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ISO 13485

Medical Devices-Quality Management System

ISO 13485 is a standard that stipulates the requirements for the quality management system of organizations providing design and development, production, installation and additional services of medical device. In addition, this standard can be applied to external organizations that provide services such as sterilization, calibration, and sales. It can provide the basis for a quality management system to organizations that provide medical devices and related services.





  • ISO 13485:2016 Requirements
    ISO 13485:2016 Requirements ISO 13485 is an international standard for the quality management system of the medical device industry, which was established based on ISO 9001 by adding items related to medical devices.

    1. Scope

    2. Normative references

    3. Terms and definitions

    4. Quality Management System

    5. Management responsibility

    6. Resource management

    7. Product realization

    8. Measurement, analysis and improvement
  • The importance of ISO 13485, image
    The importance of ISO 13485 Medical devices have a direct impact on human life and health, so they must ensure a higher level of stability than any other product. Therefore, the medical device industry must meet domestic regulatory systems, international standards and other requirements.

    In order to meet the requirements of the EU Medical Device Directive, a quality system must be established, and some countries, such as Canada, require ISO 13485 certification for product sales.

    With ISO 13485 system certification, A manufacturers who manufacture medical devices can demonstrate that their system meets the comprehensive requirements for quality management systems and the specific requirements for medical devices.

    This standard helps following:.

    1. Management of all processes of the organization through ISO 13485 quality management system

    2. Improvement of Work environment

    3. Proactive quality management

    4. Improving the awareness of the quality management system for all employees

    5. Reduce cost and increase efficiency

  • Estimated Effectiveness of ISO 13485,image
    Estimated Effectiveness of ISO 13485

    obtaining ISO 13485 certification, organizations can benefit from:

    1. Clients Satisfaction: Achieved by delivering products that consistently meet customer requirements, including quality, safety and legal requirements.

    2. Reduction of Operational cost: Operational efficiency improvement through continuous process improvement

    3. Improvement of a relationship between shareholders: increase organizational awareness with employees, customers and suppliers

    4. Compliance: Understanding legal and regulatory requirements that may affect the organization and its customers

    5. Improvement of risk management: Improve risk management through improved traceability of products and services

    6. Verification of Business credibility: business credential through certification to international standards

    7. Business Expansion: Satisfying the requirements for entering overseas markets
  • IGC’s Competency, image
    IGC’s Competency • IGC has been accredited for ISO 13485 by IAS, an Accreditation Body in the United States, and provides certification services for quality management systems.

    • The auditors of IGC are contributing to the continuous development of customers by accurately assessing the suitability of the medical device quality management system through the technology and expertise accumulated over the years.

    • As a trusted global leader in management system certification, IGC offers ISO 13485 certification as well as CE and FDA.

    • IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.




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  • 08Anti-Bribery

  • 09Education

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ISO 15378

Primary packaging materials for medicinal products

ISO 15378:2017 is a standard for primary packaging materials for medicinal products and also non-accredited standard developed to prove a quality management system to an organizations who supply materials. Primary packaging materials are packaging materials that directly contact the contents such as pharmaceuticals, medical devices and cosmetics. It includes glass, plastic, rubber, and aluminum.

The requirements of ISO 9001 and the requirements of GMP (Good Manufacturing Practice) must be applied. The requirements is integrated with GMP principles for design, manufacture and supply and quality management systems. The realization of GMP principles in the management of primary packaging within an organization is very important for the safety of patients using pharmaceuticals that come in direct contact with the materials.

In order to obtain ISO 15378:2017 certification, the following must be complied.

• Compliance with legal regulations

• Identification, reduction and control of risks, including contamination and manufacturing errors

• Approach for effective monitoring of the system

• Provide continuous improvement for overall products and processes





  • ISO 15378:2017 요구사항
    ISO 15378:2017 Requirements The ISO 15378:2017 consists of the same 10 high-level structures, and must consistently meet the requirements of the clients including the requirements of the relevant standards and international standards. The ISO 15378:2017 consists of 10 chapters and 4 appendices. Manufacturers who understand and implement the quality management system can also obtain ISO 15378 certification through understanding and reflection of additional requirements.

