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ISO 22716: Cosmetic GMP

ISO 22716 covers all aspects of the supply chain and determines the criteria for quality during the different stages of a cosmetic product. It provides a comprehensive approach for those who work in the manufacturing, packaging, testing, storage, and transportation of finished cosmetic products.

 

This standard ensures that every step of the process adheres to Good Manufacturing Practices (GMP), safeguarding product integrity and consumer safety. By implementing ISO 22716, organisations can demonstrate their commitment to maintaining consistent quality, minimising risks, and meeting both regulatory requirements and customer expectations.

 

Whether you’re a small business or a global enterprise, ISO 22716 provides the framework to improve operational efficiency, foster trust with stakeholders, and ensure compliance with international standards. It’s a vital tool for staying competitive in a demanding and highly regulated industry.

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What is ISO 22716?

The International Standardisation Organisation (ISO) published new guidelines to promote safe manufacturing and production of all cosmetic products under Good Manufacturing Practices (GMP). Regulators across the globe have adopted ISO 22716 in order to meet these requirements and open up new markets.

ISO 22716 sets organisational criteria for the quality throughout the various stages of manufacturing, including the purchase of raw materials, components, and packaging material. Therefore, all participants on the cosmetic product chain are concerned: from the ingredient production to distribution and exportation.

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What are the Benefits of ISO 22716?

ISO 22716 enables your organisation to effectively manage the quality and safety requirements across the entire supply chain. This ensures that each step in the production and distribution process meets international cosmetic Good Manufacturing Practices (GMP).

The standard helps identify and control hazards and risks associated with cosmetic products, ensuring their safety and quality. It also promotes continuous improvement, allowing your organisation to adapt and enhance processes over time.

ISO 22716 is designed to be easily implemented in businesses of all sizes and levels of complexity. Whether you are a small company or a large enterprise, the standard provides a practical framework that fits your needs.

The standard supports your organisation in meeting relevant legal requirements for cosmetics manufacturing. It helps ensure your products comply with both national and international regulations, reducing the risk of legal issues.

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More information on the Road to ISO Certification

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Learn more about ISO 22716

Download your free ISO 22716 Guide

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The Process

Steps to getting ISO 22716 certification

With our excellent support and guidance you can rest assure that your ISO 22716 certification will be successful.

1. Initial Consultation

We help you outline your goals, focusing on what your business wants to achieve and how it defines success, particularly in relation to your client’s requirements. You and your ISO consultants will agree on reasonable outcomes and delivery dates.

2. Producing System Documentation

Next, the IMSM consultant will audit your existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. The manual system documentation sets out how your business should operate going forward so that it can deliver ISO 22716.
You will be able to view the manual system documentation, along with most other relevant documentation, on our client portal IMSMLoop. It offers a comprehensive insight into the progress of your ISO implementation, along with copies of the relevant audit reports, certifications, and any necessary corrective actions. The portal serves as a central hub for tracking your ISO journey.

3. ISO 22716 Framework Adoption

While the manual is a vital document moving forward, it is even more important that it gets put to practical use. We work with the senior management team to ensure the framework is embedded throughout your organisation. We can also develop and deliver tailored training for staff to ensure that the understanding and implementation of ISO 22716 is watertight. This will create consistency across your organisation, transforming your business from day one so it is optimised for efficiency, continual improvement, and greater profitability.

4. Submission to External Auditor

Before you can be awarded the certification, your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit objectively determines whether your business conforms to ISO 22716, and the relevant accompanying documentation is accessible through our client portal, IMSMLoop.
Our Benefits

Why choose IMSM?

Simple: We make it simple. Since 1994, we've helped businesses achieve ISO certification, with over 150 experts worldwide and 15,000+ clients trusting us to implement their ISOs. We've proven to be experts at handling the logistical heavy lifting, saving your company valuable time.

With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we collaborate with your organisation to make any ISO implementation as straightforward and beneficial as possible.

Experienced ISO Consultants

How can ISO Specialists help your business?

Getting started with ISO certification might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For 30 years, we've supported and guided organisations like yours through certification. Our experienced consultants take the lead on auditing your business, helping you use the results to enhance your quality management system. If necessary, there is also plenty of room for training.

Established ISO Certifiers since 1994
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ISO 22716: Frequently Asked Questions

How does my business gain ISO 22716 certification?
The ISO 22716 standard is designed to be comprehensive, focusing on quality, which ensures a smooth integration with other management systems, such as ISO 9001. Most businesses start their ISO journey with ISO 9001 as this puts into place quality management systems and processes which can be further developed to incorporate cosmetic safety as well as other standards.
How does ISO 22716 relate to cosmetics?
ISO 22716 is a quality management system for anyone involved in the cosmetic process, not only limited to production but also the control, storage, and transportation of products, including the purchase of raw materials, components, and packaging material. Cosmetics are goods or materials intended to enhance, cleanse, or alter a consumer’s face or body through makeup, creams, deodorants, hair products, and fragrances. Cosmetics are created from a mixture of chemical compounds, from either natural sources or synthetically produced ones. In America, the Food and Drug Administration (FDA) is responsible for regulation cosmetics. The FDA defines cosmetics as products “intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions”.
How can IMSM help my business gain ISO 22716 certification?
Our experienced consultants work with the systems and processes in your business, to ensure the implementation of ISO 22716 really does fit the way your organisation uses its data. With a fixed fee and flexible approach, our consultants are focused on making standards work in your business.
Why do I need ISO 22716 certification?
Independent audit is a critical part of the ISO concept as it adds objectivity and credibility into the process. Self-regulation is critical for the ongoing success of any ISO, but it is independent audit that proves without a doubt that the ISO standard has been properly embedded throughout your organisation.
Is GMP required for cosmetics?
As part of ISO 22716, every European market product must be manufactured and produced according to the Good Manufacturing Practices (GMP) under the European Union’s Regulation (EC) No 1223/2009. By implementing ISO 22716, compliance with Good Manufacturing Practices (GMP) can be demonstrated. Although following ISO 22716 is not a legal requirement, companies can use whatever Good Manufacturing Practices (GMP) they wish. However, this would require them to demonstrate their system, which achieves the same objective as the ISO 22716 guidelines. Having ISO 22716 certification ensures companies comply with all the recommended cosmetics Good Manufacturing Practices (GMP) in the production, control, storage, and shipment of cosmetic products. Conformance to Good Manufacturing Practices (GMP) ensures that your products are produced in a hygienic environment, which creates little to no risk or harm to the consumer.
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