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This Section is prepared by Professor Mogens Jakobsen

5.2.1. Definition of ISO quality standards

The International Standards Organization (ISO) is located in Geneva, Switzerland, and is a federation of national standard bodies representing almost 100 countries.

Based on the good experience gained with the British Standards (BS) 5750 series published in 1979 they were adopted by ISO, and the ISO 9000 series were published in 1987 aiming at providing an international acknowledgement of quality efforts. Today, more than 50 countries have adopted the ISO 9000 series which is equivalent to the BS 5750 standards as just mentioned. In the United States, the standards are published as the ANSI/ASQC Q 90 series and in the European Community they are published as the European Norm (EN) 29000 Series.

The ISO 9000 series include 5 separated standards as shown in Table 5.15.

Table 5.15. ISO 9000 Series.
ISO StandardField of application
ISO 9000Selection of the appropriate ISO 9000 standard
ISO 9001Quality system requirements for product development, production, delivery and after sales functions
ISO 9002Quality system requirements for production and delivery
ISO 9003Quality system requirements for final inspection and testing
ISO 9004Guidelines for ISO 9000, quality system elements

ISO 9001, 9002 and 9003 are three specific standards describing the elements and requirements of a quality system to be implemented in a company in connection with a contractual situation, i.e. the supplier - customer relation. They standardize and outline how companies can establish efficient Quality Systems, and they form the background for obtaining a Quality System Certificate issued by an approved, independent organization (certifying body).

As seen from Table 5.15, ISO 9001 is the most comprehensive standard containing most of the elements described in the guidelines given in ISO 9004. Compared to ISO 9002 the most important difference will be that it includes development of new products and processes. The ISO 9003 is used in situations where requirements to the producer only comprise final product inspection and testing and this standard only contains a minor part of the elements of ISO 9004.

For food processing companies, the most relevant standards will be ISO 9001 and 9002 containing the elements shown in Table 5.15 and described briefly in the following paragraphs.

However, it shall be mentioned that the combined use of standards can be advantageous. For small enterprises like a fishing boat, one could use ISO 9003 and add the relevant elements of ISO 9002. This can lead to the most appropriate system manageable by such a small entity. In such a case the official certification as mentioned above, will be according to the ISO 9003.

5.2.2. Elements of the quality system

The various elements of the ISO 9000 standards are shown in Table 5.16 and shall be commented briefly in the following.

Management responsibility is the first and overall most important system requirement mentioned. Full commitment of the company top management is a must, and the entire system must be under management control and review. Management shall define the objectives and the policy of the system, and it bears the full responsibility for ensuring that the policy is understood, implemented and maintained at all levels in the company. Responsibility and authority of all personnel who manage, perform and verify work affecting quality, shall be defined by the management, and adequate resources should be provided.

If the HACCP concept is applied, it shall be stated in the company quality objective and policy.

Requirement No. 2, which has the heading, Quality System, refers to the documented system ensuring that products comply with the specified requirements. It states that management shall ensure the presence of documented procedures and instructions in accordance with the ISO 9000 standard in question as well as efficient implementation of the Quality System procedures and instructions. As mentioned later and shown in Figure 5.4, the system will often be organized in three levels comprising the Quality Manual, Procedures and Instructions. If the HACCP concept is incorporated with the more narrow quality objective, e.g. with Salmonella as the defined risk, only procedures and instructions for control of Salmonella as defined in the objective of the system will be included.

In Contract review Requirement No. 3, it is laid down that the producer shall review and evaluate all contracts to ensure that he can supply a product which meets the customer's specified requirements and expectations, e.g. the product shall conform to specified requirements which for Salmonella, could be “absence in 25 g frozen shrimps” in each of a certain number of packages according to the sampling plan agreed upon.

Obviously, this element is very important in the ISO 9000 system designed to deal with supplier - customer relations. It is also stipulated that records of such contract reviews shall be maintained.

