2.4   The existing standard package of software relating to ISO9000

Based on the updating data of quality software buyers guides from two magazines , one focus on all software products covering analysis/design of experiments (DOE), benchmarking, document control,  flowcharting, gage management, ISO 9000 and 14000, QS-9000, shape metrology, statistical process control (SPC)/statistical quality control (SQC), statistical analysis, technical drawing, and  training mainly. Another focus on the ISO9000 system which helps users meet one or more of the 20 ISO 9000 elements .
 
 
 
 

The trend for the software companies from 1984 to 1988 in the annual directory of   "Quality online " is shown as below :-

Fig. 2.1   Trend for the number of software providers

Other than the main theme of quality applications, the miscellaneous entries relevant to quality such topics as barcode labeling; forecasting; software quality control; NC verification; manufacturing-execution systems; capacity planning; simulation; gage repeatability and reproducibility; enterprise-resource planning; and reverse engineering have been defined as "Other use " category.

Refer to the 1998 ISO 9000 Software Guide in the quality digest (issue July 98) [11] , the influence and prevalence of ISO 9000 continues to grow.  There are more  than 300 software products that aid users in various aspects of  ISO 9000 documentation and/or implementation. The software ranges from products  designed specifically for ISO 9000, such as documentation and calibration management, to more general titles that cover important  areas, such as statistical process control and failure analysis software.

In the second annual Quality Digest Document Control Software Buyers Guide 1999, the size of our guide has grown more than threefold since last year;  it features more than 60 companies offering document control software, compared  with the 16 companies that appeared previously.
A well-designed and secure document control system has become an important feature for companies pursuing quality processes. To be successful, document control systems should provide a safe and secure place for documents, as well as a  means for circulating only the current document revision while keeping old revisions on file. Such a system also needs to allow for creating new revisions, routing them for approval and informing users that a new revision now supersedes the document they are currently using. An ISO 9000 environment should allow some easy way to audit all this.

For above buyer guides , once the users have identified several vendors, they may ask each for a functional demonstration package. The only way to know if a document control package will do what they want it to is by exercising it with their documents and procedures. Test-driving is time-consuming; plan on at least one week per package to load it, understand its basic operation and run some tests. Most software companies have customer support departments willing and able to help step the user through a program*s basic operation.

2.5   The existing ISO9000 certificated companies in Hong Kong
Despite the lack of statistical information, it  estimates that about 2,000 companies in Hong Kong have been awarded ISO 9000 certification so far. The whole picture could be found according to the findings  revealed by the recently published seventh cycle of The ISO Survey, which updates the ISO 9000 and ISO 14000 certification picture to the end of 1997.

The survey shows that ten years after the ISO 9000 quality management system standards were first published, their use is still increasing. Up to the end of 1997, at least 226 349 ISO 9000 certificates had been awarded in 129 countries [6]. This was an increase of  63 645 (+ 39,1 %) over the end of 1996 when the total was 162 704 in 116 countries.

The regional breakdown which has been used in the survey is justified by the performance of Hong Kong  region which rapidly showed a large certification activity comparing with the growing trend in worldwide.
 

Fig. 2.2 the growing trend of ISO 9000 Certificates
Source : The ISO Survey of ISO 9000 and ISO 14000 Certificates Seventh cycle -1997

However, there are 17 withdrawn certificates of ISO9000 for  a variety of reasons in 1997 when only 1 in 1996 . The possible reason is mainly the shut down of  the companies due to the hit by the financial turmoil for the past two years.

Since the adoption of the ISO9000 series in 1993, an infrastructure has evolved to support third party quality system certification.  Hong Kong Quality Assurance Agency (HKQAA) is a certification body authorized by the Hong Kong Government.  It has been established as a local quality system certification body since 1989 which aims at providing quality and environmental management system certification to manufacturing , construction and services companies . A number of the major international certification bodies operate in Hong Kong such as British Standards Institution (BSI) , Underwriters Laboratories Inc.(UL)  , Det Norske Veritas (DNV) , Lloyd*s and SGS international nowadays.

Fig. 2.3     ISO 9000 certification in Hong Kong at Dec 1997
Source : The ISO Survey of ISO 9000 and ISO 14000 Certificates Seventh cycle -1997
HKQAA Buyer*s Guide

When analysis  the sector distribution for the ISO9000 certificates in Hong Kong, the information from HKQAA Buyer*s Guide is quoted .
 

  Fig. 2.4   HKQAA  ISO 9000 certificates at Dec 1997
Source :HKQAA Buyer*s Guide