ISO 13485 Medical Devices Quality Management System

ISO 13485: Medical Devices Quality Management System (MDQMS)

In July of 2003, the ISO 13485 quality management system standard for businesses operating in the medical device industry was first introduced by the International Organization for Standardization (ISO). On March 1, 2016, the latest version of ISO 13485:2016—which took the place of ISO 13485:2003—was published.

ISO 13485:2016 is a rule that concentrates on how a corporation could handle a risk-based approach related to the purchase, production, storage, design and development, installation, distribution, and servicing activities, and other facets of the quality management system. It is built on the same fundamental ideas and clause schema as ISO 9001:2015. The standard outlines standards for businesses involved in one or more phases of the life cycle of a medical device. It is frequently seen as an essential first step in ensuring design and manufacturing processes continually result in high-quality goods that satisfy regulatory standards.

Objective Of ISO 13485

ISO 13485 may also be used by importers or appointed distributors that ship in and issue medical devices and may be needed to set up a quality management system under local regulations.

The primary objective of ISO 13485:2016 is to hasten the harmonisation of quality management system regulatory standards for medical devices. Because of this, it contains particular standards for medical equipment and leaves out some of the ISO 9001 requirements that are unsuitable for regulatory criteria. Due to these exemptions, organisations that have achieved ISO 13485 certification cannot assert that their quality management systems are under ISO 9001 unless they do so.

Objective Of ISO 13485

Benefits of Obtaining ISO 13485 Certification
in Malaysia

Global Regulatory Compliance

ISO 13485 in Malaysia helps medical device manufacturers align with international regulations, enhancing global market access.

Enhanced
Customer Trust

Certification assures customers in Malaysia of consistent, high-quality products, increasing trust and boosting sales.

Effective
Risk Management

ISO 13485 promotes a risk-based approach, identifying and mitigating hazards throughout product development.

Regulatory Assurance

Ensures that products in Malaysia meet all relevant technical standards and regulations, providing clients with confidence.

Improved Cleanliness
and Efficiency

Emphasises sterility in production areas, enhancing workplace safety and operational efficiency.

Market Expansion

Certification provides Malaysian companies with increased access to international markets, driving business growth.

Who Needs Certification of ISO 13485 in Malaysia?

ISO 13485 certification is essential for any organisation in Malaysia involved in the design, production, installation, and servicing of medical devices. 

Elevate your team's expertise with bespoke ISO training—contact our ISO training providers in Malaysia for tailored solutions. To find out how to obtain ISO 13485 certification, you may refer to our article for the procedures. 

Why Become ISO 13485 Certified

Medical Device Manufacturers

Companies that produce medical devices, equipment, or instruments need certification to ensure their products meet global quality and safety standards.

Suppliers and Distributors

Businesses supplying components or distributing medical devices can benefit from ISO 13485 certification to demonstrate compliance and gain trust with manufacturers and end-users.

Healthcare Facilities

Hospitals, clinics, and labs that handle medical devices should consider certification to ensure proper management and maintenance of equipment.

Contract Service Providers

Firms offering services like sterilisation, packaging, or quality control for medical devices must comply with ISO 13485 to meet client and regulatory requirements.

Top Six Reasons to Adopt ISO 13485 for Your Business

Global Recognition

ISO 13485 certification is internationally recognised, enhancing your business's credibility and allowing easier access to global markets.

Regulatory Compliance

It helps ensure your products meet all relevant regulatory and legal requirements, reducing the risk of non-compliance and potential fines.

Improved Quality
and Safety

Implementing ISO 13485 standards enhances the quality and safety of your medical devices, leading to higher customer satisfaction and fewer product recalls.

Operational Efficiency

Adopting ISO 13485 promotes efficient processes and risk management, reducing waste, errors, and costs associated with rework or non-compliance.

Increased
Customer Trust

Certification demonstrates a commitment to maintaining high standards, building trust with customers, suppliers, and stakeholders in the medical device industry.

Competitive Advantage

With ISO 13485 certification, your business gains a significant edge over competitors who lack certification, attracting more clients and business opportunities.

Steps To Certification

  • 1Request for Quotation

    Contact us to select a package that suits your needs for ISO 13485 in Malaysia

  • 2Schedule a Consultation

    Arrange a free initial consultation to discuss how ISO 13485 can benefit your organisation.

  • 3ISO Introduction Training

    Receive tailored training on ISO 13485 to understand and implement quality management practices for medical devices.

  • 4Document Preparation and Implementation

    Prepare and implement necessary documentation to align with ISO 13485 standards.

  • 5Internal and External Audits

    Conducting thorough internal and external audits ensures compliance with ISO 13485 and is essential for certification.

  • 6Obtain Certification

    Obtain your ISO 13485 certification and demonstrate your commitment to high-quality medical device management.
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Frequently Asked Questions

1What is ISO13485?
The quality medical device standard is ISO 13485, which guarantees that all medical equipment satisfies both client and legal requirements for regulatory compliance. To keep professionals and consumers safe in clinics, hospitals, and other medical settings, ISO 13485 accreditation is a valuable credential.
2Who does ISO 13485 apply to?
Organizations engaged in producing, designing, installing and maintaining medical devices and related services are intended users of ISO 13485.
3What benefits will ISO 13485 certification bring to my business?
ISO 13485 certification in Malaysia ensures your business meets international standards for medical device quality management. It enhances product quality, increases customer trust, and provides access to global markets, setting your business apart from competitors.
4Should my business get the certification of ISO 13485 in Malaysia?
If you are involved in the medical device industry, obtaining ISO 13485 in Malaysia is highly recommended. Certification demonstrates your commitment to quality and regulatory compliance, which can enhance your reputation and open up new business opportunities.
5How long does the ISO 13485 certification process take in Malaysia?
The duration of the ISO 13485 certification process in Malaysia depends on the size and complexity of your organisation. Generally, it can take a few months to a year to obtain certification, including preparation, documentation, implementation, and audits.
6What is the cost of ISO 13485 certification in Malaysia?
The cost of ISO 13485 certification in Malaysia varies based on factors like the size of your organisation, the complexity of your processes, and the level of existing compliance. To get an accurate estimate, it's best to request a quotation from a certified ISO consultant in Malaysia.
7How often do I need to perform internal audits for ISO 13485?
Internal audits must be carried out under the requirements of ISO 13485 at regular intervals to evaluate whether the quality management system complies with both external and internal standards. The business's size and its operations' sophistication are two variables that may affect how frequently internal audits are conducted.
8Is ISO 13485 certification a legal requirement for medical device companies in Malaysia?
ISO 13485 certification is not a legal prerequisite for medical device companies in Malaysia. However, it may be required for doing business with specific customers or obtaining regulatory approvals for medical devices.
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