Export Quality Standards — ISO, FSSAI, BIS, CE Marking, and FDA Guide

Quality standards are the gatekeepers of international trade. You can have the best product, the most competitive price, and a willing buyer — but if your goods do not meet the quality and safety standards required by the destination country, they will be rejected at the border. In some cases, destroyed at your cost. In the worst cases, your company gets blacklisted from future shipments.

The challenge for Indian MSME exporters is that quality standards are fragmented. There are Indian standards you must meet before goods leave the country, international standards that buyers demand as a baseline, and destination-country standards that vary market to market. This guide covers every relevant quality standard and certification — what each one is, who needs it, how to get it, what it costs, and the mistakes that trip up first-time exporters.

Why Quality Standards Matter in Exports

Quality certifications are not just bureaucratic requirements. They serve four concrete functions in export trade:

Market access. Many countries legally require specific certifications before goods can enter. You cannot sell food products in the EU without meeting EU food safety regulations. You cannot sell electronics in the EU without CE marking. No certification means no access — regardless of product quality.

Buyer requirement. Even when certifications are not legally mandatory, major buyers — supermarket chains, industrial distributors, e-commerce platforms — require them as a condition of purchase. A European retailer will not stock your products without ISO 9001 or equivalent quality management certification. It is simply a non-negotiable filter in their vendor selection process.

Regulatory compliance. Getting caught selling non-compliant goods in a foreign market can result in product recalls, import bans, lawsuits, and reputational damage that takes years to recover from. Standards compliance is your insurance policy.

Competitive advantage. Among Indian exporters competing for the same buyer, the one with stronger certifications wins. ISO 9001, FSSC 22000, SA 8000 — these certifications tell the buyer that you take quality seriously and that working with you carries lower risk.

International Standards

ISO 9001 — Quality Management System

ISO 9001 is the most widely recognised quality management standard in the world. It does not certify your product — it certifies your management system. It says that your organisation has documented processes for quality control, customer satisfaction, continuous improvement, and corrective action.

Who needs it: Virtually every exporter benefits from ISO 9001. It is especially important for manufacturers exporting to Europe, North America, Japan, and Australia. Many international tenders and buyer qualification processes list ISO 9001 as a mandatory requirement.

What it covers:

• Quality management system documentation
• Management responsibility and commitment
• Resource management (people, infrastructure, work environment)
• Product realisation process — from design to delivery
• Measurement, analysis, and improvement

Certification process:

Step	What Happens	Timeline
Gap analysis	Consultant assesses your current processes against ISO 9001 requirements	1-2 weeks
Documentation	Develop quality manual, SOPs, work instructions, forms	4-8 weeks
Implementation	Implement the documented processes, train staff	4-8 weeks
Internal audit	Your trained internal auditors audit the system	1-2 weeks
Management review	Top management reviews audit findings and system effectiveness	1 day
Stage 1 audit	Certification body reviews documentation (desk audit)	1-2 days
Stage 2 audit	Certification body audits implementation on-site	2-4 days
Certification	Certificate issued if no major non-conformities	2-4 weeks after audit

Costs:

Item	Cost Range
Consultant fees (gap analysis + documentation + implementation support)	Rs 50,000 - 1,50,000
Certification body audit fees	Rs 40,000 - 1,00,000
Annual surveillance audit (years 2 and 3)	Rs 25,000 - 60,000 per year
Recertification (every 3 years)	Rs 40,000 - 1,00,000
Total first-year cost	Rs 90,000 - 2,50,000

Costs vary based on your company size, number of employees, and which certification body you choose. Accredited certification bodies include Bureau Veritas, TUV, SGS, DNV, BSI, and URS.

Validity: 3 years, with annual surveillance audits in years 2 and 3.

ISO 22000 / FSSC 22000 — Food Safety Management System

If you export food products, ISO 22000 (or its more rigorous version, FSSC 22000) is the standard buyers expect. It combines ISO management system principles with HACCP (Hazard Analysis and Critical Control Points) food safety methodology.

Who needs it: All food exporters — processed food, spices, rice, tea, coffee, dairy, meat, seafood. If the buyer is a major food retailer, FSSC 22000 is typically required over basic ISO 22000. FSSC 22000 is benchmarked by GFSI (Global Food Safety Initiative), making it accepted by Walmart, Tesco, Carrefour, and virtually all major global retailers.

Certification process: Similar to ISO 9001 but with additional HACCP plans, allergen management, traceability, and hygiene controls. Expect 6-12 months from gap analysis to certification.

Costs: Rs 1,50,000 - 4,00,000 for first-year certification, depending on operations size and complexity.

ISO 14001 — Environmental Management System

ISO 14001 certifies that your organisation manages its environmental impact systematically. Increasingly required by European buyers, especially for chemicals, textiles (dyeing/finishing), leather, plastics, and metals. Costs Rs 80,000 - 2,00,000 for first-year certification — often obtained alongside ISO 9001 in an integrated audit, which reduces total costs.

