What is ISO 10377:2013?
ISO 10377:2013 provides practical guidance to suppliers of consumer products on ensuring product safety throughout the entire product life cycle. It is designed to reduce the risks posed by consumer products to human health and safety by incorporating preventive and corrective measures.
The standard is applicable to all types of consumer product suppliers, including designers, manufacturers, importers, distributors, and retailers. ISO 10377 emphasizes a proactive approach to safety by identifying hazards early and implementing control measures to prevent or mitigate risks before products reach consumers.
Need support with ISO 10377 compliance or integrating product safety into your operations? Contact us at support@pacificcert.com!
Scope and Purpose of ISO 10377:2013
The purpose of ISO 10377 is to help suppliers deliver safer consumer products by embedding safety thinking from design through disposal. The standard supports a risk-based approach that complements legal and regulatory requirements across global markets. It bridges the gap between product design and real-world risks.
ISO 10377 provides guidance on:
- Hazard identification and risk assessment
- Safe product design and manufacturing controls
- Post-market surveillance and incident response
- Communication of safety information and labeling
- Continuous product safety improvement
By following ISO 10377, suppliers demonstrate due diligence, reduce the likelihood of recalls or liability and improve consumer trust.
Looking to embed ISO 10377 into your quality or compliance program? Reach out to us at support@pacificcert.com!
ISO 10377:2013 Clauses Overview
Clause | Title | Objective |
1 | Scope | Defines standard’s applicability to all stages of the product life cycle |
2 | Normative References | Lists related ISO and international safety standards |
3 | Terms and Definitions | Clarifies terminology used throughout the standard |
4 | General Principles | Introduces lifecycle safety and supplier responsibilities |
5 | Risk Assessment and Management | Details hazard identification, risk analysis, and control mechanisms |
6 | Safety in Design | Provides direction for designing safety into products |
7 | Safety in Production | Focuses on process control, material compliance, and defect prevention |
8 | Safety in the Marketplace | Covers labeling, warnings, user instructions, and safety communications |
9 | Post-Market Monitoring | Describes incident management, product recalls, and corrective actions |
Need help mapping ISO 10377 to your regulatory framework? Contact us at support@pacificcert.com.
How to Implement ISO 10377:2013 in Your Organization
Implementation starts by identifying all consumer products within your scope and evaluating where safety risks may exist. Conduct a hazard analysis on existing designs and materials, evaluate past complaints or incidents, and assess product use under expected and reasonably foreseeable misuse conditions.
Build cross-functional teams involving design, manufacturing, quality, and legal personnel to draft or revise product safety policies. Introduce controls such as failure mode analysis (FMEA), design validation testing, user instruction reviews, and post-sale feedback loops.
Train staff on product safety responsibilities and regulatory obligations. Regularly review incident reports, conduct audits, and refine safety procedures based on real-world performance.
Need implementation assistance or staff training? Contact our team at support@pacificcert.com
ISO 10377 Implementation Timeline
Week | Key Activities |
Week 1 | Identify products, regulatory obligations, and assign safety responsibilities |
Week 2 | Conduct initial hazard identification and risk assessment |
Week 3 | Develop design, manufacturing, and labeling controls |
Week 4 | Train staff and suppliers on ISO 10377 safety principles |
Week 5 | Implement controls and initiate documentation protocols |
Week 6 | Review initial effectiveness and plan for audits, monitoring, and continual review |
Want to develop a tailored roadmap for your product categories? Contact support@pacificcert.com
ISO 10377:2013 Requirements
- Hazard Identification: Examine chemical, mechanical, thermal, electrical, and choking hazards throughout the product lifecycle.
- Risk Assessment: Apply a risk-based methodology combining likelihood of occurrence with severity of potential harm.
- Design for Safety: Integrate safety into design features such as automatic shutoffs, shielding, and durable materials.
- Production Control: Use verified suppliers, inspect incoming materials, and monitor production for safety-critical steps.
- Safety Information: Ensure labels, instructions, and warnings are clear, language-appropriate, and tested for consumer understanding.
- Post-Market Surveillance: Track consumer feedback, conduct trend analysis, and initiate corrective actions or recalls as necessary.
- Documented Safety Process: Maintain written policies, procedures, risk assessments, and incident logs.
Need help setting up your product safety documentation system? Get in touch at support@pacificcert.com
Benefits of ISO 10377:2013
Adopting ISO 10377 brings numerous benefits to suppliers across the consumer product value chain:
- Enhances consumer protection by minimizing safety risks
- Demonstrates compliance with national and international safety laws
- Reduces product liability exposure and recall-related costs
- Strengthens brand reputation and consumer trust
- Facilitates access to international markets through harmonized practices
- Provides structured methods for safety validation, risk communication, and post-sale monitoring
- Improves internal collaboration between R&D, legal, quality, and customer service teams
We help suppliers establish compliant, defensible, and consumer-focused safety programs. Contact us at support@pacificcert.com
Certification Cost
ISO 10377 is often assessed as part of a supplier evaluation or integrated management system audit.
Cost depends on:
- Product range and complexity
- Existing safety controls and compliance systems
- Number of sites or suppliers involved
- Need for training, documentation, or corrective action planning
Pacific Certifications offers pre-assessment and integration support tailored to your industry. Contact support@pacificcert.com for an initial consultation.
How We Can Help – Pacific Certifications
At Pacific Certifications, we assist suppliers in building robust product safety systems aligned with ISO 10377. Our services include:
- Gap analysis and supplier audits
- Development of product safety policies and risk assessment templates
- Training for cross-functional teams on hazard control and safety reporting
- Review of packaging, warnings, and user information
- Integration of ISO 10377 with ISO 9001, ISO 45001, or ISO 14001 frameworks
We work with consumer goods brands, OEMs, distributors, and startups to meet global safety standards and protect end-users.
To explore how we can support your ISO 10377 initiative, email us at support@pacificcert.com.
FAQs: ISO 10377:2013
Is ISO 10377 certifiable?
No. It is a guideline but can be audited as part of broader system reviews or supplier qualifications.
Who should follow ISO 10377?
Manufacturers, designers, importers, brand owners, retailers, and any party involved in the supply chain.
How does it relate to legal compliance?
ISO 10377 complements legal requirements but does not replace them. It provides structured processes to meet or exceed regulatory obligations.
Can it be implemented alongside ISO 9001?
Yes. ISO 10377 aligns well with ISO 9001, especially in design control, risk management, and customer satisfaction.
Ready to get ISO 10377 certified?
Contact Pacific Certifications to begin your certification journey today!
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