A Standard Guide to Preventive Action

Preventive Action guide

“If anything can go wrong, it will”. Many of you may be familiar with this expression. Yes, you are right! It’s Murphy’s Law. While many may take this expression pessimistically, we should focus on the positive side of this expression, for instance, to help us avoid potential problems, especially in our business processes and management […]

ISO 14971 Explained.

iso 14971 risk management

Before diving into ISO 14971 Medical device – Application of risk management to medical devices, we must first understand risk management. Unlike business risk management, ISO 14971 risk management is a process of identifying, analysing, controlling, and preventing failures that can have dangerous consequences in the usage of medical devices. Organisations must conduct risk management […]

Step by Step Guidance to Understanding Gap Analysis Process

gap analysis

The practice through which businesses evaluate their actual performance to their desired or expected performance is known as “gap analysis.” This assessment is used to examine if a company is achieving objectives and making effective and good use of its resources. It is a method for an organisation to realise and establish its existing condition […]

What is ISO 27017? Importance, Standards and Certification.

iso 27017

Due to the Covid-19 pandemic, there has been a gradual increase in cloud service adoption within the last two years to help cater to the rise in remote work. Cloud service providers supply cloud computing which is flexible and productive for their cloud service customers to get the job done in their comfort zone. In […]

What is Integrated Management System (IMS)? All you need to know.

Integrated Management System (IMS)

With the year-over-year increase in organisations attaining ISO certification to management systems such as: ISO 9001 – Quality Management System ISO 13485 – Medical Devices Quality Management System ISO 14001 – Environmental Management System ISO 22000 – Food Safety Management System ISO 27001 – Information Security Management System ISO 45001 – Occupational Health and Safety […]

What is Corrective Action? Plan, Report, and Examples.

We all make mistakes at some point in our domestic or professional life, but not all are a source of embarrassment. The ones that adversely affect your work and wellbeing should be identified, noted in black and white, and the root causes analysed to design a corrective and preventive plan. Companies use corrective action to […]

What is ISO 9001? Its Certification, Benefits and Requirements

Are you a business or an organisation in the extension phase and needs quality management systems such as that of the ISO 9001 to scale up but not sure what the statutory and regulatory requirements in the certification process are? If yes, you are not the only one struggling with introducing a quality management system […]

All About RTO, RPO and Their Differences

Recovery Time Objective (RTO) and Recovery Point Objective (RPO) are terms used during the implementation of a business continuity management system. As of 2020, there is about 2,200 valid ISO 22301 business continuity management system (BCMS) certificates. Organisations that provide products and services that require minimal or no disruptions are often mandated by regulatory authorities and interested […]