ISO 22716 · Cosmetics good manufacturing practices (GMP)
ISO 22716 certification consulting for cosmetics made, checked and released under control.
Get ISO 22716 certified by an independent certification body, first time, on your timeline. Sterling's expert and experienced consultants build cosmetics good manufacturing practices into the way your site actually runs, from material receipt to shipment, prepare the batch records and evidence, and stay with you through the certification audit and after it, in 60+ countries. We ensure successful certification for our clients.
- Fixed scope, one proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced cosmetics GMP consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify; an independent certification body audits and decides
8,100+ client engagements in 60+ countries.
ISO 22716 client experience
What it is
What is ISO 22716 and what is it used for?
ISO 22716 is the international standard of good manufacturing practices for cosmetics. Its full title is Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices, and the word guidelines 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; it does not cover research and development, the distribution of finished products, the safety of the plant's people or the protection of the environment.
Regulators wrote GMP into cosmetics law because a cosmetic is only as safe as the batch that reaches the customer: a product can be safely formulated and still be contaminated or made from a material nobody released. ISO 22716 is the discipline that stops that. Health Canada states that it and its partners in the International Cooperation on Cosmetics Regulation, the United States, the European Union and Japan, endorse the use of ISO 22716, which is why brand owners on four continents ask for it.
Current edition. ISO 22716:2007 is the first and only edition, published in November 2007 with a corrected version in May 2008. ISO reviewed and confirmed it in 2022, so it remains current, and no revision appears on the work programme of ISO/TC 217, the cosmetics committee, as at September 2026. There is no transition to plan for. In the European Union the identical text is the harmonised standard EN ISO 22716:2007, listed in the Official Journal under the Cosmetics Regulation. ISO 22716 and the EU Cosmetics Regulation: Article 8, the product information file and the GMP statement
Who it is for
Who needs ISO 22716 certification?
ISO 22716 applies to anyone who manufactures, fills, packs, tests or stores cosmetic products: skincare and colour cosmetics, haircare, perfume, soap and bath products, oral care and the contract manufacturers behind many brands on the shelf. The certificate should name the site, operations and product categories it covers, because a brand owner qualifying a supplier reads exactly that. Cosmetics manufacturers come to Sterling for ISO 22716 from four starting points:
- A brand owner, retailer or distributor has asked for GMP evidence. Supplier questionnaires ask for an ISO 22716 certificate or a GMP audit report before a purchase order is raised. Clarify the site, operations and product categories they expect on the certificate before you invest.
- You sell into the European Union. Regulation (EC) No 1223/2009 requires cosmetic manufacture to comply with good manufacturing practice, presumes compliance where manufacture follows EN ISO 22716, and requires the product information file to state that compliance. The statement has to be true.
- You are a contract manufacturer or filler. Brand owners cannot place their responsibility on you, so they audit you. A certified GMP system, with technical agreements that say who does what, turns an audit visit into a formality.
- Growth has outrun the controls. New lines, a second shift or a new site, and now a complaint nobody can trace to a batch, a material used before release or a label mix-up. GMP keeps quality decisions ahead of volume.
The intended benefit is control of every batch and evidence of that control. Results depend on implementation and ownership on the shop floor, not on the certificate alone.
Business benefits
How ISO 22716 protects your products, your customers and your brand
Good manufacturing practices should make the plant easier to run, not harder. We start where a missed check costs most, a contaminated batch, a rejected delivery, a recall nobody can reconcile, and build the system around them.
- Batches you can stand behindReleased raw materials, documented instructions, in-process checks and laboratory release against written acceptance criteria: fewer rejects, fewer reworks and no product shipped on a guess.
- Traceability in minutes, not daysBatch records, retained samples and shipment records that connect a complaint to the batch, the materials, the line and the people, so a recall decision rests on facts.
- Supplier qualification that goes your wayThe scope of your certificate matched to the operations and product categories a brand owner needs to see, with technical agreements already in place.
- A defensible GMP statementThe declaration in an EU product information file, or the answer to a regulator's inspection, backed by a system that runs every day rather than a folder assembled for the visit.
- Contamination controlled at sourceDefined areas and flows, cleaning and sanitisation, water control, pest control and personnel hygiene that stop contamination before the laboratory finds it.
- A plant that can growThe same documented practices for every new line, shift or site, kept current by change control and internal audit, so growth adds capacity without adding risk.
Choose a few measures that reflect these priorities, such as batches rejected at release, out-of-specification results or the time a mock recall takes. Review whether the system improves them. A thicker procedure manual is not a business result.
