ISO 13485 Documents Presentation - PowerPoint PPT Presentation

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ISO 13485 Documents Presentation


We offer ISO 13485:2016 Documentation Toolkit, which is a set of ready-to-use templates designed as per general version of standard requirements. Our readymade ISO 13485 documents includes ISO 13485 Quality Manual, ISO 13485 Procedures, Exhibits, SOPs, ISO 13485 Audit Checklist, etc. – PowerPoint PPT presentation

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Title: ISO 13485 Documents Presentation

What is ISO 134852016 ?
  • TheĀ ISO 13485 is an international standard for
    Medical Devices Quality Management System
    Requirements for regulatory purposes represent
    the requirements that the medical device
    manufacturers must incorporate into their
    management systems.
  • Our ISO 134852016 Documentation kit includes
    Quality Manual, procedures, Exhibits, SOPs, audit
    checklist, etc. in ready to edit MS-Word
  • The ISO 134852016 document kit is based on
    medical devices quality management system with
    easy to modify templates.
ISO 134852016 Documentation Requirements
  • Quality Manual
  • Procedures
  • Exhibits
  • Standard Operating Procedures (SOPs)
  • Blank sample formats for all the departments
  • Process Flow Chart
  • ISO 13485 Audit checklist
  • Medical Device File
Quality Manual
It covers sample copy of ISO 13485 manual and
requirement wise details for how ISO 134852016
is implemented. It covers sample policy for all
process areas, Quality policy and organization
structure and covers 1st tier of ISO 134852016
ISO 134852016 manual should normally contain, or
refer to
  • Context of the Organization
  • Leadership
  • Planning
  • Support
  • Operation
  • Performance evaluation
  • Improvement
ISO 134852016 Procedures
Sample copies of mandatory procedures as per ISO
134852016 are provided, which cover all the
details like purpose, scope, responsibility, how
procedure is followed as well as the list of
exhibits, reference documents and formats.
It covers sample copy of procedures covering all
the specific practice areas of 19 processes. Our
procedures help the organization to make the best
system and quick process improvements.
ISO 134852016 Exhibits
It covers 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 -
  • Exhibits for Skill requirements
  • Exhibits for Disposal of nonconforming products
  • Exhibits for Quality plan
  • Exhibits for Document codification system
ISO 134852016 Standard Operating Procedure (SOPs)
It covers sample copy of work instructions to
link with significant aspects issues in the
organization. It takes care of all such issues
and used as a training guide as well as to
establish control and make system in the
List of Standard Operating Procedure -
  • 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
ISO 134852016 Blank Sample Formats for all the
  • It covers sample copy of forms required to
    maintain records as well as establish control and
    make system in the organization. The samples
    given are as a guide and not compulsory to follow
    and organization is free to change the same to
    suit own requirements.
Process Flow Chart
  • Process approach for Despatch
  • Process approach for Design and Development
  • Process approach for Engineering
  • Process approach for Training
  • Process approach for Marketing
  • Process approach for Management Representative
  • Process approach for Production
  • Process approach for Purchase
  • Process approach for Quality Control
  • Process approach for Stores
  • Process approach for Installation and
  • Process approach for Servicing
ISO 134852016 Audit Checklist
  • There covers audit questions based on ISO
    134852016 requirements as well as for Clause
    wise questions and department wise question. It
    will be very good tool for the auditors to make
    audit Questionnaire / clause wise audit
    Questionnaire while auditing and make
    effectiveness in auditing.
  • The kit takes care of all the sections and
    sub-sections of ISO 13485 standard and helps you
    to establish better system.
  • By using these documents, you can save a lot of
    your precious time while preparing the ISO 13485
  • This set of readymade documents is extremely
    useful to ISO 13485 consultants for complying
    with requirements.
  • It is a perfect tool to educate all employees to
    achieve better performance of Medical devices in
    the pharma sector.
ISO 134852016 Documentation Kit
  • The kit contains all necessary documents as
    listed above and complies with the requirements
    of ISO 13485 standard.
  • The documents are written in easy to understand
    English language.
  • It will save much time in typing and preparing
    your documents at your own.
  • This documentation kit provides you with sample
    templates and ISO 13485 2016 audit checklist that
    you need for effective quality documentation and
    system implementation.
  • The kit content is developed under the guidance
    of experienced experts.
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