For product development Requirement No. 4, the supplier shall establish and maintain procedures which control and verify all phases of product development to ensure that the specified requirements are met. Using HACCP and Salmonella as an example, this means that the system shall ensure that new products and processes are not implemented unless they provide safety against Salmonella as laid down in the quality objective of the system. This is a complicated, demanding element of the standard, difficult to implement as well as maintain in the company. For the example used, it requires profound microbiological expertise.

Documentation is a vital part of the system, and so is Document Control as mentioned in Requirement No. 5. This control shall ensure that all necessary documents (procedures, instructions, forms, etc.) are available where needed, and obsolete documents promptly removed from all locations.

It is a key point of ISO 9000 that Purchasing (Requirement No. 6) only takes place from approved suppliers which have been selected on the basis of previous performance and an effective control system as well as their ability to meet the specified requirements. When applying the HACCP concept for the Salmonella in farmed frozen shrimp, it means that feed for the farm should only be purchased from feed mills producing feeds which do not contain Salmonella according to the specifications agreed upon. The standard reaches even further in demanding mutual cooperation and a contractual understanding with the feed mill; the mill shall be assessed to be included in the list of approved suppliers established according to ISO 9000 requirements. The feed mill shall be audited just like all other suppliers on the list, and purchased products shall be inspected on receipt, and feed-back on performance at all points shall be ensured. The very obvious reasons for these detailed requirements for purchasing obviously will be the inevitable effect of raw materials, machines, cleaning agents, services, etc. on the quality of the final product.

Procedures for product identification and traceability during all stages shall be established, maintained and recorded as stated in Requirement No. 7. If required, each batch, package, etc. shall be provided with a unique identification which shall be recorded.

Process Control (Requirement No. 8) shall ensure that all processes influencing the quality of the final product shall be specified and documented to ensure and verify that they are carried out under controlled conditions. This involves documented work instructions, including cleaning and disinfection procedures, use of appropriate equipment, machines, material and arrangement of processing facilities as well as monitoring of products and processes.

This element will be the key area for the HACCP concept with the Hazard Analysis, identification of Critical Control Points (CCPs) and monitoring of CCPs, as described in Section 5.1.

A schedule for testing and inspection of raw materials, intermediate and final products shall be established (Requirement No. 9). For the HACCP system, the schedule must be based on CCPs as identified in the hazard analysis. Test methods must be defined. Responsibilities for sampling and testing, reporting and control of non-conforming products shall be defined and reference made to the appropriate specifications.

The test equipment used shall be selected to demonstrate acceptable compliance with the defined specifications for the products and shall be calibrated at regular intervals against nationally recognized standard references (Requirement No. 10).

Proper identification of the inspection and test status shall be ensured with untested, tested, approved or rejected products being clearly marked (Requirement No. 11).

Procedures and instructions shall be established for control of non-conforming products (Requirement No. 12). In the present example, shrimp containing Salmonella will be a non-conforming product according to the specifications agreed upon. Such a product shall be identified, placed and labelled in a way that clearly isolates it and prevents it from being supplied as Salmonella-free by mistake. The responsibility for making decisions on disposition of non-conforming products shall be defined and documented. A non-conformity report shall be worked out stating the nature of the non-conformity, the disposition decided, and the corrective action to be initiated for resolving the non-conformity as described in the following.

The corrective action system (Requirement No. 13) is concerned with revising work operations etc. to try to eliminate the causes of failure. This is the system requirement that helps a company getting better and better by aiming at doing everything right the first time. To control all the activities required in the corrective action, forms containing the following points shall be applied: Clear statements of the non-conformity, responsibilities, action to be taken, date of implementation, verification and recording of the resulting new procedures.

Handling, storage, packaging and delivery (Requirement No. 14) is obviously very important for foods, to prevent damage or deterioration of the products. Temperature control including monitoring and recording shall be mentioned as examples to illustrate the importance of this requirement which obviously apply to all stages from raw materials, throughout production and delivery, and to the point of consumption. Determination and control of shelf life is needed, and so is full traceability with respect to the risk of product recall.

