Quality management systems - Requirements
|Standard´s number:||ISO 9001:2015|
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ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
Also published new ISO 9000 : 2015 - Quality management systems -- Fundamentals and vocabulary
Some others information about ISO 9001:2015 standard
The ISO Standards are checked every 5 years, to achieve maximum relevance to the commercial market. Therefore is important standard ISO 9001 under revision.
Updated version ISO 9001:2015 is available now in PDF or Hardcopy. The new version will better respond to the latest trends and will be and better correspond with other standards for management systems, for exmple ISO 14001.
Compliance with the requirements of this standard and obtaining ISO 9001 quality certificate guarantees your customers high quality products and services.
If your organization already certified according to ISO 9001:2008, you have a three-year transitional period for compliance with the requirements of ISO 9001:2015 and obtaining a certificate
The main change between ISO 9001 : 2008 - ISO 9001: 2015
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.
Introduction to QMS - ISO 9001
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by:
- its organizational environment, changes in that environment and the risks associated with that environment,
- its varying needs,
- its particular objectives,
- the products it provides,
- the processes it employs,
- its size and organizational structure
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the associated requirement.
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.
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality mana-
gement 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 inter-
actions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.
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, such an approach emphasizes the importance of:
- understanding and meeting requirements,
- the need to consider processes in terms of added value,
- obtaining results of process performance and effectiveness, and
- 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.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.
Do: implement the processes.
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
Act: take actions to continually improve process performance.
Relationship with ISO 9004
ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
At the time of publication of this International Standard, ISO 9004 is under revision. The revised edition of
ISO 9004 will provide guidance to management for achieving sustained success for any organization in a complex, demanding, and ever changing, environment. ISO 9004 provides a wider focus on quality management than ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction, by the systematic and continual improvement of the organization’s performance. However, it is not intended for certification, regulatory or contractual use.
Quality management systems – Requirements
This International Standard 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, and
- 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.
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard 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 this International Standard 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.
You I´ll find more information in the original text of this standard ISO 9001:2015.