Quality Management System
QUALITY MANAGEMENT SYSTEM
About ISO 9001 Family
WHAT IS ISO 9001:2015
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. Get an overview of ISO 9001 in this PowerPoint presentation. If you want to know more about the revision of ISO 9001:2015 see our revision page.
SECTOR SPECIFIC APPLICATION OF ISO9001
ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries. These include:
- ISO/TS 29001 – Petroleum, petrochemical and natural gas industries
- ISO 13485 – Medical devices
- ISO/IEC 90003 – Software engineering
- ISO 17582 – Electoral organizations at all levels of government
- ISO 18091 – Local government
Please tell us your requirements
It helps the organization:
- to enhance customer satisfaction by meeting customer requirements.
- to function effectively
- to manage the resources effectively
- to continually improve the processes
- to increase competitiveness of organization
- to benefit in tenders
- to increase acceptance in overseas markets (exports)
Get an overview of ISO 9001 in this PowerPoint presentation.
This International Standard specifies requirements for a quality management system for an organization where an organization:
- needs to demonstrate its ability to consistently provide product /services that meets customer and applicable statutory and regulatory requirements.
- aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
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Frequently Asked Questions
Business needs and expectations have changed significantly since the last major revision of ISO 9001 in the year 2000. Examples of these changes are ever more demanding customers, the emergence of new technologies, increasingly more complex supply chains and a much greater awareness of the need for sustainable development initiatives.
The concept of the standard has not changed; it's applicable to any type of organization, regardless of the size, type or its core business.
The structure has been changed to align with the common 10-clause high level structure developed by ISO to ensure greater harmonization among its many different management system standards. The new revision to ISO 14001 will also adopt this same structure, which is built around the PDCA (Plan-Do-Check-Act) sequence. All ISO management system standards are now required to adopt this structure. This will make it easier for organizations to address the requirements of more than one ISO Management System Standard within a single, integrated system.
The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1
An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach
- Fewer prescriptive requirements
- More flexibility regarding documentation
- Improved applicability for services
- A requirement to define the boundaries of the QMS
- Increased emphasis on organizational context
- Increased leadership requirements
- Greater emphasis on achieving desired process results to improve customer satisfaction
A quality manual is no longer specifically required. The new standard requires the organization to maintain documented information necessary for the effectiveness of the quality management system (QMS). There are many ways to do this and a quality manual is just one. If it is convenient and appropriate for an organization to continue to describe its quality management system in a quality manual then that is perfectly acceptable.
The phrase risk-based thinking is used to describe the way in which ISO 9001:2015 addresses the question of risk. The concept of risk has always been implicit in ISO 9001, by requiring the organization to plan its processes and manage its business to avoid undesirable results. Organizations have typically done this by putting greater emphasis on planning and controlling processes that have the biggest impact on the quality of the products and services they provide. The way in which organizations manage risk varies depending on their business context (e.g. the criticality of the products and services being provided, complexity of the processes, and the potential consequences of failure). Use of the phrase risk-based thinking is intended to make it clear that while an awareness of risk is important, formal risk-management methodologies and risk assessment are not necessarily appropriate for all business situations and organizations. For further information about risk-based thinking
ISO 9001:2015 requires the organization to address risks and opportunities, quality objectives and planning of changes throughout the oganization. As new products, technologies, markets and business opportunities arise, it is to be expected that organizations will want to take full advantage of these opportunities. This has to done in a controlled manner, and be balanced against the potential risks involved, which could lead to undesirable side-effects.
- Less prescriptive, but with greater focus on achieving conforming products and services
- More user friendly for service and knowledge-based organizations
- Greater leadership engagement
- More structured planning for setting objectives
- Management review is aligned to organizational results
- The opportunity for more flexible documented information
- Addresses organizational risks and opportunities in a structured manner
- Addresses supply chain management more effectively
- Opportunity for an integrated management system that addresses other elements such as
environment, health & safety, business continuity, etc.
This is the combination of those internal and external factors that affect an organization's approach to the way in which it provides products and services that are delivered to its customer.
External factors can include, for example, cultural, social, political, legal, regulatory, financial, technological, economic, and competitive environment, at the international, national, regional or local level.
Internal factors typically include the organization’s corporate culture, governance, organizational structure, technologies, information systems, and decision-making processes (both formal and informal).
The organization w i l l n e e d to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties, as outlined in clause 4.2. This does not extend past the quality management system requirements and the scope of this International Standard.
As stated in the scope, this International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.