ISO 13485 Documents Presentation

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ISO 134852016 DOCUMENTATION REQUIREMENTS
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What is ISO 134852016 ?

• The 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
  documents.
• The ISO 134852016 document kit is based on
  medical devices quality management system with
  easy to modify templates.

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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

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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
documents.
ISO 134852016 manual should normally contain, or
refer to

• Context of the Organization
• Leadership
• Planning
• Support

• Operation
• Performance evaluation
• Improvement

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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.
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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

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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
organization.
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

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ISO 134852016 Blank Sample Formats for all the
Department

• 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.

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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
  Commissioning
• Process approach for Servicing

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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.

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Benefits

• 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
  documents.
• 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.

documentationconsultancy_at_gmail.com
www.documentationconsultancy.com
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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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www.documentationconsultancy.com
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