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ISO 13485 Certification in Malaysia

Medical devices - Quality management systems

ISO 13485 Standards and its Certification

What is ISO 13485 standard?

IAS is providing the service of ISO Certification audits for various international standards. Out of these Standards, ISO 13485 certification specifies the requirement of Quality Management System of Medical devices/equipments that consistently meet the Customer and applicable regulatory requirement. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device/equipment.

ISO 13485 Certification

ISO 13485 is generally harmonized with ISO 9001 and the basic difference is that ISO 9001 requires Organization to demonstrate continual improvement whereas ISO 13485 requires an Organization to demonstrate the quality management system for medical devices is effectively implemented & maintained.

ISO 13485:2016 Certification

Adapting to the certification of ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as exhibiting the commitment to the safety & quality of medical devices.ISO 13485 is beneficial for many organizations and can be used by suppliers and external parties that are involved with providing medical device products.

This ISO 13485:2016 certification helps to expand your business locally and in global market and also definitely help to impress your clients with the quality of the business and its products.

Coverage of ISO 13485 Certification in Malaysia:

IAS is one of the most prominent ISO Certification Bodies in Malaysia. IAS conducts auditing and providing ISO certification in Malaysia for various standards in Malaysia. It also delivers ISO 13485 Lead Auditor Training , ISO 13485 Internal Auditor Training, and ISO 13485 Awareness/Foundation Training in Malaysia. All these certification and Training services by IAS for the country is managed from its office in provides including Wilayah Persekutuan Kuala Lumpur, Putrajaya, Labuan and covering all the major cities like Selangor, Terengganu, Johor, Kedah, Kelantan, Pahang, Negeri Sembilan, Perak, Melaka, Pulau Pinang, Perlis, Sabah and Sarawak.

To know more about ISO 13485  Quality Management System for medical devices and its certification, click here.

Process to obtain an ISO Certification

  • Contact IAS by sending the Application Form and call us for a discussion and we are here to guide you in getting ISO 13485:2016 certification.
  • Make your Organization ready for certification by implementing and practice the standard, monitored and continually improved.
  • Majorly, the process of ISO certification includes 2 stages

                        Stage 1 Audit : Readiness Audit

                        Stage 2 Audit : Verifying the effectiveness of the System

  • The organization applying for ISO certification will be audited based on an extensive sample of its sites, services, process, products & functions.
  • Any deviation is observed during the audit, deviation report will be submitted along with the detailed audit report. According to the grading of the deviations IAS determines the time required for its closure including the correction and corrective actions which has to be approved by IAS. 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 audit procedure.

Why IAS?

  • Having two decades of ISO Certification audit experience helps to attain the certification faster.
  • The Auditors and trainers in IAS are highly experienced, innovative, simple and practical in implementation process which helps to strengthen the business operations of an Organization.
  • IAS is an authorized ISO certification body for providing ISO 13485:2016 certificates with accreditation.
  • The Knowledge, skills gained through experience and the global presence of IAS has created a history of executing successful large-scale, complex international projects. Our auditors 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 in Medical devices unleashing a true potential for Improvement.

Benefits of ISO 13485 Certification

  1. Promotes coordination of regulatory requirements for the manufacturers of medical devices on an international scale
  2. Companies that attain ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase consistent high quality products.
  3. ISO 13485 compliant management systems adopt a risk management approach which includes evaluation to identify & estimate risk, uses risk controls and techniques with a view to eradicate hazardous situations throughout product realization.
  4. Assures the clients that the product complies with all relevant product & service-oriented technical standards & regulations.
  5. Emphasizes the cleanliness & sterility in the production area which in turn increases the efficiency & enhances safety at the workplace.
  6. Increased access to more markets globally.

What an Organization should do to achieve certification?

  • Call IAS for conducting ISO 13485 audit and discuss the audit procedure specific to your organization.
  • Understand the requirement of ISO 13485:2016 and Implement in your organization before going for certification. E.g. Documenting, training the staffs, practicing the system etc
  • Conduct one internal Audit program through trained 13485 Internal Auditors.
  • Compile the collected data and complete the analysis.
  • Conduct a Management review with the help of analyzed data and effect some decision to improve the Organization performance towards company objectives & goals.
  • Complete the audit successfully. (Stage 1 and Stage 2)
  • Closure of Non conformance, if any.
  • Collect and maintain the ISO 13485 certificate.
  • Comply with the surveillance audit yearly.
To know more about the audit details. Kindly click here.


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