Requirements
What are the main ISO 22716 requirements?
ISO 22716 follows the flow of product through the plant rather than a management cycle. After the scope and terms in clauses 1 and 2, clauses 3 to 17 each open with a principle and describe good practice for that part of the operation. The table is a plain-language map; your implementation is checked against the text of the standard, clause by clause, during the programme.
| Clause | What it requires of you | What it looks like in practice |
|---|---|---|
| 3 Personnel | Defined responsibilities, enough trained people, hygiene and health rules, control of visitors and untrained personnel | Organisation chart, GMP job descriptions, training records, hygiene rules that are followed |
| 4 Premises · 5 Equipment | Premises and equipment that protect product: defined areas, flow that prevents mix-ups, cleanable surfaces, cleaning and sanitisation, maintenance, pest control, calibration where equipment measures | Site plan with areas marked, cleaning and maintenance records, equipment register, pest control reports, calibration certificates |
| 6 Raw materials and packaging materials | Purchasing to specifications from evaluated suppliers, receipt checks, identification and status, release by authorised people, defined storage, re-evaluation after storage, control of production water | Approved supplier list, specifications, goods-receipt records, status labelling, water test results |
| 7 Production · 8 Finished products | Manufacturing and packaging to documented instructions with start-up checks and in-process controls; finished product released against acceptance criteria, stored under defined conditions, shipped with traceability and assessed when returned | Batch manufacturing and packaging records completed as the work is done, line clearance, a signed release record, shipment records |
| 9 Quality control laboratory | Testing to written methods and acceptance criteria, in-house or contracted; results recorded; out-of-specification results investigated; reagents and reference standards controlled; sampling and retained samples | Test methods and specifications, laboratory records, an out-of-specification procedure, a sampling plan, retained samples |
| 10 Treatment of product that is out of specification · 11 Wastes | Rejected and reprocessed product decided and recorded by authorised people; waste identified, collected, stored and disposed of without risk to product | A rejection and reprocessing procedure with each decision recorded; waste segregation and disposal records |
| 12 Subcontracting | A written contract or technical agreement between contract giver and contract acceptor, and assurance that the subcontractor works to GMP | Technical agreements with contract manufacturers, fillers and laboratories; supplier assessments |
| 13 Deviations · 14 Complaints and recalls | Deviations authorised, recorded and investigated; complaints reviewed and investigated; a recall procedure with a responsible person, the means to trace and retrieve product, and reconciliation | A deviation log, a complaints register with trend review, a recall procedure and the record of a mock recall |
| 15 Change control · 16 Internal audit | Changes that can affect quality approved by authorised people on the basis of data; internal audits that check GMP is applied, with corrective actions followed up | Change requests with impact assessment and approval, an audit programme covering every clause and area, reports and closed actions |
| 17 Documentation | Documentation as an integral part of GMP: procedures, instructions, specifications, protocols, reports, methods and records, written, approved, distributed, revised and archived under control | A document control procedure, current versions at the point of use, controlled forms, legible records, an archive with retention periods |
What does useful ISO 22716 evidence look like?
Batch manufacturing and packaging records, specifications and supplier approvals, receipt and release records, cleaning, pest control and calibration records, training records, laboratory results with retained samples to match, deviation and change control records, a complaints register and the report of a mock recall. We help identify the records your operation genuinely needs, without creating forms simply to fill folders, and they live in Effivity from the first workshop so the auditor sees a system that runs.
ISO 22716 requirements explained, clause by clauseCertification process
How do you get ISO 22716 certified?
First implement working good manufacturing practices. Then an independent certification body audits them. Sterling supports your organisation through preparation and implementation; the certification decision belongs to the certification body, and that separation is what makes the certificate worth showing to a brand owner. One point is particular to this standard: bodies certify ISO 22716 under their own scheme rules, and accreditation for it differs from body to body. Ask, and verify the answer.
- 01Define what the certificate needs to cover.Confirm the sites, the operations (manufacturing, filling, storage, laboratory), the product categories, the subcontractors and who will read the certificate.
- 02Gap analysis: review the current operation against the requirements.The gap analysis walks the plant clause by clause, identifies what is missing, preserves the practices that already work and agrees actions, owners, dates and resources, including any premises work.
- 03Implement and collect meaningful evidence.Put the controls into use: released materials, batch records, in-process checks, laboratory release, cleaning and calibration programmes. Train the people who run them and keep the records that show the system operating batch after batch.
