ISO 9001 Version 2015 PDF

ISO 9001 Version 2015 PDF Download

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ISO 9001 Version 2015 PDF Details
ISO 9001 Version 2015
PDF Name ISO 9001 Version 2015 PDF
No. of Pages 40
PDF Size 0.77 MB
Language English
Download LinkAvailable ✔

ISO 9001 Version 2015

Dear readers, here we are providing ISO 9001 Version 2015 PDF to all of you. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees.

Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

ISO 9001 Version 2015 PDF – Introduction

0.1 General

The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are:

  • a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;
  • b) facilitating opportunities to enhance customer satisfaction;
  • c) addressing risks and opportunities associated with its context and objectives;
  • d) the ability to demonstrate conformity to specified quality management system requirements.

This International Standard can be used by internal and external parties.

It is not the intent of this International Standard to imply the need for:

  • — uniformity in the structure of different quality management systems;
  • — alignment of documentation to the clause structure of this International Standard;
  • — the use of the specific terminology of this International Standard within the organization.

The quality management system requirements specified in this International Standard are complementary to requirements for products and services.

This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

The process approach enables an organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed, and that opportunities for improvement are determined and acted on.

Risk-based thinking enables an organization to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise (see Clause A.4).

Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.

In this International Standard, the following verbal forms are used:

  • — “shall” indicates a requirement;
  • — “should” indicates a recommendation;
  • — “may” indicates a permission;
  • — “can” indicates a possibility or a capability.

Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement

0.2 Quality management principles

This International Standard is based on the quality management principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization’s performance when applying the principle.

The quality management principles are:

  • — customer focus;
  • — leadership;
  • — engagement of people;
  • — process approach;
  • — improvement;
  • — evidence-based decision making;
  • — relationship management.

0.3 Process approach

0.3.1 General

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. Specific requirements considered essential to the adoption of a process approach are included in 4.4.

Understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its intended results. This approach enables the organization to control the interrelationships and interdependencies among the processes of the system, so that the overall performance of the organization can be enhanced.

The process approach involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

The application of the process approach in a quality management system enables:

  • a) understanding and consistency in meeting requirements;
  • b) the consideration of processes in terms of added value;
  • c) the achievement of effective process performance;
  • d) improvement of processes based on evaluation of data and information.

Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and measuring check points, which are necessary for control, are specific to each process and will vary depending on the related risks.

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