Are you ready for the ISO Transition? Is your organization currently registered/certified to ISO 9001:2008, ISO 14001:2007, or ISO 13485:2003? Get ready to transition.
Organizations can prepare by completing the following:
- Purchase the revised standard (ISO 9001:2015, ISO 14001:2015, ISO 13485:2016)
- Analyze their Management Systems
- Identify organizational gaps which need to be addressed to meet new requirements. – Do you have too much documentation?
- Include/Integrate other compliance criteria in to one manageable system, if needed
- Develop an implementation/transition plan to map out how you will manage the process to achieve transition
- Re-train/Train/Educate provide appropriate education, awareness, and training to all parties that have an impact on the effectiveness of the organization, including executives, staff, internal auditors and those responsible for the changes
- Update existing management system (QMS/EMS,MED) to meet the revised requirements and provide verification of effectiveness
- Communicate to interested parties the changes that are occurring and how the transition is being managed
- Do an Internal Audit of the 2015 system to validate changes
- Talk to your certification body auditor for transition requirements and scheduling arrangements
What MUST be completed prior to the registrar coming in for your Transition Audit? You must complete an internal audit of the entire quality system to validate changes, and complete 1 full management review to the 2015/2016 requirements. If you are unsure that your organization is ready, schedule a “2015 Systems Analysis” or “Readiness Audit” (optional) prior to the Transition Audit to be sure. This will help verify that your organization is ready.
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