Certification Standards

List of standards to suit your business and organisation’s requirements.

ISO Standard List Full Summary

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. This standard includes requirements that cover processes spanning the entire product life-cycle.

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

ISO 14001:2015 - Environmental Management System

ISO 14001 – Environmental Management System (EMS) is an international standard that aims to aid organisations to achieve environmental sustainability, striking a balance between the environment, society and economy, which are the three pillars of corporate sustainability. It provides a framework to protect the environment and adapt to changing environmental conditions.

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). It includes a series of effective processes and best practices to ensure food safety and covers concepts of Good Manufacturing Practices (GMP) and Hazard Analysis Critical Control Point(HACCP). All food chain operators should implement an FSMS to safeguard the supply of hygienic and safe food products and services to consumers.

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

ISO 27001:2013 - Information Security Management System (ISMS)

The ISO 27001 is an international standard for the Information Security Management System (ISMS). This standard is designed to enable organisations to control information security relating to all information assets belonging to the organisation. This standard can be applied to all types and sizes of organisations that consider information as an asset that must be protected.

ISO 22301:2019 - Business Continuity Management Systems

The ISO 22301 is a framework for an organisation to systematically approach and meet Business Continuity Management System (BCMS) requirements. It also specifies the requirement to implement and manage your BCMS in order to protect against and reduce the likelihood of a disruptive incident. Organisations with proper ISO 22301 in place would be prepared for, able to respond to and plan ahead on recovery procedures from disruptions when they occur.

Having an effective BCMS is important for all types of organisations, regardless of business sectors, size and nature of the business.

ISO 45001: 2018 - Occupational Health and Safety Management System (Formerly OHSAS 18001)

The ISO 45001 is an international standard for occupational health and safety (OH&S) management system that specifies requirements and gives advice for its use, to enable organisations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.

It formally replaced the OHSAS 18001 after its release in 2018.

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 Solution™ creates the organisation-specific documents that adhere to SS 444:2018 within a day. Companies can then 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 Solution™ creates the organisation-specific documents that adhere to SS 620:2016 within a day. Companies can implement the standard with ease.

SS 506 - Occupational Safety and Health Management System (OSHMS)

SS 506 is a Singapore standard that specifies requirements for occupational safety and health (OSH) management system to enable an organisation to control its OSH risks and improve its OSH performance.

The SS 506 standard consists of 3 parts; Part 1: Requirements, Part 2: Guidelines for the implementation of SS 506 Part 1, and Part 3: Requirements for the chemical industry.

The SS 506 standards are intended to provide you with elements of an effective OSH management system, which can be integrated with other management system requirements to help your organisation achieve its OSH and economic objectives.

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