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ISO 22716 – GMP for cosmetic products (Quality Management System)

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 of the following:

  • ·         Personnel
  • ·         Premises
  • ·         Equipment
  • ·         Raw and Packaging Materials
  • ·         Production
  • ·         Finished Product
  • ·         Quality Control and treatment of product that is out of specification
  • ·         Subcontracting/Vendors
  • ·         Deviations
  • ·         Complaints and recalls
  • ·         Change Control
  • ·         Documentation
  • ·         Internal Audits

The objective is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.

For more information about the Cosmetics Regulation, please contact Compliance Management Solutions or your nearest SGS agency.            

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ISO 9001:2015 and beyond – Preparing for the next 25 years of quality management standards

Compliance Management Solutions
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 sustainable development initiatives”.

This pivotal role of quality management systems as a basis for the economic growth component of the sustainability agenda has often been overlooked, with attention in recent years being focused on the more topical elements of environmental integrity and social equity (see Figure 1).

We should not forget, though, that the ISO 9001 requirements standard is, and will probably continue to be, the entry point for most organizations seeking to implement any formal management system. Although not a requirement, third-party certification to ISO 9001 will remain a key driver.

As we look to the future, however, it is important to ensure that quality management is seen as much more than certification to ISO 9001 and that it really helps organizations to achieve long-term success. This means promoting quality in the widest sense of the word, and encouraging organizations to look beyond compliance to a set of requirements. This could be achieved by providing linkages to stimulate the use of, for example, ISO 9004 and other ISO management system standards.

Basic principles revisited

Both ISO 9001 and ISO 9004 are currently based on a set of eight quality management principles. These were developed in the mid-1990s by a small group of experts who were familiar with the teachings and philosophies of the major quality “ gurus ” of the last century. These principles, together with an explanation of how organizations can benefit from their application, are available in the brochure Quality management principles, which can be downloaded free of charge from the ISO Website.

ISO/TC 176/SC 2, in collaboration with its counterparts at SC 1, Concepts and terminology, has recently undertaken a full review of the quality management principles. From this, it is pleasing (but not surprising) to report that they have stood the test of time, and that only a few minor adjustments are needed to update them for the next generation of quality management standards.

The next revision of ISO 9001

Since the publication of the minor amendment to ISO 9001 in 2008, SC 2 has been carrying out extensive research and preparation for the next major revision (currently forecast for 2015). This involves activities such as :

  • Developing a long-term strategic plan for SC 2 and its products
  • Conducting several open workshops during SC 2 plenary meetings including interactions with users of the ISO 9001 and ISO 9004 standards
  • Participating in the work of the ISO/TMB Joint Technical Coordination Group, aimed at increasing the alignment of ISO’s management system standards by developing a common high-level structure, common definitions and some common text (now published as Annex SL to the ISO Directives)
  • Studying the latest trends in quality management, including analyzing new concepts that might be considered for incorporation into future revisions of ISO 9001 and ISO 9004
  • Analyzing data from a Web-based survey of users and potential users of ISO 9001 and ISO 9004, conducted in 10 languages, with a total of 11 722 responses from 122 countries.

The results of these activities, together with the systematic review of ISO 9001 that was completed in March 2012, indicated that while there is still significant satisfaction with the current version of the standard, most people consider a revision appropriate.

This is to keep ISO 9001 relevant, reflect changes in its environment, and ensure it continues to deliver “confidence in the organization’s ability to consistently provide product that meets customer and applicable statutory and regulatory requirements”.

At the first meeting of ISO/TC 176/SC 2/WG 24, Revision of ISO 9001, in Bilbao, Spain, in June 2012, the new work item proposal for the revision of ISO 9001 was developed, together with a draft design specification and project plan. The group also developed a preliminary draft of how the new standard could look following the integration of the current version of ISO 9001 with the common text from Annex SL of the ISO Directives.

The meeting’s outputs are being circulated to SC 2 member bodies for ballot. Subject to the ballot being approved, drafting work is expected to begin in November 2012.

According to the draft design specification, the revised standard should (among other things) :

  • Provide a stable core set of requirements for the next 10 years or more
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

ISO 9001:2015 timeline

The proposed timeline for the development of ISO 9001:2015 is shown in Figure 2. While it is appreciated that more aggressive fast-track development routes are now available in ISO, ISO/TC 176/SC 2 is planning a conservative approach and is likely to adopt the default three-year timeline.

Proposed high-level timing for development of ISO 9001:2015.

 

This is to consider the need for extensive dialogue with the many interested parties involved. These include specific sectors whose own requirements standards are based on ISO 9001, organizations that have systems certified to ISO 9001:2008, certification bodies, accreditation bodies and regulators.

In view of the significant impact of any changes, verification and validation work on the new standard will be carried out using volunteer organizations in different parts of the world once the committee draft stage has been reached.

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