UPDATE: The ANSI Webstore now offers the Final International Draft Stage, ISO/FDIS 9001. See the changes in detail and help contribute to the process!
The International Organization for Standardization (ISO) is releasing a revision to one of the most popular and widely used standards, ISO 9001:2008 Quality Management Systems, next year in 2015. Currently undergoing the periodic review process that all ISO standards are subject to, ISO 9001:2015 will have several key changes both in itself and in relation to other standards. ISO 9001 is designed to be generic enough to apply to businesses of any size, in any industry, anywhere.
Key among the revisions is the switch to compliance with Annex SL, which molds the content of ISO 9001 and other related management system standards (MSS) with regard to a common structure, terms, and definitions. Essentially, Annex SL serves as a blueprint for MSS so that they can be combined and expanded upon while remaining compatible with each other without confusion.
Next, ISO 9001:2015 brings quality management into the central business outlook by taking advantage of leadership, company focus, senior managers, and complete integration into business practices. If those in charge of the company put quality management as a key priority, then that mentality (and resource allocation) will reverberate through the management hierarchy.
Finally, this revision will serve to bring ISO 9001 up to relevancy with regard to both challenges and opportunities that arise from changing technologies, globalization, and a reinforcement of a risk based approach, as well as structuring the standard to deal with future changes.
For those already familiar with ISO 9001:2008, here are the changes clause by clause:
Clause 4: Context of the Organization. This deals with the context of the organization, with a focus on senior management to understand the relationship between risk, challenges, and management systems.
Clause 4: Process Management. The determination of process risk and the allocation of responsibilities.
Clause 5: Leadership. This aims to align the company’s direction with quality management, to look at risk identification, assessment, and management from multiple directions, especially from the senior management.
Clause 6: Product Conformity and Customer Satisfaction. This section shifts from preventive action to a focus on risk and opportunity that relate to product conformity and customer satisfaction.
Clause 7: Efficient Resource Management. Newly included continuous attention to customer needs and satisfaction.
Clause 8: Contingency Planning to improve customer communication. Additionally, assessment of design suitability before operations begin.
Clause 8: Controlling Outsourced Activities. The revision highlights the importance of efficient risk management of outsourced activities.
Clause 9: Stronger Measuring and Monitoring. These requirements flow into effective risk assessment and quality management.
Clause 10: Continual Improvement Internal Audits get a more structured approach.
Taken together, the changes to ISO 9001 for the 2015 edition bring it up to date with the modern world and give it and businesses the tools necessary to anticipate and deal with future changes from a risk-based perspective.