Courtesy: ISO 9001 2015 Certification
ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.
ISO 9001 is supplemented directly by two other standards of the family:
- ISO 9000:2005 “Quality management systems. Fundamentals and vocabulary”
- ISO 9004:2009 “Managing for the sustained success of an organization. A quality management approach”
Other standards, like ISO 19011 and the ISO 10000 series, may also be used for specific parts of the quality system.
2015 version
In 2012, ISO TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001 and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently 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 the “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 new ISO 9001:2015 management system standard helps ensure that consumers get reliable, desired quality goods and services. This further increases benefits for a business.
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 standards 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 (MR) are no longer mandatory
Auditing
Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) and audits by internal staff trained for this process (internal audits). The aim is a continual process of review and assessment to verify that the system is working as it is supposed to, to find out where it can improve, and to correct or prevent identified problems. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgements. Supporting papers are provided by the ISO 9001 Auditing Practices Group. This is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).