What are the ISO 9001 specifications?

The ISO 9001 standard is organized into ten sections. The first three are introductory, while the last seven contain the Quality Management System requirements against which a company can be certified. The following are the seven main clauses:

Context of the organization

This section discusses the requirements for understanding your organization before implementing a QMS. It includes the requirements for identifying internal and external issues, identifying interested parties and their expectations, defining the QMS's scope, and identifying your processes and how they interact. Interested parties' expectations include regulatory requirements as well.

Leadership

The leadership requirements address the need for top management to be involved in the QMS implementation. Top management must demonstrate commitment to the QMS by focusing on the customer, defining and communicating the quality policy, and assigning roles and responsibilities throughout the organization.

Operation 

The operation requirements cover all aspects of the product or service's planning and creation. This section contains requirements for planning, reviewing product requirements, designing, controlling external providers, developing and releasing the product or service, and controlling nonconforming process outputs.

Performance evaluation 

This section contains the requirements needed to ensure that you can monitor how well your QMS is working. Monitoring and measuring your processes, assessing customer satisfaction, internal audits, and ongoing management review of the QMS are all part of it.

Improvement 

 The final section includes the requirements needed to improve your QMS over time. It includes assessing process nonconformity and implementing corrective actions for processes.

These sections are based on the Plan-Do-Check-Act cycle, which uses these elements to implement change within the organization's processes to drive and maintain improvements.