ISO 9001: 2015, Fifth (5th) Edition, Quality Management Systems -- Requirements, Publication Date: September 15, 2015, Published By:International Organization for Standardization, Pages: 40, English, PDF Format
Product Details
Document published on: 2015-09-15
Publisher: ISO. Distributed through American National Standards Institute (ANSI)
Language: English
Product Dimensions: 8.2 x 0.1 x 10.5 inches
Shipping Weight: 5.6 ounces
Document published on: 2015-09-15
Edition: 5 (Monolingual)
Status: Published
TC/SC: ISO/TC 176/SC 2
ICS: 03.120.10
Stage: 60.60 (2015-09-22)
Number of Pages: 40
Product Dimensions: 8.2 x 0.1 x 10.5 inches
Shipping Weight: 5.6 ounces
Revisions
Revises: ISO 9001:2008
Revises: ISO 9001:2008/Cor 1:2009
Abstract
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.
This fifth edition cancels and replaces the fourth edition (ISO 9001:2008), which has been technicallyrevised, through the adoption of a revised clause sequence and the adaptation of the revised qualitymanagement principles and of new concepts. It also cancels and replaces the Technical CorrigendumISO 9001:2008/Cor.1:2009.
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.
