For those familiar with ISO 9001:2008, here is an overview of 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.
All in all, the changes to ISO 9001 for the 2015 edition bring it up to date, and give it and businesses the tools required to anticipate and deal with future changes from a risk-based perspective.