Corrective and Preventive action: A continuous improvement tool that can be extremely effective if used correctly. This tool is used not only for ISO 9001 organisations but also for organizations that comply to Cosmetics GMP ISO 22716, TGA GMP Pharmaceuticals, ISO 13485 medical devices etc. The definitions are as follows: Corrective Action – action taken to eliminate the cause of an EXISTING nonconformance in order to prevent recurrence. This is pretty straight forward- an organization has a non conformance and they implement training or a change to prevent recurrence. Preventive Action – action taken to eliminate the cause of a potential nonconformance in order to prevent recurrence. If you are[…]

This standard provides guidance regarding Good Manufacturing Practices for cosmetics products and has been prepared for consideration by the cosmetic industry. Todays Tip: Sampling – when preparing sampling plans for raw materials/packaging/bulk or finished product, don’t randomly allocate qty but use recognised standards (such as ISO 2859) to determine your sample size. In addition, the sampling plan should be commensurate with risk. If product A is low risk then sampling should be lower than product B which is high risk. If a standard is not used, statistics can also be used to determine a sample size. You don’t want to be spending too much time and money on a low risk[…]

ISO 9001:2008 ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to. It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries. Quality Management Principles The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many[…]

The ICCR (International Cooperation on Cosmetic Regulation) agreed to implement ISO 22716 in their respective regions. Effective 11 July 2013, a new regulation will be imposed which will ensure that cosmetic products be manufactured according to GMP (Good manufacturing Practices). This means that there will be a global cosmetic network whereby cosmetic companies (includes importers/exporters etc) will be required to demonstrate compliance to this new regulation. Cosmetic manufacturers should prepare for this new requirement in order to avoid any loss of market approval.  Companies can demonstrate compliance with this regulation by implementing ISO 22716 Cosmetics – Good Manufacturing Practices (GMP). This standard introduces a management system approach with a review[…]

First published in 1987, ISO 9000 has consistently been ISO’s most popular series of standards. Now, building on 25 years of success, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommittee SC 2, Quality systems, is busy laying the groundwork for the next generation of quality management standards. As we celebrate the “silver jubilee” of the ISO 9000 series of quality management standards, we could view and discuss this key event in several ways. Looking to the future ISO/TC 176/SC 2’s vision is for its products (primarily ISO 9001 and ISO 9004) to be “recognized and respected worldwide, and used by organizations as an integral component of their[…]