Home ISO 13485 MDQMS

We are the largest ISO 13485:2016 Medical Devices – Quality Management System consulting, certification, training, implementation and facilitation organizations in the Philippines. With offices over 35 countries and clients over 78 countries, we partner companies and organizations of sizes and nature in Philippines to implement the MD-QMS as per ISO 13485:2016 standard effectively, efficiently and quickly while adding tremendous value to the profitability, performance and competitiveness of an organization.

ISO compliance is important not only to the medical service providers but also to the medical kits’ manufacturers. You may have medical devices for prevention, diagnosis and disease treatment. To ensure the quality and safety of these devices, you can hire our consultants for ISO 13485 certification in Manila.

ISO 13485 certification requirements in Philippines

There are lots of stringent regulatory requirements for the manufacturing life cycle of a product. The organizations in the medical industry have to reveal their quality management procedures. Simultaneously, you can ensure the right methodologies for dealing with the clinical kits. At ISO Philippines, we help you to get ISO 13485 certification in Manila.

The requirements can be different, depending on the medical device types, ranging from the pacemaker to wheelchair.

The processes, accomplished by this ISO certification standard, are pertinent to your organization. However, they are always accounted for QMS of the organization.

Why choose ISO 13485 certification?

ISO 13485 certification in Cube is advantageous for several organizations. Whether you are a third party or supplier, you can choose this certification standard. While the relevant regulatory needs help with the exclusions of development and design controls, you may use it as the justification of exclusion from your QMS.

As ISO 13485 mentions QMS requirements, we help you to know them. Your organization has to prove its capability of providing medical kits and relevant services, consistently fulfilling customer needs. If your organization is associated with the medical device servicing, installation, production, and design, it is best to get ISO 13485 certifications in Cube.

Now, hire our certification services for ISO 13485 medical devices QMS in Philippines. We will train you and provide you with the best guide. Your employees will also know about the process of how to get ISO 13485 certificate in Philippines.

How to get ISO 13485 MD-QMS certification in Philippines?

A successful ISO 13485:2016 implementation is possible when the project is planned professionally and implemented with expert MD-QMS consultants in Philippines. We use our internationally proven ISO 13485 MD-QMS implementation methodology that is fine-tuned to the local Philippines working culture.

  1. ISO 13485:2016 implementation plan and project charter finalization
  2. Awareness training on ISO 13485 MD-QMS to the teams and employees across the organization.
  3. Business Process Review and Gap Assessment of your existing Medical Devices – Quality Management system to find the degree of compliance and gaps as per ISO 13485:2016 standard.
  4. Process design and MD-QMS documentation including MD-QMS policy, procedures, manuals, checklist, forms, risk assessment, work instructions, templates, SOPs and process maps.
  5. Implementation and going live with the new MD-QMS system
  6. Training your employees about the newly developed ISO 13485:2016 Medical Devices – Quality Management System for effective implementation.
  7. Internal auditor training and conduct of internal audit
  8. Assistance in closure of the MD-QMS internal audit findings and ISO 13485:2016 Medical Devices – Quality Management system improvement.
  9. Pre-assessment audit if required to check readiness of the organization for the final certification audit as per ISO 13485:2016 standard and carrying our required corrections / corrective actions to ensure your organization is 100% ready for the certification audit.
  10. Coordinating with the certification body on your behalf if required and scheduling the final ISO 13485:2016 certification audit for your organization.
  11. Support during the certification audit to ensure your organization gets ISO 13485:2016 certification without any hassles.
  12. Ongoing assistance post certification for improvement of your Medical Devices – Quality Management System.

Our services in the field of ISO 13485

ISO 13485 Consulting:

    1. We provide professional, comprehensive yet simple to implement MD-QMS consulting solutions to help you plan, design, implement, certify, maintain and improve ISO 13485:2016 MD-QMS. Our consultants with rich MD-QMS experiences guide you through various phases effectively. Our ISO 13485 MD-QMS consulting services in Philippines saves you money, time, resources and help you achieve ISO 13485:2016 certification in the most optimum manner.
    2. Our ISO 13485 consultant in Philippines deploy a proven approach for a result oriented MD-QMS in your company. ISO 13485 MD-QMS consultant in Philippines from our organization ensure we remain with your till you get certified and we even provide assistance in selection of the most appropriate and reputed certification body with global accreditation.

ISO 13485 Training:

    1. We provide public and in-house ISO 13485:2016 MD-QMS training programme to cater the varying needs of various organizations in Philippines. The best tutors and internationally acclaimed instructors ensure our ISO 13485:2016 training program not only meet your organization’s requirements but help you enhance competence of your team and drive continual improvement in your origination.
    2. We provide the following ISO 13485:2016 training in Philippines:
      1. ISO 13485:2016 Lead Auditor Training in Philippines
      2. ISO 13485:2016 Awareness Training in Manila
      3. ISO 13485:2016 Internal Auditor Training in Cebu
      4. ISO 13485:2016 MD-QMS implementation training in Philippines

ISO 13485:2016 Certification

    1. Our ISO 13485:2016 certification services provide a turnkey solution to organizations looking for the maximum value of their money while optimizing on the resources use. We take care of every details while working closely with your team to ensure ISO 13485:2016 certification in time as per a pre-defined project and implementation plan.
    2. Post successful implementation, one of the global certification bodies like BSI, SGS, TUV, DNV, BV, LRQA, SNR, QEC, LMS, QSCERT may be contacted for certification audit and issuance of ISO 13485:2016 certificate. We carry required expertise and experience to ensure a successful, smooth and deviation free ISO 13485:2016 certification in Philippines.

ISO 13485 MD-QMS Software

    1. We the only ISO consulting company globally that provides an ERP kind of automation for ISO 13485:2016 Medical Devices – Quality Management System through MD-QMS software in Philippines. Our MD-QMS software MyEasyISO make ISO 13485 MD-QMS implementation, certification and maintenance simple, easy, quick and employee friendly while saving you money, resources and time.

Contact us at +63 977 815 1204 or to get ISO 14001:2015 certification today.

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Contact us at for ISO 14001 certification, ISO 14001 training and ISO 14001 implementation in Metro Manila, Caloocan, Malabon, Navotas, Valenzuela, Quezon City, Marikina, Pasig, Taguig, Makati, Manila, Mandaluyong, San Juan, Pasay, Parañaque, Las Piñas, Pateros, Cebu, Muntinlupa and the whole of Philippines for Environment Management System EMS.

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