ISO 22716 provides guidance to documenting and regulating the production, control, storage, and shipment of cosmetic products. The standard’s guidelines will provide your organisation with practical methods for managing the many factors that can affect product quality.

The European Union’s Regulation (EC) No 1223/2000 requires cosmetic products to be manufactured according to Good Manufacturing Practices (GMP). GMPs create the practical development of quality assurance through the description of the activities that are based on sound scientific judgement and risk assessments. GMP guidelines were written to define the activities that enable you to obtain a product that meets defined characteristics. GMPs are critical to organisations looking to reduce the risk and liability of their products. Your organisation can demonstrate compliance with GMP by implementing ISO 22716.

Benefits of ISO 22716 certification for your organisation:

• Improves quality management systems
• Demonstrates commitment to the safety of cosmetic products
• Ensures your compliance to international guidelines

Intertek brings in-depth knowledge of the manufacturing processes and GMP codes to cosmetics manufacturers. Intertek’s cosmetics testing services include clinical studies, safety assessments, quality control, in vitro testing, product claims verification, screening for restricted substances, and suppliers’ audits. With our global network of auditors, we provide a full compliance solution for ISO 22716 including auditing and certification*, training, and e-learning tools.

By partnering with Compliant, you’ll gain a knowledgeable business partner dedicated to helping you meet objectives, minimise risk, and optimise your supply chain. We can also combine a Cosmetics GMP audit with other standards such as ISO 9001 and ISO 14001, reducing interruptions and saving you valuable time and money.

What’s the difference between GMP and ISO?

The International Organisation for Standardisation (ISO), is a voluntary body that develops internationally recognised guidelines for best practices within business. Good Manufacturing Practices (GMP) are the recommended manufacturing for the sale of food, drug products, and active pharmaceutical products to conform to guidelines recommended by agencies that control the authorisation and licensing. These guidelines provide the minimum requirements that a manufacturer must meet to ensure any products coming to the market are of high quality and cause no risk to the consumer.

Therefore, while both ISO and GMP focus on quality assurance, there are differences between them. ISO is designed to be business-focused, and yet generic, in order to fit into multiple industries and company requirements. The different standards support effective management of quality to an international level of practice. The advantage of ISO is in the flexibility. ISO specifically explains what is needed to be achieved, while allowing each organisation the freedom to determine and justify how to achieve those requirements. In contrast, GMP is focused on specific industries and detailing what must be done to ensure safety and efficacy.

GMP can be viewed as the minimum standard and not the ultimate goal. Therefore, businesses should aspire not only to meet these requirements but to exceed them, which can be achieved through ISO 22716 and the process of continual improvement. An organisation can demonstrate compliance with GMP through implementing ISO 22716.

Is implementing ISO 22716 mandatory?

In some regions, GMP for cosmetics is endorsed and highly encouraged by national authorities but are not mandatory. However, in other areas, GMP is a legal requirement for cosmetic manufacturers. For example, in Europe, the Cosmetics Regulation (EC) 1223/2009 necessitates that any cosmetic product aimed to the EU market must comply with the cosmetic GMP guidelines outlined by ISO 22716.

Implementing ISO 22716 is an effective way to comply with legal regulations related to consumer safety and product quality. Requirements for GMP in cosmetics can vary, but having a management system in place has several benefits.

Who needs ISO 22716?

While every company can benefit from any ISO 9001 management system, the ISO 22716 provides a comprehensive approach for those who work in the manufacturing, packaging, testing, storage, and transportation of finished cosmetic products. The term ‘cosmetic’ refers to any goods or materials intended to augment, enhance, purify, or cleanse one’s face or body. These can range from makeup to perfumes, as well as body and hair products.

While certain companies achieve ISO 22716 implementation out of necessity, numerous businesses see this as a strategic move due to the vast benefits that an ISO management system offers.

Why is ISO 22716 important?

ISO 22716 covers all aspects of the supply chain and determines the criteria for quality during different stages. It provides a comprehensive approach for those who work throughout the various cosmetic manufacturing stages, including the purchase of raw materials, components, and packaging materials.

The benefits of ISO 22716 are vast and can be unique to your particular business. However, benefits of ISO 22716 include:

• Reducing cosmetic product hazards and promotes Good Manufacturing Practices (GMP)
• Ensuring quality and safety compliance of cosmetic products within the supply chain
• Adhering to an internationally recognised achievement
• Supporting legal compliance from international regulators
• A flexible approach which applies to organisations of all sizes and integrates with other standards, such as ISO 9001

How do I get ISO 22716 certified?

The process of getting ISO 22716 certified usually follows these steps:

1. Consultation with an ISO consultant and initial discussion of ISO
2. Initial assessment (gap analysis)
3. Production of documentation
4. Implementation
5. Certification through a certification body

It all starts with a free consultation with one of our experts in ISO certification. We will establish through our initial discussion the best and most relevant standard for you and your customers’ requirements, and provide a fully tailored, fixed fee quote with a simple, flexible client agreement.