ISO 13485 Certification

About ISO 13485 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 exhibit the commitment to the safety & quality of medical devices.

ISO 13485 is beneficial to 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 the global market and also definitely helps to impress your clients with the quality of the business and its products.

ISO 13485 Certification in Malaysia

13485

IAS is one of the most prominent ISO Certification Bodies in Malaysia providing Certification of ISO 13485 Malaysia. IAS has helped many businesses to get ISO 13485 Certification in Malaysia for their medical devices/equipment with international recognition.

ISO 13485 in Malaysia is applicable to any type of medical device/equipment and certification is granted to an organization that can demonstrate that it has an effective quality management system for medical devices.

Certification of ISO 13485 in Malaysia is not limited to product manufacturers but also includes service providers, distributors, and laboratories that are involved in the life-cycle of a medical device/equipment.

IAS delivers ISO 13485 Certification services in Malaysia covering 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.

Benefits of ISO 13485 Certification

  • Promotes coordination of regulatory requirements for the manufacturers of medical devices on an international scale
  • 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.
  • ISO 13485 compliant management systems adopt a risk management approach which includes evaluation to identify & estimate risk, and uses risk controls and techniques with a view to eradicating hazardous situations throughout product realization.
  • Assures the clients that the product complies with all relevant product & service-oriented technical standards & regulations.
  • Emphasizes cleanliness & sterility in the production area which in turn increases efficiency & enhances safety at the workplace.
  • Increased access to more markets globally

Out of these Standards, ISO 13485 Certification specifies the requirement of a Quality Management System of Medical devices/equipment that consistently meets the customer and applicable regulatory requirements. 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 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.

  • 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 it in your organization before going for certification. E.g. Documenting, training the staff, 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 decisions to improve the Organization’s 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.
  • 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 the implementation process which helps to strengthen the business operations of an organization.
  • IAS is an authorized ISO certification body for providing certification of ISO 13485 in Malaysia.
  • The Knowledge, skills gained through experience, and the global presence of IAS have 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.

Process to obtain an ISO 45001 Certification

  • Contact IAS by sending the Application Form and call us for a discussion we are here to guide you in getting ISO 13485 certification.
  • Make your Organization ready for certification by implementing and practicing the standard, monitored, and continually improving.
  • Majorly, the process of ISO certification includes 2 stages
      1. Stage 1 Audit: Readiness Audit            
      2. 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 observed during the audit, a 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 have to be approved by IAS. After the effective closure of Nonconformity, the Certificate is issued limiting the scope that was audited.
Click here for Audit Procedure