ISO 9001: 2015
This International Standard ISO 9001:2015 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
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ISO 9001:2008 - ISO 9001:2015 Main Change
The new version will follow a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk.
ISO 9001 Quality management systems – Requirements
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
Process approach ISO 9001:2015
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
When used within a quality management system (QMS), such an approach emphasizes the importance of:
1) understanding and meeting requirements,
2) the need to consider processes in terms of added value,
3) obtaining results of process performance and effectiveness, and
4) continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level. .
Why to implement the Standard ISO 9001?
The adoption of a quality management system should be a strategic decision of an organization.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization’s own requirements.
The design and implementation of an organization’s quality management system is influenced by :
a) its organizational environment, changes in that environment and the risks associated with that environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.

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