ISO 22000:2018 Certification Process in Nepal

8 Mins Exclusive Read: Contact Us for Legal, Tax & All Corporate Advisory Services.

For All Queries: info@taxconsultantnepal.com

ISO 22000:2018 is an internationally recognized food safety management system standard that helps organizations in the food industry ensure the safety of their products. In Nepal, obtaining ISO 22000:2018 certification has become increasingly important for food businesses looking to enhance their credibility, access international markets, and demonstrate their commitment to food safety. This comprehensive guide explores the certification process, requirements, benefits, and challenges for Nepalese food businesses seeking ISO 22000:2018 certification.

Understanding ISO 22000:2018 Standard

What is ISO 22000:2018?

ISO 22000:2018 is an international standard that specifies requirements for a food safety management system (FSMS). It integrates the principles of Hazard Analysis and Critical Control Points (HACCP) with prerequisite programs and other food safety management practices. The standard was updated in 2018 to align with other ISO management system standards and to address emerging food safety challenges. For Nepalese food businesses, implementing ISO 22000:2018 means adopting a systematic approach to identifying, preventing, and controlling food safety hazards throughout the food supply chain.

Key Components of ISO 22000:2018

The ISO 22000:2018 standard comprises several key components that organizations must implement:

High-level structure (HLS) alignment with other ISO management standards
Risk-based thinking at both operational and strategic levels
Stronger emphasis on leadership and management commitment
Process approach to food safety management
PDCA (Plan-Do-Check-Act) cycle for continuous improvement
Hazard control plan incorporating HACCP principles
Management of externally provided processes, products, and services

These components work together to create a comprehensive framework for managing food safety risks in Nepalese food businesses, from small local producers to large manufacturing facilities.

Differences Between ISO 22000:2018 and Previous Versions

The 2018 version of ISO 22000 introduced several significant changes from its predecessor:

Adoption of the High-Level Structure (HLS) for better integration with other management systems
Enhanced focus on business context and stakeholder needs
Stronger risk-based approach at both operational and business levels
Clearer distinction between different types of control measures
Improved clarity on the PDCA cycle applied at different levels
More explicit requirements for leadership and commitment

For Nepalese organizations that were certified to the previous version, understanding these differences is crucial for a successful transition to the 2018 standard.

Benefits of ISO 22000:2018 Certification in Nepal

Market Access and Competitive Advantage

ISO 22000:2018 certification provides Nepalese food businesses with significant market advantages. It opens doors to international markets where food safety certification is often a prerequisite for entry. Many global retailers and food service companies require their suppliers to have recognized food safety certifications. For Nepalese exporters of tea, spices, processed foods, and other agricultural products, ISO 22000:2018 certification can be the key to accessing lucrative markets in Europe, North America, and Asia. Domestically, certification gives businesses a competitive edge, allowing them to differentiate themselves from non-certified competitors and potentially command premium prices for their products.

Regulatory Compliance and Risk Reduction

Implementing ISO 22000:2018 helps Nepalese food businesses comply with both national and international food safety regulations. Nepal’s Food Act and Food Rules establish basic requirements for food safety, but ISO 22000:2018 provides a more comprehensive framework that often exceeds regulatory minimums. By implementing the standard, organizations can systematically identify and control food safety hazards, reducing the risk of foodborne illness outbreaks, product recalls, and regulatory penalties. This proactive approach to food safety management protects both consumers and the business itself from the potentially devastating consequences of food safety failures.

Operational Efficiency and Cost Savings

While implementing ISO 22000:2018 requires initial investment, it often leads to significant operational improvements and cost savings over time. The systematic approach to food safety management helps Nepalese businesses:

Reduce waste and product losses
Minimize the risk of expensive product recalls
Improve production efficiency through standardized processes
Decrease customer complaints and returns
Lower insurance premiums due to reduced risks
Optimize resource allocation for food safety controls

Many certified organizations in Nepal report that these efficiency gains and cost savings ultimately outweigh the costs of implementation and certification maintenance.

Enhanced Stakeholder Confidence

ISO 22000:2018 certification builds trust among all stakeholders in the food supply chain. Consumers increasingly seek assurance about the safety of the foods they purchase, especially in the wake of high-profile food safety incidents. Certification demonstrates to consumers, business partners, regulators, and investors that a Nepalese food business is committed to food safety and follows internationally recognized best practices. This enhanced confidence can lead to stronger business relationships, customer loyalty, and positive brand reputation in both domestic and international markets.

