ISO/IEC 9001: Quality Management System
What is ISO/IEC 9001:2015
The ISO 9000 family of standards provide the controls and frameworks needed to create, execute, maintain, and continually improve Quality Management System across small and big enterprises. ISO 9001 is the certifiable part of the standard that provides requirements to be fulfilled by an organization to get certified. Third-party Registrars (or Certifying Bodies) conduct a private audit and provide authorization that an organization meets the requirements of the standard. This leads to the ISO/IEC 9001:2015 certification.
Requirements of ISO 9001:2015 Quality Management Systems
ISO 9001:2015 is a 30-page document and covers all the specific requirements against which an organization is audited and certified as ISO 9001 compatible.
What are the Requirements of ISO 9001:2015
Quality Management Systems
The requirements are separated in sections as follows:
The Standard follows the classic: Plan, Do, Check, Act cycle necessary by most Management Systems standards. The Certification Body (CB) in general audits against the conditions of Section 4 through Section 10. Sections 1 through 3 are not directly audited, as they do not provide any context for the organization, but have definitions for the rest of the standard.
Certification for ISO 9001:2015
International organization for Standardization (ISO) does not conduct audits and does not certify organizations by themselves. Certification Bodies (CB), separate independent private organizations conduct audits against the standard, and Certification Bodies (BD) ultimately certifies organizations that are compliant with the standards as an ISO 9001;2015 certified organization.
Though the standard is often referred to as ISO 9000, the actual standard to which an organization’s Quality Management System is certified is ISO 9001:2015.
Every country has its own accreditation body that recognizes and accredits Certification Bodies (CB). The accreditation bodies also have internal authentication arrangements among CBs to validate certifications issued by each other (particularly in global commerce). The CBs must function under compliance with the requirements of ISO 17021 and the accreditation bodies must operate under compliance with ISO 17011.
An organization seeking certification under ISO 9001:2015 is typically audited based on the evidence collected and tested against the requirements of the standard. If all requirements are met, then the auditor recommends the organization to a CB issue the ISO 9001 Certificate. Otherwise (either full, or partially, or not met in the way it is supposed to be met), then the auditor presents a list of problems, often defines as non-conformities, observations, or opportunities for improvement. The auditee then must provide a Corrective Action Report (CAR) showing how the problems will be resolved to the CB/Auditor. Once those corrective actions have been taken and the problems have been resolved, then they issue the certificate.
The certificate applies only to the scope defined within the certificate. The certificate needs to be renewed every three years and thereby it is assured that the compliance process is an ongoing, continually evolving process.
