STANDARDS

 
 

ISO 13485:2016 | Medical Device Quality Management System

The ISO 13485 is an international standard that was specifically published to define the requirements of a quality management system for organisations within the medical device industry, with processes spanning the entire product life-cycle.

Stendard First™-generated documents include details that meet all the ISO 13485, US FDA 21 CFR Part 820, ISO 14971 and IEC 62304 requirements. 


ISO 22000:2018 | Food Safety Management System (FSMS)

The ISO 22000 standard is used as a guideline for the implementation of a food safety management system (FSMS), which includes a series of effective processes and best practices to ensure food safety. All food chain operators should implement a FSMS to safeguard the supply of hygienic and safe food products and services to consumers. 

This new version of ISO 22000:2018 was published and replaces the earlier ISO 22000:2005 edition.

To aid this transition, Stendard First™ creates the organisation-specific documents that adhere to ISO 22000:2018 within a day. Companies can implement the standard with ease.  


SS 620:2016 | Good Distribution Practice of Medical Devices (GDPMDS)

The SS 620:2016 serves as a guide on the quality management system - for the handling, storage, delivery, installation, servicing, secondary assembly and other related activities - of medical devices (including in-vitro diagnostic devices and software).

Prior to SS 620:2016, the GDPMDS was also known as the HSA GDPMDS TS-01, R2.1. Companies are required to comply with this new SS 620:2016 certification standard from 9 November 2020.

To aid this transition, Stendard First™ creates the organisation-specific documents that adhere to SS 620:2016 within a day. Companies can implement the standard with ease.  


SS 444:2018 | Hazard Analysis and Critical Control Point (HACCP)

SS 444:2018 (HACCP) is one of the solutions that food chain operators (involved in manufacturing, producing, processing, preserving, catering, storing, packaging, transporting and operating of restaurants/cafes) use to prevent food safety hazards.

Moving forward, with the SS 444:2018 published, the SS 444:2010 edition will be rendered obsolete, and companies must adopt this latest version of the HACCP standard.

To aid this transition, Stendard First™ creates the organisation-specific documents that adhere to SS 444:2018 within a day. Companies can then implement the standard with ease.