ISO22716 – Quality Associates


K&S Quality Associates can assist organizations that are seeking to become certified to ISO22716:2007 K&S Quality Associates can provide gap analysis/pre-assessments, internal audit service, on-site training, procedure writing, implementation/consulting and other services

ISO 22716:2007

Consumers are becoming more and more concerned about the safety of the cosmetic products they are using. Fears of allergies and dermatitis caused by tainted or poisoned cosmetics have been ever-present in recent years. Certain ingredients used in cosmetics such as fragrances and preservatives, can trigger an allergic reaction. Obviously, these ingredients play a pivotal role in the cosmetic products of our choice and correct dosing of these

substances therefore is of key importance to avoid irritation of the skin through over-exposure. Examples of over-exposure to preservatives have frequently been observed in several historic cases, one example being beauty creams that contained mercury. Beauty creams occasionally were reported to contain excess amounts of mercury, with poisoned consumers exhibiting clear toxic neurological symptoms. Incidents such as these have always impacted the public and therefore have forced regulators to take action to ensure consumer safety. Examples of these are the requirements manufacturers have to adhere to in terms of pre-defined and approved product specifications and by putting systematic guidance in place on how to organise manufacturing and distribution supply chains. The recent growth of extended and complex global supply chains occurring in combination with the lack of proper control and oversight have made concerns over quality and safety even more serious. Manufacturers and retailers are urged to address deficiencies in their supply chains, and several quality standards have been proposed to deliver assistance in ensuring global cosmetic products safety. The introduction of ISO 22716 marks a major step in the realisation of a globally recognised standard for cosmetic products safety.


The content of ISO 22716:2007 Guidelines on Good Manufacturing Practices for Cosmetic Products has been approved and accepted by a number of regulatory bodies around the world. For example the International Cooperation on Cosmetic Regulation (ICCR) – a joint effort by the USA, the European Union, Japan and Canada – agreed in their July 2008 meeting to implement ISO 22716 in their respective regions, wherever possible. Regulators of several of these ICCR regions have decided to act accordingly. In the USA, it was proposed that the Food & Drug Administration (FDA) modify its current guidance. (Some of these requirements are said to become manditory in 2013) 
ISO 22716 deals with all aspects of the supply chain of cosmetic products,from the early delivery of raw materials and components until the shipment of the final product to the consumer. The guidelines support those organisations that wish to follow the practical advices to manage their human, technical, and administrative sections that are affecting product quality. Good Manufacturing Practices follow the principles of sound scientific judgement and risk assessment to produce products that meet defined characteristics.

Broad Scope for ISO 22716

ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality and safety aspects of the product. In this way manufacturers of cosmetic final products are affected, as are the suppliers of cosmetic ingredients. In addition, the standard is relevant for retailers, brand holders and wholesalers of cosmetic products. Furthermore,it specifies general requirements for quality management systems by incorporating a risk assessment based approach to define critical and non-critical elements ensuring high quality supply chain operations.

K&S Quality Associates can help your organization to become ISO 22716 certified with services like procedure writing, internal auditor training, on-site training, gap analysis, consulting and other services.

The Cosmetics Quality Management System and Organisation

In a cosmetics GMP quality management organisation, the emphasis is on establishing and maintaining a qualified personnel base that is well trained and capable of consistently producing safe products. A sound knowledge base of the personnel in a cosmetics manufacturing organisation is of the utmost importance and this area is receiving serious attention in quality guidance. Another crucial element is a clear description of tasks and lines of responsibilities of all personnel in the organisation.Furthermore, setting up effective internal and external communication channels has to be the top priority of management to ensure the participation and commitment of personnel at all levels of the organisation. All these and other aspects of the quality organisation need to be established in formal writing – a controlled documentation system is therefore an intrinsic part of organisations working under ISO 22716

With the help of qualified QMS professionals in our organization, we are able to build and put into practice a Quality Management System that factors in all the aspects of your organization. You can be assured of the ISO 22716 certification after receiving our comprehensive services. K & S Quality Associates will work out a viable approach that is best suited for your organization to function in the most productive and effective manner.

Our services for organizations seeking ISO 22716:2007 certification include –

  • Policy Manual prepared by seasoned experts in the field.
  • Providing Procedures Manual by the same or similar experts.
  • Assistance in writing Work Instructions.
  • On-site assistance and evaluationof the implemention and effectiveness of GMP.
  • Gap Analysis evaluation of prepardness for certification
  • Internal Audits and Auditor Training

With such a comprehensive approach to ISO 22716:2007 compliance and certification in place, organizations that must maintain a food safety management system have benefitted from achieving higher levels of consistent performance in their operations and products. Our clients not only get the ISO 22716:2007 certification, which is what they sought, but their profitability also increases by the enhanced efficiency of manufacturing and business operations