5 Key Components of the Initial Assessment of Your Quality Management System

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June 19, 2012

When you choose a registrar for quality management certification, one of the first steps is todetermine the level of your company’s compliance with the applicable requirements. This step is known as the Quality Management System (QMS) Initial Assessment, which consists of a Stage One and Stage Two audit.

Before the registrar performs this Initial Assessment, the following must be completed at minimum:

  1. A complete discussion about any potential exclusions to your QMS (limited to Section 7 of the ISO Standard; for ISO/TS16949 only 7.3 Product Design can be excluded).
  2. Policy and procedures documents provided, reviewed and approved by the registrar.
  3. A minimum of one full-system process-based Internal Audit cycle and a subsequent completed Management Review.
  4. If you have a multi-site organizational structure, you must demonstrate the ability to collect and analyze data from all sites, including complaints and corrective action procedures, legal requirements and more.

After certification, ongoing surveillance is conducted to verify continued compliance to the requirements. Surveillance audits are conducted at least once per year. With Smithers Quality Assessments, you have an option of either five semi-annual surveillances or two annual audits in a three-year certification cycle.

Each surveillance audit includes the following at a minimum:

  • internal audits and management review
  • a review of actions taken on non-conformities identified during the previous audit
  • treatment of complaints and corrective actions
  • effectiveness of the management system with regard to achievement of objectives
  • continual improvement
  • continuing operational control
  • any changes to the quality management system
  • use of marks and/or reference to certification

Several months prior to expiration of your certificate a re-certification audit is required. The purpose of a re-certification audit is to confirm the continued conformance and effectiveness of the management system as an entirety, and its continued relevance and applicability for the scope of certification.  All requirements of the standard will be audited at this time.

Companies work with Smithers Quality Assessments when seeking ISO 9001 certificationor ISO 14001 certificationinternational standards, or to the supplemental requirements established for such industries as automotive ISO/TS 16949, aerospace AS 9100and AS 9110, and medical/pharmaceutical ISO 13485.

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