Prerequisites for ISO 22000:2018 Certification

Legal and Regulatory Requirements in Nepal

Before pursuing ISO 22000:2018 certification, Nepalese food businesses must ensure compliance with national legal requirements. These include:

Registration with the Department of Food Technology and Quality Control (DFTQC)
Compliance with Nepal’s Food Act 2023 (1966) and Food Rules 2027 (1970)
Obtaining necessary licenses and permits for food production and processing
Meeting specific regulatory requirements for particular food categories
Compliance with labeling and packaging regulations
Adherence to environmental and occupational health and safety regulations

Non-compliance with these basic legal requirements can be a significant obstacle to achieving ISO certification. TCN can assist organizations in conducting a comprehensive legal compliance assessment as a first step in the certification journey.

Organizational Readiness Assessment

Before embarking on the ISO 22000:2018 certification process, Nepalese organizations should conduct a thorough readiness assessment to:

Evaluate current food safety management practices against ISO 22000:2018 requirements
Identify gaps and areas requiring improvement
Assess resource availability (human, financial, technological)
Determine the level of management commitment and staff awareness
Review existing documentation and record-keeping systems
Evaluate the organization’s food safety culture

This assessment helps organizations understand the scope of work required and develop a realistic implementation plan. Many Nepalese organizations find it beneficial to engage experienced consultants like TCN for this initial assessment to gain an objective perspective on their readiness.

Resource Requirements

Implementing ISO 22000:2018 requires adequate resources, including:

Trained personnel with food safety knowledge and skills
Financial resources for system development, training, and certification
Appropriate infrastructure and equipment for food safety controls
Testing and monitoring equipment for verification activities
Information systems for documentation and record management
External expertise (consultants) if internal capabilities are limited

Nepalese organizations, particularly small and medium-sized enterprises (SMEs), should carefully assess these resource requirements and plan accordingly. Government programs and industry associations sometimes offer support to help businesses meet these requirements.

Step-by-Step ISO 22000:2018 Certification Process

Preparation and Planning Phase

Step 1: Secure management commitment and establish a food safety team. Top management must demonstrate commitment by providing necessary resources, defining food safety policy, and establishing clear objectives. Form a cross-functional food safety team led by a qualified food safety team leader.

Step 2: Conduct gap analysis. Compare current practices against ISO 22000:2018 requirements to identify gaps. This assessment forms the basis for implementation planning.

Step 3: Develop implementation plan. Create a detailed plan with timelines, responsibilities, and resource allocations for addressing identified gaps and implementing the standard’s requirements.

Step 4: Train key personnel. Provide appropriate training on ISO 22000:2018 requirements, HACCP principles, and food safety management to the food safety team and other relevant staff.

Implementation Phase

Step 5: Define scope and food safety policy. Clearly define the scope of the food safety management system and develop a food safety policy aligned with organizational objectives.

Step 6: Document required information. Develop necessary documentation including procedures, work instructions, forms, and records as required by the standard.

Step 7: Implement prerequisite programs (PRPs). Establish and implement basic hygiene and operational conditions necessary for producing safe food, such as:

Good Manufacturing Practices (GMP)
Good Hygiene Practices (GHP)
Pest control programs
Cleaning and sanitation procedures
Personnel hygiene requirements
Allergen management
Waste management

Step 8: Conduct hazard analysis. Identify and evaluate food safety hazards (biological, chemical, physical) that may occur in products or processes within the scope.

Step 9: Establish hazard control plan. Develop and implement a plan to control identified significant hazards, including critical control points (CCPs), operational prerequisite programs (oPRPs), and their monitoring systems.

Step 10: Implement operational processes. Put into practice all planned processes for food safety management, including traceability systems, product recall procedures, and nonconformity handling.

Verification and Validation Phase

Step 11: Conduct internal audits. Perform systematic internal audits to verify that the FSMS conforms to planned arrangements and ISO 22000:2018 requirements.

Step 12: Verify monitoring and measuring. Ensure that monitoring and measuring equipment and methods provide accurate results.

Step 13: Validate control measures. Confirm that control measures are capable of achieving intended control of food safety hazards.

Step 14: Conduct management review. Top management should review the FSMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.

Certification Phase

Step 15: Select certification body. Choose an accredited certification body recognized in Nepal. Options include international bodies operating in Nepal and the Nepal Bureau of Standards and Metrology (NBSM).

Step 16: Submit application. Complete and submit the application form with required documentation to the selected certification body.

Step 17: Undergo document review. The certification body reviews documentation to assess compliance with standard requirements.

Step 18: Undergo stage 1 audit. Auditors assess the organization’s readiness for certification by reviewing documentation, evaluating site-specific conditions, and determining preparedness for stage 2.

