ISO 9001:2015

The global association for developing the principles and practices for the conduct of conformity assessment, IAF, has passed a resolution that, as of 15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and...

ISO 45001

It now seems that the ISO 45001 which is due for publication as the Final Draft International Standard at the end of November will have the following key features: Adoption of Annex SL, and thereby sharing a high-level identical core text similar to the ISO 9001...

ISO 17025 for Laboratories

The revision of ISO/IEC 17025, quality management system for laboratories, takes into account the activities and new ways of working of laboratories today. The main changes are as follow: The process approach now matches that of newer standards such as ISO 9001...

Medical Device Single Audit Program

The International Medical Device Regulators Forum (IMDRF) recognises that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in...

Standard for Auditing

Many organisations now have several different management systems, each focusing on different areas, such as  quality, environmental management, IT and information security. ISO 19011, Guidelines for auditing management systems, will help with the effective audit of...

ISO and Service Management

Services make up an overwhelming part of the global economy, accounting for around 75 % of GDP in developed countries and around 50 % in developing countries according to World Bank data. A number of ISO technical committees support stakeholders in the services...

ISO Standards Survey 2015

The ISO Survey of Certifications is an annual survey of the number of valid certificates to ISO management system standards worldwide. A summary of the 2015 results is shown below (% increase/decrease is compared to 2014): ISO 9001 (Generic standard): Slightly down by...

ISO 9001 Certification Trends

The ISO survey shows that ISO 9001 popular quality management standard continues to experience a lull, claiming a mere 1 % growth compared to 2 % and 3 % in the previous two years. Growth has certainly plateaued since the boom times two decades ago, reflecting the...

Trends in management system standards

The ISO survey shows that 1 609 294 certificates  were issued worldwide in 2014, slightly up on the previous year. The latest survey demonstrates moderate growth for almost all the ISO management systems standards covered by the survey, confirming trends observed over...

ISO 18404:2015 Lean & Six Sigma

This International Standard defines the competencies for the attainment of specific levels of competency with regards to Six Sigma, Lean, and “Lean & Six Sigma” in individuals, e.g. Black Belt, Green Belt and Lean practitioners and their organizations. Yellow Belt...

Company impact of ISO Standards

Standards provide tangible and quantifiable benefits to companies. A series of ground-breaking case studies by ISO and partner organizations based on the experiences of companies operating in a variety of business sectors in different countries, shows that...

National Impact of ISO Standards

Macroeconomic studies on the contribution of standards to national economic growth show that : Standardization directly contributes to the growth in the French economy, for up to 0.81 %, or almost            25 % of GDP growth Macroeconomic gains are a function of...

ISO Standards

ISO is the International Organization for Standardization. ISO has a membership of 164 national standards bodies from countries large and small, industrialized, developing and in transition, in all regions of the world. ISO’s portfolio of over 19 200 standards...

ISO 13485 Quality Management System

The ISO 13485 medical devices standard is being updated and is nearing completion. The final draft of the standard has been published and ISO member countries now have two months to form a national position and vote. Further news on publication of the standard will...

Annex SL, the core part of ISO 9001

All ISO technical committees developing management system standards, such as ISO 9001, ISO 13485 and ISO 14001, have to follow Annex SL in the new consolidated ISO Supplement. Annex SL harmonizes structure, text and terms and definitions, while leaving the standards...

Management System Standards

The quality management system standard ISO 9001:2015 will not be the first ISO management standard to employ Annex SL (high level common structure), nor will it be the last. But it may be the most significant to date. The following is a list of standards that already...

Knowledge Management

The Knowledge Management Dublin 2015 (KM DUBLIN 2015) conference for the pharmaceutical industry was the first of its kind in the world. The conference addressed the integration of knowledge management and risk management in the development, manufacture, surveillance...

Food Quality Management System

On 26 February 2015, FSSC (Food Safety System Certification) 22000 published FSSC 22000-Q, a brand new and voluntary module for the certification of Food Quality Management Systems (QMS) in compliance with ISO 9001:2008. This addition will give organizations the...

Food Safety & Quality Management Systems

ISO has developed a series of standards for food safety management systems that can be used by any organization in the food supply chain. It features : • ISO 22000:2005 – Overall requirements  • ISO/TS 22002-1:2009 – Specific prerequisites for food manufacturing •...