SA 8000 / SEDEX / BSCI — Social Compliance

Social compliance audits verify that your factory meets ethical labour standards — no child labour, fair wages, reasonable working hours, safe conditions, and no discrimination.

Who needs it: Exporters of apparel, textiles, footwear, handicrafts, and any labour-intensive products — especially when selling to European and North American buyers. Major fashion brands and retailers (H&M, Zara, Primark, Nike, Walmart) require social compliance audits as a condition of doing business.

Standard	Description	Cost Range
SA 8000	Full certification — most rigorous, covers 9 elements of social accountability	Rs 1,50,000 - 3,50,000
SEDEX/SMETA	Audit-based (not certification) — SMETA 4-pillar audit covers labour, health & safety, environment, business ethics	Rs 50,000 - 1,50,000 per audit
BSCI	Audit-based — used primarily by European retail associations	Rs 40,000 - 1,00,000 per audit

Buyers expect annual or biennial audits and may send their own auditors in addition to third-party audits. Build this into your ongoing cost structure.

Indian Standards and Certifications

FSSAI License — Food Safety and Standards Authority of India

FSSAI licensing is mandatory for all food businesses in India, including food exporters. Without an FSSAI license, you cannot legally manufacture, store, distribute, or export food products from India.

Types of FSSAI registration/license:

Type	Applicable To	Annual Turnover	Fee
Basic Registration	Small food businesses, petty manufacturers	Up to Rs 12 lakh	Rs 100 per year
State License	Medium food businesses	Rs 12 lakh - 20 crore	Rs 2,000 - 5,000 per year
Central License	Large manufacturers, exporters, importers, 100% EOUs	Above Rs 20 crore, or any exporter/importer	Rs 7,500 per year

For exporters: You need a Central FSSAI License regardless of your turnover. The moment you export food products, you fall under central licensing requirements.

Application process:

1. Visit the FSSAI portal at foscos.fssai.gov.in
2. Register and fill in Form B (for state/central license)
3. Upload documents — identity proof, address proof, food safety management plan, list of food products, NOC from local authority, lab test reports
4. Pay the applicable fee
5. Inspection by FSSAI designated officer (for central license)
6. License issued — valid for 1-5 years (you choose the duration)

Timeline: 30-60 days from application to license issuance, assuming all documents are in order and the inspection goes smoothly.

Key requirement: Your FSSAI license number must be printed on all food product packaging. Buyers and destination country authorities verify this.

BIS — Bureau of Indian Standards

The Bureau of Indian Standards administers the ISI mark certification scheme. For certain product categories, BIS certification is mandatory before the product can be sold domestically or exported.

Mandatory BIS certification products (relevant to exporters):

• Cement and cement products
• Electrical equipment — wires, cables, switches, plugs
• Steel and steel products
• Electronics — certain IT and telecom products
• Household appliances
• Packaged drinking water and bottled water
• LPG cylinders and regulators

How to get BIS certification:

1. Apply on the BIS portal (manakonline.bis.gov.in)
2. BIS audits your manufacturing facility
3. Product samples are tested at BIS-recognised laboratories
4. If the facility and products meet the Indian Standard, the ISI mark license is granted
5. BIS conducts periodic surveillance — factory visits and market sample testing

Costs: Rs 1,000 application fee + testing charges (vary by product, typically Rs 5,000 - 50,000) + annual marking fee based on production volume.

Even if BIS is not mandatory for your export product, having ISI certification adds credibility with international buyers.

EIC — Export Inspection Council

The Export Inspection Council operates under the Ministry of Commerce and maintains a system of compulsory pre-shipment inspection for certain product categories. If your product falls under the EIC's mandatory inspection list, no shipment can leave India without an EIC inspection certificate.

Products requiring mandatory EIC inspection:

• Fish and fish products (for certain destinations)
• Dairy products
• Egg and egg products
• Meat and meat products
• Poultry products
• Honey
• Basmati rice (for certain destinations)
• Black pepper (for certain destinations)
• Crushed bones and bone products

How it works:

1. Register with the Export Inspection Agency (EIA) — the field arm of EIC
2. Get your facility approved through an EIA inspection
3. For each export consignment, apply for inspection through the EIA office in your region
4. EIA inspector examines the goods and draws samples for testing
5. If the goods meet the applicable standards, an inspection certificate is issued
6. This certificate must accompany the shipping documents

Costs: Inspection fees vary by product and consignment size — typically Rs 1,000 - 10,000 per consignment.

Spices Board Certification

If you export spices, registration with the Spices Board of India is mandatory. The Spices Board regulates the export of 52 spices listed under the Spices Board Act.

