Medical
ISO 13485: 2016 Medical Devices
The term of "medical devices" covers all products used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or handicap but excludes drugs. The main objective of ISO 13485: 2016 is to help foster efforts of international harmonization in medical regulatory requirements for quality management system. ISO 13485: 2016 itself is not sufficent but must be complemented by specific requirements of local regulatory authorities.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.
ISO 15189: 2012 Medical Laboratories
ISO 15189: 2012 specifies requirements for quality and competence particular to medical laboratories. ISO 15189: 2012 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Good Distribution Practice for Medical Devices (GDPMD)
Good Distribution Practice for Medical Devices (GDPMD) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorization or product specification. Companies that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement and obtain GDPMD certificate to apply for an establishment licence.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.
ISO 15189: 2012 Medical Laboratories
ISO 15189: 2012 specifies requirements for quality and competence particular to medical laboratories. ISO 15189: 2012 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Good Distribution Practice for Medical Devices (GDPMD)
Good Distribution Practice for Medical Devices (GDPMD) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorization or product specification. Companies that are involved in wholesaling and/or importing Medical Devices in Malaysia are required to implement and obtain GDPMD certificate to apply for an establishment licence.
| Code |
ISO 13485: 2016, ISO 15189: 2012, GDPMD |
Duration |
|
MMS-01 |
Understanding of ISO 13485: 2016 |
1 Day |
|
MMS-02 |
Internal Audit of ISO 13485: 2016 |
2 Days |
|
MMS-03 |
Understanding of ISO 15189: 2012 |
1 Day |
|
MMS-04 |
Internal Audit of ISO 15189: 2012 |
2 Days |
|
MMS-05 |
Understanding of Good Distribution Practice for Medical Devices (GDPMD) |
1 Day |
|
MMS-06 |
Documentation of Good Distribution Practice for Medical Devices (GDPMD) |
2 Days |