ISO 22000: qué es y qué exige la norma
ISO 22000: qué es y qué exige la norma
If you work in the food industry and are wondering how to build a solid structure for food safety management at your company, the ISO 22000 is, without question, the starting point you need. This international standard sets out the requirements for a food safety management system. It also applies to any organization in the food chain, from primary production through to final distribution. In this article you'll find everything you need to know. That is: what it is, who it applies to, and how it differs from other reference frameworks. You'll also see how to keep documentation up to date without losing your mind in the process.
What ISO 22000 is and who it applies to
The ISO 22000 standard is an international standard published by the International Organization for Standardization that sets out the requirements for food safety management systems. Its goal is to ensure that food is safe for human consumption at every link in the supply chain. It also combines the principles of Hazard Analysis and Critical Control Points (HACCP) with the elements of a management system. The latter is based on the PDCA cycle (Plan, Do, Check, Act).
The standard, managed by the International Organization for Standardization (ISO) (ISO, n.d.), applies to any organization that is directly or indirectly involved in the food chain:
- Agricultural, livestock and fishing producers.
- Food and beverage processing industries.
- Food packaging companies.
- Distributors, logistics and transport operators.
- Suppliers of ingredients, additives and food-contact materials.
- Institutional catering and catering services.
In short, if your activity has any impact on the safety of a food product before it reaches the consumer, the ISO 22000 certification puede —y en muchos mercados debe— formar parte de tu estrategia de calidad. Puedes conocer más sobre los distintos marcos normativos aplicables al sector en nuestra sección de normas y estándares de calidad.
Differences with HACCP and ISO 9001
One of the most common questions among quality managers is how ISO 22000 fits in with other tools they already know. Specifically, with HACCP and ISO 9001. Here's a practical explanation.
ISO 22000 vs. HACCP
HACCP (Hazard Analysis and Critical Control Points) is a preventive methodology. It's used to identify, assess and control significant hazards to food safety. ISO 22000 doesn't replace HACCP — it integrates it. In fact, HACCP principles are a mandatory component within the standard. The key difference is that ISO 22000 adds a complete management system around HACCP. It therefore incorporates policy, objectives, communication, resource management, internal audits and management review. HACCP tells you what to control; ISO 22000 tells you how to manage it systematically and demonstrably.
ISO 22000 vs. ISO 9001
ISO 9001 is the reference standard for quality management systems and applies to virtually any sector. ISO 22000, on the other hand, is specifically designed for food safety. Both share the same high-level structure (HLS), which makes integrating them into a single management system much easier. If your company already has ISO 9001, implementing ISO 22000 is much simpler. Indeed, the documentation, internal audit and continuous improvement processes are common to both. The main contribution of ISO 22000 over ISO 9001 is the explicit inclusion of hazard analysis. Added to this are the prerequisite programs (PRPs) focused on product safety.
Key requirements and documentation for ISO 22000 food safety
The structure of ISO 22000 food safety follows the ten-clause high-level structure (HLS), which aligns it with other management system standards. The blocks most relevant to a quality manager's day-to-day work are the following:
The six blocks of ISO 22000 requirements
1. Organizational context and leadership (clauses 4 and 5): The standard requires identifying interested parties and their requirements, as well as having visible management commitment. This translates into a documented food safety policy communicated throughout the organization.
2. Planning and risk management (clause 6): Here, food safety objectives are defined and the risks and opportunities that may affect the management system are identified.
3. Prerequisite programs —PRPs— (clause 8.2): These are the basic hygiene and operating conditions needed to produce safe food. They include pest control, cleaning and disinfection, facility maintenance, management of allergens and water control, among others. The correct application of these programs is linked to compliance with the Regulation (EC) No 852/2004 on the hygiene of foodstuffs (Regulation [EC] 852/2004, 2004), which sets out the general hygiene obligations for all food business operators.
4. HACCP system (clause 8.5): Hazard analysis, identification of Critical Control Points (CCPs) and Food Safety Control Points, critical limits, monitoring procedures, and corrective actions.
5. Traceability and non-conformity management (clauses 8.9 and 8.10): The standard requires robust traceability systems and documented procedures to manage potentially unsafe products, withdrawals, and food safety alerts.
6. Internal audit and management review (clauses 9.2 and 9.3): Periodic verification of the system and review of its effectiveness at management level.
Mandatory documentation in ISO 22000
As for documentation, ISO 22000 requires maintaining documented information that provides evidence of the system's correct operation. This includes, at minimum, the system's scope, the food safety policy, and the results of the hazard analysis. Also included is the HACCP plan and the CCP monitoring records. Finally, corrective action records, internal audit results, and management review reports are added. Managing all of this efficiently is one of the main challenges for quality teams in the food industry.
How to keep records up to date with Solved
Meeting all of ISO 22000's documentation requirements is demanding. Quality managers know it well: paper records pile up and spreadsheets scatter. On top of that, it's hard to demonstrate compliance in audits. Meanwhile, the team spends many hours on administrative tasks instead of improving the system.
This is where Solved makes the difference. Solved is quality software designed specifically for the food industry. With it, you can centralize and digitize all the processes linked to food safety management. With Solved you can:
- Manage prerequisite programs digitally, with records accessible from any device and automatic alerts when a task is pending or overdue.
- Digitize the HACCP plan, linking the monitoring records of each CCP directly to the plan, so that any auditor can verify the history in seconds.
- Control non-conformities and corrective actions with workflows that ensure no incident goes unresolved or undocumented.
- Manage traceability of raw materials and finished products quickly, making it easier to respond to potential food safety alerts.
- Prepare for internal and external audits with all the information available, organized and ready to be consulted, without frantic searches through binders or network folders.
What your team gains by digitizing ISO 22000
The result is a more efficient quality team with less administrative workload. This way, the management system works as a lever for continuous improvement, not just as a requirement to pass the audit. Want to see how Solved adapts to your company's specific needs? Explore our solution for the food industry and request a no-obligation demo.
Implementing or improving your ISO 22000-based food safety management system doesn't have to be a complicated process. With the right tool and a clear approach, it's entirely possible to turn regulatory compliance into a real competitive advantage.
References
- International Organization for Standardization. (n.d.). ISO 22000 and ISO 9001. https://www.iso.org/
- Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. (2004). https://eur-lex.europa.eu/eli/reg/2004/852/oj?locale=es