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
1. Showing Commitment to quality
2. Focus on customers
3. support quality policies
4. Carryout QMS Planning
5. Allocate QMS responsibility and authority
6. Perform QMS management reviews ("ISO 9001-2008 Quality Management Requirements")
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...
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