deGRANDSON Global Blog

News and Commentary on ISO Management System Standards

25 Apr 2024

Measuring Information Security Effectiveness with ISO 27004

ISO 27001 provides no guidance and is of little help In deciding what to monitor and measure regarding your Information Security Management System (ISMS), ISO 27001 specifies no mandatory requirements (as emphasized in our ISO 27001 training courses). Thankfully, ISO 27004 provides guidelines and principles for measuring and reporting the effectiveness of an organization's ISMS. The standard ...

24 Apr 2024

Genuine e-Learning with deGRANDSON - a superior choice

The reality behind the myths about e-Learning There's much interest in e-learning these days, but does it work? What does genuine e-Learning look like, and what does it deliver?

04 Apr 2024

Environmental Aspects - meeting ISO 14001 requirements

Systematically identifying relevant ISO 14001 environmental aspects in implementing an EMS. This is fundamental to the effectiveness of an Environmental Management System (EMS) and to ensuring that your organization meets ISO 14001 certification requirements.

19 Mar 2024

ISO 14971: Choosing the right Risk Management Tools

Using FMEA alone is a lazy choice and no longer acceptable ISO 14971, Medical Devices - Application of risk management to medical devices is frequently misapplied, and if your ISO 13485 QMS Manual claims to use ISO 14971, you'd better use it properly.

13 Mar 2024

The Climate Change Amendment to ISO Management System Standards

The ISO/Committee for Conformity Assessment (CASCO) has added a reference to “climate change” within all management systems standards operating according to Annex SL. They have stated that this is a clarification rather than a new requirement. Therefore, the publication year of the affected Annex SL standards will not change. As a ‘clarification,’ there is no transition period for the Amendment, ...

07 Mar 2024

ISO 9001 Internal Auditing: DOs and DON'Ts

Practical advice on ISO 9001:2015 Clause 9.2 NOTE: The advice here applies to all Management System Standards (MSS) and not just to implementing ISO 9001:2015. For whatever MSS you need to conduct internal audits, you have two basic approaches to choose from: Option 1: do the minimum necessary to satisfy the Certification Body (CB) [or Accreditation Board (AB)] Auditors Option 2: take the best ...

03 Mar 2024

Scenarios are a key difference with deGRANDSON e-Learning

All our Courses are true e-Learning and include extensive Scenarios The many short- and long-term scenarios presented are unique to e-learning with deGRANDSON Global. Altogether, they help bridge the void between theory learned in a classroom-like situation and the practice, and challenge, of face-to-face auditing. You get the opportunity to practice what you've learned before engaging in a ...

23 Feb 2024

FDA QMSR and ISO 13485 – what you need to do

On 02-Feb-24, the FDA published its Final Rule, amending the Current Good Manufacturing Practice (CGMP) requirement of the Quality System Regulation (QSR) of medical device manufacture. The amendments incorporate by reference (and so align more closely with) the international standard ISO 13485:2016, Medical Devices - Quality Management Systems - Requirements for regulatory purposes. The new ...

20 Feb 2024

15 Myths about deGRANDSON e-Learning

13 Feb 2024

Free ISO 13485 Implementation Handbook

This 100+ page step-by-step guide is available free with our ISO 13485 Lead Implementer Course. It is not for sale. But it is everything you'll need to develop, implement, and maintain a management system to ISO 13485 Certification standard, including sample Procedures and Forms.

Load More Posts

News & Commentary on ISO Management System Standards

News and Commentary on ISO Management System Standards

Measuring Information Security Effectiveness with ISO 27004

Genuine e-Learning with deGRANDSON - a superior choice

Environmental Aspects - meeting ISO 14001 requirements

ISO 14971: Choosing the right Risk Management Tools

The Climate Change Amendment to ISO Management System Standards

ISO 9001 Internal Auditing: DOs and DON'Ts

Scenarios are a key difference with deGRANDSON e-Learning

FDA QMSR and ISO 13485 – what you need to do

15 Myths about deGRANDSON e-Learning

Free ISO 13485 Implementation Handbook

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