What is ISO22000


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What is ISO22000

  1. 1. What is ISO 22000:2005? A step by step guide for using a food safety management system
  2. 2. Contents What is ISO 22000:2005? . . . . . . . . . . . . . . . . . . . . . . . . . 2 ISO 22000:2005. Your questions answered . . . . . . . . . . 2 ISO 22000:2005 & HACCP . . . . . . . . . . . . . . . . . . . . . . . . . 3 Not your basic food safety management system . . . . . 4 ISO 22000:2005 & Management . . . . . . . . . . . . . . . . . . . 5 Prerequisite Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 ISO 22000:2005 works with other certifications . . . . . . 6 Revisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Find out more . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 What is ISO 22000:2005? This guide is intended to provide you with an introduction to ISO 22000:2005 - Food Safety Management Systems – Requirements for any organization in the food chain. The ISO 22000:2005 family is a series of standards for organizations in the food chain. This guide refers to the requirements needed to develop a food safety management system. The benefits of implementing ISO 22000:2005 include: • A clear, auditable and global standard, which provides a state of the art definition of a food safety management system. • Incorporating the five preliminary steps and seven principles of Codex HACCP • Enhancing customer satisfaction • Improving your image with customers • Improving internal communications on food safety issues with staff • A direct link between pre-requisite programs and the HACCP plan designed to increase the effectiveness of the food safety management system • Providing an approach and structure in alignment with both ISO 9001:2000 and ISO 14001:2004. ISO 22000:2005. Your questions answered To set the stage, let us introduce you to Kristy. Kristy is the Director of Food Safety and Quality for a medium size food processing company. She recently coordinated the efforts which allowed three of the plants to become certified to ISO 22000:2005. All three plants were previously certified to ISO 9001:2000. Her experiences in the process will help you to realize that implementing ISO 22000:2005 provides a platform for strengthening existing HACCP systems and to further increase the control of food safety issues. 2
  3. 3. ISO 22000:2005 & HACCP Q: Why did your organization implement this standard? A: Implementing ISO 22000:2005 has made a difference to our organization. We pursued implementation to the ISO 22000:2005 food safety management system and are seeking third party certification for several reasons: • Food safety is a critical issue for our organization, we wanted to go beyond just meeting regulatory compliance. • We wanted a state of the art food safety system. • We wanted to ensure strong executive management commitment to food safety. • We wanted to demonstrate to both our current and future customers and suppliers our commitment to producing safe food. Q: Really? We do not understand what ISO 22000:2005 is. Is it a HACCP standard? A: The answer to the question is not a simple yes or no. ISO 22000:2005 describes the requirements of a food safety management system. The food safety management system is based on both pre-requisite programs and the five preliminary steps and seven principles of HACCP. Q: What is the difference between ISO 22000:2005 and the Codex HACCP code? A: That is a great question. There are several major differences between ISO 22000:2005 and the Codex HACCP code. The Codex HACCP code is an excellent guidance document. It provides information that explains the principles of HACCP. ISO 22000:2005 is an auditable standard. The intent is to provide a succinct description of the elements that make up a food safety management system. These elements include: • The general requirements for a food safety management system • Management responsibility • Resource management • Planning and realization of safe products • Validation, verification and improvement of the food safety management system Q: Where can I find the five preliminary steps and the seven principles of HACCP in ISO 22000:2005? A: Most of the five preliminary steps and seven principles are found in Section 7 – Planning and realization of safe products. The following table shows the relation between Codex HACCP and ISO 22000:2005. Comparison of Codex HACCP and ISO 22000:2005 HACCP step Description Number Description Preliminary step 1 Assemble the HACCP team 7.3.2 Food safety team Preliminary step 2 Describe the product 7.3.3 Product characteristics Description of the process steps and control measures Preliminary step 3 Identify intended use 7.3.4 Intended use Preliminary step 4 Construct a flow diagram Flow diagram Preliminary step 5 On site review of the flow diagram Flow diagram Principle 1 Conduct a hazard analysis 7.4 Hazard analysis 8.2 Validation of control measures combinations 8.4 Food safety management system verification Principle 6 Establish procedures for verification to confirm that the HACCP system is working effectively 7.8 Verification planning Principle 4 Establish a monitoring system for the CCP 7.6.4 Systems for the monitoring of critical control points Principle 5 Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control 7.6.5 Actions when monitoring results exceed critical limits Principle 3 Establish critical limits 7.6.3 Determination of critical limits for critical control points Principle 2 Determine CCPs 7.6.2 Identification of the critical control points (CCPs) Codex HACCP ISO 22000:2005 element Principle 7 Establish documentation and record keeping 4.2 Documentation requirements 7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP plan 3
