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ISO 9001:2015 brings quality management and continual improvement into the heart of an organization. The new standard is an opportunity for organizations to align their strategic direction with their quality management system and means that it can be used to help enhance and monitor the performance of an organization.
ISO 9001:2015 is based on Annex SL – the new high level structure. This is a common framework for all ISO management systems and helps to keep consistency, align different management system standards, offer matching sub-clauses and apply common language across all standards. There are 10 clauses within the standard and these are the changes:
Clause 1 is very similar to the 2008 version covering the scope of the standard and there has been very little change to this clause.
Clauses 2 and 3 cover normative references and term and definitions, both these clauses reference ISO 9000, Quality Management System - Fundamental and vocabulary which provides valuable guidance.
The remainder of the clauses include some new key elements which need to be considered when implementing the new standard.
This clause places requirements on “top management” which is the person or group of people who directs and controls the organization at the highest level. It is no longer the responsibility of an individual or to have a “Management Representative” who is responsible for the QMS.
Finally there are the requirements for “documented information”. This is a new term, which replaces the references in the 2008 standard to “documents” and “records”. Organizations need to determine the level of documented information necessary to control the QMS.
This could help your business grow, increase customer satisfaction, and increase profitability. It is now a powerful business improvement tool for organizations of all sizes and in manufacturing or service industries to use to help them remain resilient and achieve sustainable growth.
ISO 9001:2015 replaces previous editions and certification bodies will have up to three years to migrate certificates to the new version.
“We are just bringing ISO 9001 firmly into the 21st century. The earlier versions of ISO 9001 were quite prescriptive, with many requirements for documented procedures and records. In the 2000 and 2008 editions, we focused more on managing processes, and less on documentation.
“We have now gone a step further, and ISO 9001:2015 is even less prescriptive than its predecessor, focusing instead on performance. We have achieved this by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
“Knowing that today’s organizations will have several management standards in place, we have designed the 2015 version to be easily integrated with other management systems. The new version also provides a solid base for sector-quality standards (automotive, aerospace, medical industries, etc.), and takes into account the needs of regulators.”
The purpose if this paper is to explain the process approach in ISO 9001:2015. The process approach can be applied to any organization and any management system regardless of type, size or complexity.
International Organization for Standardization BIBC II, Chemin de Blandonnet 8 , CP 401, 1214 Vernier, Geneva , Switzerland Tel: +41227490111, Web: www.iso.org
In accordance with the requirements of ISO 9001 the following sequence of actions provides examples of how an organization may choose to build and control the processes of its quality management system. Performance can be managed and improved by applying the Plan‐Do‐Check‐ Act (PDCA) cycle. This applies equally to the system as a whole, to individual processes and to operational activities.
It clearly state organization's objectives & identify new business opportunities. It also increases productivity & efficiency, bringing internal costs down. It address the risk associated with the organization.
ISO 9001 IMPACTS business performance in terms of achieving Quality related Key Performance Indicatiors(KPI'S) with necessary documented Information for evidence,Quality Policy & Objectives.
ISO: brings quality management and continual improvement into the heart of an organization. The new standard is an opportunity for organizations to align their strategic direction with their quality management system and means that it can be used to help enhance and monitor the performance of an organization.
The main things of ISO standard is quality improvement,reduction in variation, waste elimination and continuous improvement, then it obviously help all type of business. If a company follows a standard(system) correctly then it will be definately working well.
