August, 2006 Newsletter Articles

ISO 14063 – EMS Communication

Aug 11, 2006 in Newsletter | 0 comments

ISO 14063:2006, Environmental Management – Environmental Communication – Guidelines and Examples, gives guidance to an organization on general principles, policy, strategy, and activities relating to both internal and external environmental communication. It utilizes proven and well-established approaches for communication, adapted to the specific conditions that exist in environmental communication. It is applicable to all organizations regardless of their size, type, location, structure, activities, products and services, and...

Read More

ISO 15378 – Medicinal Product Packaging

Aug 11, 2006 in Newsletter | 0 comments

ISO 15378:2006 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products (which consistently meet customer requirements, including regulatory requirements and other standards applicable to primary packaging materials). The title of ISO 15378 is Primary Packaging Materials for Medicinal Products — Particular Requirements for the Application of ISO 9001:2000, with Reference to Good Manufacturing Practice (GMP). ISO 15378:2006...

Read More

TL 9000 Handbook R4.0

Aug 11, 2006 in Newsletter | 0 comments

The new TL 9000 Quality Management System (QMS) Requirements Handbook, Release 4.0, must be used for all audits after June 30, 2007. Auditors must have delta training before conducting a third party audit to R4.0. Summary of Changes ISO 9001:2000 Base Remains Unchanged 30% of Adders Remain Unchanged 30% of Adders have Minor Changes 40% of Adders have Major Changes or are New These requirements designed to: Ensure intended results instead of specifying methods of doing Emphasize design process quality measurements Add required testing...

Read More

ISO 10014 Guidelines on Quality Benefits

Aug 11, 2006 in Newsletter | 0 comments

Are you aware of the new ISO 10014:2006, Quality Management – Guidelines for Realizing Financial and Economic Benefits? It provides guidelines for achieving financial and economic benefits from the application of the ISO 9000 quality management principles: 1. customer focus 2. leadership 3. involvement of people 4. process approach 5. system approach to management 6. continual improvement 7. factual approach to decision making 8. mutually beneficial supplier relationships Economic benefit is generally attained through effective...

Read More

Selecting a Consultant

Aug 11, 2006 in Newsletter | 0 comments

Choosing a qualified consultant is no easy task. The importance of taking the time to make a thoughtful selection cannot be underestimated. Your choice could end up affecting the efficiency and effectiveness of your business operations. 1. Understand the reasons for using a consultant Why do organizations use consultants? An organization may realize it lacks the expertise, time, experience, or objectivity to perform the work without outside assistance. 2. Identify the services you need from consultants Competent consultants should not only be...

Read More

Getting the CE Mark

Aug 11, 2006 in Newsletter | 0 comments

The CE Mark is mandatory for a wide range of products sold in the European Union. The CE Mark has been described as a “passport” that allows manufacturers to trade industrial products freely within the internal EU market. The CE Mark indicates the manufacturer has undertaken all assessment procedures required for the product. The CE Mark is not a quality mark and does not indicate conformity to a standard; it indicates conformity to the legal requirements of the EU directives. General Steps for Getting the CE Mark 1. Identify all...

Read More