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    2022

    Telemedicine 5g

    Telemedicine and 5G – affordable and preventative healthcare without borders

    The Covid-19 pandemic has accelerated the use of telemedicine across the world. The need to limit the impact of the virus has increased the acceptance of telemedicine by clinicians and patients alike. Hear about the importance of telemedicine and the digital transformation of healthcare.

    Read the full post >

    How to Spot Quality Remanufactured and Refurbished Electronics

    As we work to reduce our carbon impact, we look to sustainable methods of recycling and the reuse of electrical goods. But how can you find quality refurbished or remanufactured products that you know you can trust?

    Read the full post >

    Improve your current internal audit practices (Part 4)

    Internal auditors must prepare reports as prescribed by their own audit procedure. Remember to audit for conformity (not non-conformity) and to share some positive comments in reports to encourage improved conformance.

    Read the full post >
    Who cares wins

    Who cares wins

    In this blog, hear from Kate Field, Global Head – Health, Safety and Well-being of BSI who states that we must protect the well-being of adult social care workers. Learn more about the challenges to well-being in the social care industry, how the pandemic is having a massive added impact and what can be done.

    Read the full post >

    FM Conway’s experience of UKCA Marking

    BSI recently sat down with FM Conway to discuss all things UKCA Marking; their drivers behind it, how they found the experience and what advice they would give to other organizations considering UKCA.

    Read the full post >
    business people panel discussion board meeting

    Improve your current internal audit practices (Part 3)

    Organizations with an existing internal audit programme should review their results to ensure audit objectives are being met and to identify opportunities for improvement.

    Read the full post >
    our homes are getting smarter

    Our homes are getting smarter, but are they secure?

    According to a Gartner report, 78% of consumers don’t trust smart home technology.

    Read the full post >

    Updated requirements and guidance on symbols for use with medical devices

    BS EN ISO 15223-1:2021 includes additional symbols to support European regulatory requirements.

    Read the full post >
    Supply Chain Containers

    Supply chain decisions for business success and a greener planet

    BSI’s latest annual Supply Chain Risk Insights Report poses five questions we need to answer in 2022. Here, I’d like to highlight some aspects of the second question...

    Read the full post >
    bsi shop

    Evaluate the effectiveness of the system (Part 2)

    Auditors often struggle with, or overlook, assessing how well the system has performed. Every audit situation should be examined from three perspectives...

    Read the full post >

    MDR clinical evaluation planning - intended purpose, indications, contraindications

    The definition of the intended purpose and indications for use of the device is a critical first step which shapes all subsequent aspects of the evaluation.

    Read the full post >
    Emergency trends

    Emerging trends in the digital health landscape

    Healthcare systems globally are being challenged continually by demographic changes in population, increased patient demand and expectation, worldwide growth in chronic conditions, and shortages of clinicians and allied staff. Professor Michael Miller, International consultant in health informatics and eHealth strategy and systems, writes about the digital health landscape and the emerging trends in this area.

    Read the full post >
    social post

    Adopt a process approach to internal audits (Part 1)

    The intent of ISO 9001 is to encourage the adoption of the process approach to manage an organization. As a result, internal audits (of your management systems) need to adopt a similar approach.

    Read the full post >

    2021

    Health and telemedicine

    Defining the standards of virtual care for health and telemedicine after COVID-19

    The COVID-19 pandemic led to a surge in the urgent need to connect health and care providers to their patients through remote appointments, and a need to address the ongoing concerns about how delivery of care would be maintained.

    Read the full post >

    Digitization within healthcare

    Head of Innovation Policy at BSI, Daniel Barlow, was recently interviewed by Infinity Health, where he shared the role that we play within UK healthcare.

    Read more >

    Purpose of a clinical evaluation under the EU MDR

    The purpose of the clinical evaluation is to demonstrate, with objective and scientifically valid evidence, that the device does what it is supposed to do, achieves its intended clinical benefits (whether direct or indirect) and that the benefit-risk conclusion is acceptable in comparison to other available therapeutic or diagnostic options.

    Read the full post >

    Clinical evaluation under EU MDR

    There has been significant evolution in the European regulatory landscape over the past 10–15 years, particularly with respect to requirements for clinical evaluation.

