ISO 9001:2015 “certification†refers to the issuing of written assurance (the certificate) by an independent, external body (the Certification Body) that has audited an organization’s QMS and verified that it conforms to the requirements specified in the standard. “Registration†means that the auditing body then records the certification in its client register. The organization’s QMS has therefore been both certified and registered. The ISO 9001 standard focuses on improving an organization’s management system and processes. It does not specify any requirements for product or service quality. Customers typically set product and service quality requirements. Most Certification Bodies (CB’s) use the following process with slight variations:
1. Pre-assessment: Before the actual certification audit, a CB auditor makes a preliminary visit of your facilities, briefly reviews your QMS documentation and conduct an informal check of the QMS implementation. In essence, this preliminary audit intended to uncover areas in your QMS that might need special attention. During the initial visit the audit scope and audit program is agreed upon, as well. A Pre-assessment is an optional activity. It adds value in that it provides an organization with a clear view of the gaps in its state of readiness, a few months prior to the formal certification audit. More and more organizations now prefer experienced consultant auditors to do the Pre-assessments as they not just identify the gaps, but also provide solutions to correcting them. CB auditors may only report on the gaps, but are not allowed to provide solutions.
2.
Documentation review: The CB audit team evaluates your QMS manual to
determine the adequacy of its scope and conformity to the requirements of the
standard. The documentation review report summarizes any findings from this
process. The report indicates if your organization is ready to proceed with the
certification audit.
3.
Certification audit: During the certification audit, the CB audit team conduct
interviews, examinations and observations of the system in operation. It
provides the team essential information required for the certification process
and assesses the degree of conformity of the QMS with the requirements of the
standard. When found conforming, the certification body issues the certificate
of conformity to ISO 9001.
4.
Surveillance audits: Each issued certificate has a three-year life
period. Upon certification, the CB creates a periodic audit schedule for
surveillance audits over the three-year period. These audits confirm the
on-going compliance of the QMS with specified requirements of the standard. At
least one periodic audit per year is required.
5. Re-certification audit: After the three years are up, your certification will be extended through a re-certification audit.
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