ISO 10377:2013 Consumer product safety — Guidelines for suppliers provides practical guidance to suppliers on assessing and managing the safety of consumer products, including effective documentation of risk assessment and risk management to meet applicable requirements. It provides practical guidance for suppliers of all sizes to assist them in assessing and managing the safety of the consumer products they supply from the design of the product, to the input of raw materials, to production, to distribution, to retail and on to the final product end user and disposal.
The standard describes how to:
- identify, assess, reduce or eliminate hazards;
- manage risks by reducing them to tolerable levels;
- provide consumers with hazard warnings or instructions essential to the safe use or disposal of consumer products.
ISO 10377 is intended to apply to consumer products, but might also be applicable to decisions concerning safety in other product sectors.
The standard was last reviewed and confirmed in 2024; therefore, this version remains current.
What does it cover?
| Introduction |
| 1 Scope |
| 2 Terms and definitions |
| 3 Basic principles for addressing consumer product safety |
| 3.1 General |
| 3.2 Promoting a product safety culture within the organization |
| 3.3 Promoting a product safety culture outside the organization |
| 3.4 Committing to providing safe products |
| 3.5 Continual improvement |
| 3.6 Precautionary approach |
| 3.7 Sharing of information |
| 4 General requirements |
| 4.1 General |
| 4.2 Commitment to providing safe consumer products |
| 4.3 Continual improvement |
| 4.4 Applicable laws, regulation and standards |
| 4.5 Consumer product identification and traceability |
| 4.6 Understanding the role of consumers |
| 5 Safety in design |
| 5.1 General |
| 5.2 Design specification |
| 5.3 Safety considerations in design |
| 5.4 Documenting the design specification process |
| 6 Safety in production |
| 6.1 Basic principles during production |
| 6.2 Production planning |
| 6.3 Full production runs |
| 6.4 Post production |
| 6.5 Production support |
| 7 Safety in the marketplace |
| 7.1 General |
| 7.2 Pre-purchase assessment |
| 7.3 Proactive data collection and analysis |
| 7.4 Ongoing assessment of consumer product conformance |
| 7.5 Warranty and servicing |
| 7.6 Product incident investigation |
| Annex A Useful International Standards and Guides |
| Annex B Information and guidance for small businesses |
| B.1 General |
| B.2 Questions for suppliers to consider when designing, producing or supplying consumer products |
| B.3 Consumer product incident investigation |
| B.4 Planning and carrying out a focus group |
| Annex C Hazard and risk evaluation |
| Annex D Product safety management plans |
| D.1 General |
| D.2 Product safety management plan based on a quality assurance manual |
| D.3 Checklist for development of a product safety management plan |
Table of Contents for ISO 10377
What are the steps in applying ISO 10377?
ISO 10377 provides a framework for identifying, assessing, and managing risks associated with consumer products to enhance safety and reduce harm. Below are the key steps involved in claiming conformity with ISO 10377.
1. Understand the Scope and Requirements of ISO 10377
- Familiarize yourself with the standard – Study the contents of ISO 10377 to understand the core requirements and how they apply to your organization’s products and processes.
- Identify the relevant products – Determine which consumer products fall under the scope of ISO 10377 within your organization.
2. Establish a Product Safety Policy
- Develop a product safety policy aligned with ISO 10377 principles.
- Ensure that the policy is:
- Approved by top management.
- Communicated to all relevant stakeholders.
- Regularly reviewed and updated as necessary.
3. Assign Responsibility and Resources
- Designate a Product Safety Manager or equivalent to lead the product safety program.
- Establish a cross-functional team responsible for product safety, including design, production, quality assurance, and compliance.
- Ensure adequate resources (personnel, budget, training) are allocated to meet the safety objectives.
4. Risk Management and Hazard Identification
ISO 10377 emphasizes a risk-based approach to product safety:
a) Identify hazards
- Conduct a thorough risk assessment of products at all stages of the product life cycle (design, production, use, and disposal).
- Identify potential hazards (e.g., chemical, mechanical, electrical, thermal, or choking).
b) Assess risks
- Evaluate the likelihood and severity of potential harm from identified hazards.
- Prioritize risks based on their significance.
c) Implement controls
- Develop and implement controls to eliminate or reduce identified risks.
- Apply the following hierarchy of controls:
- Eliminate the hazard (design out the problem).
- Substitute the hazard with a safer alternative.
- Implement engineering controls.
- Apply administrative controls (e.g., warnings, user instructions).
5. Design and Develop Safe Products
- Incorporate safety into the product design phase.
- Follow relevant product safety regulations and standards.
- Ensure that materials and components meet safety requirements.
- Perform design verification and validation to confirm that safety requirements are met.
6. Establish and Implement a Production and Quality Control System
- Develop manufacturing processes that support product safety.
- Implement inspection and testing procedures to verify product conformity.
- Monitor and control production to ensure consistent product quality.
- Establish a traceability system to track product batches and components.
7. Communication and Labelling
- Provide clear and accurate product information, including:
- Proper usage instructions.
- Safety warnings.
- Disposal guidelines.
- Ensure that labelling complies with relevant regulations and standards.
8. Monitor and Respond to Safety Issues
a) Internal Monitoring
- Establish a system for collecting and analyzing data on product performance and safety incidents.
- Conduct regular internal audits to verify conformity with ISO 10377.
b) Customer Feedback and Complaints
- Set up a process for handling customer complaints related to product safety.
- Investigate reported issues and take corrective action where necessary.
c) Incident and Recall Management
- Develop a product recall procedure in case of a safety failure.
- Notify authorities and consumers if a recall is necessary.
- Track the effectiveness of corrective actions and update processes accordingly.
9. Training and Competence
- Provide regular training on product safety to all relevant staff.
- Ensure employees understand their roles and responsibilities related to product safety.
- Encourage a safety culture within the organization.
10. Continual Improvement
- Review the effectiveness of the product safety management system periodically.
- Identify opportunities for continual improvement based on performance data, feedback, and market trends.
- Adjust the product safety policy and procedures to address new risks or changes in regulations.
A few, final words…
Following these steps ensures that the organization:
- minimizes product safety risks;
- demonstrates conformity with ISO 10377;
- improves customer trust and satisfaction;
- reduces liability and legal exposure.
ISO 56001:2024 can be purchased through the ISO.org website.
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