- 04Audit, review and address the findings.An internal audit of every clause and area and a management review evaluate implementation; findings are raised by us first and closed with evidence, and a mock recall is run before the certification body asks.
- 05Complete the independent assessment.Most certification bodies run ISO 22716 on the cycle they use for their management-system schemes: a Stage 1 readiness review, then the Stage 2 audit on site. Respond to any findings and await the body's decision.
- 06Maintain the system after certification.Batch records, laboratory release, internal audits and change control continue, alongside the body's surveillance audits, usually annual, and recertification in the third year.
Check the credibility of the route, not just the quoted price. Ask for the certification body's identity, its scheme rules and accreditation status for ISO 22716, the proposed scope and the audit arrangements, and verify them with the bodies concerned. Be cautious of "no implementation, no audit" offers: a certificate that fails a brand owner's audit leaves the gaps unresolved and the money spent. A certificate does not replace the responsible person, the safety assessment or the product information file that EU law requires. How to choose a credible ISO 22716 provider · The certification buyer's checklist
Cost
How much does ISO 22716 certification cost?
There is no useful universal price for ISO 22716 implementation. A single-site filler with an in-house laboratory and segregated premises needs a different scope from a multi-line manufacturer that has to redesign its material flow and contract out its testing. What we can promise is a proposal in which every component is visible and nothing is added later.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Current maturity of hygiene and batch control, number of lines, product categories and sites, whether the laboratory is in-house or contracted, deliverables and how much of the work your team takes on (Design™ or Drive™) |
| Independent certification | The certification body's audit days, sites, travel and surveillance arrangements, and whether a customer requires a particular body or scheme |
| Internal resources | Process-owner time, management involvement, training, and any premises or equipment work the gap analysis shows: flow, segregation, cleanable surfaces, calibration, pest control |
| Software and learning | Included in a Sterling engagement: Effivity for the system and Sterling Academy access for your people, with users, courses and access period confirmed in the proposal |
| Continued support | Internal audits, system upkeep, refresher learning and mock recalls under Sustain™ |
What moves the price
- Sites, lines and product categories, and whether one certificate or several
- Headcount, shifts and the subcontractors who need technical agreements
- The state of the premises and equipment, and how much change the gap analysis calls for
- Whether testing is in-house or contracted, and what the laboratory already records
- The deadline, your markets and any customer-specific GMP requirements
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, in writing
- Certification-body fees identified separately, so the full programme cost is comparable
- Effivity, training and Academy access itemised at no additional cost
- Payment milestones tied to deliverables, not to the calendar
- One all-inclusive proposal. No surprises, ever
Timeline
How long does ISO 22716 certification take?
The realistic timeline depends on your starting point, the physical changes the plant needs, the availability of your people and the certification body's schedule. It is measured in months, not days, typically four to eight: the system has to run through enough batches to produce the records and laboratory results an auditor will ask for, and premises work takes the time it takes. We build the plan around that evidence, with milestones your team can track in Effivity.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Access to the plant, the laboratory, the people and the existing records, and the decision on which sites and operations are in scope |
| Build and implementation | The extent of premises and equipment change, the procedures, batch records and specifications to write, training and internal capacity |
| Evidence and review | Batches manufactured, tested and released under the system, records accumulating, then internal audit, a mock recall and management review |
| Certification assessment | The certification body's availability, Stage 1 and Stage 2 scheduling, and the time needed to address any findings |
If a brand owner's audit date, a tender or an EU launch is fixed, share it at the start. We will tell you what is achievable and where early decisions are needed, especially on premises. A certificate date promised before anyone has walked your plant is a sales tactic, not a plan.
Challenges
Common ISO 22716 implementation challenges
Most cosmetics GMP programmes stall for the same five reasons. Each has a practical answer.
The plant was laid out to make product, not to control flow.
Materials, bulk, packaging components and finished goods cross paths, and rejected stock sits next to released stock. We map the real flow with your production team, define the areas the standard expects, fix the cheap problems with labelling and status control, and sequence the changes that need capital so production keeps running.
Batch records live in notebooks and in people's heads.
Every batch needs a manufacturing record and a packaging record completed as the work happens, not reconstructed afterwards. We design records around your formulations and lines, short enough to be filled in on the floor, and put them in Effivity so review and release become a screen, not a search.
Water and microbiological control are assumed, not evidenced.
Water is a raw material in most cosmetics and the commonest route to contamination. We define the water quality you need, the sampling points, frequency and limits, arrange contracted testing where needed, and connect the results to release decisions.
