Implementation walkthrough
How to implement ISO 22716: video walkthrough
A walkthrough of implementing ISO 22716 good manufacturing practices for cosmetics, following the product through the plant from personnel and premises to recalls.
Key takeaways
- ISO 22716 follows the product through the plant rather than clauses 4 to 10.
- It covers production, control, storage and shipment, not R&D or distribution.
- Flows that prevent mix-ups and documented cleaning are core evidence.
- Deviations, complaints, recalls and change control are part of the system.
- Accreditation for ISO 22716 certification varies by body, so verify it.
Good manufacturing practice for cosmetics
ISO 22716 is the international standard of good manufacturing practices for cosmetics. Its full title calls it guidelines, and that matters: rather than the clause 4 to 10 structure of a management system standard, it follows the product through the plant, from personnel and premises through materials, production, finished products and the laboratory to deviations, complaints and recalls, change control, internal audit and documentation. It covers the production, control, storage and shipment of cosmetic products, but not research and development, distribution of finished products, worker safety or environmental protection.
Regulators wrote GMP into cosmetics law because a cosmetic is only as safe as the batch it comes from. This short film walks through how a manufacturer puts those practices in place.
Following the product through the plant
First define what the certificate needs to cover: the sites and the operations, whether manufacturing, filling, storage or a combination, the products and the brand owners or markets that expect the certificate. A gap analysis then walks the product flow against each clause, keeps what already works and agrees actions with owners and dates.
Implementation brings each area under documented control: defined responsibilities and trained, hygienic personnel; premises and equipment that protect the product, with flows that prevent mix-ups, cleaning, maintenance, pest control and calibration; controlled raw materials and packaging; production and finished product release; laboratory control; handling of deviations, complaints and recalls; change control; internal audit; and documentation. Records build up as production runs before an independent certification body audits the practices and decides.
One point is particular to this standard: certification bodies certify ISO 22716 under their own scheme rules, and accreditation for it differs from body to body, so ask and verify the answer. Sterling's expert and experienced consultants support the work under Sterling OS™. ISO 22716:2007 is the only edition, confirmed by ISO in 2022.
ISO 22716 at a glance
- Purpose
- Good manufacturing practices for cosmetics: production, control, storage and shipment under documented control
- Relevant to
- Manufacturers, fillers and contract manufacturers of cosmetic and personal-care products, one site or several
- Edition
- ISO 22716:2007, the only edition, confirmed by ISO in 2022; no revision on ISO's work programme as at September 2026
- Certification
- Voluntary. Assessed and decided by an independent certification body under its own scheme rules; accreditation for this standard varies by body
- Sterling's role
- Consulting with your team, Effivity, training, internal audit and certification readiness, then Sustain™
- Cost and timing
- Total investment for an ISO 22716 GMP system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 4 to 8 months
ISO 22716: questions people ask
Is ISO 22716 certification mandatory in the European Union?
No. Regulation (EC) No 1223/2009 requires the manufacture of cosmetic products to comply with good manufacturing practice (Article 8) and presumes compliance where manufacture follows the harmonised standard EN ISO 22716:2007. The product information file must contain a description of the method of manufacturing and a statement on compliance with GMP (Article 11). The Regulation requires compliance and a statement, not a certificate. A certificate is voluntary evidence that brand owners and market-surveillance authorities find easy to accept; it does not replace the responsible person, the safety assessment or the file.
Is ISO 22716 a requirements standard like ISO 9001?
No. ISO 22716 is published as guidelines, organised by the flow of product through the plant, with no clause 4 to 10 structure, management review or quality objectives of its own. Certification bodies nevertheless audit and certify against it, treating each guideline as the expectation for that part of the operation. Where a brand owner also wants a quality management system, ISO 9001 supplies what ISO 22716 leaves out.
Is ISO 22716 certification accredited?
It depends on the certification body and the market. ISO 22716 sits outside the accredited management-system schemes that accreditation bodies operate for standards such as ISO 9001 and ISO 22000, and many bodies certify it under their own scheme rules without an accreditation for this standard. Where a body says its ISO 22716 certificates are accredited, ask which accreditation body and which scope, and verify it with that body. Sterling tells you what a given offer actually is before you sign.
Does Sterling issue the ISO 22716 certificate?
No. Sterling provides consulting and hands-on support. An independent certification body conducts the audit and makes the certification decision. A provider that offers to do both is offering paper.
We are a contract manufacturer. Do we need the certificate, or does the brand?
The certificate covers the site where the product is made, so the contract manufacturer or filler is certified and the brand owner asks to see it. ISO 22716 also expects a written contract or technical agreement between contract giver and contract acceptor, and the brand owner to be satisfied that its subcontractor works to GMP. Sterling drafts those agreements as part of the engagement.
Keep exploring
Related to this video
The complete guide
Everything on ISO 22716
Start with the ISO 22716 page, or go straight to the guide you need.
On the ISO 22716 page
- What are the main ISO 22716 requirements?
- How do you get ISO 22716 certified?
- How much does ISO 22716 certification cost?
- How long does ISO 22716 certification take?
- Who needs ISO 22716 certification?
- How ISO 22716 protects your products, your customers and your brand
- Frequently asked questions about ISO 22716
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