News & Analysis as of

International Organization for Standardization

Health Care Compliance Association (HCCA)

An international standard for healthcare quality management

In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...more

Mintz - Health Care Viewpoints

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for...more

Society of Corporate Compliance and Ethics...

Third-party due diligence: Are supplier questionnaire(s) the answer?

Numerous laws (U.K. Bribery Act guidance document, German Supply Chain Act, Foreign Corrupt Practices Act resource guide, OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and...more

Akin Gump Strauss Hauer & Feld LLP

Akin International Space Law and Policy Update - January 2024

We are excited to share with you the second edition of the International Space Law and Policy Update, Akin’s quarterly newsletter focused on developments in international space law and policy. This newsletter takes a longer...more

Axinn, Veltrop & Harkrider LLP

3 Areas Look Ripe for New SEP Licensing, Litigation

Litigation over standard-essential patents, or SEPs, can be a cyclical phenomenon, where litigation follows a generational change in technology. We saw it with 3G and 4G technology, where each generational change led to a...more

The Volkov Law Group

Do We Really Need an ISO Standard for Internal Investigations?

The Volkov Law Group on

Call me a skeptic. Call me cynical. I understand that the International Organization for Standardization (ISO) provides valuable standardization services and guidance.  The ISO is comprised of 169 member countries....more

Woodruff Sawyer

Leverage an Effective Customer Complaint Program to Reduce Risk

Woodruff Sawyer on

Each year, defective, faulty, or misused food products cause severe injuries to customers. In some cases, these mishaps also result in product recalls, negative publicity, and a loss of customer goodwill....more

Hogan Lovells

Domain Name News: November / December 2022

Hogan Lovells on

This is the November / December edition of Anchovy News. Here you will find articles concerning ICANN, the domain name industry and the recuperation of domain names across the globe. In this issue we cover...more

Jenner & Block

Big Businesses Caught in the Crosshairs: Navigating the Rise in State AG Scrutiny

Jenner & Block on

With the increased activity of state attorneys general, many companies today find themselves at the center of political battles over the role businesses play in driving social policy. We feature one recent example, as a case...more

Association of Certified E-Discovery...

A New ISO Standard on Information Governance

The International Organization for Standardization, known as ISO, has been setting standards in the business world since the 1940s. Expert teams at ISO have developed more than 24,000 international standards impacting...more

Bergeson & Campbell, P.C.

ISO Publishes Standard on Characterization of CNT and CNF Aerosols for Inhalation Toxicity Tests

The International Organization for Standardization (ISO) recently published ISO/TR 23463:2022, “Nanotechnologies — Characterization of carbon nanotube and carbon nanofibre aerosols to be used in inhalation toxicity tests.”...more

McDermott Will & Emery

FDA Issues Proposed Rule to Amend Medical Device Quality System Regulation

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more

King & Spalding

New Standard Maps Medical Device Software Development Standard to Health Software and Health IT Cybersecurity

King & Spalding on

The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more

Bergeson & Campbell, P.C.

ISO Publishes Standard for Determining the Mean Size of Nano-Objects in Liquid Dispersions by SMLS

The International Organization for Standardization (ISO) recently published ISO/TS 21357:2022, “Nanotechnologies — Evaluation of the mean size of nano-objects in liquid dispersions by static multiple light scattering (SMLS).”...more

Bergeson & Campbell, P.C.

ISO TC 229 Begins Survey on Advanced and Emergent Materials

The American National Standards Institute (ANSI), which administers the U.S. Technical Advisory Group for the International Organization for Standardization (ISO) Technical Committee (TC) 229 on Nanotechnologies, announced a...more

Bergeson & Campbell, P.C.

ISO Publishes Standard on Evaluating the Antimicrobial Performance of Textiles Containing Manufactured Nanomaterials

The International Organization for Standardization (ISO) recently published ISO/TS 23650:2021, “Nanotechnologies — Evaluation of the antimicrobial performance of textiles containing manufactured nanomaterials.” ISO states...more

Goodwin

CFPB Releases New Compliance Aid

Goodwin on

In This Issue. The Consumer Financial Protection Bureau (CFPB) released a new Compliance Aid; the U.S. Securities and Exchange Commission (SEC) proposed amendments to Form N-PX with the goal of making it easier and more...more

Bergeson & Campbell, P.C.

ISO Publishes Two New Standards for Nanomaterials

The International Organization for Standardization (ISO) recently published two standards for nanomaterials. ISO/TS 21633:2021, “Label-free impedance technology to assess the toxicity of nanomaterials in vitro,” describes a...more

NAVEX

ISO37002 and the EU Whistleblower Directive: A Complementary Coupling?

NAVEX on

As the EU Whistleblower Protection Directive (Directive 2019/1937) comes into force at the end of this year, many thousands of affected organizations across the EU will be implementing a whistleblowing program for the first...more

Bergeson & Campbell, P.C.

ISO Publishes Standard Evaluating Methods for Assessing the Release of Nanomaterials from Commercial, Nanomaterial-Containing...

The International Organization for Standardization (ISO) has published ISO/TR 22293:2021, “Evaluation of methods for assessing the release of nanomaterials from commercial, nanomaterial-containing polymer composites.” ISO...more

Bergeson & Campbell, P.C.

ISO Publishes Nanotechnologies Standard for 3D Image Reconstruction of Rod-Supported Nano-Objects Using Transmission Electron...

The International Organization for Standardization (ISO) has published standard ISO/TS 22292:2021, “Nanotechnologies — 3D image reconstruction of rod-supported nano-objects using transmission electron microscopy.”...more

Snell & Wilmer

ESG and Human Capital Reporting: Contemplating Diversity Disclosures

Snell & Wilmer on

Institutional investors and other stakeholders are seeking better information from public companies on workforce diversity. Company executives and boards are discussing how and what to disclose, and many observers believe the...more

Bergeson & Campbell, P.C.

ISO Updates Series of Standards for Nanotechnology

The International Organization for Standardization (ISO) published a news item on April 1, 2021, entitled “The Science of Tiny Little Things.” According to the item, ISO has recently made some revisions and updates to its...more

Searcy Denney Scarola Barnhart & Shipley

NTSB Reports First Responders at Risk in Electric Vehicle (EV) Battery Fires

Imagine a situation in which a team of firefighters responding to a vehicle fire cannot extinguish the flames. Gallon after gallon of water does not douse them. Pile after pile of foam fails to finish them off. The car keeps...more

Kidon IP

Wi-Fi Negative Letters of Assurance Contaminate and Compromise ISO 8802 Standards

Kidon IP on

Last year, I described the broad negative and anticompetitive consequences of the IEEE’s 2015 patent policy, and was pleased to see the U.S. Department of Justice’s important 2020 Business Review Letter to IEEE (“DOJ BRL”)...more

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