ISO 22000:2018 Certification Process in Nepal is the structured procedure through which food businesses in Nepal obtain formal recognition of their Food Safety Management System (FSMS). The ISO 22000:2018 standard is an internationally recognized framework that defines the requirements for food safety management across the entire food supply chain. In Nepal, food businesses ranging from manufacturers to processors and distributors actively pursue this certification to demonstrate compliance with global food safety standards.
What is ISO 22000:2018?
ISO 22000:2018 is an international standard published by the International Organization for Standardization (ISO). It replaced ISO 22000:2005 and incorporated the High-Level Structure (HLS) common to all modern ISO management system standards. The standard integrates the principles of Hazard Analysis and Critical Control Points (HACCP) with a comprehensive food safety management system applicable to all organizations within the food chain.
Key Elements of ISO 22000:2018
ISO 22000:2018 is built on four core elements:
- Interactive communication – Across the food supply chain
- System management – Including documentation, internal audit, and management review
- Prerequisite programs (PRPs) – Basic hygiene and food safety conditions
- HACCP principles – Hazard identification and critical control point management
The standard applies to all organizations regardless of size or complexity in the food industry including food production, catering, packaging, transportation, and retail.
Why Should Nepalese Food Businesses Pursue ISO 22000:2018 Certification?
Nepalese food businesses pursue ISO 22000:2018 certification for several operational and regulatory reasons.
Market Access: Many international buyers, especially in Europe, the United States, and the Gulf Cooperation Council (GCC) countries, require suppliers to hold a valid ISO 22000:2018 certificate before entering supply agreements.
Consumer Confidence: In Nepal’s growing domestic food market, certification signals a company’s commitment to food hygiene and safety, which builds consumer trust.
Regulatory Alignment: Nepal’s food safety framework, governed by the Food Act, 2023 BS (1966 AD) and its subsequent amendments, along with the Food Rules, 2027 BS, sets out requirements for food safety that align with international standards. The Nepal Bureau of Standards and Metrology (NBSM) under the Ministry of Industry, Commerce and Supplies operates as the national standards body. NBSM coordinates with ISO and facilitates the adoption of ISO standards in Nepal.
Operational Efficiency: Implementing ISO 22000:2018 requires businesses to identify food safety hazards, document processes, and train employees, which improves overall operational performance and reduces the risk of food safety incidents.
Legal and Regulatory Framework for Food Safety in Nepal
Nepal’s food safety regulatory environment includes multiple laws and institutions that form the backbone of food safety oversight.
| Law / Regulation | Year | Administering Authority |
|---|---|---|
| Food Act (Khadya Ain) | 1966 AD (2023 BS) | Department of Food Technology and Quality Control (DFTQC) |
| Food Rules (Khadya Niyam) | 1970 AD (2027 BS) | Department of Food Technology and Quality Control (DFTQC) |
| Nepal Standards (Certification Mark) Act | 1980 AD (2037 BS) | Nepal Bureau of Standards and Metrology |
| Consumer Protection Act, 2075 | 2018 AD (2075 BS) | Department of Commerce, Supplies and Consumer Protection |
The Department of Food Technology and Quality Control (DFTQC) under the Ministry of Agriculture and Livestock Development is the primary authority that enforces food safety standards in Nepal. You can visit DFTQC’s official website for regulatory information. The NBSM functions as Nepal’s national standards body and coordinates with ISO. Visit NBSM’s official portal for standardization policies.
Although ISO 22000:2018 certification is not legally mandatory under Nepali law as of the current regulatory framework, DFTQC and NBSM actively encourage food businesses to adopt international food safety management standards.
ISO 22000:2018 Certification Process in Nepal: Step-by-Step
The ISO 22000:2018 certification process in Nepal follows a systematic procedure. Below are the steps food businesses must complete:
Step 1: Gap Analysis
The first step in the ISO 22000:2018 certification process is conducting a gap analysis. The organization assesses its existing food safety practices against the requirements of ISO 22000:2018. This analysis identifies the areas where the organization does not yet meet the standard.
