ISO 9001 - The Challenge of Certificates

You have successfully completed the Quality Management System certification process and are the proud holders of an ISO 9001 certificate for your organization… one of the approximately 10,000 ISO 9001 certificates in Romania and one of the approximately 900,000 ISO 9001 certificates worldwide.

Well done, congratulations… but as you can see you are not unique at all but just one “of the many”

What are you going to do next?

The answer to this question is the real challenge of certificates and will practically lead to the division of organizations into 2 categories:

- those who only wanted the beautifully framed certificate and displayed on the wall so that they can brag in front of customers and possibly shareholders, but who at the same time are surprised that they have quality problems constantly, lose money with rejections and returns from customers and have a large fluctuation of dissatisfied staff

- those who understand the benefits of managing a Quality Management System properly and are involved, starting with top management, in its implementation and continuous improvement

One of the requirements of the ISO 9001 standard is to implement production under controlled conditions, given a series of general criteria related to what these controlled conditions mean. The degree of understanding and implementation of these conditions can give us a clear indication of the category in which an organization is located:

- designation of competent persons

We should know which people fit better in certain positions; or is there a staff training and management system based on the qualifications recorded in a qualification matrix / skill matrix?

 

- availability of documented information

Do you only have drawings with the dimensions and shape of the product or work instructions detailing the realization of each production step, including the controls to be performed?

- availability and use of adequate monitoring and measurement resources

Do the quality inspectors use old calipers (received at the transfer of the production line) or have several new calipers been purchased, based on an analysis, even if this requires an investment?

- the analysis performed is a simple one (the caliper is old and hit> we buy another one) or a more complex study of the measurement system was performed (MSA, calibrations)

- implementation of monitoring and measurement activities in appropriate stages

Do you only check the finished product at the end of the production line or is there a first-off / last-off process that includes the use of statistical tools such as control charts (SPCs)?

- evaluation of the efficiency of the management system, through the quality objectives

Do we talk about goals up and down or do we set measurables (KPIs), set targets, allocate resources, monitor performance and react as appropriate?

- periodic validation of capability

Do we rely entirely on product measurement or is there a production process capability (SPC) study?

- prevent human error

Is it based entirely on staff training or since the design and development phase of the product and then the production process we considered the prevention of possible human errors (DFM, DFA, POKA-YOKE)?

In other words, are we content with an “internationally recognized” card or are we working to really ensure benefits both for the business and also for the people who are part of it?