Subcontracted manufacturing, filling or testing runs on a handshake.
The standard requires a written contract or technical agreement that defines who is responsible for what, and for the contract giver to be satisfied that the subcontractor works to GMP. We draft the agreements with your legal and purchasing teams and assess the subcontractors.
Complaints, deviations and changes are handled informally.
A deviation fixed on the line and never recorded is invisible at the next batch. We set up one register each for deviations, complaints and changes, with owners, investigations and approvals, and rehearse a mock recall so the reconciliation is proven before anyone asks.
Your engagement
What your ISO 22716 engagement includes
Your agreed scope brings together everything a functioning GMP system and a prepared team need. Most firms sell one piece and leave you to assemble the rest; a Sterling engagement is the whole journey, from one team, under one all-inclusive proposal.
Scope, gap analysis and implementation plan
A clause-by-clause walk of the plant, with responsibilities, dates and decision owners agreed before work starts, premises actions included.
Process development and documentation
Procedures, specifications, batch records, technical agreements and the recall procedure, tailored to your lines and formulations on Sterling's own template sets, built with your process owners.
Effivity ISO & GRC software
Your GMP system runs in Effivity from day one, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for your audit team, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Internal audit, mock recall and management review
Conducted or facilitated as agreed, with findings closed with evidence before the auditor arrives.
Certification readiness and support
Preparation for Stage 1 and Stage 2, and support until the certificate is issued.
Certification decisions remain with the independent certification body.
How we deliver
How Sterling supports your ISO 22716 implementation
Every ISO 22716 engagement runs on Sterling OS™, our delivery operating system: five phases with named deliverables, decision owners and evidence at each stage. Choose the level of support that matches your capacity; the method, the software and the accountability stay the same.
- 01Design™Guided implementation: your team implements with Sterling's structure, templates, workshops and coaching.
- 02Drive™Fully managed consulting: Sterling consultants take on the agreed consulting and documentation work with your production, laboratory and purchasing leads.
- 03Sustain™Post-certification operation: surveillance readiness, internal audits, mock recalls, refreshers and new-hire GMP training, year after year.
- 04Automate™The GMP system running in Effivity: documents, batch records, suppliers, calibration, deviations, complaints, changes and audits in one workspace.
- 05Revise™Changes in regulation, such as the EU Cosmetics Regulation's annexes or the United States GMP rulemaking under MoCRA, new markets, lines and sites, and any revision ISO publishes.
At the start we agree the named lead, the weekly working session, the deliverables and the decision owners. During delivery, progress is reviewed against those commitments so that gaps are visible early, not at Stage 1.
How Sterling OS™ worksOften combined with
Standards organisations pair with ISO 22716
- 21 CFR Part 11 / EU Annex 1121 CFR Part 11 and Annex 11 compliance for GxP systems: requirements, validation, audit trails and e-signatures, with evidence ready for FDA and EU inspectors.
- ADHICS (Abu Dhabi)ADHICS compliance consulting for DoH-regulated healthcare entities in Abu Dhabi: patient information, systems and devices protected, with audit-ready evidence.
- amfori BSCIamfori BSCI audit preparation for producers: gap assessment across the 13 performance areas, remediation, worker-facing evidence and support from Sterling.
- Better Cotton (BCI)Better Cotton (BCI) Chain of Custody certification for textile suppliers: stock and claim controls, reconciled records, training and audit readiness.
- BRCGS Packaging MaterialsBRCGS Packaging Materials certification explained: Issue 7, GFSI recognition, who asks for it and how Sterling prepares packaging sites for the audit.
- CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
Effivity · ISO 22716 GMP software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO 22716:2007.
Every Sterling ISO 22716 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the GMP workspace within the agreed scope, so specifications, suppliers, batch records, calibration, laboratory results, deviations, complaints, changes and audits live in one place, the system runs in daily production and the auditor reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Roles, training and hygiene records
The organisation chart and the GMP responsibilities of each role, training plans and records linked to Sterling Academy, and hygiene rules with the evidence that people were trained on them.
Cleaning, maintenance, pest control and calibration
Cleaning and sanitisation schedules by area, maintenance plans, pest control inspections and the calibration register with due dates and certificates, so nothing that measures or touches product is out of date.
Suppliers, specifications, receipt and release
Approved suppliers with evaluations and technical agreements, specifications with versions, goods-receipt records, quarantine and release status and water test results, each record created as the material moves.
