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    9

    Quality management system

    Abstract: In this chapter the general requirements of building ISO 9001 based quality management systems are explained. In this the emphasis is on the process approach, as well as in the documentation and management of the documents, including archiving them. Also, the building of the quality manual is explained.

    Key words: quality management systems, requirements, documentation, quality manual, processes, archiving, ISO 9001

    Quality management system [4]

    General requirements [4.1]

    What is this requirement and what happens if one does not meet this requirement?

    The organisation has to establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 9001. According to the standard (ISO 9001), the organisation needs to:

    a) Determine the processes needed for the quality man-agement system and their application throughout the organisation.

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    Managing Your Library and its Quality

    b) Determine the sequence and interaction of these processes.

    c) Determine the criteria and methods needed to ensure that both the operation and control of these processes are effective.

    d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.

    e) Monitor, measure (where applicable) and analyse these processes.

    f) Implement actions which are necessary to achieve the planned results and continual improvement of these processes.

    Clause 4.1, based on the system approach principle, estab-lishes the general features of any quality management system and lists six specifi c requirements that summarise the standard.

    The library activities can be seen as a chain of processes that crosses the librarys functional sections. Each of them produces results of added value that help the library to attain its objectives.

    All libraries have some kind of management system, more or less formalised, but clause 4.1 requires that there should be effective formalisation of the quality management system. Thus, when the quality management system is being designed, the library does not start from zero and, fortunately, many processes may already exist and may well be adequately defi ned. However, while one is setting up the librarys quality management system in accordance with the requirements of the standard, one probably will be surprised by the absence of some written procedures in the current library management system.

    The creation of a quality system requires, fi rst of all, that one must design a system having the librarys mission and

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    Quality management system

    users in mind, as well as establishing and defi ning all of the interconnected processes involved (see Figure 9.1). The processes are not independent and it is necessary to refl ect on the relationships and connections between all the processes and furthermore to ensure that all the linkages are properly working and interacting so that the outputs from a process feed and support the other processes (see Table 9.1). This should also be the case when one outsources some of the organisations processes, e.g. e-journals in academic libraries.

    The library staff need resources and information documentation and communication in order to correctly perform their tasks and to ensure that there is effective control of the processes. It is not enough merely to document what the library is already doing. When a system is established, it has to be operated consistently and, to ensure effective operation, it is necessary to set success criteria

    The chain of a librarys core processes (published by kind permission of Arja Juntunen)Figure 9.1

    Librarys core processesStrategic aimsMeasurement and evaluationSupport and management

    Docu-mentedinfor-

    mation

    Personnel resourcesLibrary premises and equipmentComputers and networksWork places and equipmentKnowledge management

    Continuous development

    Informationretrieval and

    tutoringAccess

    anddatabases

    Collections:-printed-digital

    LendingCopying,printing,usage

    User gets theinformationneeded and

    learns to searchinformationILL

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    Managing Your Library and its Quality

    which need to be met by a process in order to fulfi l its objectives and there have to be methods that will ensure effective operation.

    All the parts of the system are important; to utilise effectively the system being created, it has to be in accordance with all of the items referred to in this clause.

    How to implement it

    When you start to make a QMS:

    Acquire fl owchart software it helps in creating process charts and managing the totality.

    If you are not able to purchase software, use cheap traditional techniques: Post-Its on the wall, blackboard, etc.

    Benchmark other libraries process charts and maps.

    Involve staff and users in this process.

    Clause 4.1 lists six specifi c requirements that need to be fulfi lled.

    Examples of library processesTable 9.1

    Management processes

    Operational processes Supporting processes

    Strategic planningQuality systemHuman resources

    AcquisitionsCirculationInter-library loansKnowledge organisation process (cataloguing, indexing)Information diffusion (web)Information literacy tuitionReference

    ComputingMaintenanceCleaningPhotocopying, scanning and printingAccounting

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    Quality management system

    A) Determine the processes

    Take a look to the comments in clause 0.2 Process approach (on page 52).

    As a starting point, it can help to determine the mission statement of the library (a topdown approach). Then list the capabilities needed to accomplish this mission and thus the core processes required to deliver these capabilities will be identifi ed. If the library does not yet have a mission statement, this is the time to prepare it.

    Prepare an initial list of the librarys processes. A typical list could include: acquisitions, cataloguing, circulation, etc. Do not forget to list the outsourced processes.

    Each set of activities is not necessarily a process. If the result adds no value, continue the sequence until added value is found and this fi nally completes a process.

