ISO 9004 Sustained Success ISO 9004:2018 Quality Management – Quality of an Organisation – Guidance to achieve sustained success. Trips off the tongue, doesn’t it? Maybe not, but a closer look might tell us more. ISO 9001 Lead Auditor courses mention it and often considered a next step for organisations with a mature effective management The post Beyond ISO 9001 – Sustained Success appeared first on QCS International ..read more

   Future working and the implications for Health & Safety Talking of change, we are always on the lookout for emerging trends in management system standards and like the planned ISO 9001 updates that are due soon, ISO 45001 and the wider health and safety community are keeping one eye on the future. A report The post A safe and Healthy Future of Work appeared first on QCS International ..read more

Change Management Planning of Changes With our retained clients looking to transition to the new version of ISO 27001, Information Security Management, there can be a great deal of focus on controls and Annex A of the standard. One update to the clause structure in ISO 27001 is the inclusion of ‘Planning of Changes ‘Clause The post Planning of Change appeared first on QCS International ..read more

  Internal audits are a crucial component of an ISO 13485 Quality Management System (QMS). The audits need to be effective and deliver results (which are documented), otherwise there is little point in doing them!  Auditing forms a necessary and valuable element to any management system;  within an ISO 13485 certified QMS it can be The post ISO 13485 and the Importance of Internal Audits appeared first on QCS International ..read more

Root Cause Analysis – how we interpret the data to find the real cause  As any good lead auditor will tell you clause 10.2 of Annex SL, the template for modern ISO management system standards sets out the process for handling nonconformities. Sandwiched between correction and corrective action (preventative action is captured in 6.1, risk and opportunity, for those that thought it might have been relevant here) is the requirement to determine the cause of the nonconformity. If we’re to eliminate the cause of a nonconformity then we need to investigate further. Tools available include the ..read more

Measurement Uncertainty – have we allowed for variance Whilst measurement uncertainty is not integral to ISO9001 itself, most quality processes require consideration of data or metrics and by default the uncertainty surrounding the data we analyse may be of interest. Typically, we monitor trends in our numbers, seek explanations as to why variance may exist in data sets, (particularly where they display variance from expected results) and generally find reasons to disregard the outliers. Also of note in ISO 9001:2015, clause 7.1.5 Measurement Traceability where measurement uncertainty is to s ..read more

Quality Management software – your next improvement We’re frequently asked if we can recommend software tools to assist in quality management. At a time when we consider the implications of AI and how it may be included in the next ISO 9001 standard its more important than ever to ensure that our quality systems benefit from the best tools available. It’s not only global corporates that can benefit from quality software but micro and SME organisations have a range of low-cost tools and App’s at their disposal. Whether manufacturing a product, carrying out a process or providing a service, ens ..read more

1. Define your Health & Safety Policy Let’s define what a Health and Safety Policy actually is: it’s like the rulebook for staying safe at work. It lays out who’s responsible for what, when, and how to keep the workplace a hazard-free zone. Ignoring it isn’t an option – it’s there for a reason. The law requires that every organisation with five or more people should have a written Health and Safety Policy. The HSE Guidance on how to write one advocates it is written in three sections: Your Statement of Intent (this states what your organisation commits to, its objectives and strategic dir ..read more

Here at QCS we’re often asked during management system set up and preparation for a new ISO certification ‘how do I go about selecting a certification body?’ Well, it is first and foremost a commercial relationship and the choices of which Certification Body will come and do your ISO assessments and ultimately award your certificate is up to you. There are however several factors to consider. What is a Certification body? A Certification Body (CB) is an independent accredited organisation that is approved to audit management systems and award certificates if the system meets requirements of t ..read more

All of the core ISO management system standards whether ISO 9001, ISO14001, ISO 45001 or ISO 13485 and so on, have a requirement that the organisation undertake a regular review, what the standards call management review. Our experience is that the degree to which the meeting is completed and the content included can vary wildly – from doing the bare minimum to keep the CB off your back through to an in-depth and valuable exercise to review the effectiveness of the systems in place and to make factually based decisions on how to improve. Here are 5 key points to make your management review a ..read more