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ISO 13485 Certification

Medical devices - Quality management systems

ISO 13485 standard and its Certification

About ISO 13485 standard

ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.

Harmonization of standard allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.

The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively.

Find out more about MDR transition and IVDR transition.

IAS can now offer UQAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016.  To find out more about our Certification procedure.

What is new in ISO 13485 standard

  • One of the important changes of the revision is that the new ISO 13485 uses a risk management approach in all processes of the Quality Management System standard for Medical Devices.
  • Validation of the computer software used in the Quality Management System standard for Medical Devices
  • Establishment and maintenance of the technical documentation structured to the clauses of the standard for the technical file and design and development files
  • New requirements for complaint-handling processes
  • Validation of processes for sterile barrier systems and sterilization
  • Definition of the required competence of personnel involved in quality management; documentation and verification of the effectiveness of training measures

About ISO 13485 Certification:

ISO 13485 Certification is an activity of verifying the organization through planned and informed ISO audits to confirm that the organization complies with the standard requirement of ISO 13485.

ISO 13485 certification for medical devices is an internationally recognized quality standard which affirms the requirements of the Quality Management System standard for Medical Devices (QMS) for the design and manufacture of Medical Devices anywhere in the world.

ISO 13485 certification is a symbol of the stability and continuity of your organization’s performance to reach and outshine customer expectation. Nowadays Customers are not ready to take a chance, to reduce the risk of purchasing low quality product they always look for best quality ISO certified products and services. ISO 13485 certification for business is a powerful tool to increase the credibility of the organization by showing that your products or services meet the expectations of your customer.

ISO 13485 certifications help to expand your business locally and in overseas markets and also definitely help to impress your clients with the quality of the business and its products and services.

Coverage of ISO 13485 Certification in Singapore:

IAS is one of the highly performing as ISO Certification Bodies in Singapore. IAS conducts auditing and providing ISO 13485 certification in Singapore and also for various standards in Singapore. It also delivers ISO Lead Auditor Training, ISO 13485 Internal Auditor Trainings, and ISO 13485 Awareness/Foundation Training in Singapore. All these certification and Training services by IAS for the country is managed from its office in Singapore and in the Local cities of Singapore like Hougang, Tampines, Pasir Ris, .Yishun, Choa Chu Kang, Toa Payoh, Bukit Batok.

To know more about ISO 13485 – Quality Management System standard for Medical Devices and its certification, click here.

Process to obtain an ISO Certification:

  • Contact IAS by sending the application and call us for a free discussion and we can guide you in getting the ISO 13485 Certification.
  • Based on the Application form submitted by your organization, IAS initiates ISO certification process for your company. Your application will be scrutinized and IAS will come out with the plan to conduct audits. Our staffs will be in touch with you to discuss and help you in the certification process. Check more detailed ISO 13485 certification procedure.
  • Plan and implement ISO 13485 standards requirements through documented Information
  • (how this standard is practiced, monitored and continually improved).
  • Majorly, ISO certification audit includes 2 stages

                   Stage 1Audit: Readiness Audit

                  Stage 2 Audit: Verifying the effectiveness of the implementation of ISO 13485.

  • The organization applying for ISO certification is audit based on an extensive sample of its sites, services, process, products & functions.
  • If any deviation is observed during the audit, a deviation report will be provided along with the detailed audit report. According to the grading of the deviations the IAS determines the time required for its closure including the correction and corrective actions which has to be approved by IAS audit team. After the effective closure of Non conformity, the Certificate is issued limiting to the scope that was audited.
Click here, For more information on application and frequently asked questions

Why IAS?

  • Having two decades of audit experience helps to attain the certification faster.
  • Incorporated in 2006, we stand with 13 years of experience as a professionally strong and recognized certification body.
  • IAS issues accredited Certificates, hence universally valid.
  • The Knowledge, skills gained through experience and the International presence of IAS has created a history of executing successful large-scale, complex international projects. Our people understand the culture and nature of the local market and perform internationally in an effective and consistent manner.
  • IAS conducts the audits in more sensible and value added manner to benefit the clients of small, medium and large organization. Our flexible procedure is simple to understand and the services are timely and cost effective.
  • Our presence is in India, Singapore, Malaysia, Indonesia, Oman, Saudi Arabia, UAE, Qatar, Kuwait, Philippines countries with more than 6000 clients
  • We have successfully addressed almost all the sectors broadly diversified in Automobile industry, Consumer electronics, Chemical Industry, Steel production, Industrial equipment, FMCG industry, Aerospace manufacturing, Healthcare Industry, Food industry, Textile industry, Oil and Gas, Energy, Telecommunication, IT Industry, Hospitality industry.
  • We have more than 300 experienced empanelled auditors to effectively asses an organization’s conformance to Quality Management System standard for Medical Devices unleashing a true potential for Improvement.

We understand the culture and nature of the local market and execute the Audit in an effective and reliable manner.

Benefits of obtaining ISO 13485 certification:

  1. ISO 13485 certified organization is considered to be the most reputed in the global industry. The brand and image of the organization will be improved by achieving QMS, If you are looking to Expand internationally or locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with 13485 certification communicate a commit to quality with both customers as well as regulators.
  2. Increase to access international markets with certification.
  3. Outline how to review and improve processes across your organization
  4. Increase efficiency, cut costs and monitor supply chain performance
  5. Demonstrate that you produce safer and more effective medical devices
  6. Meet regulatory requirements and customer expectations
  7. The process-oriented QMS gives ascendancy to the organization to identify, evaluate, manage and enhance the various core business strategies that will ultimately lead to intensified business performances.
  8. A certified ISO 13485:2015 Quality Management System standard for Medical Devices gives an Organization a constructive image, rising to the level of your competitors or maybe even a level higher.
  9. ISO 13485 certifications assist organizations to grow and improve the performance, as well as exhibit high levels of service quality when bid for contracts.
  10. A certified ISO 13485 Quality Management System standard for Medical Devices gives an Organization a constructive image, rising to the level of your competitors or maybe even a level higher.
  11. You have objective evidence that your organization exhibits great importance to quality and that you have it checked regularly by an independent party (IAS Certification Body). This commitment increases the confidence in your organization.
  12. An Organization can detect and identify the problems in good time, which means that you can rapidly take steps to avoid the same mistakes in upcoming future.
  13. The organization can easily improve their quality of business and thereby achieve the customer satisfaction by getting ISO 13485 certification.
  14. As data’s are available in all areas, an organization can analyze and take action on the failures and control failures.
  15. A certified ISO 13485 Quality Management System standard for Medical Devices increases the quality of your services and raises your staff’s/Employees awareness.
  16. A certified ISO 13485 Quality Management System standard for Medical Devices ensures clear processes and (communication) structures, tasks and responsibilities throughout the whole organization. This increases in the involvement of your staffs/Employees, which promotes your Organization in Continual improvement.

What an Organization should do to achieve certification?

  • Call IAS for conducting Audit and discuss audit procedure specific to your organization
  • Implement ISO 13485-Quality Management System standard for Medical Devices in your organization. (E.g. Documenting, training the staffs with Awareness and Internal Audit, practicing the system etc)
  • Conduct at least one internal Audit program through trained QMS Internal Auditors.
  • Compile the collected data and complete the analysis.
  • Conduct a Management review with the help of analyzed data and effect the decision towards improving the Organization’s performance in line with company objectives & goals.
  • Complete the audit successfully. (Stage 1 and Stage 2)
  • Closure of Non conformance, if any.
  • Collect and maintain the ISO 13485 certification.
  • Comply with the surveillance audit annually.
To know more about the audit procedure. Kindly click here.