Quality management systems

ISO 9001:2015

ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176. ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an independent, non-governmental international organization with a membership of 164 national standards bodies. The current version of ISO 9001 released in September 2015 is ISO 9001:2015. The standard defines the fundamental concepts and principles of quality management. All of its requirements are generic and intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

What is the ISO 9001:2015 standard?

ISO 9001:2015 acts as an integral part of your organization’s efforts towards the broader aim of sustainable development. A Quality Management System (QMS) documents the processes, procedures, and responsibilities for achieving Quality Policies and Objectives. Based on the Seven Quality Management principles, ISO 9001:2015 defines the way an organization operates to meet the requirements of its customers and stakeholders in terms of:

  • Customer focus
  • Leadership
  • Engagement of people
  • Process approach
  • Improvement
  • Evidence-based decision-making
  • Relationship management

These principles are the strategic foundations for all decisions relating to Quality Management in an organization and are diffused within each aspect and the language of the ISO 9001:2015 standard.

What is the Approach of ISO 9001:2015?

To complement its Seven Quality Management principles, the ISO 9001:2015 standard employs a process approach that incorporates the Plan-Do-Check-Act (PDCA) cycle:

  • Risk-based thinking;
  • Leadership participation;
  • Unified structure, and;
  • Clarified documentation requirements.

ISO 9001:2015 standard adopts the High-Level Structure (HLS) and terminology of Annex SL (used for the development of all new ISO standards). The approach that consists in aligning the High-Level Structure (HLS) with the basic elements of PDCA, risk-based thinking, leadership involvement, and complementary standards is meant to help organizations understand the details of the standard and apply them accordingly, per their identified priorities.

The approach benefits organizations because it allows them to plan their processes and interactions. With the PDCA cycle organizations will be able to ensure that their processes are adequately resourced and managed in order to spot opportunities for improvement. The application of the PDCA cycle process approach in a quality management system (QMS) enables organizations to have:

  • An understanding and consistency in meeting requirements;
  • An understanding of considerations and processes in terms of added value;
  • An achievement of effective process performance and;
  • An improved process based on the evaluation of data and information.

What are the benefits of getting ISO 9001:2015 certified?

The benefits to an organization when implementing a quality management system based on the ISO 9001:2015 International Standards are:

  • Ability to consistently provide products and services the meet the needs of your customers, and applicable and statutory and regulatory requirements;
  • Ability to enhance customer satisfaction;
  • Address opportunities and risks associated with the context and objectives of your business:
  • Ability to demonstrate conformity specified QMS;

Who should be ISO 9001:2015 certified?

ISO 9001:2015 is a global standard for Quality Management Systems, and promote the efficiency for products, services, and international supply chains. The standard embodies the best practices of Quality Management and Quality certification, and its requirements are generic, therefore applicable to all types of industries and sectors, no matter the size of the organization. Organizations looking to move to the 2015 standard should reach out to an certification body such as GMED to benefit from the organizations’ expert knowledge and guidance.

What are the major differences between ISO 9001:2015 and ISO 9001:2008?

ISO 9001:2015 was rolled out to replace ISO 9001:2008, as a consequence of the changing business environment and to remain relevant to the current needs of the marketplace. Here are some of the major differences between ISO 9001:2008 and the new ISO 9001:2015 standard to point out.

Each version of the ISO 9001 standard is followed by a three-year transition period. The transition time which was set between ISO 9001:2008 et ISO 9001:2015, gave organizations the ability to update their own processes to comply with the new approach.

TopicsISO 9001:2008ISO 9001:2015
Context of the OrganizationNo requirement An organization must determine, monitor and review internal and external issues as well as relevant interested parties and their requirements.
StructureEight ClausesTen clauses; reorganization of clause order and content to better align with other standards
Risk Based Thinking Preventative ActionOrganizations must take actions to address risks and opportunities.
Documented InformationSix required proceduresDocument the QMS scope, objectives, quality policy and any process the organization determines needs to be documented.
Objects, outputs, products and servicesProcess Based OnlyThe process model is expanded to include anything that affects quality.
Terminology“Product” “Supplier” “Preventative actions” “Documents and records”“Products and services” “External provider” “Risk and opportunities” “Documented information”
Exclusion and RequirementsExcluding a standard requirement was specific to Product RealizationAny requirement that cannot be applied may be excluded as long as it is justified.