    Read the full post >

    Putting psychological health front and centre of prioritizing your people

    People’s psychological health and well-being in the workplace is firmly on the workplace agenda. BSI’s Global Head, Health, Safety and Well-being, Kate Field (CMIOSH) explains why.

    Read the full post >

    Consultation on revising UK medical devices regulations initiated

    The Medicines and Healthcare products Regulatory Agency (MHRA) are looking at ways to update the UK regulations on placing medical devices on the UK market.

    Read the full post >

    Resilience and innovation: the business benefits of prioritizing your people

    BSI’s new Prioritizing People Model© provides a best practice framework for organizations to plot their resilience journey from workplace welfare to innovation. The model’s creator Kate Field (CMIOSH), BSI’s Global Head, Health, Safety and Well-being, maps the milestones.

    Read the full post >

    Can we sustain a culture of workplace care beyond the era of COVID-19?

    The COVID-19 pandemic provided a worldwide wake-up call, reminding us of the human aspect of what it means to be a thriving employee. Here BSI’s Global Head, Health, Safety and Well-being Kate Field (CMIOSH) makes the case for a culture of care to be preserved.

    Read the full post >

    European amendment published for medical devices quality management system standard

    An amendment to EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes – was published in September 2021.

    Read the full post >

    Can the care built during COVID-19 establish a long-term workplace culture of trust?

    Kate Field (CMIOSH), BSI’s Global Head, Health, Safety and Well-being, reflects on whether the culture of care driven by the global pandemic can translate to long-term trust between worker and employer.

    Why has it taken a global pandemic to create a culture of care in the workplace, when there has clearly been a need for it for decades?

    Read the full post >

    Why was the requirement for an SSCP introduced?

    Under the EU MDR, there are several new provisions to increase transparency and access to information. The foundation for these instruments is encapsulated in the recitals. With respect to the Summary of Safety and Clinical Performance (SSCP), Recital 43 is particularly relevant.

    Read the full post >

    Well-being: why we need a shift in corporate mindsets

    Kate Field (CMIOSH), BSI’s Global Head, Health, Safety and Well-being, explores the link between well-being in the workplace and the need for a more profound cultural shift.

    Read the full post >

    EUDAMED and legacy devices

    Depending on device transition timing to the Regulations, manufacturers may need to submit UDI and Device Registration information for legacy devices in EUDAMED.

    Read the full post >

    EUDAMED and the UDI and Device Registration module

    EUDAMED functionality is intended to provide for the exchange of information regarding vigilance reporting, clinical investigations, certificate notifications and registration of devices and economic operators, as well as exchange of information between competent authorities.

    Read the full post >

    Making button batteries safer for consumers

    The newly published PAS 7055: 2021 specifies the safety requirements for button and coin batteries. CPIN Rep Michelle McKenna, who advocated for consumers on this standard, explains why the PAS is so important for consumer safety, and why CPIN involvement was crucial.

    Read the full post >

    Overview of the EU Basic UDI-DI

    The new EU MDR 2017/745 and IVDR 2017/746 regulations require the assignment of a Basic UDI-DI to medical devices. The concept of a Basic UDI-DI is new and currently unique to the EU. The purpose and use of the Basic UDI-DI is different from the use of the device UDI-DI.

    Read the full post >

    Why diversity and inclusion should now be a strategic imperative for every organization

    The need for organizations to focus on diversity and inclusion (D&I) has never been more pressing, but the complexities involved can discourage some from starting the journey. This blog post explains how a new international standard can help.

    Read the full post >

    Why it’s now time to start using the third version of the built environment competence standard

    In April 2021 we published the third and final version of the BSI Flex standard giving recommendations for building safety competence core criteria. This blog post explains why it’s now time for the industry to start using this document in earnest.

    Read the full post >

    Keeping the UK’s national pressure vessels code up to date

    A new edition of the UK’s pressure vessel code has just been published. This blog post discusses what the code does and why it matters. 