As mentioned several times in the above, recording is required with the purpose of demonstrating the achievement of the required quality and to demonstrate that the quality system is effective. This is stated in Requirement No. 15 Quality Records and the meaning of it will be seen from the following examples of records to be included: inspection reports, analytical results, calibration reports, audit reports and corrective action reports.

It is also demanded that the systembe internally audited on a regular basis (Requirement No. 16, Internal Quality Audits). An appropriate audit plan shall be worked with ensuring that all elements (not necessarily all details) are audited e.g. once a year. Audit teams shall be formed and it must be assured the members are independent of the activities being audited. The audit report shall be included in the quality records as mentioned above.

Management shall carry out its own independent review and evaluation of the Quality System. This has to be carried out on a regular basis e.g. twice per year and it should be based on the above international audit reports mentioned above as well as evaluation of the overall effectiveness of the system in achieving the quality objectives stated. Needs for updating, new strategies etc. should also be indicated. It all has to be documented in a report. This again demonstrates the very active role to be played by the management of the company.

Training (Requirement No. 17) is a vital part of the ISO 9000 standards. Of similar importance to food companies are cleaning and disinfection and personal hygiene. These subjects have been included as separate requirements (No. 18 and 19)in Table 5.15 to emphasize their importance and they have been used for the following illustration of the structure of the system with its various types of documents.

Table 5.16 Quality system elements.
Quality System RequirementsContents
1Management responsibilityDefine and document commitment, policy and objec- tives, responsibility and authority, verification resources and personnel. Appoint a management representative and conduct regular reviews of the system
2Quality systemEstablish and maintain a documented quality system ensuring that products conform to specified requirements
3Contract ReviewEnsure that customer's contractual requirements are evaluated and met
4Product developmentPlan, control and verify product development to ensure that specified requirements are met
5Document controlSystem for control and identification of all documents regarding quality, e.g. procedures, instructions, and specifications
6PurchasingEnsure that purchased products conform to specified requirements
7Product identification and traceabilitySystem to identify and control traceability of product at all stages from raw materials through production to the final product as delivered to the customer
8Process controlEnsure and plan the control of production which direct- ly effects quality by documented work instructions, monitoring and control of processes
9Inspection and testingInspect and test incoming products, intermediate and final product; establish product conformance to speci- fied requirements and identify non-conforming pro- ducts; maintain inspection and test records
10Inspection, measuring and test equipmentSelection and control of equipment to ensure reliability and accuracy in measuring data
11Inspection and test statusFor the whole process the products shall be identified and clearly marked concerning test status, including indication of conformance or non-conformance
12Control of non-confor- ming productsIdentification, documentation, evaluation, isolation (if possible) and disposition of non-conforming products
13Corrective actionsPrevention of reoccurrence of failures (non-conforman- ce)
14Handling, storage packaging and deliveryProtection of the quality of the product during hand- ling, storage, packaging and delivery
15Quality recordsRecords, including those which demonstrate that the specified requirements have been met, shall be control- led and maintained
16Internal Quality AuditsRegular, planned internal audits shall be carried out, documented and recorded to verify the effectiveness of the quality system
17TrainingTraining requirements at all levels shall be identified and the training planned, conducted and recorded
18Cleaning and DisinfectionAlthough not required by the ISO 9000 standards, these two points should be given special attention in all food companies
19Personal hygiene 

5.2.3 The documented quality system

As mentioned above (Table 5.16, Requirement No. 2) the ISO 9000 standards require a documented quality system.

The three-level structure of documentation shown in Figure 5.4 has proved effective in the food industry as well as in other industries.

