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The ISO 9000 family of standards, developed by the International Organization for Standardization (ISO), provides a framework for quality management systems. ISO 9001:2000, the most widely used standard, defines minimum requirements for registration, focusing on customer satisfaction and product quality. ISO 9004:2000 offers guidelines for performance improvement beyond the ISO 9001 requirements, aiming for both effectiveness and efficiency. Both standards incorporate eight quality management principles (customer focus, leadership, etc.) and fundamentals of quality management systems. They are compatible and used by over half a million organizations globally. The 2000 revision integrated quality management principles and fundamentals, resulting in three standards: ISO 9000 (fundamentals and vocabulary), ISO 9001 (requirements), and ISO 9004 (performance improvement guidelines). These standards are applicable to various industries, including food companies, with clauses addressing scope, normative references, terms and definitions, and the quality management system itself. Specific requirements and guidelines are detailed within clauses 4-8, focusing on management responsibility, resource management, product realization, and measurement, analysis, and improvement. The standards also address documentation, continual improvement, and the integration with other management systems. Good Manufacturing Practices (GMPs) and Hazard Analysis and Critical Control Points (HACCP) prerequisite programs, such as those related to building facilities, sanitation, and employee hygiene, are also relevant considerations in maintaining a quality management system within the food industry.

• The ISO 9001:2000 quality management system
standard is the recognized international quality
system standard.
• Many countries have formally adopted this
international standard as their national quality
system standard.
• Prior to the adoption of the international quality
system standard, some countries had developed
their own national quality system standards
The ISO 9000 quality system standards
• The ISO 9000 quality system standards were
developed by the International Organization for
Standardization (ISO) for use by any organization
that needs to develop, implement and operate with
a quality management system.
• The ISO 9000 quality system standards have had
considerable impact on the evolution of quality
activities on a global scale since the first set of
standards were issued in 1987.
• Estimates indicate that the ISO 9000 quality system
standards are used by more than half a million
organizations worldwide.
The evolution of the ISO 9000 quality system
standards
• The ISO 9000 quality system standards, which were
introduced in 1987, were revised in 1994 and again
in 2000.
• The objective of these periodic revisions is to satisfy
the needs of the standards’ users.
• In the 2000 revision, quality management principles
and fundamentals of quality management systems
were formally recognized and incorporated into the
ISO 9000 family of standards.
• The 2000 revision, which was the first major
revision of the standards, resulted in the following
three standards:
• ISO 9000:2000 Quality management systems—
fundamentals and vocabulary
• ISO 9001:2000 Quality management systems—
requirements
• ISO 9004:2000Quality management systems—
guidelines for performance improvements
The two standards ISO 9001:2000 and ISO
9004:2000 have been referred to as a consistent
pair, indicating that they are compatible with each
other.
• ISO 9001:2000 defines minimum requirements for
an organization that seeks to have its quality
management system recognized by a formal
registration process.
• ISO 9004:2000 is not used for registration but
provides guidance for performance improvement of
a quality management system. The scope of this
guidance extends much beyond the minimum
requirements of ISO 9001:2000.
ISO 9000:2000 quality management systems —
fundamentals and vocabulary

1. ISO 9000:2000 quality management principles
   The eight quality management principles
   recognized in the ISO 9000:2000 standard are:
   • Customer focus: The success of an organization is
   dependent on the extent to which the current and
   future needs and requirements of customers are
   known, understood, and met. Therefore, the
   organization must devote substantial effort toward
   meeting the requirements of its customers and
   should strive to exceed the expectations of its
   customers.
   • Leadership: Senior managers must establish the
   direction and the objectives of the organization,
   and must ensure that the conditions exist for
   achieving these objectives. This leadership is
   required to ensure there is a common purpose for
   everyone within the organization.
   • Involvement of people: The involvement of
   everyone within the organization is essential to
   achieving the objectives. Personnel must have the
   responsibility, authority, abilities, and skills, and the
   tools required for them to contribute fully to the
   organization.
   • Process approach: An organization’s activities are
   performed more effectively and efficiently when
   managed as a process. Therefore, an organization
   should use the process approach to manage its
   activities.
   • System approach to management: The processes
   carried out by an organization should be identified,
   understood, and managed as an interrelated set of
   processes that form a complete system. The
   effectiveness and efficiency of the entire
   organization can be enhanced by adopting this
   system approach.
   • Continual improvement: One of the ongoing
   objectives of an organization should be the
   improvement of its performance on a continual
   basis.
   • Factual approach to decision making: An
   organization should compile and analyze
   information for use in decision making.
   • Mutually beneficial supplier relationships: An
   organization can benefit from developing
   relationships with its suppliers; these relationships
   serve to enhance the performance of both the
   organization and its suppliers.