    Read the full post >

    Expert Q&A: Why energy storage is key to net zero

    Energy storage is transforming the global electric grid and is an increasingly important element of the world’s transition to sustainable energy. However, its full potential is yet to be exploited. Scott McGregor, founder and CEO of Birdwood Energy, gives his view of how he sees a market for energy storage developing, and what needs to change for that to happen.

    Read the full post >

    Expert Q&A: The future of the energy grid

    The UK’s energy system is changing. The increase in renewable sources means that the grid of the future will also need to be low-carbon, smarter and more flexible than it is now. Our expert shares valuable insights into how the grid of the future could develop.

    Read the full post >

    Bringing the PVC insulated electric cable standard up to date

    The British Standard on requirements and test methods for a popular class of PVC-insulated electric cable has now been amended to reflect developments in cable manufacture. This blog post describes what the standard does and how the amendment came about.

    Read the full post >

    How to ensure consistently safe shell boilers

    We’ve updated the European standard that details inspection requirements for shell boilers. This blog post describes the standard and explains what’s new in the revision. 

    Read the full post >

    What you should know about the new European standard on cold-formed welded hollow steel sections

    After a prolonged delay, the third in the series of European standards on cold-formed welded hollow section structural steel has been published. This blog post explains where Part 3 sits within the series and how it differs from Part 1.

    Read the full post >

    Introducing the new European standard on delivery conditions for hot-finished hollow steel

    We’ve now published the third in a series of European standards on hot-finished hollow section structural steel. This blog post explains the genesis of Part 3 and what’s covered.

    Read the full post >

    An introduction to SaMD

    The IMDRF defines ‘SaMD’ as ‘software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device’.

    Read the full post >

    Using the Medical Device Single Audit Program (MDSAP) to support EU regulatory requirements

    Medical Device Coordination Group (MDCG) endorses guidance for notified bodies.

    Read the full post >

    The definitive guide to writing instructions for use

    In 2012, ISO and IEC got together to provide common minimum requirements for the preparation, structuring, content and presentation of product instructions. The standard has now been updated, and this blog post outlines why and what’s new. 

    Read the full post >

    The value to be gained from standardizing construction data dictionaries

    As BIM becomes more established, it’s time to develop and standardize more compatible construction data dictionaries. Towards that end, we’ve recently published two new international standards and a PAS in this area. This blog post explains what each document does. 

    Read the full post >

    We now have state-of-the-art guidance on risk and resilience for utilities

    For many people, organizational resilience was probably an abstraction before COVID-19. That’s no longer the case. Hence the timely publication of new guidance on embedding risk and resilience management in utilities. This blog post explains more. 

    Read the full post >

    When six became one – in the presentation of lines

    ISO has now revised and consolidated six pre-existing standards into one clear and consistent document covering all of the requirements for how to present lines on technical drawings. This blog post explains the details. 

    Read the full post >

    An update on the revised international cross-cut paint testing standard

    We’ve revised the international standard on how paint coatings resist separation when cut. This blog post reviews how the test has changed. 

    Read the full post >

    Ensuring that household appliances comply with the latest EMC Directive

    The European EMC standard covering household appliances and electric tools has now been amended. The standard now provides a means of conformity with the latest EMC Directive, as this blog post explains.

    Read the full post >

    Updating the calliper depth gauge specification

    The international standard that specifies calliper depth gauges has been updated to make it more user-friendly. This blog post describes its contents and lists what’s new.

    Read the full post >

    Updating the standard that classifies gas metal arc welding wire electrodes

    BS EN ISO 14341:2020 is the revised international standard setting out how to classify specified wire electrodes and weld deposits. This blog post explains what the standard contains and what’s new about the updated version.

    Read the full post >

    MDR requirements for PMCF investigations

    Manufacturers should be careful to distinguish a PMCF investigation from other types of PMCF.

    Read the full post >

    BSI Flex - a new, dynamic approach to standardization

    Standards play a vital role in the adoption of innovation. But in the constantly changing economies of the 21st Century, emerging markets need to agree "what good looks like" in a faster, more flexible way. Read how BSI Flex provides a new, dynamic way to develop good practice that adapts to keep pace with fast-changing markets.

