ISO 9001 is one of those necessary, foundational, timeless standards and meeting its requirements means you have to put quality as a strategic priority at your company. We’ve gone through the requirements with a fine-toothed comb. In this blog series, we’ll point out approaches and tools that can ensure you’re always in compliance.
ISO 9001:2015 Blog Series Topics:
- Navigating ISO 9001:2015 Updates: What You Need to Know
- Risk-Based Thinking in ISO 9001:2015: A Practical Guide
- Process Approach and PDCA in ISO 9001:2015: Unlock Your Processes
- Leadership and Performance Evaluation in ISO 9001:2015
Our goal is to make this series instructional and useful as you assess your own quality management system.
Increasing global business complexity has given rise to a need for greater regulatory clarity, flexibility, and accountability.
With the increasing complexity of global businesses, regulatory clarity, flexibility, and accountability are more crucial than ever. ISO 9001:2015 has updated its high-level structure, Annex SL, with 10 clauses instead of eight. This ensures better alignment with multiple management system standards and simplifies the language. At the same time, both products and services receive equal and explicit attention. In this article, we'll explore four key elements of the updated standard and their impact on your business.
EMPHASIZING ACCOUNTABILITY FROM TOP LEADERSHIP
ISO 9001:2015 introduces new term requirements to help leaders determine the scope of the quality management system and put accountability squarely on leadership. Clause 5 requires leadership to ensure that the quality policy and objectives align with the organization's strategic direction. This involves determining the "context of the organization," including both internal and external issues relevant to the organization's strategy and quality policy, as well as identifying "interested parties" and their requirements.
DEFINING AND MANAGING PROCESSES THROUGH RISK-BASED THINKING
ISO 9001:2015 also emphasizes the importance of defining processes and managing them through the Plan Do Check Act (PDCA) cycle. Using risk-based thinking is vital and helps to identify and seize opportunities while avoiding adverse effects in processes and the QMS as a whole. What was previously referred to as "preventive action" has been replaced by risk-based thinking, with Clause 6.1 requiring determination of risks and opportunities and actions to address them. While no formal risk management methodology is required, we offer tools to help organizations meet this challenge in our next post.
EMPHASIZING PLANNING AND CONTROL OF CHANGE
With the rapidly changing business landscape, it has become more critical than ever to adapt to change. ISO 9001:2015 guidelines stress the importance of planning for change and process control, which are encapsulated in Clauses 6, 7, and 8. These Clauses dictate that any modifications to an organization's QMS should be done in an orderly, documented fashion to ensure nothing falls through the cracks. By following these guidelines, companies can operate more efficiently and effectively in the face of constant business change.
CONTINUITY THROUGH ORGANIZATIONAL KNOWLEDGE
ISO 9001:2015 introduces the new clause 7.1.6, requiring organizations to determine the knowledge necessary for operating and achieving conforming products and services.
Organizational knowledge is obtained through experience and is generally not documented. However, documenting this information can help maintain knowledge even during staff turnover or failures to do so. This clause encourages organizations to spread knowledge through experience or mentoring.
WORKING TOGETHER TO UNDERSTAND AND IMPLEMENT THE UPDATES
The updated terminology may cause some apprehension: documented information vs. document and record, external provider vs. suppliers, etc. However, there's no need to worry. Organizations can continue to use their own terms as long as they reflect their operations. ISO 9001:2015 provides organizations greater flexibility, and auditors and auditees will work together to ensure understanding. Reach out to your certifying body if you need additional guidance and clarity.
BENEFITS OF ISO 9001:2015 CERTIFICATION
Undertaking ISO 9001:2015 certification may be a bit of a headache, but remember there are many benefits to your certification including improved customer satisfaction and product quality, compliance to regulatory or customer requirements, and the opportunity for continuous improvement that can ultimately enhance your reputation and bottom line. For additional information on the transition, visit ISO’s website here.
In the next post, we will delve into risk-based thinking and offer tools.
Until then, have a great quality-filled day!