    B) Determine the sequence and interaction

    Think of the library system as a set of interconnected pro-cesses rather than as a series of interconnected functions.

    Each process delivers an output that serves as an input to the other processes. The factor order alters the output, so be careful when defi ning the sequence.

    Prepare a chart with the interconnected main processes. However, it is also important to defi ne the sub-processes, as it will be necessary to document all of them (see clause 4.2).

    In this chart level avoid including sub-processes in order to avoid unnecessary complexity.

    C) Determine criteria and methods for effective operation and control

    Identify the factors that affect the success of the per-formance (for example, deadlines, costs).

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    Managing Your Library and its Quality

    Determine the way in which the process is carried out to deliver the desired results.

    Prepare the procedures, with a description of the process.

    D) Ensure the availability of resources and information

    Determine the resources and information required to perform each library activity.

    Determine the resource allocation procedures.

    E) Monitor, measure and analyse processes

    Decide the data needed in order to provide indicators that will help to control the processes.

    F) Implement actions necessary to achieve planned results and continual improvement

    The library has to improve the effectiveness of the quality management system continually and there are several ways to achieve this goal. Some examples include:

    general improvement derived from the implementation of the quality system that helps to reformulate the current management system;

    effi ciency improvement resulting from the enhancement of library operations (e.g., less complexity, faster routines, more effective use of the resources);

    effectiveness improvement as a result of identifying better policies and objectives (e.g., new targets, new user requirements).

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    Quality management system

    Documentation requirements [4.2]

    General [4.2.1]What is this requirement and what happens if one does not meet this requirement?

    The organisation has to document the quality management system in accordance with the requirements of the standard. According to the standard (ISO 9001), the management system documentation needs to include:

    a) documented statements of a quality policy and quality objectives;

    b) a quality manual;

    c) documented procedures and records required by this international standard;

    d) documents, including records, deemed by the organisation to be necessary to ensure the effective planning, operation and control of its processes.

    It is necessary to document all the sets of interrelated processes that form the quality management system. Since the documentation can be kept in any form or type of medium and, in addition, a single document may include the requirements for one or more procedures, one does not need to panic about being drowned in a tsunami of bureaucracy.

    The extent of the quality management system documen-tation will differ from one library to another due to the size, type and complexity of the library. The library is left to decide about the documentation necessary for the effective operation and control of its processes. There are many reasons to document library activities. The most important is to communicate information on the requirements, instruc-tions, methods and results effectively. One cannot document

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    Managing Your Library and its Quality

    exhaustively everything that happens inside a library but, on the other hand, one has to bear in mind that verbal information is not a document, and often some activities developed by the library are based only on an oral tradition. Thus, it is important to be able to fi nd the perfect equilibrium on the depth and breadth of the documentation.

    A procedure is a specifi ed way to carry out an activity or a process. It is clear that procedures are useful in order to ensure that tasks are tackled with consistency, economy, repeatability and uniformity. Sometimes it has been said that documenting procedures is counterproductive for creativity and initiative. This need not be true if library procedures refl ect up-to-date practices and there is a mechanism to enhance and upgrade the documentation, as the standard states.

    How to implement it

    Decide on the best method of transmitting the information. Most of the documentation can be kept on the library intranet.

    Prepare the documentation in the form or type of medium you consider most suitable. Some libraries use commercial software, but this is not essential.

    Clause 4.2 specifi es four requirements for documentation.

    A) Statements of quality policy and quality objectives

    Establish the quality policy of the library. Choose clear and short sentences to communicate the quality commit-ment of the library.

    Include the quality statement in the quality manual.

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    Quality management system

    Establish the quality objectives of the library. Choose clear and short sentences and try to defi ne indicators for each one.

    Include the quality objectives in the quality manual, or use suitable documents exclusively for these materials.

    B) Quality manual

    See comments on clause 4.2.2 Quality manual.

    C) Procedures and records required by ISO 9001

    Procedures are not required for each clause of the standard. There are only six procedures actually required by the standard. However, this does not imply that one does not need to prepare any other procedures. The six are:

    Procedure for document control.

    Procedure for the control of records.

    Procedure for auditing.

    Procedure for nonconformity control.

    Procedure for preventive actions.

    Procedure for corrective actions.

    One possibility is to prepare the above-mentioned six procedures as separate fi les, but it may be possible to join some of them together: for example, one procedure may suffi ce for both corrective and preventive actions.

    D) Documents and records determined by the organisation

    Compile the already existing documentation on library activities.