  4. 4. Q: Why does ISO 22000:2005 separate validation and verification activities? A: Current food safety thinking recognizes validation and verification as separate activities. The following definitions may help you understand the differences between validation, verification and monitoring: • Validation is obtaining the evidence that the control measures are capable of being effective once implemented. • Verification is the confirmation through objective evidence that specified requirements have been fulfilled in practice. • Monitoring is the conducting of a planned sequence of observations or measures to determine whether control measures are operating as intended. Q: Is ISO 22000:2005 only for food processors? A: No, food safety is as strong as the weakest link in the food chain. Therefore, ISO 22000:2005 is written to be used by all organizations in the food chain, regardless of size or position in the food chain. It also provides a common description for a food safety management system regardless of whether or not an organization must also comply with national regulatory HACCP requirements. Q: Federal food regulations require my company to do HACCP. If I implement ISO 22000:2005 will I comply with US HACCP regulations that have been published by either the FDA or USDA? A: Yes. The US food processing HACCP regulations are based on the 5 preliminary steps and seven principles of HACCP. These five preliminary steps and seven principles are incorporated into ISO 22000:2005. In addition, European representatives helped write ISO 22000:2005 to ensure that it conformed to the European Union’s Hygiene regulations which included a requirement for HACCP. Food processing regulations may have some specific requirements. For example, the USDA meat and poultry HACCP regulations require that each processing establishment identify one biological critical control point (CCP). This regulatory requirement is not in conflict with ISO 22000:2005. In fact, ISO 22000:2005 goes beyond the minimum requirements of regulatory HACCP. These new requirements are designed to strengthen the food safety management system. Not your basic food safety management system Q: We have a company culture that stresses the need to continually improve and meet food regulations. We define our organizational structure so all staff are aware of their responsibilities. Isn’t that enough? A: The food safety regulations have resulted in a decrease in the number of food safety incidents and levels of food borne disease. However, these regulations describe the minimum requirements and have not eliminated food borne disease. Our companies can reduce the risk of having a food safety incident by going beyond the minimum. ISO 22000:2005 provides a practical and cost effective structure to further reduce the risk of a food safety incident. Q: US regulations require that my company manufacture food following GMP guidelines set out in the Code of Federal Regulations (21 CFR 110 ). How does this differ from what ISO 22000:2005 requires? A: There is no difference. Good Manufacturing Practices (GMPs) are those pre-requisite programs which are appropriate to food manufacturing facilities. You must determine which are applicable to your operation. ISO 22000:2005 provides a guideline to the Codex codes which are international codes of practice and guidelines (international prerequisite programs if you will) which closely mirror the US GMPs regulations. 4
  5. 5. Q: I have heard that ISO 22000:2005 is just a documentation system, is this true? A: No. Documentation is an important aspect of all management systems. Documentation should be seen as a tool to help the staff do their job. An effective documentation system ensures that the staff have access to the most current documents. This allows them to do the task correctly every time. The records provide evidence that the task was conducted. In addition, as part of the record review process, the records provide a source of data to ensure that the food safety processes are operating in an effective manner. Many companies are using business mapping processes to identify the most critical documents. In addition, some companies are using their computer systems to reduce the amount of paper needed for both documents and records. Q: What approach does ISO 22000:2005 use to ensure the production of safe foods? A: Yes. ISO 22000:2005 requires the organization to do the following: • Demonstrate an understanding of the requirements for food safety. • Demonstrate that the requirements for food safety have been fulfilled. • Understand the manufacturing processes in terms of food safety and traceability. • Use a fact based management approach to measure process performance and effectiveness. • Use measurable objectives to continually improve the food safety management system. ISO 22000:2005 & Management Q: What is the role of top management in ISO 22000:2005? A: Top management must own the food safety management system from the outset. These individuals are responsible for establishing the food safety policy and supporting objectives. In addition, top management allocates time and money to ensure the establishment, implementation, maintenance and improvement of the food safety management system. The food safety team leader reports to top management on food safety issues regardless of other assigned responsibilities. One critical activity of top management is conducting management reviews. Q: I have heard a lot about management reviews and executive retreats. What is the real function of management reviews? A: Management reviews provide a forum for top management to review the effectiveness of the food safety management system. Management reviews have the following objectives: • Make decisions that will lead to actions designed to improve the effectiveness of the food safety management system. • Ensure appropriate resources are committed to the food safety management system. • Ensure the organization’s food safety policy is current and revise it if necessary. • Ensure that food safety objectives are met and updated as needed. 5
  6. 6. Prerequisite Programs Q: Why are the prerequisite programs a big part of ISO 22000:2005? A: Prerequisite programs are critical to the effective operation of the food safety management system because they establish the environment or the basic hygiene conditions for successfully making a safe product. They are different from the HACCP plan. These programs have a number of common elements. • Prerequisite programs deal indirectly with food safety. Critical control points and HACCP deal directly with food safety. • Prerequisite programs tend to be more general and are applied across manufacturing lines in a plant, while HACCP is based on a specific product that is produced on a specific processing line. • Typically, momentary failure of a prerequisite program does not normally lead to a food safety incident. However, systematic breakdown of a pre-requisite program can lead to a food safety problem. Q: What led ISO to include these? A: In recent years, a large number of food safety recalls