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Monday, November 23, 2015

Certification/Registration to ISO 9001:2015 QMS - Part 3

Certification/Registration to ISO 9001:2015 QMS - Part 3

Certification Procedure for QMS Certification

Keshav Ram Singhal

Generally the certification body follows following procedure for QMS certification:
- Documentation review
- Initial visit
- Initial on-site audit
- Corrective actions and verification, as necessary
- Issue of certificate
- Periodical surveillance audit
- Renewal of certificate

Since you are interested to obtain ISO 9001:2015 QMS certification for your organization, you should ensure that the quality management system of your organization is in accordance with ISO 9001:2015 QMS standard. After selecting a certification body, you should inform your decision to the certification body and complete/submit the necessary prescribed application and necessary contract note with them.

Following the receipt of the prescribed application for certification from an organization, the certification body, at the beginning of the certification process, agrees with the organization on the scope of the organization's quality management system, then it carries out a review of the organization's documentation (the documented information the organization maintains). After review of such documentation the applicant organization is informed of any lapses or nonconformity in the documentation against ISO 9001:2015 QMS standard.

You may ask about what documentation should be submitted to the certification body for documentation review. Now maintenance of a quality manual is not a mandatory requirement of ISO 9001:2015 QMS standard, as it is in ISO 9001:2008 QMS standard, however the organization should make available following documented information to the certification body for their documentation review:
- Scope of the organization
- Information to support the operation of organization's processes
- Quality policy
- Quality objectives
- Information about operational planning and control
- Information on characteristics of the product/service to be provided, activities to be performed and results to be achieved
- Any other documented information determined by the organization as being necessary for the effectiveness of the quality management system

Initial visit by certification body's personnel includes provision for the certification body to plan the initial audit, confirm the basis of certification and discuss the review of documentation. As this stage, the certification body assesses the degree of implementation and any obvious lapses or nonconformity in the quality management system, which requires attention before the audit. Preparing for the audit in advance will be a right approach for which you should make the following preparations:
- Communicate to your employees about the audit, its purpose, date and audit process
- Make sure your premises (all areas of operation) are clean, safe and having good working environment
- Make sure that all current and relevant documented information are available at the point of use
- Make sure that obsolete documents are removed from the workplace
- Make sure that all monitoring and measuring resources are verified or calibrated
- Keep ready a copy of the maintained documented information available for the auditor
- Keep ready a suitable place for auditor to work, such as writing audit findings and reporting

Following the initial visit, rectification of any notified lapses or nonconformities and the establishment of an agreed audit plan, the certification body would carry out the initial audit (also known as a certification audit). On completion of the initial audit, the certification body will issue a report inter alia mentioning nonconformities with ISO 9001:2015 QMS standard. Observations may also be given to define or illustrate the nonconformity.

The applicant organization, seeking the certification, then responds to the nonconformities, and submits for approval, proposed corrective actions to the nonconformities found the quality management system. Thereafter the certification body will confirm completion of the corrective action by a documentation review or follow-up visit, as appropriate.

Upon completion of a satisfactory initial audit, the certification body issues to the applicant a Certificate of QMS Conformity, generally valid for three years, subject to compliance with the conditions of the certificate. For maintenance of the certification, the certification body performs periodical audits (known as surveillance audits) generally at six/nine monthly intervals. Renewal of certificate is carried out after three years and involves a satisfactory re-audit of the quality management system.

.... To be continued

For Training Handbook on ISO 9001:2015 QMS Awareness, please Click Here

For Training Handbook on ISO 9001:2015 QMS Implementation in a School, please Click Here

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