- Review current food safety policies and procedures
- Compare existing HACCP plans with ISO 22000:2018 requirements
- Identify gaps in documentation, training, and infrastructure
Step 2: Training and Awareness
After identifying gaps, the organization conducts internal training. All relevant staff members receive training on ISO 22000:2018 requirements, HACCP principles, and food safety policies.
- Conduct awareness sessions for management and staff
- Train the internal audit team on ISO 22000:2018 internal audit methods
- Appoint a Food Safety Team Leader (FSTL) as required by the standard
Step 3: Develop and Implement the Food Safety Management System (FSMS)
The organization develops the FSMS documentation and implements all required procedures.
- Prepare the Food Safety Policy and Food Safety Manual
- Develop Prerequisite Programs (PRPs) as defined in ISO/TS 22002-1
- Conduct hazard analysis and develop HACCP plans
- Establish operational prerequisite programs (OPRPs)
- Set up monitoring, measurement, and verification procedures
- Implement corrective action and communication procedures
Step 4: Internal Audit
The organization conducts a full internal audit of the implemented FSMS.
- Use trained internal auditors independent of the area being audited
- Document all findings and nonconformities
- Conduct management review meeting to assess the system’s performance
Step 5: Select an Accredited Certification Body
The organization selects an ISO 22000:2018 certification body accredited by a recognized accreditation body.
In Nepal, the ISO 22000:2018 certification is issued by third-party certification bodies. These bodies are typically accredited by international accreditation bodies such as:
- United Kingdom Accreditation Service (UKAS)
- National Accreditation Board for Certification Bodies (NABCB), India
- Deutsche Akkreditierungsstelle (DAkkS), Germany
- Joint Accreditation System of Australia and New Zealand (JAS-ANZ)
Several internationally accredited certification bodies operate in Nepal or accept applications from Nepalese businesses. These include Bureau Veritas, SGS, TÜV SÜD, Intertek, and DNV, among others.
Step 6: Stage 1 Audit (Documentation Review)
The certification body conducts the Stage 1 audit. This is a desk-based review of the organization’s FSMS documentation.
- The auditor reviews the Food Safety Manual and related documents
- The auditor assesses whether the organization is ready for Stage 2
- The organization receives a Stage 1 audit report with findings
Step 7: Stage 2 Audit (On-Site Certification Audit)
The Stage 2 audit is a full on-site audit of the implemented FSMS.
- Auditors visit the facility and assess actual food safety practices
- They verify whether the organization has implemented the FSMS as documented
- They review HACCP plans, PRPs, OPRPs, and monitoring records
- Nonconformities identified are classified as major or minor
Step 8: Corrective Action and Certificate Issuance
The organization addresses all nonconformities found during Stage 2 audit.
- Submit corrective action plans with evidence to the certification body
- The certification body reviews corrective actions
- Upon satisfactory closure, the certification body issues the ISO 22000:2018 certificate
Step 9: Surveillance Audits and Re-Certification
The ISO 22000:2018 certificate is valid for three years. The certification body conducts annual surveillance audits to verify continued compliance. After three years, the organization undergoes a full re-certification audit.
Documents Required for ISO 22000:2018 Certification in Nepal
Organizations must prepare the following documents to complete the ISO 22000:2018 certification process:
- Food Safety Policy and Objectives
- Food Safety Manual
- Scope of the FSMS
- Organizational chart and food safety team structure
- Hazard Analysis and HACCP Plan
- Prerequisite Programs (PRPs) documentation
- Operational Prerequisite Programs (OPRPs)
- Process flow diagrams and product descriptions
- Internal audit reports and management review minutes
- Corrective action records
- Supplier evaluation and communication records
- Monitoring and measurement records
- Calibration records for measuring equipment
- Training records for all food safety team members
Cost and Timeline of ISO 22000:2018 Certification in Nepal
The cost and timeline vary depending on the organization’s size, complexity, and the certification body selected.
| Factor | Small Organization | Medium Organization | Large Organization |
|---|---|---|---|
| Gap Analysis & Consultancy | NPR 50,000 – 1,00,000 | NPR 1,00,000 – 3,00,000 | NPR 3,00,000 – 6,00,000 |
| Certification Body Fees | NPR 1,50,000 – 3,00,000 | NPR 3,00,000 – 5,00,000 | NPR 5,00,000 – 10,00,000 |
| Training Costs | NPR 20,000 – 50,000 | NPR 50,000 – 1,00,000 | NPR 1,00,000 – 3,00,000 |
| Estimated Timeline | 3 – 6 months | 6 – 9 months | 9 – 12 months |
Note: These are approximate figures and vary across certification bodies and organizations.
