FDA To Use ISO 13485 for Medical Devices Regulation

August 29th, 2018

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.  The committee Chair, Peter Linders, added that “this bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan and the USA”.

Auditing Management Systems Standard Updated

July 16th, 2018

Management system standards are growing in popularity as organizations see how they can be applied to manage interrelated processes to achieve their objectives. From quality or energy management to food or traffic safety, the list of standards aimed at helping organizations put in place effective management systems is getting long.  In order to get the best out of a management system and ensure continuous improvement, regular auditing needs to take place.

 

ISO 19011:2018, Guidelines for Auditing Management Systems offers a uniform, harmonized approach, enabling effective auditing across multiple systems at the same time.  Key changes in the 2018 version include the addition of a risk-based approach to the principles of auditing to reflect the enhanced focus on risk in both management standards and the business application.  In addition, guidance has been expanded in a number of areas such as managing an audit program, and conducting an audit.  We highly recommend purchasing this document. You can purchase ISO 19011:2018, Guidelines for Auditing Management Systems from the Techstreet Store .

 

New AIAG Regulatory Updates Page

May 22nd, 2018

In partnership with Compliance & Risks, AIAG now offers a New Free Regulatory Updates webpage that automatically populates with relevant content as regulations are updated and customer requirements change.

This RSS feed driven page is geared toward individuals involved with corporate responsibility and sustainability (CR/S), and those performing quality functions that require reporting into IMDS, and all others dealing with global substances of concern and waste regulation. The page’s simple and straightforward format allows users to quickly skim through content if desired, but also makes it easy to find more information. Clicking on any particular update’s title takes the user to the source page, where more detail is available.

Resources like this help support proactive and reactive measures within automotive industry organizations in response to changes in global regulations. Since the page populates with fresh content as regulations are updated and customer requirements change, the process of staying informed is made stress-free – checking back often will help individuals stay up to date on the latest need-to-know regulations and requirements, and better prepared for compliance challenges. Additionally, although new content appearing at the top of the page will displace older updates, the latter will still be readily available simply by scrolling down.

To view the Regulatory Updates page, simply visit this link, or navigate to the Corporate Responsibility tab at www.aiag.org to explore related topics.

Avoiding Supply Chain Counterfeit Components

April 14th, 2018

The global trade in counterfeit electronics and equipment currently stands at $121 billion, but counterfeit products don’t just cost companies money, they ruin reputations, they’re dangerous and what’s worse, they can become harder to identify.  In March 2018, the Anti-Counterfeiting Forum, held at BAE System headquarters brought together a range of speakers who explained the steps that should be taken to prevent and combat counterfeit products.   A key topic proved to be the importance of ‘knowing your supply chain’.

A key speaker stated the U.S. Department of Defense has identified upwards of a million counterfeit components in its military supply chain, caused by poor supplier control and weak buying practices.  When sourcing parts, tell the subcontractors the full manufacturer’s part number and the current name, and if relevant, any previous names. He also said to avoid only identifying a component by using a distributor’s part number.  The problem of counterfeiting isn’t new, so existing stock should also be checked. Visual inspection alone is not sufficient, so the best course of action is to send suspicious products to a testing company.  He went on to explain that obsolete products are one of the main opportunities for counterfeiters. To combat this, he suggested better anticipating the demand for products and stocking up on them.

 

ISO 45001:2018 Published Today!

March 12th, 2018

ISO 45001 is an ISO standard for management systems of occupational safety and health. It follows the management system standard structure guideline Annex SL. The standard requirements aim to allow an organization to provide a safe and healthy workplace(s), by preventing work-related injury and/or ill health, as well as by proactively improving its OH&S performance.

ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformances associated with its activities.

ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization’s OH&S policy, the intended outcomes of an OH&S management system include:

a) continual improvement of OH&S performance;

b) fulfillment of legal requirements and other requirements;

c) achievement of OH&S objectives.

To purchase ISO 45001:2018 OH&S Management System visit the ANSI Standards Store.