    1.Scope
    2.Normative references
    3.Terms and definitions
    4.Context of the organization
    5.Leadership
    6.Planning
    7.Support
    8.Operation
    9.Performance evaluationn
    10.Improvement

    Following are the additional requirements of ISO 15378:2017.

    4.3 Determining the scope of the quality management system: The document must be signed and, if necessary, designated as a security document, and must be identified.
    4.4 A record of important process should be double checked.
    5.2 It should accept the an audit client wants and meet the requirements.
    5.5 Maintain a signed list of employees and emphasize the independence of the quality department.
    5.5.3 In internal communication, legal matters must be included and important quality situations must be communicated in a timely manner.
    5.8.3 At the management review meeting, the effectiveness of education and training should be grasped.
    6.2 GMP training was emphasized.
    6.4 Criteria for clean room and work environment must be established, and pollution control, pest control, utility, and maintenance activities must be described.
    7.1 A risk assessment must be conducted.
    7.2 Any changes to the product must be notified and client requirements for disposal of discarded packaging materials must be documented.
    7.2.3 Clients should also be notified of product problems that have not yet been discovered.
    7.3 Risk assessment should also be carried out in the design and development stages, and clients should be notified of any design changes.
    7.4 Outsourced companies should be managed, and especially those conducting experiments should evaluate their capabilities. The quality department's approval is required for key supplies.
    7.5.1 The date of manufacturing must be managed and the production environmental conditions must be approved by the client. Containers and filling and packaging lines should be identified, and reprocessed materials also require client's approval. Line checks for the next work should be performed, and change management procedures should be established.
    7.5.2 The validity of the product process must be checked and performed, and if there are any changes, the validity must be checked again. In addition, this validity should be managed as a record, and data such as a results of function test when using the software and accuracy should be maintained.
    7.5.3 It must be possible to identify and track products in the production process including important process data.
    7.5.5 The retention period and storage conditions must be specified.
    7.6 The load of automatic inspection equipment must be tested, production data must be provided upon customer request, and critical measuring equipment must be calibrated.
    8.2.4 Records of deviation and warehousing inspection, process inspection, final inspection, and stored products must be managed.
    8.3 The risk of reworked products must be evaluated, and the quality department must approve the rework, and nonconformity must be managed under client's approval.
    8.5.2 Corrective action should be carried out as quickly as possible within a specific schedule.

    * Scope
    1. If it is necessary to demonstrate the organization's ability to provide primary packaging for medicinal products, the requirements for the quality management system should be specified.

    2. This standard is applied to the design, manufacture and supply of primary packaging materials for medicinal products, and this standard can also be used for certification purposes.

    3. All requirements of this standard are general, developed to be applicable to all organizations regardless of product, and if the requirements of the standard cannot be applied to the organization and product, its provisions can be excluded.



    * Additional requirements except ISO 9001:2015

    The ISO 15378:2017 consists of 10 chapters and 4 appendices. Manufacturers who understand and implement the quality management system can also obtain ISO 15378 certification through understanding and reflection of additional requirements.




  • The importance of ISO 15378, image
    ISO The importance of ISO 15378 Certification for primary packaging materials that apply the requirements of GMP and quality management systems is recognized worldwide. Primary packaging materials in direct contact with medicinal products is especially important. Because It is directly related to the health of people or animals using pharmaceuticals.

    The advantages of ISO 15378 certification are as follows:

    1. It can reduce costs by minimizing contamination, mixing and manufacturing errors and waste in manufacturing and improving productivity.

    2. By providing guidance on risk management and validation, you can mitigate the risks identified as contamination in your products, and ensure product efficacy and shelf life.

    3. By complying with GMP requirements in accordance with the ISO 15378:2017, you can improve your production process proficiency.

    4. By producing products in compliance with the requirements of the quality management system and GMP requirements, high-quality products are guaranteed and this can lead to improved clients' satisfaction, and can establish optimized quality management system requirements.

    5. It can help protect your brand by enhancing your organization's value with key stakeholders and ensure the quality and stability of your organization.

    6. It helps organizations effectively manage risk by helping organizations identify, control and manage risks throughout the ISO 15378 audit process.


