ISO Posts

MDSAP is Flying on Auto Pilot through 2016

MDSAP is Flying on Auto Pilot through 2016

Sandy Carson, Marketing Communications & Events Manager, Pilgrim Quality Solutions

In 2012, the International Medical Device Regulators Forum (IMDRF) identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). Forum members agreed that this global approach to auditing and monitoring medical device manufacturing could improve product safety and oversight on an international scale.
(more…)

ISO 13485:2016: Are you prepared for the transition?

ISO 13485:2016: Are you prepared for the transition?

Deb Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions

How much effort will it take to get your organization ready for ISO 13485:2016? The new quality system requirement takes effect in March 2019. Medical device manufacturers that aren’t prepared for this change will need to do some heavy lifting to stay compliant with the updated standards.

Do you know if you need to do light or heavy lifting to get ready for the new version of ISO 13485? Here is some insight on where to start when reviewing changes between the old and new standard.
(more…)

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

ISO 9001:2015 and the 8 Quality Management Principles to Take You to the Head of the Class

Sandy Carson Hessen, Marketing Communication Manager, Pilgrim Quality Solutions

For more than half a century, the International Standard for Organizations (ISO) has been developing standards to protect society from potential errors. It’s been 26 years since the introduction of the Quality Management System standards model, ISO 9001, specifically.

The most current version, ISO 9001:2008 was adopted to address fulfilling regulatory requirements and customer satisfaction through continuous improvement of the quality system. The standards apply worldwide and provide consumers with a base-level confidence in an organization’s ability to provide conforming products. Theoretically, it’s been working, but for those concerned with quality, it certainly makes sense to evaluate whether there’s room for improvement. (more…)

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Go to the Head of the Class: 3 Ways Employee Training Puts Quality Front & Center

Sandy Carson-Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

There’s a popular saying: ‘You don’t know what you don’t know.’ No kidding. But nowhere is this truer than in the regulated workplace. When employees aren’t trained, they run the risk of adversely impacting its quality, its compliance, its reputation, even its profits.

That’s why employee training is an essential component of a comprehensive quality management system. In fact, you’re likely to find well-trained employees at the foundation of any successful organization that manufactures safe, dependable, quality products. (more…)

The 5th Incarnation: Proposed Changes to ISO 9001

The 5th Incarnation: Proposed Changes to ISO 9001

Konyika Nealy, Vice President of Quality Assurance & Validation, Pilgrim Quality Solutions 

Are radical changes coming? Is this fifth incarnation of ISO 9001 a drastic departure from its predecessor? Will it reshape the world of manufacturing as we know it? Word around the water cooler is “No.” (more…)

Wake Up and Watch Out: Getting Serious About QMS

“If it’s not broken, don’t fix it.” Really? If you only want to maintain the status quo, you might get away with letting sleeping dogs lie. But no one really wants to get hauled off by the dog catcher during a pleasant nap. Unfortunately, it’s happening every day to manufacturers who don’t take quality management seriously.

Quality management is about continuous improvement and product safety. And each time we optimize, we strengthen our preventive measures for avoiding unwanted surprises and disruptions in our operations. (more…)