NATIONAL STANDARDS AND COMPLIANCE

Marlin Labs have invested in certifying for all the relevant Standards to meet the high demands set by the industry. These standards include:

1.Certification to a Quality Management System for the medical devices

On the 9th of December 2016, the Government Gazette (No 1515 – 40480 – point 5) stated amongst other points that: 
“5. License to manufacture, import, export or act as a distributor or wholesaler of medical devices or IVD’s A manufacturer, wholesaler or distributor referred to in section 22C(1)(b) of the act must – …….. :
(c) as part of the application, provide acceptable documentary proof of –
(iii) Certification to a Quality Management System for the medical devices and IVDs as determined by the council;” 
Marlin Laboratory Manufacturing have been awarded the required License by the MCC. License number 00000061MD.

2.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 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 and design and development or provision of associated activities (e.g. technical support).) Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.  
Marlin Laboratory Manufacturing have achieved certification for ISO 13485:2016, as per the following scope: Design, Development, Manufacture, Installation, servicing and Distribution of RO Devices / water treatment systems, for medical and non-medical applications.


3.ISO 9001:2015

This specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. The aim is to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Marlin Laboratory Manufacturing have achieved certification for ISO 9001:2015 , as per the following scope: Design, Development, Manufacture, Installation and Distribution of RO Devices / water treatment systems, laboratory equipment for medical and non-medical applications.

4.Self declaration

We ensure that the water quality produced meets the ISO 13959 standard through testing through accredited laboratories across Southern Africa. ISO 13959:2014 specifies minimum requirements for water to be used in haemodialysis and related therapies. We ensure that the equipment used meets the ISO 26722 standards: ISO 26722:2014 is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.

All water considered in our Potable Water solutions is tested by accredited laboratories to Short Sans and Full Sans standards.