ISO 10377 / 10393 · Consumer product safety and recalls
ISO 10377 and ISO 10393 consumer product safety and recall guidance for products you can stand behind.
Build product safety into design and supply, and be ready if a product has to come back, with a Sterling consultant who works through both ISO guidelines with your team. We help our clients put it into practice and prove it.
- 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 consultants, working across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Neither guideline is certifiable; where certification is wanted, an accredited body audits a related standard such as ISO 9001
8,100+ client engagements in 60+ countries.
Sterling client experience
What it is
What are ISO 10377 and ISO 10393?
ISO 10377 and ISO 10393 are companion ISO guidelines for suppliers of consumer products, both published in April 2013. ISO 10377, Consumer product safety — Guidelines for suppliers, gives practical direction on assessing and managing the safety of a product before it reaches the consumer. ISO 10393, Consumer product recall — Guidelines for suppliers, covers what happens after a product has left the manufacturing facility, when a recall or another corrective action is needed.
Both are guidance documents: they say what good practice looks like, and nobody is certified against them. ISO notes that ISO 10393, although written for consumer products, may also be applied in other sectors.
Current editions. ISO 10377:2013 was reviewed and confirmed on 5 August 2024, and ISO 10393:2013 on 15 August 2025. iso.org shows no replacement for either.
Who it is for
Who uses ISO 10377 and ISO 10393?
Suppliers of consumer products, whether they design, make, import or sell them, turn to these guidelines at three moments:
- A retailer or brand asks how you manage product safety. You need a documented, repeatable way to identify hazards and decide what is safe enough.
- You have never rehearsed a recall. Nobody knows who decides, who tells customers or how products are traced.
- An incident or complaint has exposed a gap. You want the lessons built into design, suppliers and after-sales, not only fixed once.
The benefit is fewer unsafe products reaching consumers and a faster, calmer response when one does.
Requirements
What do ISO 10377 and ISO 10393 cover?
ISO describes the scope of the two guidelines in these terms. They are guidance, so the list is a map of good practice rather than audit criteria.
- ISO 10377, hazards: identifying, assessing, and reducing or eliminating hazards
- ISO 10377, risk: managing risks by reducing them to tolerable levels
- ISO 10377, consumer information: hazard warnings and instructions for safe use or disposal
- ISO 10377, documentation: recording risk work so that applicable requirements can be shown to be met
- ISO 10393, recall: recalls and other corrective actions after the product has left the manufacturing facility
- ISO 10393, corrective actions: refunds, retrofit, repair, replacement, disposal and public notification
What does useful ISO 10377 / 10393 evidence look like?
Product risk assessments linked to design changes, supplier test results, approved warnings and instructions, traceability records by batch, a recall plan with named roles, and a record of the last recall exercise. We help you keep these as working records, so they are ready the day they are needed.
Your engagement
What your ISO 10377 / 10393 engagement includes
There is no ISO 10377 or ISO 10393 certificate, so your agreed scope turns the guidance into procedures your team runs. Where you want third-party certification, we build product safety and recall into an ISO 9001 quality management system, which an independent, accredited certification body audits; Sterling does not certify.
Scope, gap assessment and plan
Against both guidelines, with owners, dates and decision makers agreed before work starts.
Product safety and recall procedures
Risk assessment, warnings, traceability and recall steps written with your product and quality teams.
Effivity ISO & GRC software
Risks, incidents, complaints and corrective actions in one workspace, included with the engagement at no additional cost.
Training for everyone
Workshops for design, sourcing and customer service teams, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Recall exercise
A mock recall run with your team, with lessons closed out.
Certification support where chosen
Readiness for ISO 9001 certification when it is part of the agreed scope.
Where certification to a related standard is in scope, the certification decision remains with the independent certification body.
Often combined with
Standards organisations pair with ISO 10377 / 10393
- 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.
- CE markingCE marking compliance support for manufacturers: EU rules, technical files, declaration of conformity and quality systems.
- EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
- EN 71 / ASTM F963EN 71 and ASTM F963 toy safety compliance for manufacturers: product and market mapping, material control, test planning and records that keep lots conforming.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify product safety and recall work.