2. ISO 9000:2000 fundamentals of quality
   management systems:
   • The ISO 9000 standard recognizes the following 12
   fundamentals, which are the basis for the contents
   of the ISO 9001:2000 and ISO 9004:2000 quality
   management system standards.
   • These fundamentals, which incorporate the eight
   quality management principles are:
   • Rationale for quality management systems:
   A quality management system can provide benefits
   to an organization. In general, these benefits
   include:
   – Assist in enhancing the satisfaction of the
   organization’s customers
   – Provide a framework for continual improvement
   in the organization
   – Provide confidence to the organization and its
   customers that the organization has the
   capability to provide products that meet the
   requirements of customers, regulatory agencies
   and the organization.
   • Requirements for quality management systems
   and requirements for products:
   • The ISO 9000 standards distinguish between the
   requirements of quality management systems and
   requirements of products.
   • The ISO 9001:2000 standard provides generic
   quality management system requirements that are
   applicable to any organization but does not provide
   requirements for an organization’s products.
   • An organization, its customers, and government
   regulatory agencies establish requirements for
   products; these requirements are also part of the
   quality management system.
   • Quality management systems approach:
   In the development, implementation, maintenance,
   and improvement of its quality management
   system, an organization needs to adopt an approach
   in which certain specified activities should be
   undertaken; the standard identifies these activities.
   • The process approach:
   The process approach is described as systematic
   identification and management of an organization’s
   processes and the interactions between these
   processes. This approach should be used to manage
   an organization.
   • Quality policy and quality objectives:
   An organization’s quality policy and quality
   objectives can provide a focus for the direction of
   the organization. The quality policy should provide
   a framework for establishing the quality objectives,
   which should be consistent with the quality policy.
   • Role of top management within the quality
   management system:
   An organization’s top management, through the use
   of quality management principles, and its
   leadership and actions can create an environment
   for the involvement of its people and for effective
   operation of the organization’s quality management
   system.
   • Documentation:
   Documentation is an essential feature of an organization’s
   quality management system. Various types of documents are
   needed in a quality management system, each should serve a
   particular function.
   • Evaluating quality management systems:
   An organization’s quality management system should be
   assessed by evaluating the various processes within the
   system, by auditing the system, and by top management’s
   review of the system. An organization should also carry out
   self-assessment of its activities and performance.
   • Continual improvement:
   An organization’s quality management system should include
   activities that are devoted to continually improving the
   system with the objective of enhancing the satisfaction of its
   customers and other interested parties.
   • Role of statistical techniques:
   An organization should use statistical techniques to
   understand and solve problems such as variability,
   for continual improvement of its effectiveness and
   efficiency, and in making decisions.
   • Quality management systems and other
   management system focuses:
   An organization’s quality management system can
   be integrated with other management systems
   (e.g., financial management system, environmental
   management system, employee health and safety
   management system). The quality objectives of the
   quality management system can complement the
   objectives of the other management systems.
   • Relationship between quality management
   systems and excellence models:
   The approach of ISO 9000:2000 family of standards
   has many similarities to those of excellence model.
   However, the ISO 9000 standards provide quality
   management system requirements (ISO 9001) and
   guidance for performance improvement (ISO 9004),
   while the excellence models provide assessment
   criteria for comparing an organization’s
   performance against the performance of other
   organizations.
   ISO 9001:2000 quality management systems–
   requirements
   • The ISO 9001 standard is the most widely used
   standard among the ISO 9000 family of standards.
   • It is used by companies seeking to have their quality
   management systems recognized through an
   independent registration process.
   • This standard establishes requirements for an
   organization’s quality management system.
   • It is designed for use by an organization that aims to
   enhance the satisfaction of its customers and needs
   to demonstrate that it has the ability to provide
   products that meet requirements of customers,
   regulatory agencies, and the organization.
   ISO 9004:2000 quality management systems–guidelines
   for performance improvements
   • The ISO 9004 standard provides guidelines, in contrast
   to the ISO 9001 standard, which specifies
   requirements.
   • The ISO 9004 standard is designed for use by an
   organization that seeks to move beyond the
   requirements of ISO 9001, to improve the performance
   of the organization, and to satisfy its customers and its
   other interested parties.
   • The ISO 9004 standard covers both the effectiveness
   and efficiency of an organization’s quality management
   system.
   • By contrast, the ISO 9000 standard covers the
   effectiveness of an organization’s quality management
   system.
   ISO 9001:2000 and ISO 9004:2000 standards
   • The requirements and guidelines are referred to by
   the identical numbers and titles used in the
   standard and are italicized for easy identification.
   • The quality management system requirements and
   guidelines are applicable to the operations of food
   companies.
   • The standard defines the minimum requirements
   that must be implemented in order for the quality
   management system to be recognized.
   • An organization that would like to move beyond the
   requirements of ISO 9001:2000 can use the
   guidelines given in ISO 9004:2000.
   Both standards contain the following eight clauses:


