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Quality Matters: (Part 3 of 3) Quality System – Where Do We Start?

By |2019-06-03T11:47:27-04:00June 10th, 2019|News|

Quality System – Where Do We Start? You have decided that you need a new or improved quality system, and now the question is, where do you start? To quote Stephen Covey, begin with the end in mind. Does the organization need or wish to pursue an ISO certification, Nadcap accreditation, or FDA clearance? If

Quality Matters: (Part 2 of 3) One Quality System, Please

By |2019-06-03T11:46:25-04:00June 3rd, 2019|News|

One Quality System, Please The organization should have only one quality system. And, unless there is an overwhelming need, the organization should have one quality system certification or accreditation. For clarity, an overwhelming need would include ISO certification and a regulatory registration (e.g., FDA), not two separate ISO or ISO-equivalent certifications. This is true whether

Quality Matters: A three-part series

By |2019-05-06T18:37:01-04:00May 6th, 2019|News|

Part 1: Whose Quality System Is It? Whose quality system is it? Who cares and why? The answer to the first question is, it is your quality system. How do you know it is yours? With no pun intended, the documents probably include your company’s letterhead or logo. And, whether it was developed in-house and

Consumerism

By |2019-04-01T19:10:25-04:00April 1st, 2019|News|

One of the most challenging aspects of managing any business is that of matching supply to demand and having a scalable infrastructure that can quickly adapt to accommodate fluctuations in demand in order to ensure optimal efficiency by fully utilizing the available capacity at any given time. The more complex a business is, the more

What is BPA, and Should I Care?

By |2019-01-15T18:24:06-04:00January 15th, 2019|News|

Sponsored by Promold PlasticsYou’ve probably heard of BPA and the possible related health effects. But do you know what BPA is, where it’s found, and whether it’s safe? Read on to learn more.What is BPA?Bisphenol A (BPA) is a chemical present in rigid, durable plastics called polycarbonates, and in epoxy resins.[i] Polycarbonates may be used

Prepare for Validating the Injection Molding Process

By |2018-10-01T18:44:39-04:00October 1st, 2018|News|

Molding for medical devices involves critical processes that must offer repeatability, assurance of accuracy, and a high degree of quality. The following article will describe the basic fundamentals of the injection molding process that one needs to understand before developing an effective protocol for validating the injection molding process. Somehow, everything seems to revolve

Top Ten Things Companies Need to Build Quality into Their Processes

By |2018-10-01T18:46:46-04:00September 29th, 2018|News|

Understanding customer requirements and managing the supply chain are some of today's biggest challenges in manufacturing. Find out what leading companies are looking for before just any supplier in their supply chain. Read More