Professional Documents
Culture Documents
1 s2.0 S0736584503000036 Main
1 s2.0 S0736584503000036 Main
Abstract
Maintaining, customizing, sharing and reusing ISO9000 quality documents are essential for many organizations, especially those
who work as virtual enterprises (VE). In a VE, the documents must be shared among organizations to take the full advantages of the
recent Internet advances. XML is a new browser-based language standard. The purpose of this research is to explore the capabilities
of XML and Internet technologies in electronic document management environments to comply with the ISO9000 requirements.
This research has demonstrated several XML-enabled examples beneficial for the main functions of ISO9000 document
management such as document creation, document change, document control and document access. The implemented examples
demonstrate the effectiveness and efficiencies of document customizing, querying, hierarchical linking, tracking and reusing. The
research results solve the ISO9000 document-related problems among working partners and facilitate document flow and
information integration of value chain.
r 2003 Elsevier Science Ltd. All rights reserved.
Keywords: Electronic document management; eXtensible markup language (XML); ISO9000; Virtual enterprises; Value chain
0736-5845/03/$ - see front matter r 2003 Elsevier Science Ltd. All rights reserved.
doi:10.1016/S0736-5845(03)00003-6
356 Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370
Table 1
Characteristics of XML and benefits of using XML
What’s about XML XML as a document format, document management format and data format [11]
The universal format for structured documents and data on the Web [12]
XML as a format for application data exchange and storage [13]
XML as meta data
XML as data [14]
XML is the language of integration [15]
XML as a vehicle for data interchange [16]
98, to companies seeking ISO9000 registration. The 1.2. XML and its benefits
John A. Keane & Associates Inc. provides the QMS/
9000+ document control modules to address the ISO/ XML is a web-based data language standard. It
QS9000 document control requirements from life cycle separates the document’s contents, structures and
point of view [6]. The Harrington Group offers presentations and the XML tags have their distinct
Document Control System to track, organize and meaning. Thus, with proper web development tools, the
manage documents [7]. The Business Challenge Ltd. XML document has many important applications and
provides the iSO-Pro software to help companies delivers significant benefits. Table 1 shows the summary
to achieve ISO9000 document control requirements [8]. of XML features and enabling benefits of using XML.
A database software system, called ProcedureWRITE The widespread support for XML building among
and offered by Comprose Company, is specially browsers, authoring tools, parsers, databases and other
designed for structured knowledge document manage- content applications reduces the cost and risk of
ment [10]. extending applications to XML input and output [20].
Although these benefits of EDMS are significant, In recent years, there are active moves to introduce
there are still some limitations when considering the XML as a standard data exchange format for electronic
issues of document customization, information exchange, commerce and document management applications
reusing, intelligent search and integration. For example, [21,22].
most of the available EDMS solutions are in HTML The purpose of this research is to explore the
format and developed using traditional method. Thus, capabilities of XML and Internet technologies in
their limitations are in flexible information exchange electronic document management environments to
and document customization/adaptation for multiple comply with the ISO9000 requirements. To go into the
users’ needs. Furthermore, few research or commercial main parts of the study, we must have some background
solutions really touch the integration issues in document information on ISO9000 and ISO10013 as described in
creation, review, approval, modification and release, the following sections.
which are the key functions of ISO9000 document
control. Electronically integration of these functions is 1.3. ISO90001
essential to streamline the document flow among supply
chain members and reengineer information value chain. The ISO9000 series are the international standards of
The limitations are mainly due to the facts that most quality management and quality assurance. It includes
current ISO9000 EDMS solutions are not standard
1
XML enabled. Hence, it is important to study how the The document management requirements of the study is based on
new XML capabilities and related technologies can be ISO 9001:1994. Although the standard will change to the ISO
9001:2000, the new standard still requires organizations to have
used to fulfill the ISO9000 compliant document manage-
a quality manual which includes the documented procedures or
ment and integration. Thus, a new-level of web-based procedures references [http://www.lrqa.co.uk/ass-90012000.htm]. At
knowledge management and document manipulation the time of this study, ISO 9001:2000 is only a draft version under
can be achieved. development.
Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370 357
requirements for quality systems development, * introductory pages about the organization concerned
implementation and application. The actual standards and the manual itself;
within the ISO9000 series are ISO9001, ISO9002 and * the quality policy and objectives of the organization;
ISO9003. The ISO9001 is the most comprehensive of the * a description of the organizational structure, respon-
standards and covers a wide range of activities related to sibilities and authorities; and
product quality including design, manufacturing, in- * a description of the elements of the quality system
stallation, and services [23]. It is used when the supplier and any references to documented quality system
must ensure product conformance to specified needs procedures.
throughout the entire product cycle [24]. The main body
of ISO9001 is contained in the quality system require- This research is organized in several sections. Section
ments of Section 4.0. There are 20 clauses and the most 1 provides background information of the research
related clauses to this research are Clauses 4.5, docu- including XML, ISO9000 and ISO10013. Section 2
ment and data control, and Clauses 5.3, document of the proposes the integrated ISO9000 document manage-
quality system. The main requirements of the two ment model. Section 2 also discusses the ISO9000
clauses are described as follows. quality system documents characteristics and docu-
Sub-clause 4.5.1 states ‘The supplier shall establish ment/data control requirements. This section’s effort is
and maintain documented procedures to control all helpful for deriving the document management scenario
documents and data that relate to the requirements of building, depicted in Section 3. The scenario describes
the standard.’ Documents and data can be in many the concrete sample documents flow case for XML-
forms of media. Further in Sub-clause 4.5.2 and 4.5.3, enabled document manipulation implementation. Then
ISO 9001 specifically states the importance of review, in Section 4, we show the implemented examples and
approval, issue, change and document control to ensure demonstrate XML capabilities and benefits in ISO9000
the accurate documents are created, presented and document management. Finally, Section 5 summarizes
updated. In sub-clause 5.3.2, focusing discussion is in the research results.
the purposes of a quality manual and the required
procedures for making modifications, revisions, or
additions to the content of a quality manual. 2. Integrated ISO9000 document management model
Document
management
Document
Document Document
create/
change access
release
Invite Determine
Review
doc. change security
document
review team level
Approve
Register
document
document
change
Identify Notify
document doc. change
recipients originator
Remove Remove
invalid invalid
document document
Table 2
Documents and data requirements for ISO 9001 based document control
Related functions (flow) Document and data requirements Related ISO9001 clauses
Document create and issue Quality system related draft documents (templates), 4.5.2
such as procedures, work instructions, prepared to be reviewed
Review team list 4.5.2
Reviewers’ comments 4.5.2
Master list 4.5.2
Distribution list 4.5.2
Released document 4.5.2
2 1 3
1 Documentation Documentation
Quality Manual
Review Form Approval Form
5 4
1
Specifications
Document
relationship would be helpful to comprehend the 4. Document users want to view the details of the released
scenario’s activities and XML schema definition. new version design control procedures as depicted in
The scenario is described in details as follows. the top-level master document list. Hence, they
hierarchically link from the document lists to their
1. When the scheduled next review date recorded on the children document, i.e. the design control procedures.
master list is due, the authorized reviewers link from 5. A document change is requested, the document
the master list to the documentation review form for control administrator tracks the document revision
reviewing. Besides, related documents should be logs as described in the revision history of the quality
made available for reference during the reviewing, manuals to see the details of what the document had
hence the reviewers refer back to the master list to been changed and to evaluate the proposed change
locate the pertinent documents and link to quality and rationales behind the change.
manual and design control procedures. In addition, 6. A design specification (a child document) is changed
the design control procedure has a related specifica- or updated, a new revision status to the parent
tion defined on the design specification master document (the design specification’s master docu-
document. Hence, the reviewers do associative links ment) should reflect that change. Hence, a document
[30] from design control procedures to the design control administrator enters or updates the required
specification master document. items of the design specification’s master documents
2. Document creators or users need to compile or view a to reflect these changes.
consolidated document from different related source
documents components (The source documents may In the following section, XML/XSL technologies are
come from different document levels). For example, applied for the implementation of the scenario.
they may want to query and then synthesize the
components of master document list and quality
manual into a new document. In another situation, 4. Implementation
they may want to combine the components of master
document list and design control procedure into a 4.1. Implementation environment and related
new document. technologies
3. A document has been approved by an authorized
person and the new status of the document has been The implementation environments and related tech-
entered in the blank fields of a document approval nologies including XML and XSL are shown in Fig. 5.
