ISO 17025:2017 Quality Management System for Laboratories

The new edition of ISO 17025:2017 encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management. What are the main changes in the 2017 version? The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing. The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports. A new chapter introduces the concept of risk-based...

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 standard. This will greatly facilitate organisations integrating their different management systems. Top management commitment, risk-based thinking and the process approach are emphasised throughout and therefore consistent, not only with ISO 9001 but also ISO 14001. Consultation and worker participation in identifying hazards and risks and the development and operation of the occupational health and safety management system, and An organisation must take into account mental and cognitive conditions of people as well as their physical condition. Causes of ill-health and injury can be immediate such as accidents or long-term such as repeated exposure to harmful substances or a stressful working...

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 revised in 2015 and the 2018 revision is the next step in making risk management easier and clearer and keeping it simple. The text has been reduced to its fundamental concepts to create a shorter, clearer and more concise document that is easier to read while remaining widely applicable. Knowledge of ISO 31000 will go a long way to managing risks which are a requirement of most management systems standards and in particular 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 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies). The revised standard puts the emphasis on the results of a process instead of the detailed description of its tasks and steps. With a stronger focus on information technologies, the standard now recognizes and incorporates the use of computer systems, electronic records and the production of electronic results and reports. Modern-day laboratories work increasingly with information and communication technologies and the working group felt it was necessary to develop a chapter on this topic. The new version of the standard includes a chapter on risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality management systems – Requirements. The terminology has been updated to be more in step with today’s world and the fact that hard-copy manuals, records and reports are slowly being phased out in favour of electronic versions. Examples include changes to the International Vocabulary of Metrology (VIM)and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment. A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment. The scope has been revised to cover all laboratory activities including testing, calibration and the sampling associated with subsequent calibration and testing. Using ISO/IEC 17025 facilitates cooperation between laboratories...

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 levels of performance over the long term goes far beyond the law to instil trust and effectiveness. In this context, ISO’s committee of experts that specializes in governance (ISO/TC 309) has just been given the green light to develop an ISO international guidance standard that will help organizations establish good governance practices, going beyond the avoidance of risk and contributing to their long-term value overall. It is expected that this standard will be compatible with the quality management system requirements of ISO 9001. This standard will fill a gap in standardization, allowing it to be accessible and useful for any organisation, whether it crosses different sectors and geographies or is simply a small business that feels it can benefit from better governance. The proposed new standard has the potential to increase the number of socially, environmentally and economically sustainable organisations, providing multiple benefits for investors and society as a whole. The new guidance standard for the governance of organizations is due to be published by...

Quality Management Systems for the Food industry

Since its launch in 2005, ISO 22000 has been adopted as the food safety management system of choice for more than 32,000 organisations worldwide (based on data from the annual ISO survey, 2016). The first major revision to this standard is expected to be published in 2018. In line with agreed policy for management system standards, ISO 22000:2018 will adopt the 10-section, high-level structure created by ISO, based on identical core text, and common terms and definitions. It will in essence become a business management system and will have implications for the future training of...

ISO 13485:2016 Quality Management Systems

There is a new handbook ISO 13485:2016 – Medical devices – A practical guide just published. It was written by a group of technical experts from ISO’s technical committee ISO/TC 210. The handbook provides users with practical guidance and accurate interpretation of the requirements specified in the ISO 13485:2016, Medical devices –Quality management systems – Requirements for regulatory purposes. Mapped to the structure of ISO 13485:2016, the new handbook offers a step-by-step guidance for all organisations in the medical devices sector wishing to implement and maintain a quality management system. It covers guidance applicable to various stages of a medical device’s life cycle, including the gathering of customer requirements, design, development, production, supply chain, installation, servicing and post-market surveillance of medical devices. The handbook can serve as a practical guide for auditors, regulatory agencies and certification bodies, providing in-depth perspective on how requirements can be fulfilled to meet national regulations. It thus allows for a better understanding of the standard when preparing or conducting external and internal audits, as well as establishing local regulations and guidelines. Alongside its thorough description of ISO 13485, the new handbook also incorporates information from other sources of best practice most commonly used in the medical devices industry to meet the requirements of...

Food Safety and Quality Management System Standard

Since its launch in 2005, ISO 22000 has been adopted as the food safety management system (FSMS) standard of choice for more than 32,000 organisations worldwide (based on data from the annual ISO Survey last published in 2016). In addition, more than 16,000 organisations have been certified under the Food Safety System Certification 22000 (FSSC) private certification scheme, the core requirements of which replicate ISO 22000. Given that many of these organisations are global players in the food manufacturing and processing sectors, these figures demonstrate the considerable influence that the standard exerts on global food safety. The first major revision to ISO 22000 since its launch is expected to be published in 2018. The Draft International Standard (DIS) is now available and indicates that some significant changes are planned. This will affect not only those organisations that wish to maintain their system certification, but also those that are involved in the associated auditing programmes. In line with agreed policy for management system standards, ISO 22000:2018 will adopt the 10-section, high-level structure created by ISO based on identical core text and common terms and definitions. It will therefore follow the same structure as ISO 9001. This change alone will impact the system scope, top management involvement, documentation of the system, application of the risk-based approach to organisational needs, and create a clear focus on the process approach through the Plan-Do-Check-Act (PDCA) cycle. The changes will facilitate assimilation of the FSMS with other management system disciplines using this...

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, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of, prepare for, respond to, and recover from disruptive incidents. Like ISO 9001, the standard uses the common language structure and it’s layout is similar to that of 9001. Organisations can obtain accredited certification against this standard and so demonstrate to legislators, regulators, customers, prospective customers and other interested parties that they are adhering to good practice in BCM. At present there are relatively few certificates issued, some 3,133 (ISO Survey 2015), compared to ISO 9001:2015 at 1,033,000. But this number is growing quickly, up 78 per cent over the previous year, making it the fastest growing of all ISO standards at...

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 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). The Medical Device Single Audit Program allows an MDSAP recognised Auditing Organisation to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program. International partners that are participating in the MDSAP include: Therapeutic Goods Administration of Australia Brazil’s Agência Nacional de Vigilância Sanitária Health Canada Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observers This Program was piloted for three years in the period 2014 to 2016. On 29 June 2017, a report was generated summarising the outcomes of prospective “proof-of-concept” criteria established to confirm the viability of the MDSAP. The outcomes documented in the Final MDSAP Pilot Report are based on data generated during the three year pilot. Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program....