ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify. Successful businesses understand the value of an effective Quality Management System that ensures the organization is focused on meeting customer requirements and they are satisfied with the products and services that they receive. ISO 9001 is the world’s most recognized management system standard and is used by over a million organizations across the world. .ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015. ISO 9001:2015 applies to any organization, regardless of size or industry. More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them organize processes, improve the efficiency of processes, and continually improve. You can integrate ISO 9001:2015 with other management system standards such as ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, etc. It brings quality and continual improvement into the heart of the organization and increase the involvement of the leadership team; this gives an opportunity for organizations to align their strategic direction with their quality management system.
It also introduces risk and opportunity into the management system. It’s an agile business improvement tool that makes it relevant to the requirements of your own organization to gain sustainable business improvements. The starting point of the new version of ISO 9001 is to identify internal and external parties who support the QMS. This means that it can be used to help enhance and monitor the performance of an organization.
Implementation of ISO 9001:2015 will help you become a more consistent competitor in the marketplace by helping you to meet present and identify future customer needs. It also increases efficiency that will save you time, money, and resources. By Improving operational performance, errors are reduced, and profits enhanced; by motivating, engaging, and involving the staff internal processes are efficiently improved. Continual improvement helps you to win more high-value customers and achieve improved customer retention with better customer service hence broadening business opportunities by demonstrating compliance to customers’ requirements.
All ISO management system standards are subject to a regular review under the rules by which they are written. Following a substantial user survey, the committee decided that a review was appropriate and created the following objectives to maintain its relevance in today’s marketplace:
Integrate with other management systems
Provide an integrated approach to organizational management
Provide a consistent foundation for the next 10 years
Reflect the increasingly complex environments in which organizations operate
Ensure the new standard reflects the needs of all potential user groups
Enhance an organization’s ability to satisfy its customers
The structure is based on the mandate that Annex SL from the ISO Directives is applied to management system standards. The clause structure in ISO 9001:2015 is being aligned with other management system standards. The structure is to provide a presentation of requirements. It is not a model for the document for documenting the organization’s policies, objectives, and processes. There is no requirement for the structure of an organization’s quality management system documentation to mirror that of this International Standard.
Structure of ISO 9001:2015
ISO 9001:2015 is based on Annex SL – the high-level structure. This is a common framework for all ISO management systems. This helps to keep consistency, align different management system standards, offer matching sub-clauses against the top-level structure, and apply common language across all standards. It will be easier for organizations to incorporate their QMS into core business processes and get more involvement from senior management. The Plan-Do-Check-Act (PDCA) cycle can be applied to all processes and to the quality management system as a whole. The reason for the change is to adopt the common approach outlined in Annex SL, the new document that all ISO management system standards, including ISO 9001, ISO 14001, and the recently released ISO 27001, must follow. Currently, ISO 9001 contains 8 sections, of which four attempts to approximate “plan, do, check, act.” The new structure, based on Annex SL, has 10 sections four of which also approximate to “PLAN, DO, CHECK, ACT.” All new management system standards will have this common structure. Here is the new structure:
Implementation Clauses
4 Context of the organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of the interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
5 Leadership
5.1 Leadership commitment
5.2 Policy
5.3 Organizational roles, responsibilities and authorities
6 Planning
6.1 Action to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning changes
7. Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Product and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual Improvement
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