form. The fields’ contents are fetched and reused to Fig. 5 illustrates how the various technologies and
append into the bottom row of the quality manual to standards are adopted for implementation. In the
record the new status. document modeling and analysis phase, understanding
362 Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370
ISO9000
XML Documents
Document
Schema Control
Structure
Requirements
& Data types
Validation Guiding
Guiding
Users'
Application
Integration
Needs
displayed and put the content (data) into the XML 1. Linking capability. Cross-referencing to related docu-
format. The XML and XSL capabilities used for the ments and share with authorized members.
document management implementation in this study are 2. Customized capability. Customized document’s for-
described below. mats and presentation styles for different users. For
example, documents (or some sections of documents)
Table 5 can be adapted for specific reasons or security issues,
Elements and element relationships of the sample quality manual which deliver just the information in the particular
format that users need.
Quality Background General Organization
manual information information
3. Searching and querying capabilities. Searching and
Title querying through the documents to find the exact
Document No. related document content to match keywords or
Page specified criteria.
Unit issuing 4. Information reusing and re-grouping capability. A
Revision history Revision
quality manual may be a direct compilation
Approved by or grouping of other documents [25]. By using
Effective date XML-based documents, users can reuse and re-
group parts of the documents to compile another
Body Quality policy documents.
Purposes
Responsibility
Actions
Referenced documents 4.2. Implementation examples
Records
In this section, we will demonstrate several imple-
Notes
mented examples that show how the key XML/XSL
Quality
Manual
Background
Body Notes
Information
Approved
Title Responsibility
By
Document Effective
Actions
No. Date
Referenced
Page
documents
Record
Record
capabilities can be combined to manipulate the XML information relationships being represented is based on
documents and enable the scenario activities. The the organization or the content of the information
activities are related to the key functions of ISO9000 space. When documents have a hierarchical structure, it
document management, namely documents creation, is a structural link. Associative links is cross-referencing
documents review, approval, change and access, within document(s), which based on contents of docu-
which will be discussed in the next section. The ment components without a specific structure. Refer-
sequences of the examples demonstrated are correspon- ential links provides a link between an item of
dent with the described sequences of the scenario as information and an elaboration or explanation of that
described above. The examples are listed and demon- information.
strated as follows: In this example we show how XML-based documents
can be effectively cross-referenced and make informa-
1. The first example demonstrates effective management tion link in a useful way as shown in Fig. 7.
of multiple document cross-references.
2. The second example is to synthesize components of
several document sources and customize them into a 4.2.2. Example 2: Document synthesizing from
new document. components of document sources
3. The third example is to enable retrieving and reusing Document creators or users often need to compile or
of existing documents. re-view a consolidated information from different
4. The fourth example is hierarchically linking (or document sources. In this example, we first use
searching) related information. document type (which is a tag in the XML documents)
5. The fifth example is to track document revision as search keyword. The keywords are the document
history effectively. types of quality manual and design control procedure.
6. The final example is to customize a document Then, the queried results (i.e. the document components
template for document creating/editing. that match with the keywords) are synthesized and
customized with appropriate stylesheets into XML web
The above examples are to demonstrate the XML/ pages
XSL combined capabilities to effectively manipulate the
main functions of the document management life cycle
with various stages, e.g., document creating, reviewing, 4.2.3. Example 3: Retrieve and reuse existing documents
approving, changing, and querying. Document cross- The reuse of existing documents and references can
referencing (in Example 1) is an essential activity for significantly shorten the quality related documents
most of the stages of the life cycle. Document development time. ISO9000 depicts that:
synthesizing and customizing (in Example 2) is
1. To approval a (newly created) document, the
often needed in creating stage. The effective retriev-
designated approvers shall have access to pertinent
ing and reusing current documents (in Example 3)
background information to make a decision.
facilitate document creating, changing and approv-
2. Once a document has been approved, the document
ing stages. When changing a document, the related
must be registered, a unique document number is
children documents must also be changed. Hence, it is
assigned and the document (status) is placed on the
useful to have hierarchically linked documents, as
master list.
demonstrated in Example 4. The fifth example in
revision tracking is to show the tracking of a complete The implemented example addresses these two re-
document history, which is an essential activity for quirements effectively as shown in Fig. 8. Firstly, the
document changing and approval. The customizing designated approvers query the related background
template (shown in Example 6) can easily reduce the information, i.e. the waiting to be approved document
document creating efforts. revision status, on which the approval decision is based.
