It was in 1987 that the International Organization for Standardization (ISO) developed and published ISO 9001, 9002 and 9003 and other related guidelines on international standards. This gave birth to the currently popular ‘ISO 9000 family of standards’. The first revision of the ISO 9001, 9002 and 9003 standards took place in 1994 without much alteration in their structure. The second major revision was done in 2000, when ISO 9001, 9002 and 9003 were replaced by a single standard − ‘ISO 9001:2000 Quality Management Systems − Requirements’. This was revised again in 2008 as ISO 9001:2008. Both then ISO 9001 : 2015.
The ISO 9000 family
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems (QMS) and supporting standards. The adoption of all standards published by ISO, including standards in the ISO 9000 family, is voluntary in nature. Many countries have adopted the ISO 9000 family of standards as is and have also appropriated its numbering system for their national standards. For instance in the United Kingdom, ISO 9001 is referred to as BS EN ISO 9001:2008, with BS standing for British Standard and EN for European Norm. In Sri Lanka, the standard is numbered SLS ISO 9001:2008, with SLS denoting Sri Lankan Standard. The ISO standards can be purchased (hard or soft version) from ISO through its online store. Your country’s bureau of standards may also sell ISO publications as well as its adopted version of these standards (you will probably pay less for the national version).
ISO 9001 is applicable to all sectors of industry, including manufacturing and service, and to organizations of all sizes. It is not a product standard but a management system standard to demonstrate an organization’s ability consistently to provide products or services that meet customer and regulatory requirements. ISO 9001 specifies ‘what’ is required to be done by an organization but does not indicate ‘how’ it should be done, thus giving you great flexibility in running your business. Furthermore, ISO 9001 does not set any particular level of quality. You and your customers do that. The standard will only help you to achieve the level you want. For example, if you set an objective that 99% of the time you will meet your delivery commitments, the system will help you to achieve that.
At both national and international levels, certification2 to ISO 9001 by accredited certification bodies has received wide acceptance. As of 31 December 2009, 1 064 785 certificates for ISO 9001 were issued in 178 countries. The highest share (47%) was achieved in Europe, followed by 37.4% in the Far East, 7.3% in Africa and West Asia, 3.4% in Central and South America and 0.1% in Australia and New Zealand.
ISO 9001 and the export trade
The ISO 9000 family of standards is increasingly becoming a symbol of quality in both the manufacturing and services industries. It engenders greater customer loyalty as implementation ensures that customer needs and expectations are continually met, giving customers less or no reasons to complain. More and more small and medium-sized firms are choosing to adopt the ISO 9000 family of standards – often because their customers expect them to have it. Adherence to the ISO standards can also be publicized to gain market access abroad, because many foreign buyers place a premium on these standards.
There is no definite answer to this popular question, as the cost of ISO 9001 certification depends on various factors, e.g. how long it takes to develop a quality management system, how many staff members are involved and whether an external consultant is hired or not. In view of this, this section considers only the broad cost categories and lists major cost items by category. The broad categories include the cost of establishing and implementing a quality management system, the cost of maintaining it, and the cost of the initial certification and its maintenance.
Cost of establishing and implementing the QMS
Cost of maintaining the QMS
Many of the activities listed above can be carried out by your employees after studying ISO 9001 and the guideline standards and brochures published by ISO (see question 29). While they may not incur direct costs, they will involve indirect costs arising from your employees’ efforts to educate themselves and to carry these activities out. To supplement their knowledge, you could ask one or two of your employees to undergo short training on the implementation of ISO 9001. Alternatively, you could outsource some of the above activities to consultants or experts known in the field.
Cost of initial certification and cost associated with the maintenance of certification
It may be added here that certification to ISO 9001 is not a mandatory step towards implementation of QMS. Your management should study whether it would be appropriate for strategic and other reasons for your company to implement ISO 9001 and to undergo certification before incurring the above costs.
Benefits of ISO 9001
If you implement and keep practicing the system well it will provide you with a number of benefits such as:
The biggest benefit to be gained from maintaining a QMS (which is an investment in preventing failures) is the huge savings you can make by considerably reducing the cost of failures
Every person has the right to expect that the food he/she eats is safe and will not cause injury or illness.
