Leadership and the ISO Management System Standards

  Few people and organizations are aware of the fact that there is an ISO standard, ISO 10019, available which provides guidelines for the selection of quality management system consultants and the use of their services. The selection of a consultant is important for ensuring that the resulting quality management system is capable of meeting the organization’s planned objectives in an effective and efficient manner. It is vitally important to remember that, even when the services of a consultant is used, the involvement and commitment of top management are key factors for the realization of a quality management system that is going to be effective and add value to the organization. ISO 10019 provides guidance on the factors to be taken into consideration when selecting a quality management system consultant. The organization is looking for a consultant who is able to meet their specific needs, expectations and objectives. Definitions Quality management system realization:...

  When a product is placed on the market inside the European Union, the products must be subject to conformity assessments in terms of the essential Health and safety requirements for the specific product. Definition: A conformity assessment is the process carried out by the manufacturer of the product to demonstrate whether specific requirements relating to the product have been fulfilled. A product is subjected to conformity assessment both during the design and the production phase. There are two important elements of every legislative act covering products. They are: The legislative requirements governing the characteristics of the products covered The conformity assessment procedures the manufacturer carries out in order to demonstrate that the product, before it is placed on the market, conforms to these legislative requirements. A product must be subjected to conformity assessment, during the design and the production phases. The primary responsibility for conformance...

In South Africa we have many organizations who manufacture and export products to countries who are members of the European Union. We know that many of these products must have the CE marking applied to them as proof that the product complies with all the essential health and safety requirements for that product. (In later blogs I will give more information on exactly how this works.) The essential health and safety requirements are contained in directives and regulations that have been issued by the European Parliament. In the case of the directives they are national requirements in the legal systems of each member state, while regulations apply in each member state without having to be published as national legislation. In this blog I would like to provide information on the European legislation on product liability. To ensure that the information comes across as intended, I have taken the liberty to copy the appropriate section form the Blue Guide on the Implementation of EU Pro...

  This is a brief explanation of context of the organization. For further information, contact me at the e-mail address provided at the end of the article. In the new generation management system standards we find clause 4- Context of the organization. Clause 4.1 is titled Understanding the organization and its context, while clause 4.2 is titled Understanding the needs and expectations of interested parties. (ISO 45001:2018 includes workers here as well). The question is: Why is clause 4 included in the standards? Why does ISO 9001:2015 specifically refer to strategic direction in clause 4.1? I think it has to do with the sustainability of the organization. In clause 6.1 of the standards, Actions to address risks and opportunities , we are referred to clauses 4.1 and 4.2. Risks and opportunities are to a large degree identified during the context analysis in clause 4. I have found invaluable information in training material of the Harvard Extension School that was develope...