3. Scope


4. Normative reference


5. Terms and definitions


6. Quality management system


7. Management responsibility


8. Resource management


9. Product realization


10. Measurement, analysis, and improvement
    • Clauses 1 to 3 provide general remarks on the
    standards.
    • Clauses 4 to 8 describe the requirements (ISO 9001)
    and guidelines (ISO 9004).
    • Clause 4 quality management system defines
    certain general requirements, which apply to all
    activities, while clauses 5 management
    responsibility, 6 resource management, 7 product
    realization, and 8 measurement, analysis, and
    improvement are considered the four major blocks
    of activities.
    ISO 9001:2000 and ISO 9004:2000 clause 1 scope
    This clause defines the scope and the objectives, use and application of the
    standards.
    • ISO 9001 clause 1 scope
    • Clause 1.1 General declares that the standard is an international standard
    that specifies requirements for a quality management system and identifies
    two particular situations for using the standard:
    • When an organization needs to demonstrate that it is has the ability
    to provide products that meet the requirements of its customers and
    the regulatory requirements that apply to its products and operations
    • When an organization’s objective is to enhance the satisfaction of its
    
    customers through continual improvement
    The scope of the standard is limited to products intended for, or required
    by, an organization’s customers.
    Clause 1.2 Application covers the application of the standard.
    • The requirements of the standard are generic and can be
    applied regardless of type or size of an organization or type of
    products.
    • This clause recognizes that because of the generic nature of
    the requirements of the standard, it is possible that certain
    requirements may not be applicable to some organizations,
    depending on the nature of the organization and its type of
    operations and products.
    • In these situations, an organization can exclude a requirement
    of the standard that is considered to be not applicable;
    however, only requirements contained in Clause 7 (Product
    Realization) of the standard can be considered for exclusion.
    • The standard can be used by any food company to achieve
    the food quality and food safety requirements of its products.
    ISO 9004 clause 1 scope
    • This clause describes the relationship of this standard
    to the ISO 9001 standard.
    • The following comparisons are made between the ISO
    9001 and ISO 9004 standards:
    • ISO 9004 provides guidelines that go beyond the
    requirements of ISO 9001
    • The ISO 9001 objectives relating to customer
    satisfaction and product quality are extended in ISO
    9004 to include satisfaction of interested parties and
    the performance of an organization
    • Unlike the ISO 9001 standard, which consists of
    requirements and can be used for certification or for
    contractual purposes, the ISO 9004 standard consists of
    guidelines and is not intended to be used for
    certification or for contractual purposes.
    ISO 9001:2000 and ISO 9004:2000 clause 2 normative
    reference
    • This clause is identical for both standards.
    • It identifies the reference document that is
    applicable to both standards.
    • This reference document is the standard ISO
    9000:2000 quality management systems —
    fundamentals and vocabulary.
    • In the use of the standards, the definitions of terms
    in the ISO 9000 standard are the recognized
    definitions.
    ISO 9001:2000 and ISO 9004:2000 clause 3 terms and
    definitions
    • This clause is identical for both standards.
    • It makes specific reference to the ISO 9000 standard
    as the source of the terms and definitions that are
    used in ISO 9001 and ISO 9004.
    • In addition, it clarifies the definitions of the terms
    product and supplier, and the supply chain
    relationship involving supplier, organization, and
    customer.
    • A supplier provides product to an organization,
    while a customer receives product from an
    organization.
    ISO 9001:2000 and ISO 9004:2000 clause 4 quality
    management system
