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What are the ISO 9001: 2015 Quality Management System’s Requirements?

Here we’ve “broken down” the updated ISO 9001:2015 standard to make it easier to understand and put into action. There are 10 major sections (or clauses) with supporting sections (or subclauses).Each of these sections has a specific focus and expected implementation, which are seen as being key to achieving the outcomes expected by this widely-used quality management system (QMS). To successfully implement ISO 9001:2015 quality standard within your organization, you must correctly satisfy each of the following requirements outlined within it.(Scroll for the entire summary, or click to move to individual sections)Introduction

Section 1: Scope

Section 2: Normative References

Section 3: Terms and Definitions

Section 4: Context of the Organization

Section 5: Leadership

Section 6: Planning

Section 7: Support

Section 8: Operation

Section 9: Performance Evaluation

Section 10: Improvement

ISO 9001 2015 Requirements Summary

Introduction

Section 1: Scope

Defines ISO 9001:2015 as an international standard for a QMS that:

  • Is used when an organization “needs to demonstrate” a uniformity in the delivery of its products or services.
  • Notes the value and need for a quality management system based on a repeatable and consistent process approach.
  • Meets applicable regulatory dictates
  • Satisfies customer requirements
  • Can be adapted to virtually any organization, product or service
  • Creates a pathway for continual improvement

Section 2: Normative References

Simply notes that the ISO 9001 2015 standard is built upon references to other ISO (and possibly non-ISO) documentation (including other standards). In this case, it references ISO 9001-15 terminology and basic concepts maintained by the ISO organization.

Section 3: Terms and Definitions

This section references the definitions used in the standard, which are outlined in the section noted above.

NEW! Section 4: Context of the Organization

Broadening the accountability of the organization under quality management, this section asks the QMS to address these issues:

Section 5: Leadership

While past versions of the ISO 9001 standard called for management commitment and responsibility regarding quality implementation, the latest version of the standard asks much more of leadership including:

Section 6: Planning

Building upon the need to include the influence of the wider elements of the organization (See Section 4: Context of the Organization Above), planning now fully embraces:

There is to be a conscious approach to changing the QMS itself, using a controlled process that constantly considers the reason and impacts of the considered change, as well as how it may affect the level and allocation of resources and assignments

Section 7: Support

Knowing that any endeavor needs the proper level of resources to succeed, ISO 9000 2015 specifically lists types, levels and key measures of the resources needed to maintain compliance including:

Section 8: Operation

The organization must turn their strategic quality planning into actionable tactical or operational plans and implement them, including:

Section 9: Performance Evaluation

Performance measurement has always been a key element of ISO 9001, but the latest revision has tried to consolidate most of the system level measurement requirements into a single section by mandating:

Section 10: Improvement

A core element of the standard is determining the highest return areas for continual improvement and innovation for both future and current expectations including:

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.

 

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