The hazards related to food safety are known as biological, chemical and physical hazards, which, if present in food, may cause injury or illness to the human being.
Hazard Analysis and Critical Control Points (HACCP) is defined as “a system, which identifies, evaluates and controls hazards which are significant for food safety” (FAO).
HACCP is a proactive concept. It helps to ensure that food is safe from harvest to consumption (‘from farm to fork’). Each step involved in food production, i.e. purchasing, receiving, storage, processing, packaging, warehousing, distribution up to the point of consumption is subjected to hazard analysis and necessary controls are introduced. The premise is simple: if each step of the process is carried out correctly, the end product will be safe.
HACCP was first developed in 1960 in the early days of the space programme. NASA (National Aeronautics and Space Administration) wanted assurance that food taken on board space flights would not cause food-borne diseases. As a result of this requirement, the Pillsbury Company and the United States Army Natick Research Laboratories developed a process that would ensure production of safe food; the process was named HACCP.
In 1993, the Codex Alimentarius Commission (CAC) published guidelines for the application of the HACCP system. Later, in 1997, CAC incorporated HACCP into an appendix of the ‘Recommended International Code of Practice General Principles of Food Hygiene (latest version: Rev.4-2003).
The HACCP system consists of seven principles, which give an outline of how to establish, implement and maintain a HACCP plan.
HACCP is not a stand-alone system. Good hygiene practices and other prerequisites for food processing as well as strong management commitment are also necessary. HACCP is not a substitute for these.
If your company produces a variety of food products, you should develop a separate HACCP plan for each product, abiding by the seven principles outlined above.
During the 1990s, HACCP was adopted by many countries (Australia, Denmark, Germany, India, Ireland, Netherlands, United States and others) in national standards specifying requirements for a food safety management system. It was also included in the regulations of the European Community dealing with ‘Hygiene of foodstuffs’. The International Organization for Standardization (ISO) developed in 2005 an international standard, ‘ISO 22000:2005 Food Safety Management Systems − Requirements for any organization in the food chain’, which incorporates HACCP principles.
It is important for SMEs in the food processing business to use HACCP for two reasons. First, it brings internal benefits such as reduced risk of manufacturing and selling unsafe products, which will in turn generate greater consumer confidence in these products. Second, food regulatory authorities in many countries are adopting or are likely to adopt HACCP in their food regulations. By implementing HACCP, you will have greater chances of succeeding as an exporter to these countries. For example, in the guidance document entitled ‘Key questions related to import requirements and the new rules on food hygiene and official food control’, issued by the European Commission’s Directorate General, Health and Consumer Protection, EU has clarified that the new EU rules on food hygiene (effective 1 January 2006) confirm that all food businesses after primary production must put in place, implement and maintain a procedure based on HACCP principles. These rules are, however, more flexible than under the old system, as the HACCP-based procedures can be adapted to all situations (European Commission, 2006).
The primary objective of both the Codex HACCP principles and the ISO 22000 food safety management system (FSMS) is to ensure that the food produced by an organization is safe for human consumption.
The system elements of the Codex HACCP consist of seven principles and five presteps for developing and implementing a HACCP plan. All these elements have since been included in ISO 22000 (published in 2005 as ‘ISO 22000:2005 – Food safety management systems – Requirements for any organization in the food chain’) and many more management system requirements have been added. The format of ISO 22000 is in line with the format of ISO 9001 (‘Quality management system − Requirements’), thus making it compatible with other management systems.
The development of ISO 22000 was based on the assumption that the most effective food systems are designed, operated and continually improved within the framework of an organization’s structured management system. ISO 22000 thus carries some management system requirements that are not explicitly stated in Codex HACCP. These include a food safety policy and related objectives, planning and documenting the food safety system, effective external and internal communication arrangements, the assignment of specific responsibilities to the food safety team leader, internal audits, management reviews, continual improvement and updating of FSMS. Briefly, the ISO 22000 requirements are a combination of the following four key elements:
The Codex HACCP uses the last element and also recommends that prerequisite programmes related to food hygiene should be in place before the development of a HACCP plan.
