ISO 13485 – MDQMS

Medical Devices Quality Management System

ISO 13485
Free ISO 13485 Certification Cheat Sheet
ISO 13485 Consulting
ISO 13485 Lead Auditor Training
ISO 13485 Lead Implementer Training

What is ISO 13485?

ISO 13485 specifies the requirements for Quality Management System (QMS) where an organization able to exhibit the competency to deliver medical devices and medical relevant services that can fulfill not only the requirements of customers’ but of applicable regulatory requirements. The most updated version of ISO 13485 is ISO 13485:2016. It is an internationally recognized quality management system for medical devices.

Why is ISO 13485 important?

The medical device industry can make use of ISO 13485 standard at any stage be it one of the stages of product life cycle development that include design and maturing the developed design, product manufacturing, storage and distribution of final product, installation and relevant services of medical devices along with provision of all the associated activities which might be in the form of technical (on-site or remote) support.

What are the benefits of ISO 13485 – Medical Devices — Quality Management System?

A Quality Management System for medical devices complying with the international standard, such as ISO 13485 would increase your company’s worth manifolds. It will reduce your costs. Some notable benefits of being ISO 13485 certified are as follows:

  • An improvement in processes would see a reduction in operational costs
  • The stakeholder relationship with an organization will strengthen with the reliability of the management.
  • Fulfilling ISO 13485 requirements will project a trust-able and meticulous image of your organization which is all-important in the Medical world.
  • The upgraded risk management will be cost-effective to your organization with its better consistency by adhering to ISO 13485 quality management principles.
  • You can accept a wider market range than the time when your organization wasn’t adhering to ISO 13485 standards. The internal and national authorities prefer a third-party audited and certified organization.
  • ISO 13485 requirements fully cover all the regulatory requirements of legal and contractual requirements and it has been recognized by Global Harmonization Task Force (GHTF) by becoming model MDQMS standard for the medical industry.
  • Since ISO 13485’s standard is very close to the requirements of the Food and Drug Administration (FDA) so it partially covers the criteria of the FDA too.
  • Adherence to appropriate medical devices quality management principles will aid your organization in achieving business objectives and goals, whereas a poorly designed quality management system would result in a huge overall deterioration of your company’s structure.

    What is difference between ISO 9001 and ISO 13485?
    ISO 9001 and ISO 13485 high-level structure are different but there is a good overlap on individual clauses.

    The mandatory compliance requirements around the Documented Information, Internal Audit, Nonconformance, Corrective Actions, Management Review, Risk Management are the same for both standards.

    ISO 13485 focuses on the specific Medical Device product/service which is identified per the scope. Additionally, Regulatory requirements, health and safety, device master records, and device history files need to be defined and addressed.

    So short answer is, if you have a strong ISO 9001 framework, you are halfway there in meeting the ISO 13485 requirements.

    Please contact us at [email protected] for PPT for ISO 9001 VS ISO 13485

    What are the practical steps for ISO 13485 Certification?

    Stage 1: Discovery

  • Gap Analysis to identify the gaps as compared to standard requirements
  • Awareness Training

    Stage 2: Documentation & Implementation

  • Documentation
    Documenting Management System procedures, WI-based on document structure most suitable and value adds to the Organization.

  • Implementation
    Once documents are drafted, reviewed, and approved, process owners, will implement the documented processes. Management involvement for in-depth product /service-related risk assessment and management of DMR, DHF, and Medical Device Reporting process.

    Stage 3: Audit (Internal and External)

  • Internal Audit of the implemented QMS and Management Review is a mandatory requirement. An internal Audit program with an Internal Audit schedule and plan is required. Internal audit needs to be conducted by Trained Internal Auditors/External Contracted Auditors
  • After Internal Audit, External Audit can be scheduled and conducted.
    This entire process can take up to 6-8 months depending on the number of locations, employees, scope, number of processes, and resource commitment by the organization.
  • Is the ISO 13485 certification applicable to distributors or merchant exporters?
    ISO 13485 is a Quality Management System for Medical devices applicable to the entire lifecycle for product and service. The processes involved from maintenance, post-manufacturing processes like packaging, shipping, and distribution are required to be compliant with the ISO standard. This in light of ensuring the accurate and quality performance of the product at the point of use. Hence all the support processes have to be certified to the standard.
    How long will it take to get certified?
    Certification timelines depend on multiple factors:

    Scope and Complexity
    Number of Locations
    Number of employees
    Resource allocation
    Timeline for certification ranges from 6-8 months depending on the factors above. Additionally, if the core process & standard operating procedures are defined, that makes the process go faster and the timeline of implementation is shorter. For a small size, organization certification can be achieved in 6 months. During the external audit, it will be very important that every process owner is able to demonstrate competence and awareness of their processes. Auditor will want to see a system that has been implemented for at least 3-4 months.

