If your EMS provider is certified 9001:2008, they should be taking the next step to 2015 certification, as it can be done without a huge strain on staff and resources (keeping your manufacturing relationship on track). If your EMS provider is starting on this process, you have the confidence that they are committed to maintaining a customer-focused business relationship and are committed to keeping strong standards in place to support it. We’ve created this guide to help you understand key revisions involved, so you can understand the process as well as the benefits involved.
STARTING THE MOVE TO ISO 9001:2015
Once your EMS provider has the 9001:2015 standard “in hand,” the leadership team can begin the process of understanding and preparing for the transition. Although one may feel anxious about any revision to international standards, the amendments equate to improvements in quality for you and your customers. You will find that the switch to a process-approach with increased leadership involvement (and accountability) are the most obvious differences, along with a new emphasis on risk management and improved communication. Understand that this process doesn’t happen overnight, and ISO has granted a three-year transition period beginning September 2015. This allows EMS providers until September 2018 to complete their upgrade and certification.
STEPS TO ISO 9001:2015
Some of the steps here involve a new FOCUS, while others are simply standard practices.
- Learning about ISO 9001:2015. Your EMS provider will likely have a team of managers pouring over the latest certification documents, to prepare themselves for the work ahead. The new 2015 version involves some additions and subtractions, including
Getting leadership onboard. One benefit sure to please is the increased involvement of leadership in the 2015 version. Gone are representatives of management, as now leaders must take a more active role in creating, administering, and reviewing their company’s Quality Management System (QMS), which is designed to ensure effective performance of the EMS provider.
Leadership must now specifically spell out various aspects of the organization: the context (spelling out issues which affect its ability to achieve its stated results), stakeholders (internal team members, customers, and agencies), and review the QMS.
Demonstrate leadership. Leadership is revealed when individuals and teams in authority are personally involved in processes, establishing and promoting policies, and taking responsibility of the successes (and failures) of the QMS. By participating in QMS review, leaders become accountable for results and are personally involved in solutions (see previous blog).
Alignment of quality objectives, policies, and processes with the company’s strategy. The company culture (focused on customer satisfaction) must show through in all aspects of performance.
Assessing risks/opportunities. Your EMS provider must fully comprehend the variety of risks (and opportunities) which can arise during their operation, and be prepared with processes for resolving them. This provides you with peace of mind that they are prepared for whatever comes their way, and can still meet customer demands within international standards.
Streamlining documentation. This is a new tactic; since there is an increased focus on risk assessment (and corresponding solutions), fewer individual procedures should be necessary, simplifying while improving the process.
Expand control. A more process-focused approach provides a framework for any scenario. With clear criteria, there is a process for everything.
Re-examine the design and development process. One additional reward from a more process—focused approach means that this part of operations is controlled more effectively. By including definitions of who and what is involved, the entire team has a strong framework to increase quality and minimize errors during the design and development process.
Strengthen control over third party inputs (products or services). ISO 9001:2015 certified providers will control more tightly those inputs, outputs and even participation by third parties in your business relationship. By increasing leadership involvement and increasing review of third parties, the process can be improved.
Improve performance evaluations. Leadership will participate in evaluations, ensuring that the QMS remains effective. KPIs (key performance indicators) will be established or revised.
Metrics. Part of the ISO 9001:2015 revision introduces a stronger focus on measuring & reporting. Increased evaluations provide additional points for measurement, and results allow for improvements to be discovered. Internal audits will become more comprehensive and include a management review section. This creates a cycle of strength within the QMS, providing outcomes which can lead to continual improvement.
- 7 principles vs. 8 in the 2008 version
- 10 clauses vs. 8 in the 2008 version
- 6 mandatory documents (which were previously mandatory procedures)
- 26 mandatory records, no change from the 2008 version
- Removal of the management representative, with a change to leadership involvement)
- Removal of a quality manual, but addition of a “context” of the organization
ISO 9001:2015 Bottom Line = Better Communication, Better Performance, and Better Compliance
You may have a successful working relationship with your EMS provider; if that is the case, then ISO 9001:2015 will only build upon your previous success. If you are looking for an EMS provider who is certified and committed to building partnerships which provide outstanding quality and customer satisfaction, look to SMC. We are already near the end of the upgrade process, and ready to assist you with your EMS and Systems Integration needs, meeting the latest standards.