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An Insider’s Guide to Design – Part II

Following on from my last blog, here is what you need to do to meet the requirements of the second section on design for which the standard says –
7 Product Realization
7.3 Design and Development
7.3.2 Design and Development Inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include:
a) functional […]

An Insider’s Guide to Design – Part I

Why oh why does the ISO 9001 Quality Management Systems standard make the clause for designing products so complicated. Sure, good design prevents problems for both the company producing the product and the customer buying them but, there are other important business considerations in the standard such as continuous improvement and management commitment. So why […]

What on Earth is Preventive Action?

If the preventive action clause in the management standards confuses you, join the club! Most people find this one confusing – “I record the problems (non conformances) AND I fix them (short term corrective actions) AND I address the root causes of problems (long term corrective actions). What more do they want?”

All three of the […]

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