Secondly, once the document is approved and the
4.2.1. Example 1: Effective management of multiple document new status is entered in the blank fields of
document cross-references the approval form, the fields’ contents are fetched and
As described in Section 2, the ISO9000 documents reused to append them into the bottom row of the
contain various types of relationships between docu- quality manual.
ments or elements within documents. Hence, it is
essential to have an effective multiple documents
cross-reference (or link) management. There are 4.2.4. Example 4: Hierarchically linking related
three kinds of links, namely, structural links, associ- documents
ative links and referential links [30]. The link taxo- The hierarchical link is the hyper-link to children
nomy is classified depending on whether the type of elements or documents. ISO9000 quality system
Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370 365
documentation often exhibits a four-level structure as document users. The implemented example is shown in
described in Section 2. ISO9000 requires this kind of Fig. 9. In this example, the master documentation list is
hierarchical collection of procedural documents. They the parent document and the design control procedure is
must be hierarchically linked and easily accessible by one of its children documents.
366 Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370
4.2.5. Example 5: Track document revision history project number and name, document version number
effectively and date of last revision, specifications, accep-
Documents change over time, and they have a history. tance criteria, government standards and regu-
It is often necessary to access and track the revision latory requirements [23] as shown in Fig. 10. The
history of a document. In this example, a complete information content and presentation style of the
document history showing all the revisions or changes document template must suit various needs and
that have taken place, who has authorized the changes preferences.
and what specific revision were made to each document.
Each revision can be further hierarchically linked to see
its details. By defining XML tags or meta data about
document properly, one can catalog and track docu- 5. Discussion
ments based on mutual understanding semantics. Thus,
users can track document revision history by organiza- This section discusses why the XML/XSL mechan-
tion issuing, document title/type, document number, isms or capabilities are useful for the imple-
approver or revision types (add, delete or change) mented examples. It also discusses how these examples
effectively. can be integrated into a system to fulfill the ISO9000
document control requirements. The discussion is
4.2.6. Example 6: Customizing a document template for shown in Table 6 and Fig. 11. Table 6 summarizes the
document creating/editing XML/XSL capabilities applying in implemented exam-
A document template includes standard entries ples. All examples demonstrate main functions of the
for consistency and ease of document creation [32]. It ISO9000 document management (e.g., document crea-
is a way to help standardize the creation process and tion, review, approval, change and access). The im-
safeguard against the omission of important and plemented examples do not affiliate with islands of
mandatory information. Thus, decrease the likeli- independent activities. They are integrated into a system
hood of invalid documents being submitted [9,32–34]. to satisfy ISO9000 document control requirements and
For example, a customized design specification’s to enable document management functions as shown in
master document template includes items such as Fig. 11.
Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370 367
XML
documents
repository
revision
reviewed
history
documents
logs
Fig. 11. Document flow and mechanisms for integration of document creation, review, approval and change.
Y.-H. Yao et al. / Robotics and Computer Integrated Manufacturing 19 (2003) 355–370 369
Table 6
Usefulness of XML/XSL capabilities and mechanisms for the implemented examples
Examples Useful for related document Why XML/XSL are useful in the example implementation
management functions
1. Cross-referencing Useful for most of the Based on the document tree structures, one can easily create a hyperlink
main functions table of contents for cross-referencing.
2. Synthesizing Document creation XML tags and meta data such as document title, document type and document
author, facilitate querying, cataloging, displaying and then combining
only those relevant information into a new document.
Document review
3. Reusing Document creating By defining XML document properly, users can search based on content or
meta data of the documents and then reusing and rearranging the contents
of what the user want for compiling a new document.
Document change
Document approve
4. Hierarchically Document change XML tags and document tree structures provide an inherent hierarchical link
linking (searching) between documents and enable searching the hierarchical document
linkage (linkage to the whole document or elements within a document).
Document accessing
5. Tracking Document change With XSL and by defining XML tags or meta data about document properly,
it is easy to track a complete document history and show all the revisions or
changes that have taken place. It is also possible to show only the relevant
latest revision or changes.
Document approve
6. Customizing Document creating Because, there is a quasi-standard structure and format of the ISO9000
document templates quality documentation, it is easy to define the XML document structure. Thus,
with XSL it is easily to provide the XML documents’ templates and then
customized them for document preparation.
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