If you’re planning to comply with ISO 9001, you probably do not know how the standard is structured and what it requires to implement a QMS. Read further to learn more.
- Clauses 0 to 3: Introduction, Scope, References, Terms and Definitions
- Clause 4: Context of the organization
- Clause 5: Leadership and commitment
- Clause 6: Planning for the QMS
- Clause 7: Support & resource management
- Clause 8: Operational planning and control
- Clause 9: Performance evaluation
- Clause 10: Improvement actions
The ISO 9001 requirements provide a set of standard elements that will guide you in the implementation, maintenance, and improvement of a Quality Management System (QMS). The requirements are designed to be applicable to any kind of organization, for profit or nonprofit, manufacturing or service-based, large or small, regardless of the economic sector. The requirements describe which elements are mandatory in a QMS, but not how to implement those necessary elements. Organizations with a QMS according to ISO 9001 can be certified in what is called ISO 9001 certification.
The ISO 9001:2015 requirements are broadly separated into 11 sections (called ISO 9001 clauses). Clauses 0 to 3 are not mandatory for implementation, while clauses 4 to 10 are mandatory; the exception is clause 8, which can be excluded from the implementation if the company finds some parts of it to be not applicable.
Clauses 0 to 3: Introduction, Scope, References, Terms and Definitions
Clause 0 mentions the benefits of implementing a QMS and the quality management principles, and presents the process approach, the Plan-Do-Check-Act cycle, and risk-based thinking. People often overlook this clause, but they shouldn’t, as it frames much of the information that comes next, especially about how the various clauses relate to each other.
Clauses 1 through 3 include no requirements, but instead deal with the scope of the standard, references to better understand the standard, and terms and definitions.
Clause 4: Context of the organization
An organization is not a closed system, isolated from the outside; it is inserted in a particular context and cannot be independent of what customers are looking for, or what regulators define. So, this section deals with the internal and external issues that can influence an organization in setting and meeting its objectives, as well as the interested parties that interact with the QMS. It also includes the requirements about the scope of the QMS and the process mapping and characterization.
Clause 5: Leadership and commitment
The section on leadership outlines the requirements concerning top management, which are:
- promoting a customer focus all over the organization,
- developing and standing by a Quality Policy that sets direction and alignment, and
- determining responsibilities and authorities all over the QMS, to make clear who has the power to make decisions, and what is expected from every function working in the system.
Clause 6: Planning for the QMS
This section presents the requirements for determining and working with risks and opportunities, as well as those for setting quality objectives, aligned with the Quality Policy, and plans to meet them.
Clause 7: Support & resource management
Clause 7 is a very diverse section that includes requirements for management to provide resources, i.e., human resources, infrastructure (including equipment, hardware and software, and building facilities), work environment (including temperature control, humidity control, dust control, and sterilization control), the control of any equipment used to monitor or measure the product or service, and the organizational knowledge required to operate the QMS. The importance of competence, awareness, and communication for human resources is emphasized.
Clause 8: Operational planning and control
This section is the only part of the standard where a company can choose to exclude sections of the requirements (such as excluding the design requirements if your company does not do design work). The requirements deal with planning for product (or service) and include determining and reviewing the product requirements, design and development, and purchasing, followed by manufacturing of a product or provision of a service and its supply. The final requirements deal with quality control and product or service nonconformities.
Clause 9: Performance evaluation
The performance evaluation section outlines requirements for assessing customer satisfaction, internal audit, monitoring, analysis, and evaluation of process performance. Also included are the requirements of the management review, including the mandatory inputs and outputs for the review.
Clause 10: Improvement actions
The last section deals with improving your QMS through corrective actions and continual improvement.
An important note about the implementation
The greatest difficulty when implementing the standard’s requirements is to ensure that the resulting collection of policies, procedures, processes, and records meets the needs of the company and its customers, while still allowing for improvement of the system. Improvement of the system is one of the main reasons for implementing a QMS, as it benefits the company in the long run. A QMS is a system, and a system is more than just the simple sum of answers to requirements.
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