ISO 9001:2015 – A New Approach
August 19, 2015 - Kestrel Management
It has been years in the making—the new ISO 9001:2015 standard is getting ready for final publication (expected in September 2015). This is the first revision to ISO 9001 since 2008 and the first major revision since ISO 9001:2000.
The new ISO 9001:2015 standard is designed to simplify the requirements, focus more on the organization’s needs, and make the ISO standards more user-friendly by:
- Making the standard more applicable to service industries, not just product industries
- Integrating quality management into overall business strategy
- Making it easier for companies to adopt multiple ISO and/or vertical standards
ISO 9001:2015 focuses on a core set of requirements, effective process management to produce desired outcome(s), and viewing the QMS through a risk management prism for all actions taken by the organization. Once published, the three-year transition period to become certified to ISO 9001:2015 will begin.
Simplification and Standardization
All ISO management systems standards are being developed and/or reformatted according to ISO Directive Annex SL 2013, to simplify their design and implementation by creating a “universal management system.” The idea is that, in the future, each standard will use a consistent structure and outline. This will allow an organization to easily add new ISO standards to its certified repertoire and create integrated management systems without having to learn new terminology and requirements for each standard.
ISO 9001 is first up to bat—ISO 14001 and others will be revised in accordance with the same structure to ensure consistency across the standards. ISO is going to issue a completely new standard for OHS Management (ISO 45001), which will follow the new format.
One of the most notable changes in ISO 9001:2015 is the use of High-Level Structures, which replace the concept of clauses under current ISO management systems. The High-Level Structure is designed to serve as a uniform basis for all standards to improve compatibility.
According to this structure, ISO 9001:2015 will expand to 10 sections (with additions for performance management and evaluation), as shown below.
Risk and Opportunities
Risk and opportunities is a new concept under ISO 9001:2015. Organizations are required to use risk-based thinking and analyze risks in operations, as they relate to quality management. This change signifies movement away from a traditional corrective/preventive action approach to a risk management model. Taking a risk-based strategy requires that the organization identify risks in QMS processes and then develop countermeasures to mitigate them.
This risk-based approach ties to additions regarding the context of the organization. Organizations must balance the relationship of the organization with “interested parties” and demonstrate broader measurement, planning, and implementation that takes into account sustainability/business continuity.
ISO 9001:2015 puts much more emphasis on management leadership. In fact, top management takes on the role of the QMS Representative and must take accountability for the effectiveness of the QMS. This includes the following:
- Objectives and targets must be more explicit and monitored frequently, with the management team providing support for staff with relevant tasks.
- Management needs to create vision and strategy for the organization.
- There must be alignment of personnel to job duties.
- The QMS must be connected to business strategy.
- Management needs to develop and facilitate a sustainable business plan with a clear link to the QMS.
- Management actions should address risks and opportunities.
- Scope of management review should consider the strategic direction of the organization, relevant interested parties, and risks and opportunities.
Under a process approach, the organization needs to exhibit systematic control of any/all changes to products and/or services. This includes defining the inputs and outputs of each process, measuring performance indicators, and assigning appropriate responsibility.
Documentation requirements become much more flexible under ISO 9001:2015. Organizations only need to maintain the documentation that the organization deems necessary for enhanced QMS performance. “Documented information” also offers more flexibility on the types and formats of documentation used to provide the necessary controls.
This flexibility helps companies avoid creating additional and/or unnecessary documents, and documentation can be aligned far more closely to the company’s individual needs and risks. A Quality Management Manual is no longer a requirement.
Once the standard is published, there will be a three-year transition period during which both the old (ISO 9001:2008) and new (ISO 9001:2015) standards will apply in parallel. This provides a good opportunity for companies to learn about the changes and begin to implement them during annual audits leading up to recertification.
Kestrel recommends following a simple approach to make recertification as simple as possible:
- Learn and understand the new ISO 9001:2015 standard requirements
- Complete a gap analysis
- Implement strategies for critical activities
- Complete process audits of new QMS
- Complete Management Review meetings on QMS
- Determine and implement improvement strategies
- Earn ISO 9001:2015 certification
Maintaining certification to ISO 9001 will allow companies to continue realizing the benefits of a formal QMS, including:
- Providing access to new markets
- Meeting customer quality requirements
- Increasing internal operating efficiency
- Improving existing quality and preventing quality concerns
- Enhancing overall customer satisfaction
Submitted by: Randy Block