    • ISO 9001:2000 Clause 4 provides general
    requirements and documentation requirements that
    apply to the entire quality management system,
    including the other clauses of the standard.
    • ISO 9004:2000 Clause 4 provides guidelines for
    managing systems and processes, documentation,
    and use of quality management principles.
    • These guidelines apply to the entire quality
    management system, including the other clauses of
    the standard.
    ISO 9001 clause 4.1 general requirements
    • A quality management system must be established,
    documented, implemented, and maintained by the
    organization, and the effectiveness of the system must
    be continually improved.
    • This must be done in accordance with the requirements
    of the standard.
    • In addition, the process approach of the standard is
    emphasized in this clause, by requiring that the
    organization address the following points:
    • The organization must identify and manage the
    processes to be included in the quality management
    system. The standard specifically mentions processes
    for communication, product realization, customer-
    related issues, purchasing, production and service
    provision, monitoring, measurement, analysis, and
    improvement.
    • The sequence and interaction of these processes
    must be determined.
    • The criteria and methods required to ensure the
    effective operation and control of the processes must
    be determined.
    • The required resources and information must be
    made available to operate and monitor these
    processes.
    • The processes must be monitored, measured, and
    analyzed.
    • The actions required to obtain expected results, and
    for continual improvement of the processes, must be
    implemented.
    • If an organization outsources any of the processes that
    affect the quality of its products, the outsourced
    processes must be included in the organization’s quality
    management system.
    ISO 9004 clause 4.1 managing systems and processes
    • This clause recognizes the importance of quality
    management in the management of an
    organization.
    • It associates success with the implementation and
    maintenance of a management system that aims to
    continually improve both the effectiveness and
    efficiency of the organization’s performance, and
    the organization’s systems and processes in relation
    to the needs of interested parties.
    • The standard recommends that a customer-oriented
    organization should be established by the organization’s top
    management and proposes that this should be achieved by:
    • Defining the organization’s systems and processes in such a
    manner that they can be managed, and both their
    effectiveness and efficiency can be improved
    • Ensuring that there is effective and efficient operation and
    control of the organization’s processes, and the measures and
    data that are used to determine its performance is
    satisfactory.
    • The clause provides examples of activities that can result in a
    customer- oriented organization, including the organization’s
    use of processes that lead to performance improvement, the
    continuous use of data and information from processes, and
    the use of self-assessments and management reviews to
    evaluate the improvement of processes.
    ISO 9001 clause 4.2 documentation requirements
    • The documentation requirements for an
    organization’s quality management system are
    given in four clauses.
    • Clause 4.2.1 General identifies five categories of
    documents that must be included in an
    organization’s quality management system:
    • Documented statements of the organization’s
    quality policy and quality objectives
    • The organization’s quality manual
    • Procedures that must be documented by the
    organization based on the requirements of the
    standard. Documented procedures are required
    specifically by the following six clauses of the
    standard:
    – 4.2.3. Control of documents
    – 4.2.4. Control of records
    – 8.2.2. Internal audit
    – 8.3. Control of nonconforming product
    – 8.5.2. Corrective action
    – 8.5.3. Preventive action
    