Batch records, in-process checks and release
Batch manufacturing and packaging records with line clearance and in-process checks completed on the floor, product status, authorised release and shipment records that keep traceability intact.
Methods, results, out-of-specification and retained samples
Test methods and acceptance criteria, results recorded against each batch, out-of-specification investigations, reagent and reference-standard control and the retained-sample register.
Deviations, complaints, recalls and reprocessing
Deviations raised, investigated and closed with root cause; complaints trended by product and batch; the recall procedure with traceability queries and reconciliation; rejection and reprocessing decisions.
Change requests and the audit programme
Change requests with impact assessment, approval and implementation evidence; an internal audit programme covering every clause and area, with findings followed to closure.
Procedures, records and your own forms
Documents with versions, approvals, distribution and archiving, controlled forms that become records when completed, and workflows and reports adapted to your plant, without code.
What this means at the audit
The certification auditor asks for the batch records of a recent lot, the release decision and the laboratory results behind it, the calibration certificate for the balance on that line, the operator's training record, the open deviations and the last internal audit. In Effivity each of those is a screen, with dates, owners and evidence attached, not a folder assembled the week before Stage 1. After certification, Sustain™ runs in the same workspace, so surveillance audits find a system that never stopped.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your specifications, batch records and registers migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, FSMS and more when you integrate other standards
ISO 22716 client experience
Client letters on file, available on request.
Signed client letters for ISO 22716 are available on request. The client feedback wall lists every letter by standard.
How an ISO 22716 programme runs
What a cosmetics GMP engagement looks like in practice.
- 01How an integrated GMP, quality and halal programme runs
Cosmetics manufacturing: ISO 22716, ISO 9001 and halal certification on one system
The typical route for a skincare or personal-care manufacturer whose brand-owner customers ask for GMP evidence and whose distributors in the GCC, Malaysia or Indonesia ask for a recognised halal certificate. The gap analysis walks the plant clause by clause; material flow and status control are fixed first, then batch records, laboratory release and the cleaning, calibration and pest control programmes, with technical agreements for the contract filler and the laboratory. ISO 9001 supplies the customer, supplier and management-review layer that ISO 22716 does not, on the same documents and audit programme, and the halal materials register is built from the formulations the GMP specifications already control. A mock recall and the internal audit come before Stage 1, and the halal certifier is chosen from the destination market's recognised list before the application is filed.
Sterling Academy · ISO 22716 e-learning
Train every operator on ISO 22716, not just the quality team.
Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- ISO 22716 awareness for every employee, with the training records the standard requires
- Practitioner courses for production supervisors, the laboratory and the GMP lead
- Internal auditor training for the people who will audit the system, as applicable to your standard, as part of the engagement
- Learner progress by department and a training status report for the auditor
- New hires trained as they arrive, so evidence is current at every surveillance audit
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about ISO 22716
Watch a video on how to implement ISO 22716 here.
Watch a video on ISO 22716 requirements here.
Why Sterling
Want successful ISO 22716 certification? Come to Sterling.
Whether you run one filling hall or sites in several countries, Sterling helps you establish shared good manufacturing practices with clear local ownership. We work through differences in formulations, water, laboratory arrangements, subcontractors and markets, so the system supports growth without losing sight of how each plant actually makes product.
Management systems in 60+ countries since 2003
Manufacturing, laboratory and hygiene-critical systems implemented for producers, contract manufacturers and packers across every region we serve, with one engagement team accountable in every country you operate in.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with certification-body fees identified separately. No surprises, ever.
A system your operators can use
Less documentation and maximum effectiveness: batch records, training and software connected to the mixing vessel and the filling line, so your people adopt the system rather than tolerate it.
Expert and experienced consultants
Consultants who have advised on management systems across sectors and countries since 2003, and who build your GMP system properly the first time, so the certification audit confirms what already works.
The Sterling Promise
What our ISO 22716 certification success guarantee means
We stay with you until your agreed ISO 22716 certification outcome is achieved, supporting implementation, preparation and the resolution of assessment findings. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability rather than a certificate on a wall.
The engagement identifies the standard, scope, outcome and responsibilities. Your organisation supplies accurate information, carries out the agreed premises work and puts the agreed controls into use. The independent certification body assesses conformity and retains its certification decision. Our commitment concerns the agreed certification support, not a promise of every future supplier approval or error-free batch.
After certification
What happens after ISO 22716 certification?
