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ISO 13485:2016/ SS 620:2016 – Quality Management System for Medical Devices

Medical devices – Quality management systems – Requirements for regulatory purposes

(ISO 13485:2016)

ISO 13485 is the worldwide Quality Management System (QMS) standard for medical device organizations. ISO 13485 is potentially beneficial for medical device organizations as it:

Enhances the organization’s ability to meet customers and regulatory requirements
Helps organizations to address product safety and effectiveness
Allows organizations to obtain external recognition of conformity to quality management system

The standard has been revised by the International Organization for Standardization (ISO) to ISO 13485:2016 and as of 28 February 2019, ISO13485:2016 has officially replaced ISO 13485:2003.

What are the main changes of ISO 13485:2016?

New design specification based on ISO Guide 72
Harmonization with US CFR, Brazilian law (ANVISA), CMDR (Canada), and other law
The standard has integrated risk throughout the quality management system, and product life-cycle, risk-based decision-making has been incorporated
Emphasis on documentation for regulatory purposes
Integration with QMS software
Emphasis on appropriate infrastructure
New references to other standards have been included for usability, sterile barrier, etc
New sections on complaint handling and reporting to regulatory authorities
Clarity for auditing
Planning and documenting corrective action and preventive action

However, ISO 13485:2016 has maintained its current format (based on ISO 9001:2008).

Accreditation
SCS has obtained accreditation from the Singapore Accreditation Council (SAC).

Good Distribution Practice for Medical Devices (SS 620:2016)

In Singapore, companies that are involved in the import, storage, distribution, installation, servicing, and secondary assembly of medical devices are required to pass the Good Distribution Practice for Medical Devices (GDPMDS) certification audit prior to applying for Importer or Wholesaler’s License.

SCS is the leading pioneer in the SAC accredited GDPMDS certification; SCS has had the largest number of clients for this scheme since the year 2008. The auditors have extensive experience in the medical device and healthcare industries.

As of 8 November 2020, GDPMDS TS-01, Revision 2.1 has been officially replaced by SS 620:2016.

Key Benefits of GDPMDS

Customer confidence - Medical device quality is maintained throughout the distribution network
Regulation compliance for Import and Wholesale license application
Positive image of the company

Accreditation

SCS has obtained accreditation from the Singapore Accreditation Council (SAC).