occurred due to system failures of the prerequisite programs. This led ISO to directly link prerequisite programs to the food safety system, to ensure that they are properly designed, implemented, maintained and that the activities are both validated and verified. ISO 22000:2005 works with other certifications Q: I am certified to ISO 9001:2000. Must I develop a separate food safety management standard to ensure compliance with ISO 22000:2005? A: No. Both standards have elements that are common, which can be used as a basis for integration. These elements include management reviews, internal audits, policy and objectives, systems processes, documentation, planning, improvement mechanisms and unified management support and a coherent approach. You need only to determine what level of integration of both management systems is appropriate for your company. Q: Should I integrate my ISO 9001:2000 quality management system with the ISO 22000:2005 food safety management system? A: The response to that question is not simple. An integrated management system implies that the organization uses a single management system that addresses both quality and food safety issues. If you are considering integrating the quality management system and the food safety management system, you need to consider the following: • The level of integration. • If the corporate culture and politics support integration. • The level of competency needed to implement and maintain an integrated quality and food safety management system. • The implications with regard to legal and regulatory concerns HACCP is a regulatory requirement for many food processing companies. When a regulatory official reviews the HACCP system for regulatory compliance, the person prefers to see only the documents that support compliance to the regulations. Providing other documentation is not necessary and may slow down the regulatory audit process. Thus, a company may want to have a separate food safety management system and a quality management system. Q: I would like to be certified to both ISO 9001:2000 and ISO 22000:2005. Must I have two separate audits? A: No. BSI offers a combined audit service for companies which have two or more management systems assessed at the same time. These systems are not seen as integrated and usually have separate manuals and controls. A combined audit service is a value added service offered by BSI to ensure assessments are coordinated and conducted at the same time. As a result, it is possible to reduce the administration costs and the disruptions to your organization. 6
  7. 7. Q: My customer requires that my HACCP system be certified. I mentioned to them that I was planning to have my food safety management system certified to ISO 22000:2005. Will I have to have separate certification audits for both the HACCP system and the food safety management system? A: ISO 22000:2005 incorporates the 5 preliminary steps and the 7 principles of HACCP that are described by Codex (the international HACCP standard) and by the National Advisory Committee for the Microbiological Criteria Foods (the US HACCP standard). Therefore, certification to ISO 22000:2005 should provide adequate evidence to the customer that you have an effective HACCP system. If the customer does not plan to accept the ISO 22000:2005 certification, as certification to the requirements of HACCP, please have the customer call BSI at 1 800 862 4977. We will discuss these issues with your customer and explain that an ISO 22000:2005 certificate ensures compliance with all of the requirements of HACCP. This may be enough to satisfy your clients. If your client still insists on a separate HACCP certificate, BSI can make arrangements to issue a separate HACCP certificate, stating that the HACCP system has been certified by BSI, in addition to the ISO 22000:2005 certificate. Revisions Q: Is there any chance that ISO 22000:2005 will become an antiquated standard? A: No. ISO requires that all of their standards be reviewed every five years, taking into account the experience that has been gained by the users of the standard and on the basis of this determining the need to revise and improve the standard. This review requirement ensures that all of their standards continue to describe the current industrial practice. Q: Will ISO 22000:2005 be revised? A: Yes. It is expected that the Working Group responsible for writing this standard will start the review and revision process during 2008. This review process will include reviewing the experience gained by the users of the standard from around the world. Find out more Q: Are there any resources that will help me to further understand ISO 22000:2005? A: ISO published ISO/TS 22004:2005 – Food Safety Management System: Guidance on the application of ISO 22000:2005. You can purchase copies of both ISO 22000:2005 and ISO/TS 22004 from BSI at www.bsiamericas.com/22000purchase. Also, BSI offers a full suite of food safety guidance documents for free download at www.bsiamericas.com/fsguidance For further information, please contact BSI at: BSI Management Systems 12110 Sunset Hills Road, Suite 200 Reston, VA 20190-5902 Tel: 1 800 862 4977 1 703 437 9000 Fax: 1 703 437 9001 inquiry.msamericas@bsi-global.com www.bsiamericas.com 7
  8. 8. F O O D S A F E T Y M A N A G E M E N T I S O 2 2 0 0 0 : 2 0 0 5 BSIUSA84/0606/E BSI Group: Standards • Information • Training • Inspection • Testing • Assessment • Certification raising standards worldwide USA BSI Management Systems 12110 Sunset Hills Road, Suite 200 Reston, VA 20190 USA Tel: 1 800 862 4977 703 437 9000 Fax: 703 437 9001 inquiry.msamericas@bsi-global.com Canada BSI Management Systems Canada, Inc. 17 Four Seasons Place Suite 102 Toronto, ON M9B 6E6 Canada Tel: 1 800 862 6752 Fax: 416 620 9911 inquiry.canada@bsi-global.com www.bsiamericas.com More from BSI… Food Safety Training www.bsiamericas.com/fstraining Food Safety Email Update Service www.bsiamericas.com/fsupdate Communication Day Events www.bsiamericas.com/commsdays Author John G. Surak, PhD authored this publication. Dr. Surak is a consultant in process control, statistics, and development of management systems that meet ISO 9001 and 22000 requirements. Dr. Surak led the United States delegation to the meetings of Working Group 8 of ISO TC 34. This Working Group wrote ISO 22000:2005 and ISO TS 22004. He can be reached at 864 506 2190 or jgsurak@yahoo.com