    • Documents that the organization must have in order
    to plan, operate, and control its processes
    • Records that must be maintained:
    – Records from the organization’s management
    reviews (5.6 Management review, 5.6.1 General)
    – Records of education, training, skills, and experience
    for personnel who perform work that affects the
    quality of the organization’s product (6.2.2
    Competence, awareness, and training)
    – Records to demonstrate that the organization’s
    product realization processes and the products
    resulting from these processes meet the requirements
    (7.1 Planning of product realization)
    – Records of the results of review of requirements of
    the organization’s products, and of the actions resulting
    from this review (7.2.2 Review of requirements related
    to product)
    – Records of design and development inputs relating to
    requirements of the organization’s products (7.3.2 Design and
    development inputs)
    – Records of the results of design and development reviews,
    and any actions resulting from these reviews (7.3.4 Design
    and development review)
    – Records of the results of design and development
    verification, and any actions from this verification (7.3.5
    Design and development verification)
    – Records of the results of design and development
    validation, and any actions from this validation (7.3.6 Design
    and development validation)
    – Records of review of design and development changes, and
    any actions from this review (7.3.3 Control of design and
    development changes)
    – Records of results of evaluations of the organization’s
    suppliers, and any actions resulting from these evaluations
    (7.4.1 Purchasing process)
    – Records to demonstrate the validation of the organization’s
    processes from which output cannot be verified by
    subsequent monitoring or measurement (7.5.2 Validation of
    processes for production and service provision)
    – Records for unique identification of the organization’s
    product, where traceability is required (7.5.3 Identification
    and traceability)
    – For property that is provided to the organization by its
    customer, the records of customer property that is lost,
    damaged, or unsuitable for use (7.5.4 Customer property)
    – Records of the basis used for calibration or verification of
    measuring equipment where no international or national
    standards exist (7.6 Control of monitoring and measuring
    devices)
    – Records of the validity of previous measuring results when
    the measuring equipment is found not to conform to
    requirements (7.6 Control of monitoring and measuring
    devices)
    – Records of results of calibration and verification of monitoring
    and measuring devices used to provide evidence that the
    organization’s products meet requirements (7.6 Control of
    monitoring and measuring devices)
    – Records of the organization’s internal audits (8.2.2 Internal
    audit)
    – Records of conformity of the organization’s product based on
    the acceptance criteria and the personnel responsible for the
    release of the organization’s product (8.2.4 Monitoring and
    measurement of product)
    – Records of nonconformities of the organization’s products and
    subsequent actions relating to the nonconforming products (8.3
    Control of nonconforming product)
    – Records of the results of corrective action taken by the
    organization to eliminate the cause of nonconformities in order to
    prevent recurrence (8.5.2 Corrective action)
    – Records of the results of preventive action taken by the
    organization to eliminate the causes of potential nonconformities
    in order to prevent their occurrence (8.5.3 Preventive action).
    GMPs and HACCP prerequisite programs
    • prerequisite program includes the GMP items
    addressed in the sections on Plants and grounds
    and Sanitary facilities and controls of Subpart B-
    Buildings and Facilities of the Current Good
    Manufacturing Practices
    • Relationship to ISO 9001:2000: The requirements
    of 6.3 Infrastructure address the topics covered by
    this prerequisite program.
    Location
    The buildings in which food is processed or stored
    should not be located in close proximity to sites
    that are sources of environmental pollutants, pest
    infestations, smoke or dust, to areas that
    accumulate wastes or stagnantwater, or have
    industrial, agricultural or other activities which are
    potential sources of food contamination. If any of
    these undesirable conditions exist, there should be
    adequate safeguard to protect against any potential
    contamination or pest infestation.
    Grounds
    • The grounds of buildings in which food is processed or
    stored should be adequately sloped and drained to
    prevent stagnant water, be free of waste and debris, be
    controlled for dust, and be adequately maintained to
    protect against becoming a source of contamination or
    pest infestation.
    • In order to protect from pests, maintenance of the
