V. How to prepare for external audit
|
|
|
|
As an organization progresses towards ISO 9001 certification, a crucial step is preparing for the external audit conducted by an independent certification body. This external audit validates the organization's compliance with ISO 9001 requirements and determines whether the organization is eligible for certification. The Management Representative (MR) plays a key role in ensuring that the organization is well-prepared for this audit. Let's delve into the essential steps and requirements for preparing for the external audit:
A. Document Review and Verification
The MR should review all documentation related to the Quality Management System (QMS) to ensure that it aligns with ISO 9001 requirements. This includes policies, procedures, work instructions, records, and any other relevant documentation. The MR should verify that the documentation accurately reflects the organization's processes and adherence to ISO 9001 principles.
Reading Sources:
- Hoyle, D. (2007). ISO 9000 Quality Systems Handbook: Using the Standards as a Framework for Business Improvement (5th ed.). Routledge.
- Kasperskaya, Y., & Dumea, A. (2015). Evaluation and improvement of audit planning and effectiveness. Procedia Economics and Finance, 26, 715-719.
B. Mock Audits and Pre-Assessment
To simulate the actual external audit process, the MR should organize mock audits or pre-assessment audits. These audits involve internal auditors or consultants assessing the organization's QMS against ISO 9001 requirements. The findings from mock audits help identify any gaps or non-conformities that need to be addressed before the external audit.
Reading Sources:
- Kara, A., & Spillan, J. E. (2016). ISO 9001:2015 Transition: A practical guide for internal auditors. Quality Progress, 49(2), 52-57.
- Pivac, T., & Pivac, S. (2016). Key performance indicators for quality management in procurement. Total Quality Management & Business Excellence, 27(7-8), 800-818.
C. Corrective Actions and Improvement
Based on the findings of mock audits, internal audits, and ongoing reviews, the MR should ensure that corrective actions are taken to address any identified non-conformities or areas of improvement. These corrective actions demonstrate the organization's commitment to resolving issues and continuously enhancing its QMS.
Reading Sources:
- Pivac, T., & Pivac, S. (2016). Key performance indicators for quality management in procurement. Total Quality Management & Business Excellence, 27(7-8), 800-818.
- Vineyard, B. S., Sanders, J. A., & Hildreth, P. M. (2012). Auditing and assurance services. Cengage Learning.
D. Documentation Preparation
The MR should organize and prepare all necessary documentation for the external audit. This includes assembling records, reports, evidence of corrective actions, and any other documentation that the certification body may require to assess the organization's compliance with ISO 9001.
Reading Sources:
- Lozano, R., & Carpenter, A. (2011). A review of literature on the barriers to higher education participation. International Journal of Sustainability in Higher Education, 12(3), 257-276.
- Sampaio, P., Saraiva, P., & Rodrigues, A. G. (2014). ISO 9001 and ISO 14001: towards a research agenda on management system standards. International Journal of Quality & Reliability Management, 31(2), 129-144.
E. Communication and Readiness
The MR should ensure that all relevant personnel are informed about the upcoming external audit. This includes communicating the audit schedule, explaining its purpose, and addressing any concerns or questions. By fostering a sense of readiness and cooperation among employees, the organization can better navigate the external audit process.
Reading Sources:
- Santos-Vijande, M. L., López-Sánchez, J. Á., & Trespalacios, J. A. (2012). How organizational learning affects a firm's flexibility, competitive strategy, and performance. Journal of Business Research, 65(8), 1079-1089.
- Ferreira, A., & Otley, D. (2009). The design and use of performance management systems: An extended framework for analysis. Management Accounting Research, 20(4), 263-282.
F. Coordination with Certification Body
The MR should establish communication with the chosen certification body to confirm the audit schedule, discuss logistical details, and address any queries. This communication ensures a smooth audit process and sets clear expectations for both parties.
Reading Sources:
- Vouzas, F., & Psychogios, A. G. (2015). ISO 9001 and service quality: In search of a missing link. Total Quality Management & Business Excellence, 26(7-8), 881-899.
- Karapetrovic, S. (2001). Requirements for Quality Management System Documentation. The TQM Magazine, 13(2), 123-130.
G. Audit Preparation and Review
In the days leading up to the external audit, the MR should conduct a final review of all documentation, evidence, and preparations. This ensures that everything is in order and aligns with ISO 9001 requirements. The MR should also brief the internal audit team on their roles and responsibilities during the external audit.
Reading Sources:
- Kara, A., & Kaynak, H. (2003). The effect of management commitment to service quality on employees' affective and performance outcomes. Journal of Operations Management, 21(5), 491-511.
- Tukel, O. I. (2016). Developing an ISO 9001 audit checklist: A case study. Total Quality Management & Business Excellence, 27(11-12), 1249-1263.
Conclusion
Preparation for the external audit is a pivotal phase in the ISO 9001 certification journey. By ensuring document alignment, conducting mock audits, addressing corrective actions, preparing necessary documentation, fostering communication and readiness, coordinating with the certification body, and conducting a final audit review, the MR plays a key role in positioning the organization for a successful external audit. This preparation not only paves the way for certification but also underscores the organization's commitment to adhering to ISO 9001 standards and principles.
0 komentar:
Posting Komentar