Tag: Risk 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.

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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!

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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.

New MIL-STD-881 Revision C, Work Breakdown Structures for Defense Materiel Items

MIL-STD-881 was reinstated on 3 October 2011 with the release of Revision C so that it can be used for new and existing designs and acquisitions.  Titled “Work Breakdown Structures for Defense Materiel Items,” the new revision replaces both the MIL-STD-881B from March 1993 and the MIL-HDBK-881A from July 2005 (which is cancelled by this new release).

A Work Breakdown Structure (WBS) provides a consistent and visible framework for defense materiel items and contracts within a program. This Standard offers uniformity in definition and consistency of approach for developing all levels of the WBS. Generating and applying uniform work breakdown structures improves communication in the acquisition process. It also provides direction to industry in extending contract work breakdown structures.

MIL-STD-881C presents direction for effectively preparing, understanding, and presenting a Work Breakdown Structure. It provides the framework for Department of Defense (DoD) Program Managers to define their program’s WBS and also to defense contractors in their application and extension of the contract’s WBS. Section 1 defines and describes the WBS. Section 2 provides instructions on how the WBS is applied as well as how to develop a Program WBS in the pre-award timeframe. Section 3 provides direction for developing and implementing a Contract WBS and Section 4 examines the role of the WBS in the post-award timeframe. This Standard also provides WBS definitions for specific defense materiel commodity systems in Appendices A through K. Appendix L addresses WBS elements that are common to all systems.

The document supports mandatory procedures for all programs subject to DoD Instruction 5000.02.  It is is applicable to all defense materiel items (or major modifications) (a) established as an integral program element of the Future Years Defense Program (FYDP), or (b) otherwise designated by the DoD Component or the Under Secretary of Defense (Acquisition). This Standard is mandatory for all Acquisition Category (ACAT) I, II, and III programs.

MIL-STD-881C and all publicly distributed (non-classified) military specifications and standards are available from Document Center Inc. at our website, www.document-center.com.  You can also reach us by phone (650-591-7600), fax (650-591-7617) or email (650-591-7617).  We have been known throughout the years for low prices on these government documents, with superior notification services for updating information on changes.

 

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.