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What you need to know about ISO13485

Benefits of ISO13485 Certification What is a medical device? A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Who is ISO13485 for? ISO 13485 is designed for use by organisations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. Certification/Registration to ISO1348 Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organisations can reap many benefits from implementing the standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that you have met the requirements of the standard. Why was ISO13485 revised, and what are the main improve

What you need to know about AI

What is AI? In its essence, AI pertains to the capability of a machine or computer system t o carry out tasks that would normally necessitate human intelligence. This entails programming systems to analyse data, acquire knowledge from experiences, and make intelligent decisions with human guidance. While virtual assistants like Siri or Alexa are the most recognisable form of AI, there exist numerous versions of this technology. AI holds the promise of transforming diverse industries by empowering machines to tackle intricate problems and exhibit intuitive thinking, surpassing mere automation. This encompasses a wide array of subfields and technologies, including machine learning and natural language processing. Building a responsible artificial intelligence? Artificial intelligence possesses an extraordinary capacity to swiftly process, analyse, and act upon massive volumes of data. As with any potent technology, it is essential to implement AI responsibly in order to maximise its pote

29 September 2025

Overview of the ISO 9001:2026 Update

The upcoming ISO 9001:2026 revision is anticipated to introduce significant enhancements, reinforcing its role as a cornerstone of modern quality management. Building on the existing framework, the update will place greater emphasis on risk management, supply chain oversight, digital transformation, and sustainability, while also integrating stakeholder engagement, ethics, and alignment with other management systems such as ISO 14001. Below is an in-depth exploration of the expected changes: 1. Enhanced Risk Management The revised standard will strengthen the risk-based approach, requiring organisations to proactively identify, assess, and mitigate risks across operations. This may involve adopting methodologies from AS9100 (the aerospace industry’s quality management standard) to ensure more rigorous risk controls. 2. Supply Chain Oversight Organisations will need to deepen their scrutiny of supplier quality and ethical practices, ensuring that supply chain partners align with their o

Good Manufacturing Practices as per the ISO 22716 standard

ISO 22716 defines certain quality and safety standards for cosmetic products to be placed in the European market. It standardises the below-mentioned aspects to be taken care of: 1. Premises The premises should be located and designed in such a way that it should ensure the product’s safety and efficacy, and must be regularly sanitised and maintained correctly to avoid contamination of raw materials/products/operational flows. 2. Equipment The equipment used must be suitable for the purpose of the product and manufacturing process. They must be kept in a condition that avoids any cross-contamination. 3. Raw Materials and Packaging Items The raw material and packaging items used in the manufacturing process are required to meet a defined and relevant set of criteria to ensure the quality of the finished product. The manufacturers must establish a dynamic supplier chain process for the raw materials to easily trace any issues that might arise during procurement. In addition, the purchase

Compass Rose provides ISO 9001:2015 training to help organisations attain the ISO 9001 quality certification. The primary benefit gained from implementing the ISO 9001 QMS, which stands above all the rest, is building a better organisation. The very exacting process that your organisation will go through will guarantee that all major or critical processes are thoroughly reviewed and evaluated to ensure that only the best practices remain in place and are well defined, documented and are understood by all involved individuals. This review/documentation process forms the foundation for a better organisation. We are now establishing documented guidelines that ensure consistency from day to day and become the basis for training new or transferred employees. Additional benefits that will be realised from a well-implemented ISO 9001 Quality Management System are listed below in no order of relevance: Greatly improved customer satisfaction levels A continuous improvement process is establishe

Risk Based Thinking

RISK-BASED THINKING FOR ISO 9001, ISO 14001, ISO 27001, ISO 45001 In every ISO standard, the main theme that drives the process of the management system implementation is risk. Leaders must evaluate the risks the ir businesses face, determine their sources, and develop methods for controlling risk outcomes. Traditionally carrying a negative association, risk in business, especially as it relates to ISO certification, is looked at more as an unknown than a threat. How compan ies choose to handle the risks is known as their risk management strategy and requires close tracking of procedures to ensure positive outcomes. By acknowledging risk and facing it head-on, companies are able to increase their likelihood of success. The individualised approach to risk varies from business to business and is lar gely driven by the company’s appetite for growth and its risk tolerance. From ultra-conservative tactics to bold steps into the unknown, all risk management strategies are as unique as the pe

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