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    Managing Your Library and its Quality

    Most of the library processes can probably be broken down and categorised into several sub-processes. This is also the time to refl ect more deeply on each process.

    Chart the processes and identify where documents are needed to explain tasks and activities.

    Some basic questions can help to identify the essential documents to be prepared: What has to be done? Identify the process. How will it be done? Identify the tasks and competencies related to each process, determine and defi ne methods and procedures, and determine the resources needed: people, equipment and information. Records must also register the results. Thus sometimes one needs to answer questions such as: What was done? And one must be able to verify the achievement of objectives.

    The form is not exactly defi ned in the content of the proce-dures, but a typical procedure could include information on the purpose, objectives, fl ow of activities, relations with other processes, competencies and resources required; performance measures; list of supporting information; and a list of records indicating activities performed and the results of the measurements conducted.

    Start by listing all the documents that should conform to the requirements of the quality system that are already in existence or need to be prepared, such as: quality policy and quality objectives; quality manual (see comments on clause 4.2.2 Quality

    Manual); procedures of all identifi ed processes (including out-

    sourced processes); other documents necessary for effective planning,

    operation and control, such as: laws related to library activities; library standards, e.g. cataloguing rules; regulations from the parent organisation of the library;

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    Quality management system

    regulations from library consortia; agreements and contracts.

    Plan the writing process of the missing documents and decide who is going to be responsible for doing this task.

    Quality manual [4.2.2]What is this requirement and what happens if one does not meet this requirement?

    The organisation has to prepare and maintain a quality manual that includes the scope of the quality management system, the documented procedures and the interaction between the processes. The quality manual can also be viewed as a kind of business card for ones quality system and it is important to be able to include all the general and important information in the manual. In other words, the manual must also be seen as a way of marketing the library.

    The manuals content is not defi ned exactly, but a typical quality manual would include an introduction with infor-mation on the purpose, scope, applicability and defi nitions of terms used in the manual, a business overview with general information about the library, its mission, vision and values, the services offered and the organisation chart, and an explanation of the key processes and how they are intercon-nected. The manual will probably contain information on the physical, human and fi nancial resources, as well as on the design, production and service delivery, and an ISO 9001 compliance matrix.

    The quality manual provides consistency, coherence and visibility to the quality management system.

    How to implement it

    When preparing a quality manual (see Table 9.2):

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    Managing Your Library and its Quality

    Take a look at other quality manuals to familiarise yourself with the organisation of the manuals information. You will be able to fi nd several examples on the Internet.

    1.0 Scope

    2.0 Normative reference

    3.0 Terms and defi nitions

    4.0 Quality management system

    4.1 General

    4.2 Documentation

    5.0 Management responsibility

    5.1 Management commitment

    5.2 Customer focus

    5.3 Quality policy

    5.4 Planning Quality objectives

    5.5 Responsibility, authority and communication

    5.6 Management review

    6.0 Resource management

    6.1 Provision of resources

    6.2 Human resources

    6.3 Infrastructure

    6.4 Work environment

    7.0 Product realisation

    7.1 Planning of product realisation

    7.2 Customer-related processes

    7.3 Design and development

    7.4 Purchasing

    7.5 Production and service provision

    7.6 Control of monitoring and measuring devices

    8.0 Measurement, analysis and improvement

    8.1 General

    8.2 Monitoring and measurement

    8.3 Control of nonconforming product

    8.4 Analysis of data

    8.5 Improvement

    Typical contents of a quality manualTable 9.2

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    Quality management system

    List the documents of the quality management system.

    Prepare a short statement to explain how each of the ISOs clauses has been approached in the quality management system of the library.

    Remember that all the clauses are mandatory with the exception of Chapter 7 (see comments on clause 1.2 Application, p. 63). Consider the exclusion of some of these requirements, provided that there is valid justifi cation, and prepare an explanation to be included in the quality manual.

    Use organisation charts and other graphics to facilitate the understanding.

    Prepare a matrix in order to show the relationships between the ISO clauses, and the documents of the quality management system of the library.

    Control of documents [4.2.3]What is this requirement and what happens if one does not meet this requirement?