Registration process:

1. Apply online at indianspices.com (Spices Board portal)
2. Submit IEC copy, FSSAI license, factory address proof, and product details
3. Spices Board issues the Certificate of Registration
4. Register each buyer and destination for your spice exports

Quality requirements: The Spices Board sets minimum quality standards for export. Spices are tested for aflatoxin levels, pesticide residues, moisture content, extraneous matter, and microbiological contamination. Consignments that fail testing are not allowed to be exported.

APEDA TraceNet — Organic Food Exports

If you export organic food products, APEDA's TraceNet system provides traceability certification recognised by importing countries, particularly the EU. Register on the TraceNet portal (apeda.gov.in/tracenet), where your NPOP-accredited certification body uploads farm and processing details. Each consignment is traced from farm to port, and TraceNet issues a Transaction Certificate required for organic food exports under the India-EU organic equivalence arrangement.

Destination-Country Standards

This is where things get complex. Each importing country has its own regulatory framework, and the standards you need depend on where you are shipping.

EU — CE Marking

CE marking is mandatory for certain product categories sold in the European Union, plus Norway, Iceland, Liechtenstein, Switzerland, and Turkey. It is not a quality mark — it is a declaration that the product meets all applicable EU directives for safety, health, and environmental protection.

Product categories requiring CE marking:

• Machinery and mechanical equipment
• Electrical and electronic equipment
• Medical devices
• Construction products
• Personal protective equipment
• Toys
• Pressure equipment
• Measuring instruments
• Radio equipment

Two routes to CE marking:

• Self-declaration — for low-risk products. You test the product against applicable harmonised European standards (EN standards), prepare a technical file with design details, test results, and risk assessment, draft a Declaration of Conformity (DoC), and affix the CE mark.
• Notified Body — for high-risk products (medical devices, pressure equipment). A third-party body tests and certifies conformity.

Process: Identify which EU directives apply (Low Voltage, EMC, Machinery, etc.), test against the relevant EN standards, prepare the technical file, and appoint an Authorised Representative in the EU.

Costs: Rs 50,000 - 5,00,000+ depending on product complexity and whether a Notified Body is required. If you change your product design or manufacturing process, you must re-evaluate conformity.

EU — REACH Regulation

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU's chemical substance regulation. It affects chemical exporters directly and any manufacturer whose products contain chemicals — textiles with dyes, leather goods with tanning agents, plastics with additives, electronics with solder.

Key obligations: Substances exported above 1 tonne per year must be registered with ECHA through an Only Representative (OR) based in the EU. Substances of Very High Concern (SVHC) must be declared if present above 0.1% by weight. Restricted substances (Annex XVII) must not exceed specified limits.

Practical impact: Your EU importer typically handles REACH registration, but you must provide Safety Data Sheets (SDS) and chemical composition information. Buyers will ask for REACH compliance confirmation — if you cannot provide it, they will switch to a supplier who can.

US — FDA Requirements

The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, cosmetics, and tobacco products entering the United States.

For food exporters:

Requirement	Description
Facility Registration	Your food manufacturing facility must be registered with the FDA (free, done online at fda.gov)
Prior Notice	Every food shipment must have a Prior Notice filed with the FDA at least 15 days before arrival (for sea shipments)
FSMA Compliance	Foreign Supplier Verification Programme (FSVP) — your US importer must verify that your food safety practices are equivalent to US standards
Labelling	All food labels must comply with FDA labelling requirements — nutrition facts panel, ingredient list, allergen declarations, net weight in US customary units

For medical device exporters:

Requirement	Description
Establishment Registration	Register your facility with the FDA
Device Listing	List each device you manufacture with the FDA
510(k) Clearance	For most devices — demonstrate substantial equivalence to a legally marketed device
Quality System Regulation (QSR)	Comply with 21 CFR 820 — similar to ISO 13485
US Agent	Appoint a US-based agent for FDA communications

Costs: FDA facility registration is free. 510(k) submissions have a user fee that varies annually (currently in the range of Rs 10-15 lakh for small businesses). Testing and documentation costs can add Rs 5-50 lakh depending on device complexity.

US — CPSC Requirements

The Consumer Product Safety Commission (CPSC) regulates consumer products (excluding food, drugs, and vehicles) sold in the US. Children's products require third-party testing by a CPSC-accepted laboratory and a Children's Product Certificate (CPC). General use products require a General Certificate of Conformity (GCC). Products most affected include toys, children's clothing, electronics, furniture, and textiles (flammability standards).

Japan — JIS and JAS Standards

JIS (Japanese Industrial Standards) applies to industrial products. Certification is voluntary for most products, but Japanese buyers strongly prefer JIS-certified goods. JAS (Japanese Agricultural Standards) applies to food and agricultural products. Organic food exports to Japan require JAS organic certification — a separate standard from EU or US organic certifications.