Your GMP system should keep working as formulations, materials, suppliers, operators and lines change. Batch records keep being completed, the laboratory keeps releasing, deviations keep being investigated and changes keep being approved before they reach product. The certification body returns for surveillance audits, usually each year, and for recertification, usually in the third year.
As your business grows, the system should evolve with it. Under Sterling OS™ Sustain™ we review complaint trends, out-of-specification results and supplier performance with you alongside the planned internal audits, management reviews and surveillance preparation, so the system stays alive between audits rather than being revived the week before one.
FAQs
Frequently asked questions about ISO 22716
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.
Does ISO 22716 cover product safety assessment, labelling, research and development or distribution?
No. The standard covers production, control, storage and shipment. It excludes research and development and the distribution of finished products, and does not deal with worker safety or the environment. The safety assessment, ingredient restrictions, labelling and claims are separate obligations under each market's cosmetics law; the certificate does not answer them.
We sell in South East Asia. Is ISO 22716 the same as ASEAN cosmetic GMP?
The ASEAN Cosmetic Directive carries its own GMP guideline, the ASEAN Guidelines for Cosmetic Good Manufacturing Practices, and some regulators audit against it: Singapore's Health Sciences Authority, for example, issues a voluntary cosmetic GMP certificate to manufacturers that pass its audit, mainly to support export. ISO 22716 covers the same ground and is the usual foundation for either audit. Whether a regulator accepts an ISO 22716 certificate in place of its own inspection is its decision, so we confirm it market by market before we scope the work.
Can we combine ISO 22716 with other standards?
Yes, where appropriate. ISO 9001 adds customer requirements, supplier evaluation and management review; halal certification builds its materials register on the specifications GMP already controls; ISO 14001 and ISO 45001 cover the environmental and worker-safety aspects ISO 22716 leaves out. Shared document control, internal audit and change control support one integrated system; each standard's own requirements still need to be addressed.
What do you need to prepare an ISO 22716 proposal?
The sites and operations to be covered, the product categories and number of lines, whether testing is in-house or contracted, approximate headcount, whether any GMP or quality system exists today, any customer or regulator requirement, and your deadline. That is enough for a scoped, all-inclusive proposal; there is no need to prepare a site master file first.
Before the first call
Prepare a useful ISO 22716 readiness brief
You do not need a site master file before the first discussion. Bring a short account of how the plant works and where the certificate should help. Seven questions are enough:
- Who has asked for GMP evidence, and which site, operations and product categories do they expect the certificate to cover? Or, if nobody has asked, what should the plant do better?
- Which product categories and how many lines are in scope, and which operations are subcontracted: manufacturing, filling, testing or storage?
- How are raw and packaging materials received, checked and released today, and how is your water tested?
- What do batch records, rejected lots, out-of-specification results or complaints tell you about the starting point?
- Which existing practices, records and laboratory arrangements already work well?
- Who can make decisions and contribute time to implementation, internal audit and staff learning?
- Is there an existing certificate, a customer audit date or an EU launch to plan around?
Use these answers to scope the work and prepare a realistic proposal. They are preparation for a discussion, not a scored assessment or a certification decision.
Don’t be fooled by certification scams
If it takes ten days, it is not ISO 22716 certification.
A GMP certificate is useful when its scope names your site and operations, its issuer can be checked and the practices behind it stand up to a brand owner's audit or a regulator's inspection. The market is full of paper: "GMP certificates" issued after a document review and no site visit, certificates from bodies nobody can verify, and consultants who promise a certificate for a plant they have never walked. They cost less, until a customer's auditor opens the batch records.
How to choose a credible ISO 22716 provider
- Ask who will issue the certificate and how you can check its current status and scope directly on the certification body's public register.
- Ask plainly whether the ISO 22716 certificate is accredited, under which body and scope, and check the answer with that body rather than relying on a logo in a quotation. An accurate "not accredited for this standard" beats a claim that fails a customer's check.
- Ask how the programme will look at actual batches, materials, laboratory results and complaints. Procedures should describe your plant, not a template with another company's name in it.
- Identify who carries each task, which premises work is yours, which assessment costs are separate, and what support exists when findings need corrective action.
- Ask what your operators will learn and what software the system will run in. No training and no system means nothing survives the consultant leaving.
- Walk away from "GMP certified in 7 to 10 days", "no site visit needed" and one invoice for consulting and certificate. Good manufacturing practices have to run through real batches before they can be audited.
Keep exploring
More on ISO 22716 and related standards
More in Consumer goods, textiles & packaging
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