ISO 22000, backed by international consensus, harmonizes the requirements for systematically managing safety in food supply chains, and offers a unique solution for good practice on a worldwide basis. ISO cooperated closely with the Codex Alimentarius Commission in developing this standard. ISO 22000 makes extensive reference to the Codex hygiene recommendations for the development of prerequisite programmes for different sectors of the food industry. ISO 22000 in its Annex B provides a comparison of the various requirements of FSMS with those of Codex HACCP.
ISO 22000 is designed to allow all types of organizations within the food chain to implement a food safety management system. These include crop producers, feed producers, primary producers, food manufacturers, transport and storage operators, retailers, food service operators and caterers together with related organizations such as producers of the equipment, packaging materials, cleaning agents, additives and ingredients needed during food processing.
As CODEX HACCP is a guidance document, certification to it is not possible. To fill this gap many countries such as Australia, Denmark, Germany, India, Ireland and the United States have developed national standards on the basis of the Codex HACCP. The Netherlands also did so, and the standard is popularly referred to as the Dutch HACCP. Certification against these standards is possible. ISO 22000 has made it easier for organizations worldwide to implement the Codex HACCP system for food safety in a harmonized way, i.e. it does not vary with the country or food product or service concerned. ISO 22000 can be used for certification, and this may be acceptable as an alternative to certification against different national standards.
Setting up an ISO 22000 FSMS and having it certified have cost implications. The costs fall under the following categories.
These costs can vary greatly, depending on the size of your facility, range of products, nature of your operation, existing infrastructure and facilities. The cost items and the benefits of implementing FSMS are described below.
Costs of establishing and implementing FSMS
Cost of maintaining the FSMS
Cost of initial certification and cost associated with the maintenance of certification payable to the certification body you selected
It may be added here that certification to ISO 22000 is not a mandatory step after the implementation of FSMS. The decision to have it is always a need-based decision, which your management should take before incurring the above costs.
The implementation of ISO 22000 FSMS will provide both internal and external benefits, for example:
OHSAS 18001 is a standard for establishing and practicing an occupational health and safety management system. It provides a framework for an organization to identify and control its health and safety risks, reduce its potential for accidents, ensure compliance with legislative requirements, and improve its overall health and safety performance.
OHSAS 18001 is not an ISO standard as it has not been developed by the International Organization for Standardization. It was formulated by three national standards bodies (those of Ireland, South Africa and the United Kingdom), 10 certification bodies and other stakeholders. The target was to address a gap where no third-party certifiable international standard existed. While developing this standard, in order to enhance its compatibility with other management system standards, due consideration was given to the provisions of ISO 9001, ISO 14001 and the guidelines for an occupational health and safety management system published by the International Labour Organization.
This standard can be used by all types (private, public, manufacturing, service) and size (small, mediumsized, large) of organizations. It can also accommodate diverse geographical, cultural and social conditions.
OHSAS 18001 only addresses occupational health and safety (OHS) issues at the workplace – for example, any physical location in which work-related activities are performed under the control of an organization. Health and safety at the workplace covers employees, individual contractors, customers and citizens. The standard does not deal with other health and safety areas such as the employees’ wellbeing or wellness, product safety, property damage or environmental impact.
OHSAS 18001 covers the following key areas:
As with any other management system standard, you will need to follow some steps for the implementation of OHSAS 18001:
Once the system stabilizes and if you wish to obtain certification, you may select an accredited certification body from among those who provide OHSAS 18001 certification services. According to the BSI group, by the end of December 2009, a total of 54 357 certificates to OHSAS 18001 or its equivalent had been issued by various certification bodies. The process of certification is the same as that followed for other management systems such as ISO 9001, ISO 22000 and ISO 14001.
It may be added here that compliance with OHSAS 18001 does not exempt you from fulfilling legal obligations. However, it will enable you to demonstrate legal compliance in a systematic way.
By implementing OHSAS 18001, you will be able to provide assurance of safe work practices to foreign buyers who prefer to trade with suppliers that provide a safe working environment to their employees
ISO 14000 family of standards
Organizations around the world as well as their stakeholders are becoming increasingly aware of the need for environmental protection. To enable organizations to manage environmental issues proactively, ISO has developed the ISO 14000 family of environmental management standards. Its two main standards are: ‘ISO 14001:2004 Environmental management systems − Requirements with guidance for use’ and ‘ISO 14004:2004 Environmental management systems − General guidelines on principles, systems and support techniques’.
