You can start preparing for the transition immediately, educating the relevant people in your business and re-structuring your processes in line with the new high level structure. We have a downloadable internal communications pack that you may find useful for this. We suggest that you build new processes outside of your existing system.
Quality Management System
ISO 9001, the world’s leading international quality standard has helped millions of organizations to improve their quality and operational performance since it was first published as BS 5750 in 1979. The new version ensures ISO 9001 maintains relevance in today’s market place and continues to offer organizations improved performance and business benefits. All organizations currently certified to ISO 9001:2008 will need to transition to the new requirements by September 2018.
The new standard provides a great opportunity for your organization to review your quality management system and ensure that it’s aligned with the strategic priorities of your organization. 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. Here we aim to address those initial questions that you may have as you begin your journey towards the revised standard.
ISO 9001:2015 allows organization flexibility in a way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continuous improvement of the effectiveness of its QMS.
- You will understand the purposes and business benefits of a quality management system, quality management system standards, management system audits and third party certification
- As well as the role and responsibilities of an auditor in planning, conducting, reporting and following up on a quality management system audit to establish conformity (or otherwise) with ISO 9001, in accordance with ISO 19011 and ISO/IEC 17021, as applicable.
ISO 9001:2008 will be recognized and can be audited until September 2018, which will be the end of the 3 year transition period for ISO 9001:2015. It’s best to get started with your transition planning as soon as possible so that you can pro-actively manage this process. Please note, all organizations must have transition to the new standard by the transition deadline at which point certificates for ISO 9001:2008 will no longer be valid.
While there is no specific requirement for a quality manual in ISO 9001:2015, there is a requirement to provide evidence of “documented information” to support the QMS. As long as the information needed to evidence the management system is kept and available, how an organization does it is not important. While some organizations may choose to keep a dedicated quality manual, others can use a less centralized approach. This recognizes changes in technology and the differing media now used to record and monitor information.
Anexas has produced a mapping guide which compares the clauses between both versions of the standard. This is a useful document that will help you to quickly identify the key changes and which clauses they refer to.
The adoption of the high level structure as set out in Annex SL of ISO Directives Part. An explicit requirement for risk-based thinking to support and improve the understanding and application of the process approach. Fewer prescriptive requirements More flexibility regarding documentation Improved applicability for services. A requirement to define the boundaries of the QMS Increased emphasis on organizational context Increased leadership requirements Greater emphasis on achieving desired process results to improve customer satisfaction