ISO 13485: Understanding the importance of complete Quality management system

ISO 13485 is an effective solution to meet the global requirements for a quality management system (QMS). The adoption of the ISO 13485 standard provides a convenient base for manufacturers to deal with rules and responsibilities and demonstrate a commitment to safety and quality of medical devices.

ISO 13485 is a stand-alone QMS standard, derived from the ISO 9000 quality management standard internationally recognized and accepted standard. ISO 13485 adapts the model based on ISO 9000 process for a regulated environment for medical device manufacturing.

Key Importance of ISO 13485:

ISO 13485 Documents are  important for designers, medical device manufacturers and distributors. In addition, suppliers and service providers can improve the marketing of an organization increasingly manufacturers require certification to do business with a supplier.

When it comes to the manufacture of medical devices, patient safety depends greatly on the quality and consistency of medical products, and ensure the efficiency, control and maintenance of your quality management system is essential for customers, stakeholders, patients and users, and regulators.

The value of ISO 13485 is not only in implementation but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer with a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. In addition, it can help minimize surprises and failures that could affect patient safety and harm the reputation of a manufacturer.

The beneficial outputs of an effective ISO 13485 are as follows:

  • Meaningful feedback on the effectiveness of the quality management system.
  • Confidence in regulatory compliance.
  • Identification of areas requiring attention.
  • Confirmation that the best practice is achieved.
  • Detection of areas of non-compliance and risk possible.
  • Reports and certification is valuable and recognized.

What is Requirement of ISO 13485 Documentation for Medical Devices QMS

The ISO 13485 documentation is a very easy process, if it is developed with the basic knowledge of ISO 13485 documents and medical devices in quality management system (QMS). The ISO 13485 Documentation kit include are ISO 13485 quality manual, procedures for quality management system, exhibits and SOPs, sample format and forms maintaining record,  process flow chart as well as ISO 13485 audit checklist templates written in English. Ready to use document toolkit for ISO 13485 certification is as per requirements international standard for Quality Management System in Medical devices manufacturing organizations.

ISO 13485 Manual

The 1st tier of ISO 13485 quality manual documents for requirements medical device manufacturing company is implements quality management system. This manual document includes quality policy, and organization structure and macro level system for medical devices manufacturing in QMS implementation.

ISO 13485 Procedures

ISO 13485 procedures documents which should be designed and develop quality management system for your medical devices company to meet ISO 13485 standard requirements.  The procedures documents helps to the medical devices company to make the best system and quick process improvement. List of procedures below:

  1. Procedure for Management review
  2. Procedure for Document and Data Control
  3. Procedure for Control of records
  4. Procedure for Internal Audit
  5. Procedure for Training
  6. Procedure For Corrective And Preventive Action
  7. Procedure For Control of Monitoring And Measuring Equipments
  8. Procedure for Control of Monitoring of work environment
  9. Procedure for validation of sterilization process
  10. Procedure for Monitoring and Measurement of Processes and more.

ISO 13485 Exhibits

ISO 13485 exhibits documents guidelines for training to the user to implements the process and get detailed ideas for process implementation and improvements.

  • Skill Requirements
  • Disposal of Non–conforming Products
  • Quality Plan
  • Document codification system

ISO 13485 Templates and Format

Following ISO 13485 Templates and format documents require for maintaining record as well as establish control and make system in the organization. List of format below:

  1. Purchase Order
  2. Indent cum Incoming inspection report
  3. Approved Vendor list cum open purchase order
  4. Supplier Registration form
  5. Open Purchase Order
  6. Design And Development Plan
  7. Design Review Minutes Of Meeting
  8. Design Verification Report
  9. Equipment Wise preventive maintenance checkpoints
  10. Customer Complaint report
  11. Medical Practitioner Feedback Form
  12. Validation Of Autoclave By Biological Indicator

ISO 13485 SOP (Standard Operating Procedures)

This ISO 13485 SOPs documents very helpful of any 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.

  • 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 13485 Audit Checklist

The ISO 13485 audit checklist documents based on requirements as well as for clause wise questions and department wise question. It will be very helpful tool for the auditor to make audit questionnaire clause wise audit questionnaire while auditing and make effectiveness in auditing.

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