In my experience organisations have misconceptions when it comes to ISO9001 certification. In many cases there is a belief that a perfectly documented and mature Quality Management System (QMS) supported by an extensive record database is required to achieve certification. Ideally this would be great but the reality is that a fledgling QMS that satisfies the “intent” of the standard is sufficient to achieve initial certification. We encourage our clients to embrace rather than “fear” the process. Those that do, quickly achieve certification and in fact we have facilitated this in a matter of weeks for some of our clients.
The recent introduction of the ISO9001: 2015 standard is intended to keep ISO9001 relevant and ensure it continues to deliver “confidence in the organisation’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements”.
The ISO recognised that the standard needed to address the increasing complexity of the business environment. Business models continue to become more diverse as evidenced by the importance of the global economy and the move towards online business. To address these challenges proposed revisions include a greater emphasis on leadership as opposed to management responsibility, risk based thinking and a process approach to quality management.
Key Changes Proposed
- Management responsibility expanded to Leadership
- Top management are required to ”demonstrate leadership and commitment” which represents an expanded role. The QMS is expected to be closely integrated with the organisations strategic direction and business processes.
- Customer satisfaction
- There is now greater emphasis on achieving desired outcomes to improve customer satisfaction
- A process approach to quality management is required
- ISO 9001:2015 has this as an explicit requirement and clearly identifies what is expected in the process approach. This process will identify the boundaries of the QMS.
- Risk-based thinking
- The ISO 9001: 2015 standard explicitly requires risk-based thinking to support and improve the understanding and application of the process approach.
- Improved applicability of services
- The ISO 9001: 2015 term “goods and services” is adopted in place of the term “product” and will assist service organisations understanding and application of the standard.
- A common structure for all management system standards
- ISO has developed a new common ISO format for use across all management system standards
- Fewer prescribed requirements
- A “Quality Manual” or “documented procedures” are no longer mandatory. “Documented information” must be maintained as evidence. These are what are known as “records” under ISO 9001: 2008. Preventive action is now covered under risk-based thinking.
- Exclusions more difficult
- ISO 9001:2008 clause 1.2 (exclusions) is removed as the ISO is of the view that there should be no technical reasons for an organisation’s QMS not to be able to meet all the requirements of the revised standard.
Adoption and Transitional Arrangements
Organisations that are certified under ISO 9001: 2008, have a 3-year transition period to ISO9001: 2015. These organisations will be expected to perform a gap analysis against the ISO 9001: 2015 requirements, develop an implementation plan to update their existing QMS, provide staff training and liaise with their certification body.
If you need information about the transition period and what your options are, please feel free to contact us.