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...

Risk Management and ISO 31000

ISO 31000 on risk management is now being revised and a new edition is scheduled for early 2018. In order to ensure that the principles and guidelines in the standard remain relevant to users, ISO 31000 and ISO Guide 73, which lays down the operative terminology, were...

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...

Governance of Organisations

Trust in business is at an all-time low. Trust in governments is rock bottom as well. At the same time, huge challenges remain to create sustainable societies. While laws and regulations are necessary foundations, truly good governance that takes organisations to new...

Business Continuity Management System

ISO 22301 is a management systems standard for business continuity management. It is a ‘generic standard’ in that it is designed to be used by organisations regardless of size and type or nature. It specifies requirements to plan, establish, implement, operate,...

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...

ISO 45001

The latest draft of ISO 45001 has now been approved and will replace OHSAS 18001:2007. When published the final ISO 45001 will join a suite of management systems standards including ISO 9001. The structure and layout will be similar to 9001 which will make the...

Organisational Resilience

A new standard, ISO 22316, Security and resilience – Organizational resilience – Principles and attributes, provides a framework to help organizations future-proof their business, detailing key principles, attributes and activities that have been agreed on by experts...

Information Security Management System

The recent malware attack serves as a reminder for businesses to have a rigorous information security management system in place to mitigate against such threats. This is why the use of ISO/IEC 27001:2017 can be very beneficial for organisations to: • Examine the...

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...

Occupational Health and Safety Management Systems

All ISO standards must go through a series of pre-defined development stages before it is finally released. This process is designed to provide national bodies, other relevant bodies and the general public with an opportunity to shape the finished document. ISO 45001...

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 45001

The new international standard for occupational health and safety ISO 45001 has been delayed again, following a decision from the elected committee to publish a second draft. The move means the Draft International Standard version two will be released early next year,...

ISO 45001

ISO/DIS 45001 is the first internationally recognized worldwide standard on Occupational Health and Safety that will enable organisations, regardless of context and size, to provide a safe and healthy workplace for their workers, visitors, contractors and other...

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...

Global Impact of ISO Standards

Estimates by the Organisation for Economic Cooperation and Development (OECD) and the US Department of Commerce both show that standards and related conformity assessment (checking that products and services measure up to standards) have an impact on 80 % of the...

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...

ISO 14001:2015

The new ISO 14001:2015 has been released and is now written using a common core structure (Annex SL), similar to the quality management system, ISO 9001:2015. The following is a summary of the main changes: • CONTEXT (Clause 4) The organization is required to identify...

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...

Environmental Management System

The ISO 14001 has undergone its first major revision and restructuring since it was initially published in 1996. There was a revision in 2004, but it focused on clarifying the existing requirements. The new revision is quite different. It is a total restructuring and...

ISO 9001 Quality Management System

 The last published ISO survey once again demonstrates comprehensive growth for all seven ISO management systems standards covered by the survey, with a 4 % increase in numbers of certificates issued worldwide. Three sectors exhibit steady growth, in particular...

Compliance Management

Compliance has become one of the biggest challenges facing businesses today. Failing to have the right controls and culture in place could mean forking out millions in fines. There are now newly published guidelines on compliance management systems, ISO 19600:2014....

Standards for Cloud Computing

The first international cloud computing standards have just been published: ISO/IEC 17788 and ISO/IEC 17789. Drawing on the knowledge of experts from over 30 countries, these standards lay down the basic terminology and architectural framework for this sector. ISO/IEC...