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Chapter 2
Understanding ISO 9001:2000
Requirements for Quality Management Systems
0.1 Introduction
0.1 General:
The implementation of a QMS should be a strategic decision for your organization. Various factors influence the design and implementation of your QMS. These include - diverse needs and risks of organizations; particular goals and objectives; complexity of products and services provided; number of and complexity of processes employed; and size and structure of the organization. As a result of these and other underlying factors, the ISO 9001 standard does not require uniformity of QMS structure or documentation.
The QMS requirements specified in ISO 9001 are complementary to requirements for product. The standard specifies requirements for your QMS, whereas requirements for your product come from customers and regulatory authorities. Information marked “Note” is for guidance in understanding or clarifying the requirement.
This international standard can be used by internal and external parties, including certification bodies, to assess an organization’s ability to meet customer, regulatory and the organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration in developing this standard.
Key Explanation Points and Tips:
The purpose of an organization is to identify and meet the needs and expectations of its customers and other stakeholders and gain competitive advantage. One of the strategies it might use to achieve this goal is to continually improving the effectiveness and efficiency of its capabilities.
ISO 9001:2000 is a powerful business tool that organizations may use to achieve this. Organizations use ISO 9001 to achieve goals and objectives related to meeting customer and regulatory requirements and enhancing customer satisfaction.
While the focus is on quality management, the ISO 9001 business model may be applied just as well to manage the entire organization. The standard embodies business concepts and principles universally recognized and applied for sound business management. As such, ISO 9001 should be used as a strategic business management tool.
The ISO 9001 standard defines a generic set of requirements for all organizations, regardless of size, complexity or industry sector. These requirements define controls for your quality management system that focus on continually improving the effectiveness of your QMS in meeting customer requirements and thus enhancing customer satisfaction.
It is important to note that the ISO 9001 standard does not specify requirements for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By effectively controlling and continually improving your QMS processes, there will obviously be a positive impact on product quality performance and conformity to customer requirements.
You must ensure that the scope of your QMS addresses all customer requirements. Customer requirements may show up in contracts, blueprints, their supplier quality manuals, or referenced to applicable industry and regulatory standards and codes, etc.
It is important to state here that ISO 9001 certification must not be the ultimate goal of QMS implementation. Your constant goal must be to continually improve the effectiveness and efficiency of the organization for the benefit of all its stakeholders. Obtaining certification must be considered as just a stepping stone in this journey. Organizations that understand and follow this approach will get the most benefit from QMS development and implementation.
Organizations implementing an ISO 9001 based QMS must conform to all applicable requirements that the standard specifies. This provides internal and external parties (customers, registrars and regulatory bodies), the basis (i.e. a benchmark) against which to assess the organizations ability to meet customer, regulatory and internal requirements. It is now a common practice to use ISO 9001 certification as a requirement for making contractual decisions.
QMS design and implementation will vary from organization to organization. ISO 9001 allows this flexibility because organizations may have differing - goals and objectives; business risks; range and complexity of products; processes and resources; organizational size and structure; workforce competence and stability; etc. This flexibility may relate to QMS scope; structure; documentation or application of ISO 9001 requirements.
Personnel performing QMS assessments must - have adequate training on the requirements of the ISO 9001 standard and auditing practices as defined by ISO 19011; be familiar with your QMS, customer requirements and applicable regulatory requirements.
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