    Read more >

    Developments in the standardization request for harmonized standards

    European request for standards to support the regulations of medical devices rejected by the European Standards Organizations.

    Read the full post >

    Clinical investigations and the MDR: SAE reporting to Member States

    The need to report only serious adverse events (SAEs) with a causal relationship with the investigational device, comparator or investigation procedure is an important difference from the AIMDD and MDD.

    Read the full post >

    Standard for employee wellbeing

    Today’s work environment is stressful, especially now that work spaces have moved inside the home.

    Read the full post >

    UK guidance on stand-alone medical device software including apps issued

    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance to help identify the health apps which are medical devices.

    Read the full post >

    We have a new standard on how to manage standardization BS 202000:2020

    We’ve now published an all-new standard on standardization itself, with the aim of optimizing its value. This blog post looks at the background to the standard and at what it delivers. 

    Read the full post >

    Clinical investigations and the MDR: sponsors and legal representatives

    The MDR introduces new requirements, which need to be carefully reviewed and addressed in applicable procedures for the conduct of clinical investigations under the MDR.

    Read the full post >

    Remaining resilient – Top tips for maintaining business continuity

    With disruptions to businesses like never before, it’s important that your organization is well-equipped to effectively minimize disruptions to your business.

    Read our top tips on how you can better prepare and respond to disruptions whilst remaining resilient.

    Read the full post >

    Finding the safest design solutions for electrical equipment

    Insulation coordination is basic to the safety of electrical equipment. It’s the mutual correlation of the insulation characteristics of equipment, taking into account the expected micro-environment and other influencing stresses.

    Read the full post >

    The consequences of disruptions in an ever-evolving risk landscape

    We know that preparing for the unexpected is crucial, but it is also key to recognize the consequences that disruptions can have on employees and wider operations.

    Read the full post >

    New international specification gives general requirements for sterilizing equipment

    The delivery of a validated and accurately controlled sterilization process is enabled by the use of sterilizing equipment that is designed, constructed and installed to deliver the sterilization process safely and reproducibly. There are currently no international standards for sterilizing equipment.

    Read the full post >

    Innovation in regulatory approaches to AI

    Modifications to regulatory approaches for AI–based medical device software will depend on the type and nature of the algorithm, and the associated risks.

    Read the full post >

    MDR requirements for pre-market clinical investigations – General considerations

    The MDR sets out very detailed requirements regarding clinical investigations in comparison with the Directives.

    Read the full post >

    Regulation and standardization of AI in healthcare

    As further advancements are made with AI technology, regulators may consider multiple approaches for addressing the safety and effectiveness of AI in healthcare.

    Read the full post >
    engineers examining air plane aerospace

    Aerospace goes back to work: the human factors

    Human factors are central to many quality management systems. Clause 7.1.4 of both ISO 9001:2015 and AS 9100 require us to consider human and physical factors in the environment for the operation of processes, including social, psychological and physical.

    Read the full post >

    Clinical investigations and the MDR

    Under the European MDR, there are important new requirements for pre-market and post-market clinical investigations.

    Read the full post >

    What is 2020 teaching us about learning?

    With the 2020 pandemic becoming a reality, an appetite for virtual classroom solutions is growing. But is virtual training second best? Discover the 10 ingredients we’re embedding in our virtual training courses to create an inspirational learning experience, that rivals the traditional classroom setting.

    Read the full post >

    New guidance on regulatory pathways for personalized medical devices

    The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world. They have recently issued a final guidance document - Personalized Medical Devices – Regulatory Pathways.

    Read the full post >

    Machine learning and medical devices: data quality and bias

    Data quality is a key factor in the success or failure of a machine learning system; in fact, data quality is as or more important than the machine learning algorithm.

    Read the full post >

    Updated guidance on packaging for terminally-sterilized devices

    Guidance on the application of the BS EN ISO 11607 series of standards, which specifies requirements for sterile barrier systems, is being balloted.

    Read the full post >

    Microbiological methods and sterilization

    There are several microbiological methods that are used in developing, validating and routinely controlling sterilization processes.

    Read the full post >

    Do you have sufficient clinical evidence for your medical device?

