ISO 13485


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How to Start ISO 13485 Certification


What Is An ISMS ISO 13485

Safety and quality are not negotiated in the case of medical devices, and so is a requirement of ISO 13485, which specifies the need for a quality management system, where an organization must maintain its capabilities to meet medical devices and related services. needs to be shown. applicable regulatory requirements. These organizations are involved in one or more life-cycle phases such as design, storage and distribution, production, development, installation or servicing of medical equipment and design and development or provision of any associated activities/services. This ISO 13485 is also used by suppliers or external parties to provide a product with services related to the quality management system to organizations.

ISO 13485 aligns with the earlier version of ISO 9001, the internationally recognized standard for quality management systems established by ISO. The requirements set by ISO are recognized worldwide for implementing a quality management system. Although the ISO 13485 standard emerged after a major update to ISO 9001, it does not align with a new revision of ISO 9001, as it was determined that the most recent changes to ISO 9001 were unnecessary for medical devices.

ISO 13485 is the medical device organization that accepts most international standards for quality management. Third-party certification of ISO 13485 is necessary to prove that the organization is complying with the requirements of the standard as it issues the International Organization for Standardization (ISO), which meets the broad requirements for quality management systems in medicine. is an effective solution. Equipment organization.

ISO 13485 is divided into eight sections; The first three are introductory, and the last five are mandatory requirements for a quality management system (QMS), which are quality management system, management responsibility, resource management, product receipt and measurement, analysis and improvement.

    Important amendments to the ISO 13485 standard are as follows:

  • ISO 13485:2016 has replaced ISO 13485:2003 and 13485:2012
  • Revised ISO 13485:2016 Published 1 March 2016
  • ISO 13485:2016 compliant with ISO 9001:2008 and not with ISO 9001:2015
  • Changes are managed by ISO Technical Committee 210, ensuring that the Quality Management System (QMS) standard is maintained.

Advantages and Benefits of Getting ISO 13485 Certification

    Following are benefits of getting ISO certification are as follows:

  • Contains an internationally recognized EN ISO 13485 certified Quality Management System (QMS)
  • more product opportunities
  • broad market access approval
  • Medical device manufacturers or other subcontractors have the chance to take advantage of their certified Quality Management System (QMS) status for a smooth and seamless transition into specialty certification.
  • Meaningful Feedback on the Effectiveness of the Quality Management System (QMS)
  • confidence in compliance with the rules
  • Identification of areas needing attention
  • Identification of areas of non-compliance and risk
  • future growth and expansion
  • Valuable and recognized reporting and certification
  • more opportunities
  • clear understanding of equipment

Pre - Requisites for ISO 13485 Certification

The list of pre - requisites required to get ISO 13485 Certification is as follows

Common requirements
include the need to comply with the standard, the need to document documents, maintain the written procedures required by the organization and ensure the effectiveness of a system that the organization implements, considering risk factors in all activities, Initiate steps to reduce identified risk and target not to cause catastrophic events, identify how things should be done and stick to procedures to generate medical equipment, Tracking activities, collecting any process failures or oversights and producing records to show all activities, determining requirements that the organization is legally bound to and ensuring accountability is maintained even in the case of outsourcing work And also ensuring that the manufacturing processes are in place and working effectively.

Documentation requirements
include quality manuals, commitments with policy or purpose statements, specific requirements for both medical device manufacturing processes and records, including its file, product specifications and guidelines on intended use, planning plans and control records.

Management responsibility
is where the organization's management shows and is committed that they can be held accountable or accountable for operations within the organization and must ensure that their focus does not constrain the needs of consumers. It also ensures that the management is following the proper laws in the manufacturing process. Management has full responsibility for supporting the quality policy, proper alignment with the laws of the country of work and for the objectives of the employees.

Resource Management
includes the management’s responsibility to assure that the Quality Management System (QMS) is compliant with ISO 13485 and other regulatory requirements. The management must assure adequate resources are available to perform the Organisation’s promised work. Provide personnel, infrastructure, consumables, equipment, succession planning, etc.

