International Organization for Standardization (ISO) does not certify organizations itself. Numerous certification bodies exist, which audit organisations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as “ISO 9000” certification, the actual standard to which an organisation’s quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 will expire by around September 2018). Many countries have formed accreditation bodies to authorize (“accredit”) the certification bodies. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the accredited certification bodies (CB) are accepted worldwide. Certification bodies themselves operate under another quality standard, ISO/IEC 17021,while accreditation bodies operate under ISO/IEC 17011.
An organization applying for ISO 9001 certification is audited based on an extensive sample of its sites, functions, products, services and processes. The auditor presents a list of problems (defined as “nonconformities”, “observations”, or “opportunities for improvement”) to management. If there are no major nonconformities, the certification body will issue a certificate. Where major nonconformities are identified, the organization will present an improvement plan to the certification body (e.g., corrective action reports showing how the problems will be resolved); once the certification body is satisfied that the organization has carried out sufficient corrective action, it will issue a certificate. The certificate is limited by a certain scope (e.g., production of golf balls) and will display the addresses to which the certificate refers.
An ISO 9001 certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually once every three years. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard) or it is not. In this respect, ISO 9001 certification contrasts with measurement-based quality systems.
In 2012, ISO TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001,and concluded that it is necessary to create a new QMS model for the next 25 years.
This is why they commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as “beginning of a new era in the development of quality management systems.”As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
Some of the key changes include:
High Level Structure of 10 clauses is implemented. Now all new standard released by ISO will have this High level structure.
Greater emphasis on building a management system suited to each organization’s particular needs
A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in
Alignment with other key management system standards through the use of a common structure and core text
Inclusion of Knowledge Management principles
Quality Manual & Management representative is now not mandatory requirements.
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