Every Sterling ISO 10377 / 10393 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so documents, risks, audits, nonconformities, complaints, supplier evaluations, training records and management review live in one place, the system runs in daily work and your customer or auditor reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Context, scope and interested parties
The scope statement, the internal and external issues and the interested parties are kept in one register and reviewed on a schedule, so the context stays current as the business changes instead of being rewritten before each audit.
Quality policy, roles and objectives
The policy, the responsibilities and the quality objectives with their measures, owners and dates live where the people who own them work; progress is reported from the system, not from a separate spreadsheet.
Risks and opportunities
A risk and opportunity register with owners, actions and review dates; treatments tracked to closure and brought to management review automatically.
Competence, awareness and documented information
Training and competence records for every person, linked to Sterling Academy; documents with versions, approvals and distribution, so the current version is the only one in use.
Customer requirements, design, suppliers and delivery
Requirement reviews, design controls where they apply, supplier evaluation, production or service delivery, inspection, release, calibration and maintenance, each with its record created as the work is done.
Monitoring, internal audit and management review
Audit programmes, findings and follow-up; customer satisfaction and KPIs on live dashboards; a management review that records its inputs, decisions and actions.
Nonconformity, complaints and corrective action
Raised, investigated and closed with root cause and the evidence that the action worked; recurring issues visible to management before they become a finding.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how you work, without code; legal and customer requirements tracked to the processes they affect.
What this means when something goes wrong
A complaint arrives about a product in the market. In Effivity the risk assessment, the batch records, the supplier results and the recall plan are screens with dates and owners, not files somebody has to find. After the event, Sustain™ keeps the corrective actions and lessons in the same workspace.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for EMS, OHSMS, ISMS, FSMS and more when you integrate other standards
Sterling Academy · ISO 10377 / 10393 e-learning
Train every employee on ISO 10377 / 10393, 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 10377 / 10393 awareness for every employee, with a record of who completed it
- Practitioner learning for product managers, sourcing and the quality 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 your customer or auditor
- New hires trained as they arrive, so evidence stays current
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about ISO 10377 / 10393
ISO 10377 / 10393 resources
Services for ISO 10377 / 10393
Why Sterling
Want to put ISO 10377 and ISO 10393 into practice? Come to Sterling.
Whether you make one product line or source from suppliers in several countries, Sterling helps you build product safety and recall readiness into the way the business already works.
60+ countries since 2003
Quality and product compliance systems implemented for manufacturers, importers and retailers across every region we serve, with one engagement team accountable across every site.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with any certification-body fees identified separately. No surprises, ever.
A system your people can use
Less documentation and maximum effectiveness: documents, training and software connected to day-to-day operations, so your people adopt the system rather than tolerate it.
Expert and experienced consultants
Consultants who have advised on quality and risk management systems across sectors and countries since 2003, and who build your product safety controls properly the first time.
The Sterling Promise
What the Sterling Promise means for your product safety programme
We stay with you until your agreed ISO 10377 and ISO 10393 outcome is achieved, supporting implementation, the recall exercise and the closure of gaps. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the guidelines, scope, outcome and responsibilities. Your organisation supplies accurate information and puts the agreed controls into use. No certificate exists for either guideline; where ISO 9001 certification is in scope, the independent certification body retains its decision. Our commitment concerns the agreed support, not a promise that no product will ever fail.
FAQs
Frequently asked questions about ISO 10377 / 10393
Can we get certified to ISO 10377?
No. ISO 10377 and ISO 10393 are guidelines, so there is nothing to certify against. Organisations that want an audited system usually build the guidance into ISO 9001 and seek certification to that standard.
Are ISO 10377 and ISO 10393 still current?
Yes. iso.org shows ISO 10377:2013 confirmed in August 2024 and ISO 10393:2013 confirmed in August 2025, with no replacement listed for either.
Does ISO 10393 apply outside consumer products?
It can. ISO states that ISO 10393 is written for consumer products but may also be applied in other sectors, so the recall steps suit many business-to-business suppliers too.
Keep exploring
More on ISO 10377 / 10393 and related standards
More in Consumer goods, textiles & packaging
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