Tag: management

New Standards on Company Organization And Management In General Including Legal Aspects And Risk Management Q1 of 2020

These are all the changes for documents on Company Organization And Management In General Including Legal Aspects And Risk Management. A complete list of these standards can be found here.

If you would like to search other standards by subject, go here

It’s Finally Here! ISO/TR 24971

The wait is finally over! ISO has finally released the long awaited companion standard for ISO 14971:2019. Get your copy of ISO/TR 24971 here.

Photo by Jan Friml from FreeImages

As per the publisher, this technical report provides guidance to help manufacturers develop, implement, and maintain the risk management process described in ISO 14971:2019. It includes medical devices such as active, non-active, implantable, non implantable, in vitro diagnostic medical devices as well as software used as medical devices. If you need a little more information about this document, please look at our previous post on the topic found here.

So What’s New?

The new edition of ISO/TR 24971 cancels and replaces the 1st Edition of the report. If you would like to remain compliant, this document will be needed. Aside from some format changes for readability, here are some of the changes of note according to the publisher:

  • Clauses and annexes have been merged, restructured, technically revised and supplemented with additional guidance
  • Some structural changes for readability
  • Addition of informative annexes for additional guidance on specific aspects of rist management

Get your copy of ISO/TR 24971:2020 this companion standard today. You can also get yourself a copy of ISO 14971 while you are there if you need one. This document is also available for our standards subscription service. Add this document to a personalized site where you and your team can access it on any device at any time. Stop being limited by a shared single copy. Stop buying multiple copies of the same document. to learn more or try a demo, click here!

If you would like to keep up to date on new releases, ask us about our notification services. Get emails about updates on all the standards you need as soon as they come out. No more guess work or having to do research. With a simple email, you never have to worry about not being ready for your next audit. Ask us today!

ISO 14971 (2019) Released

If you haven’t heard by now, you should know that ISO-14971, Medical devices — Application of risk management to medical devices, has released its 3rd edition, which you can purchase here. We also offer a redline edition of the document available here.

14971 goes over the principles and processes for risk management specifically those pertaining to medical devices and in vitro diagnostic medical devices. Specifically, this will help you identify, control, and monitor the risks and effectiveness of the controls. For more details on the subject, I would suggest checking out our previous posts on the standards easily accessible here and here.

Companion Standard

Photo by Angel Norris from FreeImages

ISO 24971 is also now available for purchase! It has been long awaited but it is finally made it out of committee review. You can grab your own copy here! Don’t for get to ask us about out subscription service.

So What’s New?

Aside from a few new terms and some format changes for accessibility, there a few fundamental changes made to the document. Some of these changes include as per the publisher:

  • a clause on normative references to respect requirements for fixed ISO/IEC directives
  • terms have been updated to match up with ISO/IEC Guide 63:2019
  • Definitions of certain terms such as benefit, state of the art have been added
  • More attention to the benefits of use of medical devices. Benefit-risk analysis has been aligned with terminology used in some regulations.
  • The process descruved can be used for managing risk
  • Requirements to disclose residual risks have been merged into one requirement
  • Results of reviews is now risk management report
  • Requirements for production and post production activities have been restructured and clarified.
  • Several annexes moved to guidance of ISO/TR 24971

If you would like a more detailed representation of the differences between editions, check out the redline edition available here. This is a great option if you want to easily see what was changed without having to spend any time comparing it with the older edition. Change are clearly marked for viability. Ordering redline editions will give you access to both marked and unmarked editions for convenience. You can find an unmarked edition here.

This document is part of our yearly subscription service, StandardsOnline. We make it easy for you and your team to access the same document without the hassle of buying multiple copies. If you would like to learn more about this service, go here.

ISO 50001 2011 Edition tackles the problem of Energy management systems – Requirements with guidance for use

The new ISO 50001:2011 specifies requirements for establishing, implementing, maintaining and improving an energy management system.  The new document, titled “Energy management systems — Requirements with guidance for use,” is expected to be adopted by the European Union as EN-ISO-50001 and will replace EN-16001.

ISO 50001:2011 specifies requirements applicable to energy use and consumption, including measurement, documentation and reporting, design and procurement practices for equipment, systems, processes and personnel that contribute to energy performance.  And Annex A provides informative guidance on its use.

The ISO standard applies to all variables affecting energy performance that can be monitored and influenced by the organization. However, it does not prescribe specific performance criteria with respect to energy.