  • IGC’s Competency, image
    IGC’s Competency 1. IGC has been accredited for ISO 13485 by IAS, an Accreditation Body in the United States, and provides certification services for quality management systems.

    2. The auditors of IGC are contributing to the continuous development of customers by accurately assessing the suitability of the medical device quality management system through the technology and expertise accumulated over the years.

    3. As a trusted global leader in management system certification, IGC offers ISO 9001 and ISO 13485 certification as well as environmental management and other management systems.

    4. IGC has up-to-date knowledge of a wide range of specific scopes and legal requirements in major markets around the world, and provides the knowledge and services to support your entire global operation.





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  • 02Environment

  • 03Health and Safety

  • 04Medical Devices

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ISO 14155

Clinical investigation of medical devices for human subjects — Good clinical practice

ISO 14155 is 'Clinical investigation of medical devices for human subjects -Good Clinical Practice (GCP)', which provides guidelines for clinical investigation principles, procedures to be carried out, and information to be collected.

By conducting clinical investigation according to ISO 14155, it is possible to collect objective and reliable scientific clinical data while protecting the safety and health of subjects. In addition, not only the EU, but also United States, Canada, Brazil, Australia, Japan, China, and Russia have recognized medical device clinical investigation and clinical data based on ISO 14155, so their importance and efficiency will increase further.





  • ISO 14155:2011 RequirementsISO, image
    ISO 14155:2011 RequirementsISO ISO 14155:2011 is a standard that introduces not only the GCP, but also the concept of research review by sponsors, researchers, and sites related to the clinical quality management process. It enables accurate and reliable clinical data collection with ethical considerations and a step-by-step approach to clinical investigation.

    1. Scope

    2. Normative reference

    3. Terms and definitions

    4. Summary of good clinical practice (GCP) principles

    5. Ethical considerations

    6. Clinical investigation planning

    7. Clinical investigation conduct

    8. Suspension, termination, and close-out of the clinical investigation

    9. Responsibilities of the sponsor

    10. Responsibilities of the principal investigator

  • The importance of ISO 14155, image
    The importance of ISO 14155 Proper design of the clinical investigation plan is essential. Failure to disclose the proper rules and procedures for data collection is very important as it can result in the medical device manufacturer's safety and performance claims being insufficiently supported. In addition, compliance with this standard is vital evidence that the rights, stability, and well-being of subjects are guaranteed and that clinical investigation data are reliable.

    This standard helps following:

    1. Identification of all possible risks associated with medical devices

    2. Clinical data related to safety and performance can be collected

    3. Protecting patient safety and welfare

    4. Device’s conformity assessment
  • Estimated Effectiveness of ISO 14155,image
    Estimated Effectiveness of ISO 14155

    1. Quality Management System Certification and Audit Specialist
    In general, approval of medical devices requires implementation of a quality management system. IGC performs quality management system certification, audit and factory audit in accordance with most international regulations and standards, allowing customers to reduce time and cost and receive integrated inspection and audit.

    2. Provision of the best solution
    IGC provides testing services necessary to enter the major medical device market in accordance with international standards and regulations.

    3. Partnership with professional groups
    IGC has accumulated expertise in technology and regulation for medical devices for a long time, and is consistently trusted by various organizations ranging from global manufacturers to local research institutes.
  • IGC’s Competency, image
    IGC’s Competency From May 2020, when MDR is fully applied, clinical data and research results based on ISO 14155 will be required for the export of medical devices to the EU. IGC's medical device clinical experts will conduct a GCP compliance review for your clinical investigation and provide corrective action recommendations.

    IGC has the best Competency to:

    1. Clinical investigation management and monitoring of Medical device

    2. Design of medical device clinical investigation research and Support of protocol development

    3. Review of clinical investigation report

    4. Review of Clinical Trial Master File





Related Services from IGC

  • 01Quality

  • 02Environment

  • 03Health and Safety

  • 04Medical Devices

  • 05Food

  • 06Energy

  • 07Information Security

  • 08Anti-Bribery

  • 09Education

  • 10Business Continuity

  • 11Cosmetics

  • 12Customer Satisfaction

  • 13Social Accountability