    The Medical Device Coordination Group (MDCG), which is composed of representatives of Member States and chaired by the EU Commission, has issued four further guidance documents on clinical investigation and evaluation.

    Read the full post >

    Connected Learning Live brings the classroom to you

    As new risks have emerged, many organizations have had to adapt the way in which they function. With many industries beginning to operate again, what can employers do to support their staff’s development and better prepare them for when they return to work?

    Read the full post >

    Restoring confidence in the travelling public

    Restoring confidence in the travelling public will be key to regenerating the aerospace sector following COVID-19. Find out more about the challenges faced by airports and airlines in the ‘next normal’ and considerations for the sector to consider during the rebuild and recovery phase.

    Read the full post >

    Trust and machine learning AI in medical devices

    If medical device regulators, clinicians, and patients are going to reap the benefits of machine learning AI, it is critical that an appropriate level of trust in these systems be established by a collaborative regulatory system.

    Read the full post >

    Reopening and rebuilding the automotive sector following COVID-19

    What is the next normal for automotive? Find out more about the new automotive landscape and what organizations operating in this sector should consider as they drive their return to work plans forward.

    Read the full post >

    PMCF plans and the MDR date of application

    PMS requirements under the MDR must be met from 26 May 2021; however, some companies have questioned whether this also applies to the development of PMCF plans.

    Read the full post >

    Are your Class I devices ready for the MDR?

    Even with the postponement of the date of application for the MDR to 26 May 2021, manufacturers still need to pay attention to devices for which there are no transitional provisions.

    Read the full post >

    Meeting net zero, with help from hydrogen

    How important is hydrogen to achieving net zero targets? Countries around the world, including the UK, are trying pioneering new ways to use hydrogen to meet their emissions targets. We explore how hydrogen is being used as a fuel for the future.

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    Delay to implementation of the Medical Devices Regulation

    Postponement of the date of application of the MDR provides some respite to all those manufacturers, notified bodies and competent authorities trying to deal with the demands of the COVID-19 pandemic.

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    Validation and routine control of sterilization processes

    Standards for validation and routine control have a common format and use a common set of definitions.

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    Machine-learning AI—What makes it different?

    Machine learning AI systems, unlike simple rules-based systems, are cognitive in some sense and can modify their outputs accordingly.

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    Updates to the list of standards harmonized for the European medical devices Directives

    On 25 March 2020, three Commission Implementing Decisions on harmonized standards were issued to support the MDD, AIMDD and IVDD. This is a new format for updating the list of harmonized standards.

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    New standard on information to be supplied by the manufacturer of medical devices

    ISO 20417 sets out requirements for the identification, marking and labels on a medical device or accessory, and the information necessary to accompany the device or accessory.

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    Progress on European and international standards on symbols for medical device labelling

    Ballots on amendment to European adoption and new international edition of ISO 15223-1.

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    Designating of medical devices as sterile and the MDR

    The MDR presents requirements for sterile devices but does not provide a definition of the term ‘sterile’. The EN 556 series of standards defines requirements for designating devices as sterile.

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    Sterilization, harmonization and the state of the art

    Work is in progress to include Annex Zs into new editions or amendments to the applicable sterilization and aseptic processing standards.

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    Notified Body capacity for In Vitro Diagnostics

    Arguably the biggest change in the IVDR is the introduction of a risk-based approach to classification in combination with increased Notified Body oversight.

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    Risk classification and the IVDR: an introduction

    The new system of risk classification of IVD medical devices is one of the few radical changes brought about by the new medical device regulations. It aligns the classification of IVD medical devices with other medical devices and international practice as advocated by the GHTF.

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    Managing healthcare cybersecurity in 2020 pt.2

    It’s widely accepted that healthcare has lagged behind other industries when it comes to cybersecurity, and that the industry needs to close the gap. Thankfully, healthcare managers can use standards to build resilience across diverse cybersecurity fronts simultaneously.

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    Managing healthcare cybersecurity in 2020 pt.1

    With significant data breaches hitting the headlines each year, healthcare cybersecurity is a major and expanding area for investment. Some experts predict the market will grow by almost 20% over the next five years, and it’s not difficult to see why.