Role of NBSM and DFTQC in ISO 22000:2018 Certification
The Nepal Bureau of Standards and Metrology (NBSM) serves as Nepal’s ISO member body. It participates in ISO technical committees and adopts ISO standards as Nepal Standards (NS). NBSM does not itself issue ISO 22000:2018 certificates but supports the national standardization ecosystem.
The Department of Food Technology and Quality Control (DFTQC) provides technical guidance on food safety management for Nepali businesses. DFTQC also issues food registration certificates and conducts food inspections under the Food Act, 1966. Food businesses seeking ISO 22000:2018 certification must also ensure compliance with DFTQC registration requirements.
Challenges in ISO 22000:2018 Certification for Nepalese Businesses
Food businesses in Nepal face several challenges during the ISO 22000:2018 certification process:
- Limited awareness of FSMS requirements among small and medium food enterprises
- Documentation burden due to the extensive records required by the standard
- Cost constraints especially for small food processors in rural Nepal
- Absence of local accredited certification bodies requiring businesses to engage international bodies with higher fees
- Infrastructure gaps such as inadequate cold chain facilities and laboratory testing capacity
FAQs
1. Is ISO 22000:2018 certification mandatory for food businesses in Nepal?
No, ISO 22000:2018 certification is not legally mandatory under Nepal’s Food Act or Food Rules. However, DFTQC and NBSM encourage food businesses to adopt this standard. Many export-oriented food companies pursue it to meet international buyer requirements.
2. Which authority issues ISO 22000:2018 certificates in Nepal?
ISO 22000:2018 certificates are issued by third-party certification bodies accredited by recognized international accreditation bodies. NBSM does not directly issue ISO 22000:2018 certificates. Organizations select from internationally accredited certifiers like SGS, Bureau Veritas, or TÜV SÜD.
3. How long is the ISO 22000:2018 certificate valid in Nepal?
The ISO 22000:2018 certificate is valid for three years from the date of issuance. The certification body conducts annual surveillance audits during this period. After three years, the organization must complete a full re-certification audit to maintain certification.
4. What is the difference between ISO 22000:2018 and HACCP?
HACCP is a food safety tool focused on identifying and controlling hazards. ISO 22000:2018 is a comprehensive management system standard that incorporates HACCP principles along with PRPs, management commitment, communication, and continual improvement requirements within a structured FSMS framework.
5. How much does ISO 22000:2018 certification cost in Nepal?
The cost varies by organization size. Small food businesses may spend NPR 2,00,000 to 4,50,000 in total including consultancy, training, and certification fees. Larger organizations may spend NPR 9,00,000 or more. Costs depend on the certification body selected and scope of certification.
6. Can DFTQC help Nepali businesses obtain ISO 22000:2018 certification?
DFTQC provides technical support and capacity building for food safety practices in Nepal. It does not directly grant ISO 22000:2018 certificates. Businesses should contact DFTQC at www.dftqc.gov.np for guidance on food safety compliance alongside ISO certification.
Conclusion
The ISO 22000:2018 Certification Process in Nepal requires food businesses to develop a robust Food Safety Management System, undergo rigorous internal and external audits, and work with accredited third-party certification bodies. With Nepal’s food export sector growing and domestic food safety awareness rising, ISO 22000:2018 certification offers Nepalese food businesses a structured and globally recognized path to demonstrate food safety excellence. Organizations should engage with NBSM and DFTQC for regulatory alignment while working with internationally accredited certification bodies to complete the certification process efficiently.
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