By David Felin, Missouri Enterprise Project Manager
ISO standards are reviewed and revised on a regular basis to stay relevant to the current business environment. In fact, the 2008 revision of the ISO 9001 Standard will become obsolete on September 14, 2018, being completely replaced by the 2015 revision at that time.
Some of the issues driving the changes found in the new revision are increasing globalization, and with it a greater emphasis on supply chain management. The new standard features a number of changes, including a greater emphasis on leadership engagement, addressing organizational risks and opportunities, and a common structure with other management systems such as those for environmental management, health & safety, and business continuity, among others
Missouri Enterprise has developed a five-step process to assist our customers in managing their transition process. The first step in that process is becoming familiar with the new standard. Missouri Enterprise does this by holding a workshop to introduce the changes found in the 2015 revision.
One of the major changes in the new revision is a requirement for organizations to align their strategic direction with their quality management system (QMS). This requires organizations to identify internal and external parties that are affected by the quality management system. Another major change is the introduction of risk and opportunity management along with planning to achieve quality objectives.
A major formatting change in ISO 9001:2015 is the introduction of Annex SL, commonly called the new high-level structure (HLS). This is now a common framework for all ISO management systems. For instance, the format of the ISO 9001standard is organized in the same way as the ISO 14001 standard. This will make it easier for organizations to combine the QMS into their core business processes or to add additional management systems once ISO 9001:2015 has been implemented.
Step two on the transition journey is to identify any gaps between what the current QMS covers and what is required in the 2015 revision, usually called a gap analysis. Organizations that attend a transition workshop presented by Missouri Enterprise receive a consulting session to identify gaps in their current QMS relative to the requirements of ISO 9001:2015.
Some of the many items addressed in the gap analysis include the determination of internal and external issues, positive and negative, that affect the organization; who are the organization’s interested parties and what are their needs and expectations; and what are the risks associated with the threats and opportunities faced by the organization.
The third step is probably the most important in the transition process, the development of an implementation plan. It is important because it will drive the entire transition process. The gaps identified in the review of the QMS must each be addressed on a manageable schedule including what will be done, who will be responsible, and when it will be completed.
Step four is the updating of the existing QMS to reflect the new requirements and the ways the organization has elected to respond to them. Organizations that already have an ISO 9001 quality management system do not have to discard their existing procedures and documentation, however most people are pleased to find that the 2015 revision is much less prescriptive regarding documentation than previous revisions. This is a good opportunity to simplify existing QMS documentation, where possible.
The trick here is not to over-simplify. For instance, while the new standard does not specifically require a quality manual or a management representative, I have yet to work with a company making the transition to the 2015 revision that was getting rid of either of these, at least not yet.
Step five involves providing awareness of the new QMS requirements and addressing any training needs that may arise, such as training auditors on the new system. Registrars generally require a complete round of audits along with a Management Review of the revised QMS before the organization can be registered to 2015.
While the complexity of the QMS will vary from one organization to another, the process outlined above will generally allow an organization to complete the transition journey in six months to a year.
ISO 9000, Quality management systems – Fundamentals and vocabulary
ISO 9004, Managing for the sustained success of an organization – A quality management approach
ISO 10004, quality management – Customer satisfaction – Guidelines for monitoring and measuring
ISO 10014, Quality management – Guidelines for realizing financial and economic benefits
ISO 19011, Guidelines for auditing management systems