ISO 13485 Certification


What is ISO 13485 certification(MDQMS)

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

ISO 13485 Certification was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

What are the benefits of being certified to ISO 13485 Certification?

ISO 13485 Certification can support you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

Demonstrate that you produce safer medical devices
Meet regulatory requirements and customer expectations
Outline how to review and improve processes
Increase efficiency, cut costs and monitor performance

What are the requirements for ISO 13485 Certification?

Clause 4: Context of the organization
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance evaluation
Clause 10: Improvement


Obtaining an ISO 13485 certification can be explained as a simple process. Follow these steps to get started:

Get management support
Identify requirements
Define the scope
Define processes & procedures
Implement processes and procedures
Deploy training and awareness programs
Connect with SIS Certifications
Operate the MDQMS / Measure the system
Conduct internal-audits
Conduct management review
Take corrective action
Perform the stage 1 certification audit
Stage 2 certification audit
Get Certification

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      Management system standards such as ISO 13485 is one of the Standard which is also know as the mother of all standards needs to be understood. We at SIS Certifications are well equipped with the experts and trainers who can train you and get you to another level of understanding of the requirements of the standard.
      There are various types of ISO 13485 training which you can undergo based on your requirement of level of understanding and need of the standard.
      The training can be categorized in to Awareness training, Internal auditor training, lead auditor training and Implementation training.

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        ISO 13485 Certification  is an international standard that defines the requirements for the Quality Management system for the manufacturers, contract services, suppliers, distributors of the medical devices, So ISO 13485:2016 Certification also called MDQMS. The major aim of the standard is to maintain harmony between the legal requirements and the management system, the one which is being followed to manufacture or trade the medical devices. The basis for ISO 13485  standard is ISO 9001  and the same is structure is referred and followed for ISO 13485 Certification completion. It is obligatory to implement ISO 13485:2016 Certification for the organizations exporting medical devices to other countries.

        What is ISO 13485:2016 Certification?

        ISO 13485:2016 Certification – Quality management system for Medical devices ensures that all the medical devices manufactured or transported meets all the relevant compliances and the specifications given by the customer. ISO 13485  acts as a valuable credential which helps all the professionals and customers to be safe in clinics and hospitals.

        ISO 13485 is basically based on the international system- ISO 9001 Certification. The special requirements of the medical industry are integrated in ISO 9001:2015 to make it a standard specific to medical industry. The major objective of this standard is to keep all the medical device regulations in place. The standard consists of the requirements for the manufacturing, installation and servicing of medical devices.

        The major portion taken care by the standard are-

        1. Implementation of the ISO 13485:2016 Certification- Medical Devices Management system Certification and get the intended output.
        2. The development of the product and their realization through the risk management approach.
        3. Validation of processes
        4. Compliance with statutory and regulatory requirements
        5. Effective product traceability and recall systems

        ISO 13485:2016 Certification – Quality Management System- medical devices- provides a framework which helps organization to reduce the safety, legal and statutory risks involved in the manufacturing of the medical devices. ISO 13485 Certification helps the organization to gain trust and reputation in the industry and marks the name of the organization in the trustworthy providers and manufacturers. The Standard is reviewed every five years and is subjected to be revised according to the new regulations.

        What are the requirements of ISO 13485 Certification (MDQMS)?

        ISO 13485 Certification – international management system standard for Medical industries also known as “Quality management system for medical devices” helps the organization to consistently meet the customer and applicable regulatory requirements. The standard can be applied to any type of organization regardless of size, type, except where explicitly stated. ISO 13485:2016 can be applied to the medial industry – manufacturing as well as the associated services delivered by the organizations such as transportation, storage, Software development, etc.

        The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about:

        Section 4: Quality Management System – This section talks about general QMS requirements. The documentation of the Manuals, procedures, records, documents, and different level of documentations.

        Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be instrumental in the implementation and maintenance of the QMS. Along with planning for the QMS, there is a need for top management to be involved in the ongoing review of the system to ensure customer satisfaction and improvement.

        Section 6: Resource Management The section on management of resources is short, but covers the necessity to control all resources, including human resources, buildings, and infrastructure and the working environment.

        Section 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. ISO 13485 (MDQMS) allows for requirements in the section to be excluded if they are not applicable to the company (such as a company that does not design products or services).

        Section 8: Measurement, Analysis and Improvement – This last section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions.

        What is the difference between ISO 9001 and ISO 13485?

        Although, ISO 13485:2016 is a standalone standard but the base of this standard is ISO 9001 Certification (QMS). ISO 9001 is an internationally recognized standard for any organization in any industry, ISO 13485 can be considered as the extended version of ISO 9001 Certification. The specific requirements according to the regulations and worldwide system in medical industry is incorporated in ISO 13485:2016 (MDQMS) international management system standard. Some of the specific requirements of ISO 13485 for the Medical devices are as stated below.
        The documentation of the medical devices technical file is one of the specific requirements of the standard.
        Specific environment conditions In the organization.
        Control of the contamination in the organization which can act adversely in the process.
        Housekeeping and cleanliness of the products.
        Production requirements for sterile medical devices, and
        Requirements for reporting to regulatory authorities.

        As can be seen, these additional requirements are applicable only to medical device manufacturers.

        Is ISO 13485 Certification mandatory?

        None of the ISO Certification are mandatory to be opted for. But ISO 13485 is one of the standard which almost all the customers demands from their vendors. This standard makes sure that the process of manufacturing or providing services are upto the international level. Not only ISO 13485 certification helps in getting the management system implemented but also makes sures that all the legal and statutory requirements are being met and are reported to the authority. The medical devices which are being maintained are used as applying for various tenders/ approval of the product at client’s place. The EU MDR regulation is also fulfilled by applying ISO 13485 in your organization. If the organization wishes to go for CE mark for their medical products, this international standard- ISO 13485- Quality Management system for Medical devices is the mandatory certification which needs to be done.

        What is “ISO 13485 certified”?

        ISO 13485 certification means that the organization has been completely assessed and audited as per this international management system standard by the competent personal. This also shows that the certification awarded is accepted worldwide and is a symbol which says that the organization is following the Management system standard for Medical devices in their organization.

        The Certification to ISO 13485 Certification takes place in two stages:

        • Stage 1 audit- this is also known as the documentation review. The documentation done by the organization as per the requirements of the standard ISO 13485 Certifiction is being audited and it is made sure that the organization has all the relevant documentations ready and can proceed for the final audit.
        • Stage 2 audit- this is also known as the process audit. The implementation of the documentations that are available as per the requirements of the standards is being verified and assessed if the requirements of the standard is being met completely.

        Benefits of ISO 13485 Certification

        Customer satisfaction
        Reduced operating costs
        Improved stakeholder relationships
        Legal compliance
        Proven business credentials
        Ability to win business in regulated sectors
        Improved risk management

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