Level 1 is described in the Quality Manual. It is normally a short easy-to-read manual briefly stating the company's quality objectives and policies. All requirements of the appropriate ISO Standard will be addressed. The Quality Manual need not contain confidential information, and it is intended to be handed out to potential customers and others, to inspire confidence in the company being able to satisfy customers' expectations. In the example chosen, a proposal for Chapter 18, Cleaning and Disinfection, is shown in Table 5.17 for the plant producing frozen shrimps. The Table also shows the various formal requirements for the documents of the Quality System. Normally, the individual pages of the Quality Manual will be signed by the managing director or by the chairman of the board to demonstrate the commitment of the top management.

Figure 5.4.

Figure5.4. Typical structure of the Quality System.

The second level will comprise procedures, describing how the statements of the Quality Manual are deployed and implemented in the company. Persons responsible, as well as where and when will be stated. An example of a procedure is shown in Table 5.18. The above mentioned Chapter 18 of the Quality Manual underlies this procedure which could be issued by the QC-Manager and approved by the Technical Director.

The third level will comprise the work instructions giving all details on how the contents of the procedures are accomplished. Table 5.19 shows an instruction linked with the procedure featured in Table 5.18.

In levels 2 and 3, appropriate references will be given to various forms to be filled out e.g. the list of approved suppliers mentioned earlier and being part of the system documentation. An overview of the categories of documents included in a Quality System is given in Table 5.20. The Table almost speaks for itself and it clearly underlines the requirements for documentation including record keeping.

Table 5.17. Example of company policy (cleaning and disinfection). Quality manual, Chapter 18, level 1. Figure 5.4.



EDITION:1 1993–01–15 PAGE: 1 of 1


It is the policy of Company XX to maintain a high standard of hygiene.

Procedures and instructions will be maintained to ensure that the high standard is in accordance with the requirements specified.

Detergents and disinfectants shall be selected and disinfection procedures worked out to ensure that the plant is free from Salmonella after cleaning and disinfection


Table 5.18. Example of Procedure, Cleaning and Disinfection. Level 2, Figure 5.4.


PROCEDURE NO.: P 18 10 05 REVISION NO.:3 DATE: 1993-03-16

1. EDITION: 1993-01-15 PAGE:1of1



Description of the procedure for cleaning and disinfection to ensure that the processing plant is visibly clean and Salmonella non-detectable after cleaning and disinfection.


The Technical Director is responsible for implementing and maintaining this procedure.


This procedure is valid for all areas, equipment, etc. where shrimp are handled within Company XX.


With reference to the Technical Director, the foreman of the various sections of the processing plant are responsible for cleaning and disinfection.

Cleaning and disinfection is carried out at the end of each working day. The QC-Manager shall select and organize the use of cleaning agents and disinfectants in order to eliminate Salmonella, to prevent the buildup of scales or other residues as well as resistant microbial populations.

The QC-Manager is responsible for control and monitoring of the effectiveness of the cleaning and disinfection performed.


The QC-Manager and the foreman shall report their findings to the Technical Director


Table 5.19. Example of work instruction for cleaning and disinfection. Level 3, Figure 5.4.


INSTRUCTION NO.: P 18 10 05 REVISION NO.: 3 DATE: 1993-03-16

1. EDITION: 1993-01-15 PAGE: 1 of 2




It is the objective of this instruction to describe the cleaning and disinfection of cooler and conveyer for cooked shrimp carried out at the end of each working day, and before production in case the plant has not been in operation for more than two days.


The Technical Director is responsible for implementing and maintaining this instruction.

The Foreman of Processing Hall C is responsible for carrying out this instruction.


This instruction is valid for Processing Hall C.


  1. Preparations Cooler and conveyer are emptied and dismantled to allow cleaning of all parts.

  2. Rinse Hosing with cold water

  3. Cleaning Alkaline detergent “ZZ” is applied to all surfaces. Dosage: 3 l in 50 l cold water. pH: 12.5 Contact time: 15 min.

