Question: Under ISO 9001:2015 there is no longer a requirement for a Management Representative in clause 5.3, only that Top Management “ensure responsibilities and authorities for relevant roles are assigned.” Can organizations still have one person as the Management Representative?
Answer: Clause 5.3 requires Top Management to assign responsibility and authority for the system, but does not specify that it must be more than one person. It can be – to alleviate some of the stress from a single person – but it’s the organizations choice.
COO of QUAL-TECH, INC.
Question: We have heard the companies are being told they have to “get rid of their old system of a manual and procedures and start over” to meet ISO 9001:2015. Can an organization still keep their quality manual and documented procedures?
Answer: Organizations must ensure their system meets the requirements of the new standard. ISO 9001:2015 clause 4.4 Quality management system and its processes, (following summarized):
4.4.2 To the extent necessary, the organization shall:
It is the organizations choice if they want to keep their quality manual, procedures, work instructions, master list of documents and/or records, etc. There is no statement in ISO 9011:2015 or the Annex SL requiring the system to be “thrown out and start over.”
COO of QUAL-TECH, INC.
Question: 9104-001 clause 8.4.d – In this clause what does “re-established” mean?
Answer: The term “re-established” does not mean closure of the nonconformity. The root cause analysis and corrective action to prevent recurrence may not have been accomplished in the 60 day time frame. However, the intent is to ensure all “containment” actions are complete. Containment actions will include taking the necessary action to ensure conformance to the existing QMS requirements. Additional root cause and corrective action (to prevent recurrence) may take more than 60 days to complete but all steps and actions to be taken must be documented with in the corrective action response.
Certification Body Advisor
Question: How long do I have to revise my QMS to meet ISO 9011:2015? How does this affect my AS90100 Certifications?
Answer: When the standard is released you’ll have three years to transition. The IAQG is going to add a significant number of additions to the AS standards once it is released to continue alignment with ISO.
Question: What is QUAL-TECH going to do to address the revised ISO and AS standards?
Answer: We will be putting our schedule out regarding training once Exemplar Global Provides the details of what will be required for transition training, a full lead auditor class, etc. Once the standard is released and we get a full explanation from the Certification Bodies for 3rd party auditor requirements, how they are going to audit and interpret, what the IAQG is going to require, we can submit our courses for approval
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