The Case for an Integrated Quality Management and EHS System

[fa icon="calendar'] Wed, Apr 18, 2018 / by Sean Salvas

By bringing together quality management and environmental health and safety (EHS), the integrated QEHS system is a powerful proposition that delivers a real return on investment over relatively short timescales

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Getting Ready for GDPR

[fa icon="calendar'] Mon, Apr 16, 2018 / by Rachel Beavins Tracy

Going into effect May 25, 2018, the General Data Protection Regulation (GDPR) represents the most sweeping changes to EU data privacy laws in 20 years. However, signs are growing that companies are ready for the new requirements, including a new UK report showing fewer than half of organizations have made preparations.

Companies that sell products or services to people in the EU will need to comply with the new regulations or risk a fine of up to 4% of revenue or €20 million, whichever is greater.

In today’s post, we’re examining what companies need to do to get in compliance with the fast-approaching regulatory deadlines.

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Life Sciences General Quality

How Product Stewardship Impacts EHSQ Performance

[fa icon="calendar'] Fri, Apr 13, 2018 / by Rachel Beavins Tracy

Once upon a time, few people gave any thought to the fate of what happened to light bulbs, paint cans, computers and leftover medications after they were done with them. Use them up, throw them away and leave it to the city to figure out how to dispose of them.

Today, that paradigm has been flipped on its head, with companies engaging in product stewardship initiatives that make disposal the responsibility of the manufacturer.  

In today’s post, we’ll look at the business case for product stewardship, including how it directly impacts Environment, Health, Safety and Quality (EHSQ) performance.

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How Quality Management Systems Take the Crisis Out of Food Recalls

[fa icon="calendar'] Wed, Apr 11, 2018 / by Tim Lozier

Food recalls present a real crisis for manufacturers and producers, but the proper use of food safety management systems could be key to mitigating the damage that a recall can do to your organization.

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The Industry 4.0 Approach to Quality

[fa icon="calendar'] Mon, Apr 09, 2018 / by Rachel Beavins Tracy

Experts are calling Industry 4.0 the fourth Industrial Revolution (hence the 4.0). The concept represents a push towards manufacturing digitization that experts say will deliver massive improvements in efficiency, costs and profits in as little as just a few years.

But what will it take to get there, and how can it help improve quality? Today we’re lifting the lid on what Industry 4.0 means in terms of quality, focusing on benefits, challenges and the tools companies will need to make it a success.

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General Quality Industry 4.0

What Are the Changes in ISO 13485:2016?

[fa icon="calendar'] Fri, Apr 06, 2018 / by Rachel Beavins Tracy

If your organization is one of the more than 59,000 certified to ISO 13485, you should already be planning for your transition to the newest version of the standard. As of February 28, 2019, all ISO 13485:2003 certificates will expire, with the Medical Device Single Audit Program (MDSAP) requiring manufacturers to transition by January 1, 2019.

ISO 13485 is based on the popular ISO 9001 for quality management systems, although key structural differences make it a standalone standard. In this post, we’re looking at what the changes are in ISO 13485:2016, and what companies can do to streamline the transition process.

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Life Sciences

Selecting an Enterprise Quality Management System for Your Business

[fa icon="calendar'] Wed, Apr 04, 2018 / by Sean Salvas

Whether you’re looking to make your first investment in an Enterprise Quality Management System (EQMS) or replace your existing one, visibility and control should be front of mind, as EtQ’s Tim Lozier explains.

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4 Hidden Costs of Poor Document Control [Infographic]

[fa icon="calendar'] Mon, Apr 02, 2018 / by Rachel Beavins Tracy

Poorly controlled documents are a huge source of risk in organizations today,costing millions in profits and productivity every year. This infographic highlights four hidden costs of poor document control and how automation can help. 

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General Quality

Data Harmonization in Europe’s Life Sciences ‒ How a Quality Management System Can Help

[fa icon="calendar'] Wed, Mar 28, 2018 / by Tony Parise

A quality management system can help your life sciences company deal with new EU regulations and cope with the demands of data harmonization.

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ISO 45001—What You Need to Know

[fa icon="calendar'] Tue, Mar 27, 2018 / by Sean Salvas

Why ISO 45001? What Does It Mean to EHS Leaders?

Did you know that over 7,600 people die each day from work-related accidents or diseases—that’s over 2.78 million every year as stated by the International Labour Organization. Clearly, this number (or any number besides zero) is too high. The burden of occupational injuries and diseases is significant, both for employers and the wider economy, resulting in losses from early retirements, absenteeism and rising insurance premiums. Even worse, employee productivity and morale suffer directly which affects an organization’s bottom line.

To combat the issue, ISO has developed a new standard, ISO 45001 for Occupational Health and Safety Management Systems.

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