ISO 9001-2015 “Quality Management System Standard”

A Preface
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ISO 9001-2015 “Quality Management System Standard”

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The committees responsible for this document are Technical Committee ISO/TC 176, Quality Management and Quality Assurance, Sub-committee SC 2, Quality Systems.

The fifth edition removes and replaces the fourth edition (ISO 9001:2008), which has been technically revised by adopting the revised order of provisions and adapting the revised quality management principles and new concepts. It also eliminates and replaces ISO 9001:2008 / Cor.1:2009 Technical survey.

ISO 9001-2015 “Quality Management System Standard”

0.1 Overview
The adoption of a quality management system is a strategic decision for an organization that can help improve its overall performance and provide a solid foundation for sustainability initiatives.

The potential benefits to an organization of implementing a quality management system based on this international standard are:

1) the ability to consistently provide products and services that meet customer and applicable legal and regulatory requirements;

b) promote opportunities to improve customer satisfaction;

c) address risks and opportunities related to its context and objectives;

d) Ability to demonstrate compliance with specified quality management system requirements.

ISO 9001-2015 “Quality Management System Standard”

This international standard can be used by internal and external parties.

It is not the intention of this international standard to imply the need for:

– Unity of different quality management architectures;

– to align the document with the clause structure of this international standard;

– Use of specific terms of this standard within the organization.

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

ISO 9001-2015 “Quality Management System Standard”

This international standard adopts a process approach, which combines the plan-do-check-Act (PDCA) cycle with risk-based thinking.

The process approach enables organizations to plan their processes and their interactions.

The PDCA cycle enables organizations to ensure that their processes are adequately resourced and managed, and to identify and act on improvement opportunities.

Risk-based thinking enables an organization to identify factors that may cause its processes and quality management system to deviate from planned outcomes, implement preventive controls to minimize negative impacts, and take advantage of opportunities as best they can when they arise (see Clause A.4).

ISO 9001-2015 “Quality Management System Standard”

Consistently meeting demand and meeting future needs and expectations in an increasingly dynamic and complex environment poses challenges to organizations. In order to achieve this goal, organizations may find it necessary to adopt various forms of improvement, such as radical change, innovation and restructuring, in addition to corrective and continuous improvement.

In this standard, the following oral forms are used:

– “shall” indicates a request;

– “should” indicates a suggestion;

– “May” indicates permission;

– “Can” indicates a possibility or an ability.

Information marked “attention” is used to guide understanding or clarify relevant requirements.

0.2 Quality management principles
This international standard is based on the quality management principles described in ISO 9000. These descriptions include a statement of each principle, reasons why the principle is important to the organization, some examples of benefits associated with the principle and examples of typical actions that improve organizational performance when applying the principle.

ISO 9001-2015 “Quality Management System Standard”

The principles of quality management are:

– Customer-centric;

— Leadership;

— people’s participation;

– Process approach;

— improvement;

– evidence-based decision making;

— Relationship management.

0.3 Process Approach
0.3.1 Overview

This standard promotes the use of a process approach in developing, implementing and improving the effectiveness of a quality management system to improve customer satisfaction by meeting customer requirements. 4.4 includes specific requirements that are considered to be of great importance to the adoption of a process approach.

ISO 9001-2015 “Quality Management System Standard”

Understanding and managing interrelated processes as a system contributes to the effectiveness and efficiency of the organization in achieving its desired outcomes. This approach enables the organization to control the interrelations and interdependencies between the processes of the system, which can improve the overall performance of the organization.

The process approach concerns the systematic definition and management of processes and their interactions in order to achieve the desired results in accordance with the quality policy and strategic direction of the organization. The management of processes and the whole system 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 exploiting opportunities and preventing undesirable outcomes.

The application of process approach in quality management system can:

1) Understand and consistently meet the requirements;

b) Considering the process in terms of added value;

c) Achieve effective process performance;

d) Process improvement based on data and information evaluation.

0.3.2 The plan-Do-check-action cycle

The PDCA cycle can be applied to all processes and the whole quality management system.

The PDCA cycle can be briefly described as follows:

– Planning: establish the goals of the system and its processes, and the resources needed to deliver results according to customer requirements and organizational policies, and identify and address risks and opportunities;

— To do: to execute a plan;

– Inspection: monitor and, if applicable, measure processes and resulting products and services against policies, objectives, requirements and planned activities and report the results;

— Action: Take actions to improve performance as needed.

0.3.3 Risk-based thinking

ISO 9001-2015 “Quality Management System Standard”

The importance of risk-based thinking (see clause A.4) for achieving an effective quality management system cannot be overstated. The concept of risk-based thinking has been implicit in previous versions of this standard, including, for example, taking precautions to eliminate potential nonconformans, analysing any nonconformans that do occur, and taking steps to prevent recurrence that are appropriate to the impact of the nonconformans.

To comply with the requirements of this international standard, organizations need to plan and implement actions to address risks and opportunities. Addressing risks and opportunities lays the foundation for increasing the effectiveness of the quality management system, improving results and preventing negative impacts.

Opportunities may arise due to circumstances conducive to achieving desired outcomes, for example, a set of circumstances that allow organizations to attract customers, develop new products and services, reduce waste, or increase productivity. Actions in response to opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty may have a positive or negative effect. Positive deviations generated by risk can provide opportunities, but not all positive effects of risk will lead to opportunities.

0.4 Relationship with other management system standards

ISO 9001-2015 “Quality Management System Standard”

This international standard applies the framework developed by ISO to improve the consistency between its international standards for management systems (see Article A.1).

This international standard enables organizations to use a process approach, combined with PDCA cycles and risk-based thinking, to align or integrate their quality management systems with the requirements of other management system standards.

This international standard is related to ISO 9000 and ISO 9004 as follows:

– ISO 9000 Quality management System – Basic knowledge and vocabulary provide the necessary background for proper understanding and implementation of this international standard;

– ISO 9004 Management for the continued success of an organization – The quality management approach provides guidance for selecting organizations that exceed the requirements of this international standard.

Annex B provides details of other international standards for quality management and QMS developed by ISO/TC 176.

This standard does not include other management system specific requirements, such as environmental management, occupational health and safety management or financial management.

Sector-specific QMS standards based on the requirements of this international standard have been developed for many sectors. Some of these standards specify additional QMS requirements, while others are limited to providing guidance for the application of this standard in specific sectors.

According to this version on the international standard and a version (ISO 9001:2008) terms and conditions of the mutual relationship between matrix can be in ISO/TC 176 / SC 2 open access website:

ISO 9001-2015 “Quality Management System Standard”

1 Scope
This standard specifies the requirements of an organization for a quality management system if:

I) need to demonstrate its ability to consistently provide products and services that meet customer and applicable legal and regulatory requirements, and

b) Aims to improve customer satisfaction through the effective application of the system, including system improvement processes and ensuring compliance with customer and applicable legal and regulatory requirements.

All requirements of this standard are general and are intended to be applicable to any organization, regardless of its type or size, and regardless of the products and services it provides.

Note 1 In this international standard, the terms “product” or “service” apply only to products and services directed to customers or requested by customers.

Note 2 Statutory and regulatory requirements can be expressed as legal requirements.

2 Normative references
The following documents are referred to normatively in whole or in part in this document and are required for their application. For dated references, only the cited version applies. For undated references, the new version of the reference (including any revisions) applies.

ISO 9000:2015, Quality management systems-basics and vocabulary

ISO 9001-2015 “Quality Management System Standard”

3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply.

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