Software for ISO 22716

ISO 22716, without folders or surprises

Good manufacturing practice for cosmetics: staff, premises, raw materials and finished product, all under control.

What it is and which edition applies

ISO 22716 sets out good manufacturing practices (GMP) for the cosmetics sector. Its relevance is not voluntary: article 8 of Regulation (EC) 1223/2009 on cosmetic products requires manufacturing in line with good manufacturing practices and presumes compliance where a harmonised standard is followed, which is the role ISO 22716 plays. It covers personnel, premises, equipment, raw materials, production, quality control, out-of-specification product, waste, subcontracting, complaints, recalls and documentation.

Content reviewed on 25 August 2026

Current edition: ISO 22716:2007 Good manufacturing practices for cosmetics
EU legal basis: Art. 8 of Regulation (EC) 1223/2009 Requires manufacturing under good manufacturing practices
Presumption of conformity: Harmonised standard Following ISO 22716 presumes compliance with art. 8
Product file: Product Information File Required by art. 11 of the Cosmetics Regulation
Responsible person: Mandatory role Art. 4 of Regulation (EC) 1223/2009

Document control

Versions, approvals and distribution with read receipts.

Connected to your document cloud

Publish and version documents by connecting to OneDrive, Google Drive or SharePoint, without duplicating folders.

Audits

Annual program, checklists per standard, findings linked to actions.

Non-conformities

Root cause, action, owner, deadline and effectiveness check.

KPIs

Process objectives fed with real operating data.

Legal requirements

A register of legal and other requirements, with validity and compliance evaluation per standard.

Corrective actions

Root cause, action, owner, deadline and effectiveness check, all linked to the nonconformity.

Improvement actions

Improvement opportunities with an owner and tracking, beyond just fixing what already failed.

Management review

A pre-built report with indicators, audits and nonconformities, ready for the meeting.

Raw material approval

Approved suppliers with their control history.

Product recall

Recall procedure with batch traceability.

Batch traceability

From the manufacturing batch to the finished product, across the whole chain.

Finished product control

Control results linked to the batch before release.

Requirements covered

What it solves for ISO 22716

Approval and control of raw materials
Manufacturing batch traceability
Finished product quality control
Deviation and complaint management
Product recall procedure
Internal good-practice audits

Standards covered

Pick your standard and see what it solves

GMP+ Animal feed safety Food industry · animal feed IATF 16949 Automotive Automotive SQAS2022 Chemical and logistics assessment Quality · chemical and logistics ISO 19600 Compliance management systems Compliance · guidance ISO 37301 Compliance management systems Compliance ISO 22716 Cosmetics manufacturing Quality · cosmetics GDPR Data protection Legal · data protection ISO 14001 Environmental management Environment SGE 21 Ethical and responsible management Social responsibility IFS Food Food safety Food industry ISO 22000 Food safety Food industry FSSC 22000 Food safety management system Food industry BRCGS Global food standard Food industry ISO 14064 Greenhouse gases Environment · carbon footprint HACCP Hazard analysis and critical control points Food industry ISO 27001 Information security Cybersecurity ISO 20000 IT service management Quality · IT services ISO 13485 Medical devices Healthcare ISO 15189 Medical laboratories Quality · healthcare ENS National Security Framework Security · public sector UNE 73401 Nuclear quality assurance Quality · nuclear ISO 45001 Occupational health and safety Health & safety ISO 27701 Privacy management Cybersecurity ISO 9001 Quality management Quality · every sector ISO 26000:2010 Social responsibility Social responsibility · guidance Sustainability Sustainability management ESG UNE 19602 Tax compliance Compliance · tax ISO 17025 Testing and calibration laboratories Quality · laboratories

Templates and records

ISO 22716 records, explained one by one

Which clause of ISO 22716 calls for each record, which fields it needs, a completed example and what the auditor usually flags.

See all ISO 22716 templates and records

Frequently asked questions

What people ask us before getting started

Which edition of the standard is current?

The edition in force is ISO 22716:2007. When the issuing body publishes a new one, a transition period opens; once it closes, certificates issued against the previous edition stop being valid.

Does this work if we are already certified?

Yes. Your existing system — processes, documents, records, audit history — is loaded in and kept alive from day one. Nothing needs redesigning and the certification cycle does not restart.

Will the auditor accept digital records?

Yes, provided they are traceable, controlled and able to show who did what and when. No standard requires paper; every standard requires reliable evidence, and a properly controlled electronic record provides it better than a folder.

Can it be combined with other standards?

Yes, and that is the sensible route. The common Annex SL structure lets a single integrated system share the process map, document control, internal audits, nonconformities and indicators between ISO 22716 and the rest, leaving only the standard-specific parts separate.

How long does it take to be ready for an audit?

It depends on the starting point. An organisation already working with written procedures is usually ready in two or three months; one starting from scratch needs longer. The bottleneck is rarely the tool — it is the availability of the people who know the processes.

What happens to the documentation we already have?

It is migrated. Existing procedures, forms and records are loaded with their version and approver, so the history is not lost and the system starts with the memory the organisation already had.

Can the auditor look directly at the system?

Yes. They are given read-only access with a defined scope and an expiry date. It is more comfortable for both sides than preparing a folder of screenshots and exports.

What is the difference between a major and a minor nonconformity?

A major one compromises the system's ability to meet a requirement — a required process missing altogether, systematic failure, or a failure affecting the product — and usually blocks certification until it is closed. A minor one is a specific lapse resolved with an action plan.

Are the indicators calculated automatically?

Yes, from the data the processes themselves generate. That is the difference between a dashboard that reflects what is happening and a spreadsheet somebody fills in the week before the management review.

Does it work across several sites or legal entities?

Yes. The model is multi-company and multi-site: what makes sense to share is shared, and what belongs to each location stays separate — including the certificate scope where it differs.

Get ready for your ISO 22716

We'll show you the module running with data similar to yours.

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Keep exploring

Software for ISO 22716 — Cosmetics manufacturing

Kimobox is a software for ISO 22716 that digitizes the requirements of the standard: approval and control of raw materials, manufacturing batch traceability, finished product quality control, deviation and complaint management, with full traceability and evidence ready for the auditor.

The platform lets you run an integrated management system that combines ISO 22716 with other ISO standards and sector protocols, sharing the process map, document control, internal audits, non-conformities and KPIs.

ISO 22716, without folders or surprises

What it is and which edition applies

Document control

Connected to your document cloud

Audits

Non-conformities

KPIs

Legal requirements

Corrective actions

Improvement actions

Management review

Raw material approval

Product recall

Batch traceability

Finished product control

What it solves for ISO 22716

Pick your standard and see what it solves

ISO 22716 records, explained one by one

Raw material receipt and release

Equipment cleaning and sanitisation

Manufacturing batch record

Packaging record

Finished product release

Out-of-specification result

Deviation record

Complaints and recalls

Change control