Terms

Terms

Thursday, 10 September 2009 17:35

What is ISO 14001 & why do I need it?

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ISO 14001 is an international environmental management standard that companies use to certify that their businesses have made a commitment to reducing the company’s impact on the environment. Not only is being “green” a significant marketing advantage, but it is also a very popular commitment to employees and your neighbors. If you are cringing at the potential cost of becoming a “green” company, think again. Unlike the quality management standards that identify specific areas where you must meet minimum requirements for certification, this standard is a “voluntary” standard – you identify:
Friday, 10 September 2010 17:34

What is ISO 9001 & why do I need it?

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For many small companies the whole concept of quality assurance, quality management systems, and especially ISO 9001 certification can seem overwhelming. But the truth is, ISO 9001 is really just good business practices written down. And all it asks is that you follow a few basic guidelines to ensure that your company’s product or service is consistent. It doesn’t have to be big, complicated, expensive or time consuming –”The extent of the quality management system documentation can differ from one organization to another due to a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel.” (Section 4.2.1 of ISO 9001:2008).
Sunday, 25 October 2009 17:05

What is ISO 13485 & why do I need it?

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ISO 13485:2003 lists the International Standards Organization requirements for quality management systems for medical devices. Like many of ISO's 17,500 different standards, ISO 13485 takes the core quality management concepts of ISO 9001:2008 and adapts them to the medical device industry. The ISO technical committee for this standard took input from the Global Harmonization Taskforce and from food and drug agencies around the world, to ensure that those who pursued 13485 certification would be well-positioned to meet the requirements of a variety of medical device regulatory bodies – a true benefit to those designing, manufacturing and marketing anything to the medical device industry.
Thursday, 27 May 2010 16:56

Corrective Action vs. Preventive Action

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There is a lot of confusion within the quality industry, and especially new companies about these two actions. Part of the reason is that ISO 9001:2008 (and its predecessor 9001:2000) describe their associated activities in a similar structure, with a couple of key wording differences... We'll discuss the specific actions in a later blog. For now lets clear the confusion of terms.
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