Q – ISO 9001:2015 has been published. What now?
A – Obtain a copy of the Standard. They are available at www.ISO.org
Review the standard in detail and also become familiar with Annex SL. Annex SL establishes a consistent structure featuring 10 clauses and common terminology and definitions applicable to all ISO Management System Standards.
Check out the numerous publications, briefs, FAQ’s, and White Papers offered by Quality Resource Center.
Review the manner in which your organization currently manages the new and significantly changed areas of the standard and how this relates to your quality or integrated management system. Consider a full GAP Analysis performed by Quality Resource Center professional.
Start by putting together an outline as well as a Gantt chart, taking into account milestones and timings for when and how you will upgrade your current management system. Make sure to start including Risk Management in every aspect of planning.
Establish a transition team, identify requirements and a plan for necessary training for key team members, managers, and other leadership. It is imperative that executive Management update their knowledge ISO 9001:2015, as their responsibilities have been significantly expanded.
Q – Who needs to be aware of the revisions to ISO 9001:2015?
A – Determine the key stakeholders who need to be aware of and understand the ISO 9001:2015 revisions:
- While there is no longer a requirement for a designated management representative, significant responsibilities still remain; they can delegated by Top Management to the System Manager.
- Top Management must understand and engage the leadership aspects of the revised standard.
- Key Process Owners must understand their obligations in managing their defined processes and associated Key Process Indicators.
- Internal Auditors and Audit Program Managers need to understand their specific requirements.
Q – What changes and revisions have been made to ISO 9001:2015?
A – Annex SL, Annex SL, Annex SL! It is the single biggest change to the ISO 9001:2015 document.
Other new areas include:
- Organizational context
- Control of externally provided products and services
- Formal introduction of a risk based approach (several clauses), among others.
Revisions to the standard include:
- Increased emphasis on top management engagement with ISO 9001
- Managing change
- Performance and evaluation
- Management review
- Risk Management
Q – How do the changes impact integrated management systems?
A – Annex SL has the goal of aligning ISO 9001:2015, ISO 14001:2015, and ISO 45001 (replaces OHSAS 18001). Since each of the standards share the structure and terminology of Annex SL, integration of these three important standards is much straightforward.
Q – Who are the key internal interested parties for large and medium size organizations in relation to the ISO 9001:2015 revision?
A – The most important internal interested party is top management. ISO 9001:2015 requires much greater understanding of the external environment, including addressing risk as well as greater top management ‘quality leadership’, and establishing tighter links between the management system and product/service quality.
There is increased emphasis on their direct involvement or oversight for the design, implementation, structure and performance of the organization’s management system and to ensure the QMS is an integral part of the organization’s business processes.
Q – How are smaller organizations impacted?
A – All the new and changed requirements will likely apply. The approach and degree of formality should be appropriate to the organization’s operating environment. Bear in mind that an organization should not be doing more than it needs to do to meet its customer and product/ service regulatory requirements but should be achieving this through a management systems approach based on ISO 9001:2015.
Q – When does the transition need to be achieved?
The transition guidance from ISO shows that organizations have three years from publication of ISO 9001:2015 to transition to the new standard. The cutoff point is September 2018. While some may choose their next certification cycle, many will want to be among the first to benefit from the increased functionality that ISO 9001:2015.
Q – What is the bottom line?
Focus on the areas of ISO 9001:2015 that are completely new or have been revised. Those are the areas that need to be included in your transition plan. Make sure that quality managers and internal auditors understand the differences that Annex SL (common text and structure) will bring to the design, operation and performance of your QMS.
Engage a professional –
Talk to Quality Resource Center – We not only understand the revisions, but more importantly, we know what the revisions mean to your QMS and wider organization – and how to apply it to best effect.
Engage with QRC to find out how a gap analysis and training on specific areas of ISO 9001:2015 can benefit you personally, as well as your organization.
Quality Resource Center offers a range of services to help you transition to the revised standards. Find out more at www.qrccentral.com