Simple Rules on Purchasing – Part II

Following on from my last blog, here is some more common sense on purchasing from the ISO 9001 Quality Management Systems standard which says - 7 Product Realization 7.4 Purchasing 7.4.2 Purchasing Information Purchasing information shall describe the product to be purchased, including, where appropriate: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their [...]

Simple Rules on Purchasing

Simple Rules on Purchasing – Part I  When it comes to purchasing goods and services for your business the ISO 9001 Quality Management Systems standard is full of good common sense. Here is what it says – 7 Product Realisation 7.4 Purchasing 7.4.1 Purchasing Process The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased [...]

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 [...]

Keep it Simple

The following information is so important that it is one of my downloadable Top 5 Essential Tips for ISO systems. Why is it so important? Because a) your management system must be simple and practical or your staff won't use it; b) cumbersome systems don't help a business achieve its goals; and c) overcomplicated systems are expensive to maintain. You need a simple system that effectively helps run the business & meet the needs of both customers & stakeholders. Just [...]

What are Corrective Actions?

I ended my previous blog by stating that there is a relationship between non-conformances (problems) and corrective actions (solutions). Clearly action is necessary to fix a problem and this action can take 2 forms – immediate corrective action and root cause corrective action. The names really say it all. You need to take immediate action to prevent the material or service from being used and to fix it. You need to take root cause corrective action to prevent a recurrence [...]

Non-conformance is Just a Fancy Word

No Quality, WHS or Environmental System is perfect and no business is perfect. Problems may occur with the service you provide, your products, your processes, and your suppliers, the result being that stated requirements are not met. Those requirements might be stated in the specifications for the product, the service level agreements, a regulatory body, or your own internal procedures. In the language of management systems these problems are called non-conformances, but you may call them anything you like. It [...]

Quality Manual Secrets Revealed

When I audit ISO management systems - be they ISO 9001 for Quality, ISO 14001 for the Environment, ISO 18001 or AS/NZS 4801 for work, health and safety, or ISO 22000 for food safety - I see soooooo many Quality Manuals that are 20, 30, 40 Pages long. There is a better way. The ISO 9001 Quality Management System Requirements Standard states: 4.2.2 Quality manual The organisation has established & will maintain a quality manual that includes: a.  the scope of the quality management system, including [...]

What is an Integrated Management System?

An integrated management system (IMS) combines all related components of a business into one system for easier management and operations. Quality (QMS), Environmental (EMS), and Safety (OHSMS) management systems are the ones most often combined and managed as an IMS but you can integrate any of the ISO management system standards. What's in Common? It makes sense to integrate management standards because approximately 30% of the requirements in ISO 9001, ISO 14001 and AS/NZS 4801 or ISO 18001 are the [...]