ISO technical committee TC-207, which is responsible for developing the ISO 14000 family, has since 1996 been developing standards in other areas as well, such as environmental labelling, life cycle assessment, greenhouse gas management and related activities, and carbon footprint of products.
ISO 14001 is the world’s most recognized framework for environmental management systems (EMS).
The overall aim of an EMS based upon ISO 14001 is to support environmental protection and the prevention of pollution in a balance with socio-economic needs.
ISO 14001 can be implemented by any type (public, private, manufacturing, service) and size (small, medium-sized or large) of organization. An EMS based upon ISO 14001 provides a framework to help you identify those aspects of your business activities that have significant impacts on the environment, to set objectives and targets to minimize those impacts, and to develop programs to achieve targets and implement other operational control measures to ensure compliance with your environmental policy.
ISO 14001 does not establish a minimum level of environmental performance. Rather, it requires you to achieve the objectives for environmental performance that your management has set in your environmental policy. It also requires you to demonstrate a commitment to complying with the applicable environmental legislation and to the continual improvement of your environmental performance.
It will be possible for you to integrate your ISO 14001 EMS with your ISO 9001 QMS as they are compatible with each other.
The impact of the environmental performance of an organization goes beyond its customers and suppliers to a broader range of stakeholders − ordinary citizens, regulators, employees, insurance companies and shareholders. Everyone has an interest in the quality of the environment around them.
Thus, demonstrating compliance with an environmental management system based on ISO 14001:2004 is a sound business decision.
Certification to ISO 14001 has been constantly increasing. By the end of December 2009, a total of 223149 certificates had been issued to organizations in over 159 countries.
The costs of implementing ISO 14001 and obtaining certification for it vary greatly. They depend on the size of the facility and the nature of the operation. They can be divided into the following three categories.
The main cost items under each category are listed below. A discussion of the benefits of implementing ISO 14000 follows.
Cost of establishing and implementing the EMS
Cost of maintaining the EMS
Many training activities can be handled by the employees themselves after studying the ISO 14001:2004 standard and ISO 14004:2004, the guideline standard. One or two of these can be asked to undergo a short course on implementing ISO 14001 to supplement their knowledge. Alternatively, you could hire consultants or experts known in the field to carry out a training programme for your employees.
Cost of initial certification and cost associated with maintenance of certification, payable to the certification body of your choice
It may be added here that certification to ISO 14001 is not a mandatory step after the implementation of EMS. It is always a need-based decision which your management should take before incurring the above costs.
Benefits of implementing an ISO 14001 EMS
While there are several costs associated with implementing and maintaining an EMS, its many tangible and intangible benefits will offset these costs. The important benefits arising from implementing the EMS include the following:
Here are some examples of the benefits that can be gained from an effective EMS.
In Singapore, SGS-Thomson has saved US$ 200,000 by improving the energy efficiency of its cooling plant. Another company, Sony Display Devices, has saved about US$ 7.5 million a year by eliminating raw material wastage. Baxter, which has obtained ISO 14001 certification, has disclosed savings and cost-avoidance of up to US$ 3.4 million by implementing an environmental management system.
A medium-sized manufacturer of precision fittings for the automotive and refrigeration industries identified inefficiencies in its oil recovery procedures in the course of the EMS implementation. By addressing the problem, the firm expects to realize more than US$ 20,000 per year in savings. Another manufacturer reported a 70% reduction in waste disposal costs as its ISO 14001 EMS was put into place.
Larger companies may not find it too difficult to implement the EMS – they have financial strength and economies of scale. However, many SMEs are likely to have problems in adopting environmental controls because of their lack of resources.
Some governments are therefore providing SMEs financial support for implementing EMS. For example, in Singapore, the government agency SPRING (Standards, Productivity and Innovation Board) has extended its Local Enterprise Technical Assistance Scheme to give financial assistance to SMEs wishing to implement EMS and gain certification to ISO 14001. In India, financial assistance is provided to SMEs for acquiring quality, environmental and food safety (HACCP) management systems.