    It is necessary to prepare a procedure to defi ne the controls needed to approve and maintain quality system documents. According to the standard, a documented procedure must be prepared in order to guarantee that one is able:

    a) to approve documents for adequacy prior to issue;

    b) to review and update as necessary and re-approve documents;

    c) to ensure that changes and the current revision status of documents are identifi ed;

    d) to ensure that relevant versions of applicable documents are available at points of use;

    e) to ensure that documents remain legible and readily identifi able;

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    Managing Your Library and its Quality

    f) to ensure that documents of external origin determined by the organisation to be necessary for the planning and operation of the quality management system are identifi ed and their distribution controlled;

    g) to prevent the unintended use of obsolete documents, and to apply suitable identifi cation to them if they are retained for any purpose.

    Documentation has to be constantly upgraded and thus it is important that the new documentation should be disseminated to all library staff so that they can use it as soon as possible. In this way, one can be sure that nobody is performing their work using out-of-date information. For this reason, clause 4.2.3 states that a documented procedure has to be established. One needs to defi ne the controls required to approve documents for adequacy prior to their issue and to re-approve documents following updating, and there need to be mechanisms in place to alert users to these changes.

    One must note that though the permanent upgrade and control of internal documentation are important tasks, it is equally essential to ensure that the documents of external origin determined by the organisation to be necessary for the planning and operation of the quality management system are identifi ed and their distribution controlled. For example: what is the quality of a library catalogue if half of the library staff are using the valid edition of the cataloguing rules while the other half are still utilising an older edition which has not been updated?

    How to implement it

    Compile the already existing documentation on library activities and processes. Make a list of internal and

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    Quality management system

    external documentation of the quality management system of the library.

    Identify gaps in the quality system documentation: prepare a two-column list. List all of the ISO 9001 clauses in the fi rst column. Copy into the second column all of the docu-ments that cover the standards requirements. It is possible that one document may encapsulate more than one clause. The blank cells will then reveal the documentation that needs to be prepared.

    Prepare a plan to produce the new documentation or to improve that already in existence.

    Prepare the list of external documentation that is important for the quality management system of the library (e.g., laws, MARC21). It is especially important to keep in mind the relevant copyright laws and other relevant legislation.

    Decide on the methodology to produce the documenta-tion and prepare a procedure: who will prepare which document, what will be its format and the content of documents, forms and diagrams, how it will be identifi ed, who will review and approve them, how will they be disseminated to the staff and users and how to deal with document revisions. Who will do this task, who will approve the requests, who will implement the changes, and how will the changes be demonstrated?

    Decide the most useful and easiest way to track and iden-tify the changes in the documents. There are different pos-sibilities to identify changes in documents. Some examples include: by sidelining, underlining or emboldening, or by a change note at the beginning of the document that gives details about what has changed and why.

    Prepare an easy-to-remember codifi cation to identify pro-perly each document and its status. Use fi xed document templates.

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    Managing Your Library and its Quality

    Control of records [4.2.4]What is this requirement and what happens if one does not meet this requirement?

    It is necessary to prepare a procedure to defi ne the controls needed to identify storage, protection, retrieval, retention and disposal of records to provide evidence of conformity to the requirements, as well as demonstrating the effective operation of the quality management system.

    Records represent the evidence that helps to demonstrate the conformity of the quality system to the requirements of the standard. Since records are at the core of the system, they should have some kind of identifi cation, for example, a reference number to guarantee their traceability (see comments on clause 7.5.3 Identifi cation and traceability).

    If one does not keep the records properly, one risks losing information about the steps performed by the library and ultimately it may become impossible to access evidence to verify that the activities have actually been performed.

    Nowadays, with digitally stored information, problems that used to be associated with this subject have almost disappeared and the librarys intranet is a good place where records can be kept and controlled. One should also check the information systems used in the parent organisation, e.g. archival systems.

    Libraries traditionally have kept extensive records. When preparing the librarys quality system, one usually fi nds that a substantial number of the quality records required by the standard already exist at the library, as over the centuries librarians have developed a culture of revision and control.

    How to implement it

    Decide on the methodology to control the quality records and prepare the procedure: this should include how to

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    Quality management system

    identify, where to store, how to protect, how to retrieve and retain the quality records.

    Use the archiving plan of your institution if one already exists.

    Refl ect on the records already existing at the library and determine whether they can have a new role as quality records (for example, all the information on the ILS (integrated library system)) database.

    Ensure that the personal data of the users (who they are, where they live, phone numbers, e-mail addresses, what they have on loan, etc.) are protected, and explain in the procedure how this is guaranteed. Do this according to data privacy laws and regulations.

    For each process, decide which records guarantee the traceability of the quality information.

    Do not keep more records than those that are strictly necessary. Also, scan the older records regularly and set timelines for document management and disposal.

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