    grounds should address grass and lawns, shrubs, trees,
    receptacles for storage of garbage, and any structures
    located on the grounds. In particular, the perimeter of
    the building exterior should be well maintained to
    prevent breeding or attraction of pests.
    • Parking lots and roadways should be maintained so that
    they are not sources of dust and airborne contaminants
    that can enter the building.
    Building exterior
    • The design, construction and maintenance of exterior
    walls and roofs of buildings, should prevent the entry of
    sources of contamination and pests, and leakage of
    water into the building.
    • Exterior walls should be free of cracks that could be
    breeding sites for pests.
    • Openings for exhaust fans and air intake ducts, and
    exterior drainpipes should be adequately screened and
    protected to prevent entry of pests.
    • The loading and unloading areas of the building, and all
    exterior doors and windows should be adequately
    protected to prevent entry of pests.
    • The location of exterior lighting should not attract
    insects into the building.
    Building interior
    • Design and layout:
    -The design and layout of the building interior and the location of
    all structures, equipment, services, and facilities should permit
    movement of personnel and equipment, flow of air, materials and
    products, movement of waste and garbage, and storage of
    materials and products, in a manner that prevents contamination
    and cross-contamination of materials and products.
    -There should be designated areas for processing, for packaging, for
    raw materials storage and preparation, and for finished product
    storage. Processing activities that are potential sources of cross-
    contamination should be located in areas that are separated from
    other processing activities.
    -The layout of the building should provide adequate workspace for
    plant employees to perform their tasks satisfactorily, and adequate
    space for cleaning of all structures. The location of equipment
    should be such that it is accessible for regular cleaning and
    maintenance.
    • Structures:
    -The design and construction of all building structures
    such as floors, walls, ceilings, overhead structures,
    windows, doors, and stairs, and all utilities and service
    structures such as ducts, pipes and drains should meet
    all requirements for construction of food plants.
    -The materials used for construction and finishing of
    these structures should not be sources of
    contamination and should be durable, impervious,
    smooth and easily cleaned and maintained.
    -The materials used for construction of walls and floors
    should withstand the routine plant operating
    conditions and the routine cleaning and sanitizing
    conditions.
    • Glass:
    -Glass or glass-like materials such as breakable plastic
    in food plants can be sources of physical hazards and
    should not be used in processing areas where there is a
    likelihood of breakage that will result in contamination
    of product.
    -If these materials must be used, they must be
    adequately protected from breakage. Overhead light
    bulbs should be protected from breakage if they are a
    potential source of contamination.
    -The control of glass and glass-like materials in a food
    plant should be addressed in a glass policy that should
    cover instructions for dealing with breakage of glass,
    and the control of glass and glass-like materials in items
    such as clocks, lights, gauges, containers and glassware.
    • Corners and joints:
    -Corners and joints in all structures should be
    designed to prevent accumulation of contaminants
    and to facilitate cleaning; they should be free of
    cracks and openings.
    -The junctions between walls and floors should be
    designed to facilitate cleaning.
    -Joints on walls, floors, and ceilings should be sealed
    and should be easily cleaned.
    • Floors:
    The surface of floors should be even, but with the
    appropriate slope for waste-water and other liquids
    to be drained at the designated outlets. Floor
    surfaces should be impervious, durable and free of
    cracks to facilitate cleaning.
    • Windows and doors:
    Windows on exterior walls should be sealed or fitted
    with screens to prevent entry of pests. Exterior
    doors should be self-closing, should always be kept
    closed, and should be without gaps or openings
    when closed, to prevent entry of pests. Exterior
    doors should be kept closed to prevent
    unauthorized access into the building.
    • Lighting:
    The building interior should be equipped with
    adequate light and lighting facilities to permit
    employees to carry out their designated tasks in
    areas where processing, handling, storage, testing,
    inspection and cleaning activities take place.
    Adequate lighting should also be provided in hand-
    washing areas, change-rooms, locker rooms and
    toilet rooms.
    • Ventilation:

