Strategy

Strategy

Sunday, 28 September 2008 17:20

Do I need a consultant if we’re just starting a QMS?

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When putting a quality management system in place for the first time, you need guidance through the concepts, terms and requirements. How you achieve that depends on the size and previous experience within your company – books, classes, or consultant are all viable options. A consultant can provide valuable training and guidance for those charged with maintenance of your system. However, it is a mistake to assume that a consultant will “do it all for us”. It is, after all, your company’s system – not the consultant’s – and at the end of the day you are responsible for its maintenance. As an alternative to hiring a consultant, make training the start of your implementation and learn together as a management team -- that way everyone is on the same page when making strategic decisions later. After all, ISO requires top management to provide evidence of their commitment by being involved in key strategic activities to direct your QMS, and requires that all employees are aware of, and understand their contribution to the management system.
Monday, 05 October 2009 17:17

Collecting and analyzing data

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Collecting and analyzing data doesn't make us money - I don't have time. Survival is a big deal in this economy. But wouldn’t you want to stop money from invisibly hemorrhaging out of the company? Many small company owners have a hard time seeing the return on investment in data collection. But those who collect even simple information about how their company is doing, and find where they are losing time or money, can stop those invisible leaks in profitability and productivity.
While ISO uses the term “certifying body” (because they certify the management systems of companies), many organizations in the USA use the term “registrar” (because they maintain a register of certified companies). Same concept, just different words. Choosing a relationship with a certifying body is an important decision. First - Always look for an accredited organization – this means that, like you, they are audited and monitored, and meet the stringent requirements of both the ISO requirements for certifying, and the requirement of their accrediting body. This ensures that you are being certified by an organization worth trusting.
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.
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