    What additional cost are associated with ISO certification and maintenance?
    While considering ISO certification it is very critical to understand the various costs incurred.

    These costs include:

    1st Year Cost

  • Create and Charter ISO project (Quality Manager)
  • External Registrar Cost+ Logistic Cost
  • Consultant Support( if external consultant used)

    2nd Year Cost

  • Surveillance Audit and Logistics cost.
  • Soft Cost associated with Internal Audit, Reporting, and Maintenance of the QMS

    Recertification cost( every 3 years)

  • External Audit and Logistics cost
  • What is difference between ISO 9001 and ISO 13485?
    ISO 9001 and ISO 13485 high-level structure are different but there is a good overlap on individual clauses.

    The mandatory compliance requirements around the Documented Information, Internal Audit, Nonconformance, Corrective Actions, Management Review, Risk Management are the same for both standards.

    ISO 13485 focuses on the specific Medical Device product/service which is identified per the scope. Additionally, Regulatory requirements, health and safety, device master records, and device history files need to be defined and addressed.

    So short answer is, if you have a strong ISO 9001 framework, you are halfway there in meeting the ISO 13485 requirements.

    Please contact us at [email protected] for PPT for ISO 9001 VS ISO 13485

    What are the practical steps for ISO 13485 Certification?

    Stage 1: Discovery

  • Gap Analysis to identify the gaps as compared to standard requirements
  • Awareness Training

    Stage 2: Documentation & Implementation

  • Documentation
    Documenting Management System procedures, WI-based on document structure most suitable and value adds to the Organization.

  • Implementation
    Once documents are drafted, reviewed, and approved, process owners, will implement the documented processes. Management involvement for in-depth product /service-related risk assessment and management of DMR, DHF, and Medical Device Reporting process.

    Stage 3: Audit (Internal and External)

  • Internal Audit of the implemented QMS and Management Review is a mandatory requirement. An internal Audit program with an Internal Audit schedule and plan is required. Internal audit needs to be conducted by Trained Internal Auditors/External Contracted Auditors
  • After Internal Audit, External Audit can be scheduled and conducted.
    This entire process can take up to 6-8 months depending on the number of locations, employees, scope, number of processes, and resource commitment by the organization.
  • Is the ISO 13485 certification applicable to distributors or merchant exporters?
    ISO 13485 is a Quality Management System for Medical devices applicable to the entire lifecycle for product and service. The processes involved from maintenance, post-manufacturing processes like packaging, shipping, and distribution are required to be compliant with the ISO standard. This in light of ensuring the accurate and quality performance of the product at the point of use. Hence all the support processes have to be certified to the standard.
    How long will it take to get certified?
    Certification timelines depend on multiple factors:

    Scope and Complexity
    Number of Locations
    Number of employees
    Resource allocation
    Timeline for certification ranges from 6-8 months depending on the factors above. Additionally, if the core process & standard operating procedures are defined, that makes the process go faster and the timeline of implementation is shorter. For a small size, organization certification can be achieved in 6 months. During the external audit, it will be very important that every process owner is able to demonstrate competence and awareness of their processes. Auditor will want to see a system that has been implemented for at least 3-4 months.

    What additional cost are associated with ISO certification and maintenance?
    While considering ISO certification it is very critical to understand the various costs incurred.

    These costs include:

    1st Year Cost

  • Create and Charter ISO project (Quality Manager)
  • External Registrar Cost+ Logistic Cost
  • Consultant Support( if external consultant used)

    2nd Year Cost

  • Surveillance Audit and Logistics cost.
  • Soft Cost associated with Internal Audit, Reporting, and Maintenance of the QMS

    Recertification cost( every 3 years)

  • External Audit and Logistics cost
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