• There should be adequate ventilation and air
  exchange throughout the building to prevent airborne
  contamination, condensation on any structure or
  equipment, and accumulation of dust.
  -High humidity should be avoided to prevent mold
  growth and some types of insects.
  -The direction of air-flow should not result in
  contamination or cross-contamination of foods.
  -In addition, fans and other air-blowing equipment
  should be operated in a manner that does not result in
  contamination.
  -Air filters and dust collectors should be cleaned,
  maintained and replaced so that they are effective and
  do not become sources of contamination.
  • Drainage and sewage systems:
  -The drainage and sewage systems should be
  designed to prevent cross-connection of sewage
  with other wastes from the plant in order to avoid
  any potential for contamination.
  -Drains should be adequately sloped to ensure
  there is no accumulation of wastewater or other
  liquids.
  -The location of drains and drain traps should
  permit ready access for cleaning. The design and
  maintenance of the drainage system should prevent
  backflow of wastewater into the building.
  • Pipes and hoses:
  -Water pipes should be free of condensation.
  -Insulated pipes should be well maintained and
  should be free of condensation drips and mold
  growth.
  -Water taps, faucets, and hose connections should
  be free of leaks and water drips.
  -Hose reels should be provided for storage of water
  hoses when not in use.
  Access to premises
  • The entrances and exits of a food plant should be
  controlled to prevent access by unauthorized
  personnel.
  • Exterior doors should not open from the outside of
  the building.
  • Food plant employees should use only the
  designated entrances and exits.
  • Receiving and shipping locations should not be used
  by employees as entrances or exits.
  • Access of visitors into food plants should be
  controlled.
  • Washrooms and toilet rooms:
  Washrooms and toilet rooms in particular, should be
  separated from and should not open directly into food
  storage, handling and processing areas. Washrooms should
  be equipped with the required hand-washing facilities,
  covered garbage receptacles, and easily understandable signs
  to serve as reminders to employees.
  • Change-rooms:
  -Change-rooms should be available for employees to change
  from their personal external clothing into designated work
  uniform and footwear.
  -Change-rooms should be equipped with lockers or suitable
  storage racks for employees to store clothing, footwear and
  other personal items, with receptacles for dirty work clothes,
  and covered garbage receptacles.
  -The design and location of lockers and storage racks in
  change-rooms should facilitate cleaning.
  Employee facilities
  • Hand-washing:
  -There should be accessible hand-washing stations at the
  appropriate locations, with potable running water at a
  suitable temperature, soap or other hand-cleaning and
  sanitizing materials, sanitary hand-drying equipment or
  supplies for employees to wash and dry hands as required.
  -The water control devices at the hand-washing stations
  should be designed to protect against recontamination of
  washed hands.
  -If disposable towel is used for hand-drying, a covered
  garbage receptacle should be provided for used towels.
  -There should be easily understandable signs posted at
  hand-washing stations to remind employees to wash
  hands.
  • Lunchrooms and break-rooms:
  -There should be designated lunchrooms and
  break-rooms for employees.
  -Lunchrooms should be equipped with appropriate
  appliances and food storage facilities for
  employees’ food and with covered garbage
  receptacles.
  -If smoking is permitted in lunchrooms and break-
  rooms, it should be restricted to designated areas
  and ashtrays should be provided.
  • Cleaning and sanitizing facilities
  -Potable running water at the required temperatures
  and pressures should be available for all cleaning and
  sanitizing activities.
  -The required equipment and tools for cleaning and
  sanitizing should be available.
  -Equipment and tools used for cleaning of food-contact
  surfaces, food processing equipment and utensils
  should be appropriately identified and stored so that
  they are separate from those used for cleaning of
  building structures such as floors and walls.
  -There should be designated areas for cleaning of
  cleaning equipment and tools and for their storage
  when they are not in use.
  • Storage facilities
  -There should be adequate and appropriate facilities such as
  warehouse, storage rooms, silos, tanks, vats, bins, or other
  containers, for the storage of raw materials, ingredients,
  packaging materials, products to be reworked or recycled,
  semi-finished products, finished products, cleaning materials
  and nonfood chemicals.
  -These storage facilities should be designed to ensure that
  there is no contamination, cross-contamination, or pest
  infestation of raw materials, ingredients, packaging materials,
  and semi-finished and finished products during storage.
  -There should be separate storage facilities to segregate food
  materials from nonfood chemicals.
  -There should also be appropriate storage facilities for idle
  food processing equipment and for tools, materials, and spare
  parts used for repair and maintenance of equipment.
  • Waste collection and storage facilities
  -There should be designated containers with covers,
  if necessary, for collection of waste and garbage and
  for their temporary storage until disposal.
  -These containers should be properly identified,
  and be made of durable, impervious material and
  maintained in a sanitary condition.
  -There should be no leakage from waste containers.
  -Waste collection containers located on the grounds
  outside of the building should be maintained so
  that they are not sources of contamination or pest
  infestation.
  Water
  • Water supply:
  -There should be an adequate supply of potable water, at
  the desired temperatures and pressures, for use in processing
  operations and for cleaning.
  -There should be facilities to ensure that temperature and
  pressure requirements for water can be achieved.
  • Water quality:
  -Only potable water should be used in all food plant
  processing and cleaning operations. The water quality should
  conform to the guidelines for potable water based on
  microbiological, chemical, and physical specifications of
  applicable government agencies.
  -Water should be tested periodically to determine if it
  complies with these specifications; the records of water
  quality test results should be maintained.