ISO 9001 is one of the most frequently used standards for various aspects of quality management, with over 1.1 million certificates issued worldwide. ISO 9001 helps organizations demonstrate to consumers that products and services they can offer are of consistently good quality.
The new ISO 9001:2015 standard is based on a number of quality management principles including strong customer focus, the motivation and involvement of top management, the process approach and continual improvement. The update is designed to be more flexible so the framework can be implemented for any organization type. ISO 9001:2015 follows the basic ISO structure of all management system standards and is therefore easy to integrate with Environmental Management (ISO 14001) or Occupational Health and Safety (ISO 45001).
Get an overview of ISO 9001 in this PowerPoint presentation.
(1) Why is ISO 9001 being revised?
Every five years ISO standards are reviewed to determine if a revision is necessary to keep it current and relevant in the marketplace. ISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems.
(2) How long will ISO 9001:2008 continue to be recognized and audited to?
The current standard will be recognized and can be audited to until the end of the 3 year transition period for ISO 9001:2015 (14th September 2018). All organizations must transition to the new standard by the transition deadline at which point certificates for ISO 9001:2008 will no longer be valid.
(3) What is Annex SL?
With the revision of the ISO 9001 standard, AuditComply has seen a lot of questions about Annex SL. Annex SL provides a new structure to the ISO systems standard. It will be replacing the original ISO Guide 83 and expands on the base structure already implemented.
(4) How do we demonstrate and provide evidence for risk-based thinking? (Clause 5.1.1 h)
Part of the new standard comes with a large “Risk-based thinking” element. The revised ISO 9001 standard has moved away from “preventive action” to a “risk-based approach”. It was found that preventive action failed to drive change and continuous improvement.
When planning for your management system, the organization is required to establish risks and opportunities that need to be addressed. This is important when determining the risks and opportunities, the planning of how these actions will be addressed, how the new management system will be implemented and how the organization will measure the overall effectiveness.
It’s important to remember that ISO 9001:2015 does not require any formal risk management and there is no specific requirement on how to document the results of risks and opportunities. It is up to the organization to determine to the extent of the documentation and how they use this documentation to provide sufficient evidence of application of risk-based thinking.
(5) How are you accountable for the effectiveness of the Quality Management System (QMS)? (Clause 5.1.1 a)
High-level management is now accountable for their QMS more than ever. Being accountable means they have ultimate responsibility and they are expected to make decisions and justify their actions.
(6) How has the QMS been integrated into the organization’s business processes?
This question is likely to be asked during your re-accreditation audit. This question really means, how are you using ISO 9001:2015 to help you run the company?
This is asked directly of top management (sub-clause 5.1.1c). The point is that ISO 9001 is moving away from being a quality management system standard and becoming a strategic management system. It’s not just about making sure products or services meet requirements anymore. The standard is about managing every aspect of the business. ISO 9001:2015 touches every corner of the organization and this is exactly how ISO 9001:2015 is intended to be used.
(7) Why should I use AuditComply for my ISO 9001:2015 re-accreditation?
If you are an AuditComply customer using our Risk & Performance platform, the good news is that you already have the platform you need to comply with ISO 9001:2015.
If not, we can proudly say that other organizations across multiple industries are finding AuditComply’s Risk & Performance platform very useful in mitigating risk, driving compliance and improving quality. AuditComply has been utilized regularly in assisting organizations with their re-accreditation goals over the last four years.
AuditComply has a complete solution for Quality, Compliance, EHS & Risk management, all in one centralized platform. Part of this solution, is our unique web portal, mobile app, and executive dashboards.
Check out just some of the features offered in the AuditComply platform which can be used to help you comply with ISO 9001:2015:
–Centralized QMS: Ready-to-use document control feature for multiple document types as manuals, procedures, work instructions, SOP, GMP, test methods etc. Providing full control and visibility for any organization.
–Customer feedback tracking: Record customer feedback
–Risk Management and CAPA: Use our advanced risk, issue management and decision tree models to identify and eliminate hazards. Using CAPA management to assess risks and turn them into actionable solutions.
–Corrective actions: Show risk-based thinking with the implementation of corrective and preventative actions throughout your business processes.
–Auditing: Flexible audit management, both external and internal with direct links to CAPA management.
–Audit trail: Time, date and GPS stamping of every record – delivering a full and complete audit trail.
–Reporting and analytics: A comprehensive real-time analytics dashboard allows organizations to locate issues immediately. Multi-site, 360-degree visibility prevents issues from recurring and slowing performance. Adhoc assessments using AuditComply’s offline template library for your quality and risk reporting.
–Non-conformance tracking: Automatic notifications and workflows for tracking and resolving non-conformities.
–Reporting: Automatic report generation and optional grading to provide full understanding and visibility from board level down.
ISO, HACCP, BRC, SQF, FSA, IATF, IFS and many more processes can all be efficiently and effectively managed with AuditComply. Uphold standards, create visibility and control with the right RPM software. Start with our 30-day free trial today! No payment required!
For more information on ISO9001:2015 please visit: https://www.iso.org.
To find out more about how AuditComply can help you reach ISO 9001:2015 compliance please contact us at firstname.lastname@example.org
Disclaimer: This blog is not legal advice and should be considered educational in nature.