Medical Device QMS 2
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HACCP – MS 1480
OHSAS 18001
TS 16949


  • Certification Procedure of KGS

  • KGS will provide you with fixed price quotes for the Stage 1 and Stage 2 audits and the first surveillance audit. Travel will not be part of the quotation but will be charged at actual cost.An estimate will be provided for the surveillances and recertification based on KGS’s current daily charges.


  • Stage-1 Audit

    • The Stage 1 audit is to evaluate your location and site-specific conditions and to determine preparedness for the Stage 2 audit. This will include a manual and procedure review, a review of your understanding and implementation of the standard and related statutory, regulatory and compliance issues (e.g. quality, environmental, legal aspects of the operation, associated risks, etc.), verification of scope and other relevant information, a review of your internal audit and management review and planning for the Stage 2 Audit. The audit will identify any areas of concern that could become nonconformities at the State 2 audit. You will receive a written report detailing the audit findings.In order to become certified, your company must demonstrate that its management system is functioning and the various control mechanisms are operable. Before the Stage 1 audit is conducted:
    • your management system should have been in effect for a minimum of three months;
    • one complete internal audit cycle should have been completed;
    • one management review should have been completed.


  • Stage-2 Audit

    • The Stage 2 audit determines if your company has successfully documented and implemented all of the requirements of the specified standard. This is accomplished via an in-depth review of your manual and procedures and the confirmation of their implementation. The audit also verifies conformance to the identified standard. The audit is performed in accordance with the requirements of ISO 17021:2011 and KGS procedures. This audit will involve on-site interviews, examinations of documents and records and observations to thoroughly determine the implementation of the standard. This stage also reviews any areas of concern identified in Stage 1.Any nonconformities will be documented and identified as major or minor nonconformities. A major nonconformity is the absence or total breakdown of a system to meet a clause or sub-clause of a standard. A number of minor nonconformities against one clause or sub-clause can represent a total breakdown of the system and thus be considered a major nonconformity. A situation that raises significant doubt about the ability of the client’s management system to achieve its intended outputs is also a major nonconformity. A minor nonconformity might be a procedure that is not comprehensive enough, a person who did not follow the procedure, or a lack of a required record. A major nonconformity requires a separate successful re-audit of the applicable clause or sub clause before you can be certified. A minor nonconformity will generally be addressed by submitting a response to the Lead Auditor before you can be certified. Depending on the standard, the corrective action for a minor nonconformity may not have to be closed prior to certification. A written audit report, containing any nonconformities, is issued after the audit.Although KGS is constrained from consulting, and therefore cannot advise you on how to react to a nonconformity, our auditors are often able to offer a range of examples of actions that would meet the requirements of the standard, or examples of compliant (and nonproprietary) systems we have seen. Because only you know what is right for your business, our auditors cannot say what solutions will work best within your company. You must determine your own nonconformity resolution.
  • Corrective Action Audits

    If a major nonconformity is found during any audit, a corrective action audit will be scheduled to verify the implementation of the action(s) to resolve the nonconformity. The scope of the audit is limited to the clause or sub clause where major nonconformities were found.

  • Issuance of Certification

    Based upon the Lead Auditor’s recommendation and/or Technical report reviewer’s recommendation for certification and the Certifier’s decision for certification, the Management system Certificate will be issued. The Lead Auditor’s recommendation will be based upon the successful completion of the Stage 1 and Stage 2 audits and resolution of all nonconformities identified. Certification is valid for three years, and is dependent upon your company’s maintenance of your management system and upon your adherence to KGS’s Certification Regulations.

  • Surveillance Assessments

    • Surveillance audits may be conducted either every six months or annually, at your discretion. The re-certification is conducted three years after the Stage 2 audit, and at three year intervals thereafter.A surveillance audit is a mini-audit that reviews a portion of the standard to determine if your company has maintained its implementation of the standard. In addition, surveillance audits will review your use of KGS’s and the accreditation body’s certification mark, status and closure of audit nonconformities and your customers’ complaints.For minor nonconformities, a response must be submitted. If a major nonconformity is found during a surveillance audit, a separate corrective action audit will be conducted. A specific audit plan will be developed for the clauses found to have major nonconformities.
  • Recertification Audits

    A recertification is conducted every three years to review the status of the applicable requirements. The recertification consists of an on-site audit. A documentation review will also be conducted if there have been major changes to the documentation since the previous document review. It must cover the interaction between all elements of the system, the overall effectiveness of the system, and commitment to maintain the effectiveness of the system. In practice, this means that the entire standard must be reviewed in a single audit at least once every three years, and that this shall be in addition to regularly scheduled surveillance audits. In general, a recertification requires less time than the original Stage 1 and Stage 2 audits. After successful completion of the recertification, surveillance audits will be conducted until the next three-year anniversary occurs, prior to which another recertification will be conducted.

    For minor nonconformities, you must submit a response to the Lead Auditor. If a major nonconformity is found during a recertification audit, a separate corrective action audit will be conducted. A specific audit plan will be developed for the clauses or sub clauses found to have major nonconformities.


Popular Standards

  • Quality Management System ISO 9001
  • Environmental Management System ISO 14001
  • Occupational Health Safety Assessment Series OHSAS 18001+MS 1722
  • Medical Device Quality Management System ISO 13485
  • Hazard Analysis Critical Control Point & MS 1480
  • Food Safety Management System ISO 22000