Quality Policies: 5 Things You Must Know

Yes, I can hear you groaning already. Quality policies, motherhood statements, stick them on the wall and forget about them. Correct? You may feel that way, but the standard for ISO 9001 Quality Management Systems clearly states that you must have a quality policy. It does not so clearly states what should be in it. This is what the standard says: 5 Management Responsibility 5.3 Quality Policy Top management shall ensure that the quality policy: a) is appropriate to the [...]

Is Certification Worth It?

Is Certification Worth It? “To be or not to be that is the question” although I don’t think Hamlet had certification in mind when he said this. It is a decision to be taken on business grounds. Here are some of the reasons why organisations choose certification: By setting a clear goal, certification motivates staff and helps to gain their commitment. Certification improves processes and refines activities. There is nothing like certification for focusing one’s attention on this key requirement. [...]

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 and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) [...]

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 design gets pages in the standard when other requirements get a line or two is beyond me. Anyhow, my rant is over. Here is what [...]

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 most popular management systems - ISO 9001 Quality, AS4801 OHS, and ISO 14001 Environmental Management Systems have a preventive action clause. Here is the [...]