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1 Title/current version
ISO 9001:2015 Quality management systems – Requirements.
2 The basics
ISO 9001 is part of the ISO 9000 family of standards, and represents an international consensus on good quality management practices. The ISO 9000 family consists of standards and guidelines relating to quality management systems and related supporting standards. General guidance on the fundamentals of Quality management systems can be found in the publication ISO 9000:2015 – Fundamentals and vocabulary.
3 Summary
ISO 9001, owned and maintained by the International Standards Organization (ISO) was first published in 1987, based on British Standards Institute (BSI) BS5750 series. ISO 9001:2000
combined the three standards—9001, 9002, and 9003—into one, called 9001.
The current 5th version ISO 9001:2015 has undergone a restructuring and now is compliant to ISO’s high level structure (HLS) for management system standards (MSS).
The high level structure consists of 10 clauses:
1 – Scope
2 – Normative references
3 – Terms and definitions
4 – Context of the organization
5 – Leadership
6 – Planning
7 – Support
8 – Operation
9 – Performance evaluation
10 – Improvement
The HLS supports the ease of integration for organizations who want to comply to more than one ISO MSS (cf. ISO 14001 environmental management and ISO 27001 Information security management).
The ISO 9000 family addresses ‘Quality management’.
It adresses the needs of an organization to fulfill its customer’s quality requirements and applicable regulatory requirements, while at the same time aiming to enhance customer satisfaction, and achieve continual improvement of its performance in pursuit of these objectives.
ISO 9001:2015 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is
in the private, or public sector. It is the only standard in the ISO 9000 family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
ISO 9001:2015 lays down the requirements a quality system must meet, but does not dictate how they should be met in any particular organization. This leaves freedom of scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, total quality management (TQM), auditing, documentation, training, and financial and economic aspects.
The quality management system standards of the ISO 9000 series are based on seven quality management principles:
a customer focus,
b leadership,
c involvement of people,
d process approach,
e continual improvement,
f factual approach to decision-making and
g mutually beneficial supplier relationships.
These principles can be used by senior management as a framework to guide their organizations towards improved performance.
4 Target audience
Managers in any organization that need to demonstrate that they have consistent quality processes in place to meet customer expectations;
Purchasing managers to buy products or services of consistently high quality;
Auditors.
5 Scope, strengths and constraints
ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill. The ISO 9001 standard is generalized and abstract; its parts must be carefully interpreted to make sense within a particular organization. Because they are business management requirements, the ISO 9001:2015 can be applied to a very diverse range of organizations.
- A strong point of ISO 9001:2015 is that it provides a single quality management ‘requirements’ standard that is applicable to all organizations, products and services.
- The new released ISO 9001:2015 puts greater emphasis on leadership engagement, helps adress organizational risks and opportunities in a structured manner, and adresses supply chain management more effectively.
Constraints:
- The process can be costly and gaining accreditation may be time-consuming, especially for organizations that are mainly interested in getting certified and less in the continual improvement philosophy of the ISO standard.
6 Market acceptance
ISO 9001 is the most popular international management system standard worldwide. Since the first publication of the standard in 1987 the number of accredited organizations rose up to 1.1 million in 2010, since then it has stabilized at that level until the last ISO survey of 2014.