 is quality management system standard
for medical devices. This standard requirement is
various factors in Quality management system.

• Scope
• Normative references
• Terms and definitions
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement

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Documents needs for ISO 13485 Certification?
The key sections of ISO 13485 set out a range of
documents requirements for developing,
implementing and maintaining a Quality management
system tailored to the design and production of
medical devices.

• ISO 13485 Quality Manual
• ISO 13485 Procedures
• Exhibits
• Sample Formats / Templates
• Quality SOP
• ISO 13485 Audit Checklist

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ISO 13485 Total Documents by Global Manager
Group
The ISO 13485 documents by Globalmanagergroup.com
are very useful for Medical Devices Quality
Management System. This document includes QMS
manual, procedures, exhibits, formats and audit
checklist are very helpful of upgraded and
implements QMS System and easy way of ISO 13485
certification. This document are written in
English and easily editable, which saves much
time.
Click to Download
Global Manager Group
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What is ISO 13485 Quality Manual?
The ISO 13485 quality manual is a mandatory
documents for ISO13485 certification, which
maintain quality management system in medical
devices. This quality manual included in total
documentation kit by Global Manager Group, is
given with ready to use templates for creating
Company profile, Control and distribution,
organization structure, Management Responsibility
and more. The ISO 13485 quality manual shall
outline the structure of the documentation used
in the quality management system your
organization.
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What is ISO 13485 Procedures?
The ISO 13485 procedures are designed to help the
organization in developing effective QMS
procedures for medical devices as per ISO
134852012 requirements, which accelerates the
process of certification.
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What is ISO 13485 Exhibits?
The ISO 13485 exhibits are very helpful tool to
teach all employees and staff about how to
implements and improvements of Quality management
system that helps organization to continues
improvements and get number of benefits. Followin
g list of Exhibits will be given along with
documents.

• Skill Requirements
• Disposal of Nonconforming Products
• Document codification system

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What is ISO 13485 Formats?
The ISO 13485 formats documents are not
compulsory to follow organization, but this
documents very helpful of maintain records as
well as establish control and make quality system
in the organization.
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What is ISO 13485 SOPs?
The ISO 13485 SOPs are given to help to any
significant aspects issues and used as a training
guide as well as to establish control and make
system in the organization. Following list of
Sample ISO 13485 SOPs are given by GMG.

• 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

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What is ISO 13485 Audit Checklist?
The ISO 13485 audit checklist is a good tool for
the auditor to make audit question to make
effective ISO 13485 internal audit for their
organization.
There are audit questions based on ISO 134852012
clausewise and department wise requirements are
included in the total documentation kit for ISO
134852012.
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Futures of ISO 13485 Documents

• Contains all necessary documents as listed above
  and comply with the requirements of ISO
  134852012 guidelines for product and services
  development technical report.
• 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 model of a Management system that is
  simple and free from excessive paperwork.

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Advantages of ISO 13485 Documents

• By using these documents, you can save a lot of
  your precious time while preparing ISO 13485
  documents for your company.
• Take care for all the section and sub sections
  of ISO 134852012 guidelines and helps you in
  establishing better system.
• Document kit enables users to modify the
  documents as per their industry and create own
  ISO 134852012 documents for their organization.
• Readymade templates and sample documents are
  available which can reduce your time in document
  preparation.
• The audit questions helps in making perfect
  audit checklist.
• You will get better control in your system due
  to our proven formats and templates.

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