ISO 9001 User Survey 2020

September 2nd, 2020

The committee responsible for the development of the international standard, ISO 9001:2015—”Quality management systems—Requirements,” has announced a user survey to gather information on the value of ISO 9001:2015.

According to a press release from ISO/Technical Committee 176/Subcommittee 2, ISO 9001:2015 is currently undergoing a formal “systematic review” that is due to close on Dec. 2, 2020. Following the review, ISO/TC 176/SC2 will have up to six months in which to decide whether the standard should be “confirmed” (i.e., left unchanged), be revised or amended, or be withdrawn.

The goal is to capture data on standard value, advantages and disadvantages, and User opinions on how to ensure this standard remains relevant in the future. In addition, ISO/TC 176 has been giving consideration to “future concepts” for quality. SC2 would like to test the acceptability of such concepts with users, for potential inclusion in a future edition of ISO 9001.

The committee invites all categories of users of ISO 9001 from all over the world to participate in a global survey about ISO 9001’s future. For your convenience, the survey has been developed in 13 languages on Survey Monkey; choose the language that is most convenient for you using the language link in the upper right corner of the survey page. 

Take the User Survey Here

Medical Device Safety Focus

July 14th, 2020

Reducing and managing risks related to medical devices s the objective of a key industry standard, ISO 14971. Detailed guidance to optimize its use has just been updated. ISO 14971, Medical devices – Application of risk management to medical devices specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.

Recently published ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, is a companion document to the globally recognized risk management standard.

Intended for use by manufacturers of medical devices, both ISO 14971 and ISO/TR 24971 are designed to be read and applied together, providing information on how to identify the hazards associated with medical devices, and measure and manage related risks. ISO/TR 24971 Medical Devices can be purchased here at the ANSI Webstore.

CFOs Preparing for Up to 30% Decline in Revenue

May 12th, 2020

Gartner, the world’s leading research and advisory company survey shows 51% of CFOs Are Preparing for Up to 30% Decline in Revenue This Year Due to COVID-19.

A survey of 145 CFOs and senior finance leaders on April 12, 2020 revealed 51% of respondents said they were preparing for a revenue contraction of up to 30% this year due to the coronavirus pandemic. Twenty-eight percent of respondents believe the impact to their organization’s revenue could be higher than 30%. “Most CFOs have told us they are using the most severe downside scenarios to inform their decisions right now. This is leading CFOs to consider drastic cost management actions across April and May”, said Alexander Bant, practice vice president, research, for the Gartner Finance Practice. “When CFOs were asked how these downside scenarios are impacting their ability to fund long-term growth investments,  70% of CFOs said they are now showing caution in this area.” 

For more information on the Gartner Survey visit the Gartner Newsroom.

Guidelines for Engagement

March 24th, 2020

Building Success through People

The term “people engagement” has been around for a couple of decades and is an often used buzzword, yet many organizations and managers are not entirely sure what it means. People engagement means much more than being present as an employee; it means making an active contribution, feeling genuinely valued and achieving quality outcomes for your organization.

Two ISO standards on people management have undergone an update to include useful steps on how the value of an employee can be enhanced, extended and nurtured. ISO 10015 has become Quality management – Guidelines for competence management and people development, and ISO 10018 is now Quality management – Guidelines for people engagement. Both International Standards present practical steps for managers and leaders to follow, adopt and measure. These standards are designed to be regularly referred to and not simply handed to employees in binders and then left to gather dust on the shelf.

Engaged organizations will have well-thought-out ways of developing their staff. Their aim is to have people there for a career, not just a job. Successful organizations often provide opportunities for staff to move to different areas within the organization to learn new skills and enhance their expertise. These important guideline documents are scheduled to be published in April 2020.

Information Security Management System Auditing

February 17th, 2020

In an age of increasing data usage and the risk of information security breaches and cyber-attacks, the benefits of an information security are clear. Not only can it help to minimize the chance of such breaches occurring, it can reduce the costs associated with keeping information safe. Many organizations do this with the help of an information security management system (ISMS). The international guidance standard for auditing an ISMS has just been updated.

ISO/IEC 27001 is one of the world’s best-known International Standards for the requirements of an ISMS, part of a series of standards designed to help organizations manage the security of their information.  One of the standards that has just been revised in that series, ISO/IEC 27007, Information technology – Security techniques – Guidelines for information security management systems auditing, provides guidelines for effective audits of ISMS to ensure they are as robust and competent as they are intended to be. It has just been revised to ensure it remains fit for purpose and align it with updates to its complementary standard, ISO 19011, Guidelines for auditing management systems.

The standard provides extensive guidance on auditing the requirements stated in ISO/IEC 27001 as well as on the competence of ISMS auditors. It is also intended to be used in conjunction with the guidance contained in ISO 19011.  You can purchase the newly revised ISO/IEC 27007 at the ANSI Web Store.

Medical Device Risk Management

January 16th, 2020

This just revised ISO standard promotes the safety of devices and equipment used for medical purposes.  It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment.

ISO 14971, Medical Devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products. ISO 14971 helps manufacturers to identify the hazards and estimate the risks associated with a medical device, enabling them to control those risks and monitor the effectiveness of the controls they put in place.  

ISO 14971, Medical Devices – Application of risk management to medical devices can be purchased at the Techstreet Store.