1.0 Introduction to Quality Management Systems
The objective of the implementation of a Quality Management System (QMS) is for providing objective evidence that production is being performed in a controlled and consistent way, and that the product meets its intended purpose as well as the contractual technical requirements. This implies that business related activities, especially production, must be narrated in procedures and recorded and documented in a traceable manner. The QMS also must include written instructions for corrective actions and improvements. A quality audit, for verifying compliance with the ISO 9001-2008 standard, as well with the company quality system, shall be regularly conducted.
2.1 Quality Audits
Regular audits are to be conducted for verification of compliance with the company’s QMS, the ISO 9001-2008 standard for Quality Management Systems, company Quality Assurance and Quality Control (QAQC) procedures, and contractual and technical requirements. Audits shall follow a formal audit plan and must to be conducted by a qualified quality assurance auditor, who is to evaluate the degree of compliance, confirm the existence of the company QMS and verify that the quality management activities are being performed and the quality records are being properly maintained Quality assurance activities on project audits must also be reported in the periodic reports.
2.2 Audit Timing
Audits are to be conducted on a regular basis.
Audits may be rescheduled to allow for variations in project execution schedules or to allow for the availability of objective evidence. Specific audit schemes and issues may be communicated in advance with the auditees. Prior to the audit a pre-audit meeting must be conducted with the auditees for reviewing specific issues as appropriate. An audit close out meeting for reviewing the audit findings must be conducted at completion of the audit.
2.3 Audit Categories
Audit results can be categorized as follows:
● Full Compliance – No further action required.
● Observation - Action for improvement is recommended but not mandatory, however repeated observations on the same issue may indicate a weakness and may result in a nonconformity on the next audit.
● Minor nonconformity – This is a minor issue and often can be resolved at close out of the audit.
● Major nonconformity – This is a major issue and require the utmost attention,
Evidence of the attainment of required quality levels must be identified, collected, and retained in the appropriate (project) dossiers. The critical quality records that should be audited may include the following:
3.1 Administration / Control
4.0 Continuous improvement preventive and corrective actions
With the intent of improving upon the standards of work and quality, a process of preventive and corrective actions must be implemented. This method is to utilize a systematic approach in which problems are identified and documented. Once a nonconformity or noncompliance has been identified, the cause must be researched. The implementations of preventive and corrective actions must be documented and retained in the Quality Records. Quality system awareness must be integrated in the business and execution policy. Training must include preparation of documents, ensure compliance with project requirements, project improvement schemes, and continuous improvement programs.