As it applies specifically to the ISO 9001:2008 which replaced the ISO9002: 1994, the ISO 9001 concerns itself with quality management. In fact it is a quality management system that establishes various requirements ("ISO 9001:2008"). In order to gain certification the organization must:
1. Demonstrate its capacity to consistently offer product that meets customer and applicable statutory and regulatory requirements ("ISO 9001:2008").
2. Plan to improve customer satisfaction through the effective application of the system ("ISO 9001:2008"). This plan will include procedures that enforce continual improvement of the system and the pledge of conformity to customer and proper statutory and regulatory requirements ("ISO 9001:2008").
It is also the case that all the provisions established by the ISO 9001:2008 are universal and intended to be pertinent to all organizations, despite their nature, size or product manufactured ("ISO 9001:2008"). Additionally
"Where any requirement(s) of ISO 9001:2008 cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to ISO 9001:2008 are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements ("ISO 9001:2008")."
In addition to the aforementioned aspects of ISO 9001:2008 there are several other dimensions associated with the system. There are general requirements, management requirements, realization requirements and resource requirements and remedial requirements.
The general requirements are inclusive of developing the quality management system (QMS) including
1. Establishing the organization's QMS.
2. Documenting the organization's QMS.
3. Implementing the organization's QMS.
4. Maintaining organization's QMS.
5. Improving the organization's QMS ("ISO 9001-2008 Quality Management Requirements")
All of these requirements are designed to not only establish the quality system but maintain it and improve it. The end result of this is to improve the overall quality of the products and the manner in which these products are delivered to consumers.
In addition to the general requirements there are also some management requirements that also exist. Theses requirements include
The management requirements are present to ensure that those in positions of authority work in compliance with the standards established by the certification. Managers play a critical role in ensuring that employees know how to comply with the regulations established by the certification. If managers fail to carry out their duties the entire organization will suffer.
In addition to general and management requirements certified organizations must also adhere to realization requirements. These requirements include:
1. Properly manage product realization planning
2. Manage customer related processes
3. Manage product design and development
4. Manage purchasing and purchased products
5. Manage production and serve provision ("ISO 9001-2008 Quality Management Requirements")
These requirements are very much related to meeting the needs of customers and the proper handling of products. Proper handling of products is inclusive of all aspects of the product including development and distribution of produces.
Resource requirements are also an important aspect of the ISO 9001:2008 certification. These requirements are as follows:
1. Supply required QMS resources
2. Supply capable QMS Personnel
3. Supply needed infrastructure
4. Supply a work environment that is efficient ("ISO 9001-2008 Quality Management Requirements")
Resource requirements are vitally important because it focuses on ensuring that the company has the resources necessary to ensure that employees can carryout their jobs effectively. These requirements draw attention to the stability of the work environment and the infrastructure available.
Finally there are remedial requirements associated with the certification. These requirements are as follows:
1. Establish Monitoring and Measurement Processes
2. perform monitoring and Measurement Activities
3. recognize and manage nonconforming products
4. Collect and analyze Quality Management Data
5. Make improvements and take remedial actions ("ISO 9001-2008 Quality Management Requirements")
According to Sampioa et al. (2009), the implementation of a quality management system, and its subsequent certification, is a voluntary process, supported by the organisation's own motivations, goals and policies. The authors further explain that "The diffusion of ISO 9001 certifications started mostly in Europe. Then, European companies pressured their suppliers around the world to become also ISO 9001 certified, and such suppliers sought certification as a protection mechanism against the perceived threat of having ISO 9001 certification to become an international trade barrier (Sampioa et al. 2009; Corbett et al., 2003)."
According to Levine & Toffel (2008) today "Nearly 900,000 organizations in 170 countries have adopted the ISO 9001 Quality Management System standard, a remarkable figure given the lack of rigorous evidence regarding how the standard actually affects organizational practices and performance (Levine & Toffel, 2008) ." The authors report that although the impact of the certification is difficult to measure many companies have sought and achieved certification (Levine & Toffel, 2008; O'Connor, 2005).
SIRIM came about as a result of an inquiry designed to establish some national industry standards ("Background"). This inquiry came in 1964 as the request of the Government of Malaysia directed the Minister of Commerce and Industry ("Background"). The request came because there was an urgent need to adopt the principles of standardization in the wake of Malaysia's growing industrial development ("Background").
This inquiry led to the establishment of the Standards Institution of Malaysia (SIM). In the beginning, the SIM was created as a Government department under the Ministry of Commerce and Industry in 1966 ("Background"). By October of 1966, "the Standards Act No: 76, 1966 was passed in Parliament making SIM the national standards body. SIM was governed by the Standards Council ("Background")." The purpose of the act is to supply the Standards Council with sovereign authority as it relates to the declaration of standards and the proving of certification mark licenses ("Background"). In addition,
"In 1974, the National Action Council decided that SIM be merged with the National Institute for Scientific and Industrial Research (NISIR) to form the Standards and Industrial Research Institute of Malaysia (SIRIM). As a result of this decision, SIRIM was established as a statutory body under the Ministry of Science, Technology and the Environment by the SIRIM (Incorporation) Act, 1975 which came into effect on 15 September 1975 ("Background")."
As a result of the aforementioned merger, SIRIM is better prepared to enlarge its reach as it pertains to the manner in which the entity functions ("Background"). This improvement is essential because of the rapid growth of industrialization in Malaysia ("Background"). Additionally as a result of rapidly shifting market requirements that occurred because of the accelerating national industrialization and globalization of markets, the SIRIM (Incorporation) Act 1975 had to be amended. These amendments were designed to provide required flexibility for SIRIM to counter to these changes ("Background").
There have also been some other amendments of the SIRIM since its inception. These amendments came into effect in July of 1993("Background"). The Amendments to the SIRIM (Incorporation) Act, were approved by Parliament ("Background"). Among the amendments is the ability to permit SIRIM to embark on profitable partnerships through the development of joint-venture or wholly-owned subsidiaries ("Background"). In addition the amendment abolished the 24-member SIRIM Council and replaced it with a 13-member SIRIM ("Background"). Seven of the members were from the private sector and six were from the public sector ("Background"). This redesigned Council allows an increased amount of accountability and competence. It also serves to fortify the connection between SIRIM and the industry ("Background").
There were also additional changes that occurred with SIRIM. For instance
"On 1 September 1996, SIRIM was corporatised to be known as SIRIM Berhad. SIRIM Berhad incorporated under the Companies Act was vested with all the rights, privileges and obligations of SIRIM; and 1 September 2006, marked the 10th anniversary of corporatisation of SIRIM Berhad ("Background")."
This thesis utilizes a qualitative methodology. A qualitative methodology does not rely on figures and statistics. Instead the qualitative method utilizes interviews and other methods of gaining information. In addition, the "Qualitative methodology includes a variety and diversity of methods, procedures, and research designs. All kinds of qualitative methods have in common that their main research aim is a deeper understanding of the research object. Therefore, they are nonstandardized tools that can be adapted flexibly to every kind of research object, which can better be called research subjects because qualitative methods do not measure them objectively but interact with them, insofar as method is not a neutral tool in order to gain knowledge about researched subjects but is part of the social reality investigated ("Qualitative Methodology")."
This method was chosen because it will provide the most accurate information concerning the ISO 9001: 2008 and its impact upon NMSB.
Findings and Analysis
The research indicates that NMSB has utilized the ISO 9001 certification to improve the quality of the products that…