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    Where is the consumer genetic testing industry headed?

    From uncovering health risks to long lost family, consumer popularity for DNA testing has soared. This has put a spotlight on the quality and purpose of these test kits. We explore the challenges and opportunities within the consumer genetic testing market.

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    Relationship between the revised risk management standard and European regulatory requirements

    The final draft of EN ISO 14971 circulated for ballot included drafts for five European Annexes Z. However, these Annexes Z were not included in the published text. This was because comments received from the independent review of the Annex Zs were taking time to resolve.

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    Three tips for implementing the MDR

    BSI’s Bill Enos (Americas Senior Commercial Director, Medical Devices) and John Bis (VP of Medical Device Solutions Sales) offer three key pieces of advice for medical device companies trying to compete in the new EU MDR environment.

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    Harmonized standards and the countdown to the MDR

    Standards writers for medical devices, in particular anaesthetic and respiratory devices, are concerned about the EU Commission’s timelines for harmonized standards.

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    Which smart cities are leading the electric transport revolution?

    Driven by the impact on climate change and public health, the electric transport revolution is here. We explore the innovations from global smart cities that are transforming the way people live, work and travel every day.

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    Risk control in the third edition of ISO 14971

    Medical device manufacturers have several risk control options for eliminating or reducing risks to an acceptable level.

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    Risk management plans and the new ISO 14971

    The risk management process described in the new ISO 14971 consists of several steps. The first of these steps is the risk management plan. All risk management activities must be planned. The plan provides a roadmap for the risk management activities to be conducted during the life cycle of the medical device.

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    Implementation and interpretation of IVDR classification rules

    Under the IVDR the manufacturer is responsible for identifying the risk class applicable to its IVD device.

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    The future of aerospace through the lens of sustainability: part 1

    With uncertainty affecting many sectors, now is a good moment to take stock and understand what the future may hold, what will remain the same and what may be different in our futures for Aerospace.

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    Helping the oil and gas sector to become more efficient

    At this difficult time, how can oil and gas sector organizations improve productivity and reduce risk? One tried and tested route is by implementing a quality management system. To that end, in May we published BS EN ISO 29001:2020 Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations.

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    Revisions have updated the European standard for alloyed aluminium ingots

    BS EN 1676: 2020 specifies the classifications and designations that apply to these grades, the conditions in which they are produced, their properties and the marks by which they are identified. This standard was first published in 1997 and then revised in 2010. The 2020 standard is its second revision.

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    What Exploration & Production companies will get from the new ISO quality standard for the oil and gas sector

    BS EN ISO 29001:2020 Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations. This is a quality management standard for the oil and gas industry, but what can it do for E&P companies?

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    We’ve made big changes to the important European standard for aluminium casting

    BS EN 1706:2020 Aluminium and aluminium alloys — Castings — Chemical composition and mechanical properties specifies the chemical composition limits for aluminium casting alloys and the mechanical properties of separately cast test pieces for these alloys. It includes an annex on the selection of alloys for a specific use or process. This standard was first published in 1998 and then revised in 2010. The 2020 standard is its second revision.

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    What mid and downstream organizations will gain from the new ISO quality standard for the oil and gas sector

    In May we published ISO’s revised sector-specific quality management standard for the oil and gas industry. This blog post looks at what this standard can do to help post-production companies in the sector.

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    What you need to know about our new British Standard on water safety planning for buildings

    Building water systems can be dangerous if they’re poorly designed and managed – yet it’s a problem that’s easily solved by a proper Water Safety Plan. We’ve just produced a new standard giving guidance on water safety planning. This blog post sets out why it’s been written and what it does.

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    Changes to the key safety standard on household electrical appliances

    BS EN 60335-1 is the European standard on general requirements and conditions for domestic safety testing of electrical household appliances. The work-horse European standard on the safety of electrical appliances has gone through multiple amendments. This new version incorporates the latest, as this blog post explains.

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    Restoring compliance to the MME emission requirements standard

    An informative annex has been added to the European MME emission requirements standard. This blog post explains the background to the amendment and the impact on users’ ability to demonstrate compliance with the current applicable EU Directive. 

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