ISO 50001 has been designed to be used independently, but it can be aligned or integrated with other management systems.

It is applicable to any organization wishing to ensure that it conforms to its stated energy policy and wishing to demonstrate this to others, such conformity being confirmed either by means of self-evaluation and self-declaration of conformity, or by certification of the energy management system by an external organization.

Energy management can reduce energy consumption, leading to:

  • Reduced energy costs
  • Reduced carbon emissions
  • A more secure supply of energy
  • Improved reputation when implemented with certification

    • ISO 50001 enables organizations to take a systematic approach to energy management. It’s goal is to help companies achieve continual improvement of energy performance, energy efficiency and energy conservation.

    Who should buy this standard?

  • Anyone who wants to reduce their energy costs, reduce carbon emissions or improve their organization’s reputation
  • Those who want a better understanding of international best practice energy management
  • Users of ISO 14001 who want to further develop their management of energy and increase their performance and savings
  • Those responsible for planning and implementing an energy management system

    • ISO 50001:2011 is available from Document Center Inc. at our website, www.document-center.com.  Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).   We have been an authorized distributor of ISO standards since the 1990’s.

    European Risk Management Standards center on Medical Devices

    Looking for European Standards on risk management?  If you’re interested in EN standards specific to the region, you’ll find most are focused on medical devices and laboratories.  And they’re almost all adoptions of ISO and IEC standards as well!

    Here’s a list with links to the existing Official English language editions of the EN standards on Risk Management:

    EN 31010:2010 Risk management – Risk assessment techniques,

    CEN ISO/TS 22367:2010 Medical laboratories – Reduction of error through risk management and continual improvement (ISO/TS 22367:2008, including Cor 1:2009),

    EN ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) – Includes Corrigendum 1,

    EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management (ISO 22442-1:2007),

    EN ISO 14971:2009 Medical devices – Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01),

    EN 80001-1:2011 Application of risk management for IT-networks incorporating medical devices – Part 1: Roles, responsibilities and activities,

    EN ISO 17666:2003 Space systems – Risk management (ISO 17666:2003),

    EN ISO 15743:2008 Ergonomics of the thermal environment – Cold workplaces – Risk assessment and management (ISO 15743:2008),

    EN 15975-1:2011 Security of drinking water supply – Guidelines for risk and crisis management – Part 1: Crisis management, and

    EN 62305-2:2006 Protection against lightning – Part 2: Risk management.

    EN standards are not available as stand-alone items, but only as reprints by each country in the European Union, released as the EN is adopted.  The official English language editions and other national issues are all available from Document Center Inc. at our website, www.document-center.com.  You may prefer to contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  We’re here from 8 am to 5 pm Monday through Friday California time to help you with your standards requirements and questions.

    Finding Standards Expertise Again

    As owner of Document Center Inc. since 1985, I’ve seen tremendous changes in the world of Standards.  And the change that concerns me the most is the lost of Standards Expertise.

    Three trends have caused the loss of personnel with real knowledge of standards, the standards process, and how to manage standards collections.

    The first was MIL Spec Reform during the mid-1990’s.  When the Department of Defense decided to get out of the spec-writing business, the migration to industry-managed standards was a costly exercise for many business.  Information that had been free or extremely low-cost  was  suddenly 5 to 10 times as expensive.  Of course, the true migration of cost was from tax-payer money to fees from the actual document users.  But the pocket book effect significantly reduced the number of standards most businesses used.  With this reduction came the first loss of standards personnel as large standards libraries became obsolete.

    The second trend was the Internationalization of Standards.  As companies started using non-U.S. documents,  the price differential was immediately noticeable.  European information has come with a high price tag.  Again, price pressure caused a reduction in documentation and the personnel to manage that information as companies strove to lower their out-of-pocket costs.

    And finally, the repeated down-sizing and loss of manufacturing facilities in the United States has left many organizations without employees who understand what Standards bring to business.  Thus, many companies are limited in their ability to use Standards to their best advantage.

    Having been in the business for over 25 years, and hearing customers express confusion about Standards every day, this blog represents the perfect opportunity to discuss  common  Standards and Standardization questions.

    I also look forward to discussing trends and issues that are more strategic in nature.  In my mind, standards are one of the foundations of our economy and well-being.  I look forward to being part of a process that improves the effect they have on our world.