  4. Rinse 60°C water; hosing until all detergent is removed

5. Visual inspection All cleaned surfaces are inspected. If residues are observed steps 2, 3 and 4 are repeated. The inspection is recorded in the Logbook of Hall C.

6. Disinfection Chlorine (YY) is applied to all surfaces. Dosage: 1 l to 50 l of cold water. Free chlorine level: > 200 ppm. Contact time: 10–15 min.

7. Rinse Hosing with cold water

8. Inspection Before start of production a visual inspection is carried out and the result is recorded in the logbook of the Process Hall C.

9. Reporting Inspection result are reported by the Foreman to the Technical Director, who decides on the corrective actions to be initiated.


Table 5.20. Overview of the categories of documents included in a Quality System.

5.2.4. Establishment and implementation of Quality System

The work involved in establishing and implementing a Quality System e.g. ISO 9001 or 9002 should not be underestimated. It is a very demanding project both in terms of man-hours and of resources. Proper planning including well defined project organisation and very often with assistance from outside consultants is a necessity for a successful result. Further, full commitment and motivation as well as intensive training of all employees are indispensable requirements.

Table 5.20 and Figure 5.5 illustrate the various activities involved as well as a time schedule for a smaller company. To initiate the project and as responsible for its completion, a Quality Management Group will normally be formed. For food industries this Group may comprise the following persons: Managing Director, Technical Director, R & D Manager, Sales Manager and Head of Laboratory. The key functions of the Group can be summarized as follows:

The various phases and activities following the formation of the Quality Management Group are shown in Table 5.21 and Figure 5.5 which almost speak for themselves. The time required i.e. about 1–2 years or more, for the implementation and certification of the system in a medium size company, should be noticed.

Table 5.21. Phases of a quality system approach.

Formation of a quality management group

Hazard Analysis

Audit of present system elements

Estimation of resources and total period of time required for the project including certification

Formation of project organisation

Preparation of Quality Manual (level 1)

Training of all staff members

Definition of procedures and instructions (levels 2 and 3) to be included in departmental manuals i.e. table of contents

Decision on time schedule for preparation of departmental manuals

Establishment of working groups for the preparation of the individual procedures and instructions

Commenting, reviewing, approving and issuing procedures and instructions

Implementation of procedures and instructions

First approach to certifying body

Internal auditing

Corrections, adjustments etc.

Further training of staff


Figure 5.5

Figure 5.5. Time schedule for establishing and implementing a quality system in a small size food processing plant.

5.2.5. Advantages and disadvantages experienced by ISO 9000 certified companies

An analysis encompassing one hundred ISO 9000 certified companies showed that they all had experienced significant advantages. Marketing merits, reduced quality costs, and higher efficiency were the main advantages mentioned, all contributing to a higher profitability. Findings which agree very well with the general opinion within the food industry in Europe. As regards quality costs, Figure 5.6 shows how profit is typically created when Quality Management is implemented in a company. The reduction in quality costs observed in practice can be as much as 5–15% of the company turnover, and investment in Quality Management have proved to be profitable.

The disadvantages experienced appear to be too much bureaucracy and lack of flexibility, which are inherent parts of the ISO standards, together with the significant amount of paper work involved.

The main objective of Quality Management according to the ISO 9000 series can be defined as meeting the agreed requirements of the customer. This underlines that the quality of a company's products is the key factor in the performance of the company. ISO 9000 is clearly a system seeing quality from the industry's point of view.

The response from the food industry has been slow compared to other industries. However, a rapidly increasing interest is now seen in Denmark and several other European countries. The interest is not limited to food processing plants; all links from primary production to the final product are becoming involved. One may expect that in the near future the whole chain from the primary producer to consumers will be covered by certified quality systems. Projects on certification of farms are in progress in Denmark, and fishing boats have already been certified according to ISO 9000.

This development will form a proper background for meeting the worldwide trend towards more stringent customer expectations.

Figure 5.6

Figure 5.6 Economical benefits from introducing a quality system.

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