Step 19: Address stage 1 findings. Correct any nonconformities or areas of concern identified during the stage 1 audit.

Step 20: Undergo stage 2 audit. Auditors conduct a comprehensive on-site assessment to evaluate the implementation and effectiveness of the FSMS.

Step 21: Address nonconformities. Develop and implement corrective actions for any nonconformities identified during the stage 2 audit.

Step 22: Receive certification decision. The certification body reviews audit findings and makes a certification decision.

Step 23: Obtain ISO 22000:2018 certificate. If successful, receive the certificate, typically valid for three years.

Challenges and Solutions in the Certification Process

Common Obstacles for Nepalese Organizations

Nepalese food businesses often face several challenges when implementing ISO 22000:2018:

Limited awareness and understanding of the standard’s requirements
Inadequate technical expertise in food safety management
Resource constraints, particularly for small and medium enterprises
Difficulty in maintaining comprehensive documentation
Challenges in implementing prerequisite programs due to infrastructure limitations
Cultural resistance to change and new practices
Limited availability of accredited testing facilities
Inconsistent enforcement of food safety regulations

These challenges can make the certification process more difficult, but they are not insurmountable with proper planning and support.

Practical Solutions and Best Practices

To overcome these challenges, Nepalese organizations can adopt several strategies:

Phased implementation approach: Break down the implementation into manageable phases rather than attempting to implement everything simultaneously.
Leverage external expertise: Engage qualified consultants like TCN with experience in ISO 22000:2018 implementation in the Nepalese context.
Utilize available resources: Take advantage of guidance materials, templates, and training programs offered by certification bodies, industry associations, and government agencies.
Focus on food safety culture: Build awareness and commitment at all levels of the organization through regular communication and training.
Simplify documentation: Develop a documentation system that meets requirements without creating unnecessary bureaucracy.
Collaborate with industry peers: Share experiences and best practices with other organizations in similar sectors.
Seek government support: Explore support programs offered by agencies like the Nepal Bureau of Standards and Metrology (NBSM) and Department of Food Technology and Quality Control (DFTQC).
Integrate with existing systems: Build on existing quality management systems rather than creating entirely new processes.

Maintaining ISO 22000:2018 Certification

Surveillance Audits and Recertification

After initial certification, Nepalese organizations must maintain their ISO 22000:2018 certification through:

Surveillance audits: Conducted at least annually by the certification body to verify continued compliance with the standard. These audits typically cover selected parts of the standard rather than the entire system.
Recertification audit: A comprehensive audit conducted every three years before certificate expiration to renew certification for another three-year period.

Organizations should prepare for these audits by conducting regular internal audits, addressing any nonconformities promptly, and continuously improving their food safety management system.

Continuous Improvement Practices

ISO 22000:2018 emphasizes continuous improvement as a key principle. Nepalese organizations can maintain and enhance their food safety management systems through:

Regular review and updating of hazard analyses and control measures
Monitoring of key performance indicators related to food safety
Analysis of audit findings, customer feedback, and nonconformities
Implementation of corrective and preventive actions
Regular management reviews to identify improvement opportunities
Staying updated on changes in food safety regulations and standards
Benchmarking against industry best practices
Investing in ongoing training and competence development

By embedding continuous improvement in their organizational culture, Nepalese food businesses can not only maintain certification but also realize increasing benefits from their food safety management system over time.

Handling Changes and Updates

Food businesses must effectively manage changes that may impact food safety, such as:

New products or processes
Changes in raw materials or suppliers
Modifications to equipment or facilities
Organizational changes
Updates to food safety regulations
Revisions to the ISO 22000 standard itself

A formal change management process should be established to evaluate potential impacts on food safety before implementing changes. This includes updating hazard analyses, control measures, and documentation as needed.

Conclusion

ISO 22000:2018 certification represents a significant achievement for Nepalese food businesses, demonstrating their commitment to food safety and international best practices. While the certification process requires substantial effort and resources, the benefits in terms of market access, risk reduction, operational efficiency, and stakeholder confidence make it a worthwhile investment. By understanding the certification process, preparing adequately, and addressing challenges proactively, Nepalese organizations can successfully implement ISO 22000:2018 and contribute to raising food safety standards across Nepal’s food industry.

For organizations seeking guidance and support in their ISO 22000:2018 certification journey, TCN offers comprehensive consulting services tailored to the unique needs and challenges of the Nepalese food sector. With expert knowledge of both international standards and local regulatory requirements, TCN can help streamline the certification process and maximize the benefits of ISO 22000:2018 implementation.

OUR CAPABILITIES