Product Realization
means a plan for a journey from conceptualisation to implementation. It includes developing a process for documenting how products are initiated and verified, and products are designed, verified, developed, designed, and validated to ISO 13485 requirements.

Measure, analyze and improve, i.e. the product of the organization is created and released for general use. This includes handling complaints, reporting incidents to regulatory authorities, conducting internal assessment through auditing, internally continuous process and product evaluation, identifying and controlling products that do not meet original design requirements, and analyzing generated data. and continuous improvement in the process.

Documents Required for ISO 13485 Certification

    Essential Documents needed for compliance with ISO 13485 are related to the following:

  • Roles that the organization performs under applicable regulatory requirements
  • quality manual
  • medical equipment file
  • Records for verification of application of computer software
  • process for document control
  • process for record control
  • quality policy
  • quality objectives
  • Responsibilities and Officers
  • Procedure and records for management review
  • training process
  • Requirements for infrastructure and maintenance activities
  • Arrangements for the control of contaminated or potentially contaminated product
  • product procurement plan results
  • work environment requirements
  • Records the results of a review of customer requirements and actions arising therefrom
  • communication with customers
  • process for design and development
  • Risk management process in product receipt
  • design and development plan
  • Design and Development Output
  • Design and development review records
  • Design Verification Plan, Results and Conclusions
  • Design Verification Plan, Results and Conclusions
  • Process for transfer of design and development output to manufacturing
  • Process and records for control of design and development changes
  • design and development file
  • procurement process
  • Criteria and records for evaluation and selection of suppliers
  • Record of verification of purchased product
  • Record for medical device or batch that provides traceability
  • Product cleaning requirements
  • Requirements for medical device installation and verification of installation
  • Procedures and records for servicing medical equipment
  • record of sterilization procedure
  • Process and production records as well as service provision process verification
  • Procedure and Records for the Verification of a Process for Sterilization and Sterilization Barrier Systems
  • Process for product identification
  • Process for Traceability
  • Record of traceability with the name and address of the shipping package consignee
  • Report on changes in customer assets
  • Procedure for maintaining product conformity
  • Monitoring and Measuring Process
  • record of calibration
  • Procedure and records for verification of application of computer software used to monitor and measure
  • Process for customer feedback
  • Procedure and records for handling complaints
  • Records for reporting to regulatory authorities
  • internal audit process
  • Audit records and their result
  • Identification of the person authorizing the release of the product
  • Control procedures and records of non-conforming product
  • resume work record
  • Process and records for data analysis
  • Procedure and record for corrective action
  • Procedure and records for a preventive

Process to Achieve ISO 13485 Certification

    There are four essentials steps to be followed to get ISO 13485 certification:

  • Optional preliminary audit

    Voluntary site inspections are conducted, and quality management documents are reviewed, assessing the organization's readiness for full scale I and II auditing phases.

  • Audit: Stage I

    Eligibility for certification is determined by the results of on-site auditing, business assessment and quality management document analysis.

  • Audit: Stage II

    On-site assessment of Quality Management System (QMS) for excellence in the areas of applied practice and competencies.

  • Certification

    Official confirmation certifies the integrity of your quality management system and compliance with standards.

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Frequently Asked Questions

ISO 13485:2016 is the third edition of ISO 13485 standards titled Medical Device: Quality Management Systems: Requirements for regulatory purposes.

ISO is a short form for International Organization for Standardisation, a worldwide federation of national standards bodies.

THe ISO 13485 is adapted to provide a practical foundation for manufacturer to address the EU Medical Device Directive, EU Medical Device Regulation and other regulations, as well as to commit to the security and quality of medical devices

ISO 13485 requires the organization to identify the role under the regulatory requirements and regulatory requirements applicable to activities under the roles and incorporate these regulatory requirements within the quality management system.

The latest version of ISO 13485 is ISO 13485:2016, which was adopted in march 2016.

Designers, manufacturers and distributors of medical devices are eligible to be certified under ISO 13485

The ISO 13485 certification is not done under ISO; rather, by a third party, an organization can achieve such certification.

ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.

Abstract. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485 Certification cost is approx @ Rs: 4999/- (For 3 Years)

To know More about ISMS ISO 27001 click Detailed ISMS 27001

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