Gulf Countries — GSO Standards

The GCC Standardization Organization sets standards for Saudi Arabia, UAE, Kuwait, Bahrain, Oman, and Qatar. Products sold in Saudi Arabia need SASO standards compliance, with many requiring SABER certification before shipment. The UAE has its own ESMA standards. For food products, halal certification from an accredited body recognised by the destination country is effectively mandatory.

Use the HS Code Finder to identify your product code, then check specific requirements on the relevant country export guides.

Testing Laboratories in India

India has a strong network of NABL-accredited testing laboratories. Major chains include SGS India (40+ locations, all product categories), Bureau Veritas (textiles, food, consumer products), TUV SUD/Nord/Rheinland (machinery, electronics, medical devices), and Intertek (textiles, food, chemicals). Government labs like CFTRI, Textile Committee labs, and Export Inspection Agency labs serve specific product categories.

Costs and turnaround:

Test Type	Typical Cost Range	Turnaround Time
Food safety (microbiological + chemical)	Rs 3,000 - 15,000 per sample	5-10 working days
Textile testing (composition, colour fastness, shrinkage)	Rs 2,000 - 10,000 per sample	5-7 working days
Chemical testing (REACH compliance, heavy metals)	Rs 5,000 - 25,000 per sample	7-15 working days
CE marking testing (electronics/machinery)	Rs 25,000 - 2,00,000+	2-6 weeks
Product safety testing (CPSC, EN standards)	Rs 10,000 - 1,00,000	2-4 weeks

Tip: Get testing done early in your export planning process — not after you have received an order. A failed test report with a shipment deadline looming is one of the most stressful situations in export business.

Building a Certification Strategy

Do not try to get every certification at once. Prioritise based on your target markets and buyer requirements.

Phase 1 — Before your first export: FSSAI license (food exporters), EIC registration (fish, meat, dairy), Spices Board registration (spice exporters), and ISO 9001 as a baseline for all exporters.

Phase 2 — Within the first year: ISO 22000/FSSC 22000 (food exporters), social compliance audit such as SEDEX/BSCI (apparel, textiles, handicrafts), and destination-country certifications — CE marking, FDA registration, or SASO as needed.

Phase 3 — As you scale: ISO 14001 (Environmental Management), SA 8000 (social accountability), FSSC 22000 upgrade, and additional market-specific certifications as you enter new countries.

This phased approach keeps costs manageable while ensuring you meet minimum market access requirements from day one.

Common Mistakes with Quality Standards

Assuming Indian standards are sufficient for export. An ISI mark or FSSAI license proves compliance with Indian standards — not EU, US, or Japanese standards. Research destination market requirements before your first shipment, not after your goods are rejected.

Not getting certification before the first shipment. Some exporters ship first and plan to get certified later. If the buyer or destination authority asks for a certificate you do not have, your goods sit in a foreign warehouse accumulating storage charges. Get certifications in order before you commit to delivery dates.

Not understanding destination-country requirements. The standards you need depend on where and what you are shipping. Check the country export guides for market-specific requirements and the Duty Calculator for tariff implications. A product that clears customs in Dubai may be stopped at the EU border.

Ignoring social compliance audits. Indian MSME exporters often focus on product quality and ignore social compliance. European and US buyers care deeply about labour practices. If you cannot produce a SEDEX or BSCI audit report, you will lose orders to competitors who can.

Treating certification as a one-time exercise. ISO certifications require annual surveillance audits. FSSAI licenses need renewal. REACH Candidate Lists are updated twice a year. Build ongoing compliance into your operations — assign someone to track validity dates and regulatory changes.

Not keeping test reports on file. Buyers and customs authorities can ask for test reports at any time. Maintain an organised file of all certificates and audit records.

Key Takeaways

• Quality standards are not optional — they determine whether your goods can enter a foreign market and whether buyers will work with you
• ISO 9001 (Quality Management) is the baseline certification every exporter should have — costs Rs 90,000 to Rs 2,50,000 for first-year certification
• FSSAI Central License is mandatory for all food exporters — apply at foscos.fssai.gov.in
• EIC inspection is compulsory for fish, meat, dairy, egg, and certain other products — register with EIA before your first shipment
• CE marking is mandatory for machinery, electronics, medical devices, and toys sold in the EU — determine whether you need self-declaration or Notified Body involvement
• FDA registration is required for food facilities and medical device manufacturers exporting to the US — register at fda.gov
• Social compliance (SEDEX, BSCI, SA 8000) is essential for apparel, textiles, and handicraft exporters targeting European and US buyers
• Get testing done early — use NABL-accredited labs and keep reports on file
• Build a phased certification strategy — start with mandatory certifications, then add market-specific ones as you scale
• Read the export documentation guide to understand how quality certificates fit into your shipping document set
• Use the HS Code Finder to correctly classify your product — your HS code determines which standards and certifications apply