Understanding ISO 9001
ISO 9001 Quality Management System (QMS) is an internationally recognized QMS standard that has been implemented by over one million organizations across the globe. This standard gained global acceptance due to its scope, demonstrating a consistent supply of products and services that meet customer pertaining requirements and aim to enhance customer satisfaction. The standard is generic and can be applied by any organization, irrespective of industry, product, the complexity of processes, and size of the organization.
ISO 9001’s- Framework
The framework of ISO 9001 has been developed based on 7 quality management principles:
- Customer focus
- Leadership
- People engagement
- Process approach
- Improvement
- Informed decision making
- Relationship management
While adopting QMS, organizations should integrate these principles into their business goals and deploy them using an effective Business Operating System (BOS):
ISO 9001 has reinforced leadership principles and emphasized the adoption of QMS. This gives importance to strategic decisions that focus on sustained growth.
Why implement ISO 9001?
The figure below depicts the clause framework using the PDCA cycle in a simple way;
With effective implementation of QMS using ISO 9001, an organization can increase the likelihood of achieving their business goals. The standard’s requirement utilizes management tools like process approach, risk-based thinking, internal audits procedure, improvement process, and management reviews to effectively demonstrate sustainable growth for the organization.
What are internal audits?
Internal audits play a vital role in evaluating the performance and assessing conformance of the QMS towards effectiveness. Internal auditing is the process of gathering evidence that’s used to determine the conformity to the requirements of ISO 9001 and the implemented QMS. Evidence gathered is applied to determine whether the audit criteria are fulfilled and its extent of fulfilment. The audit process utilizes an effective audit programme and is conducted objectively and independently in an impartial, unbiased manner. Instead of acting like a cop, the auditor should move like a physician exploring the system’s health.
Why conduct ISO 9001 internal Audits?
Performing internal audits provide opportunities for improvement, non-conformities and its corrective actions. Top management should utilize the audit process to review and evaluate the effectiveness of the implemented system and initiate necessary actions to achieve performance goals.
If an organization conducts the internal audit process in an effective manner, it can reap benefits on improving systems, identifying cost reduction opportunities, and process optimization. An organization can conduct a process approach based audit for implemented systems, or a result-oriented process audit on manufacturing or service processes. Effective audits of either kind will add value to any organizational goals. The audit criteria can be integrated with business goals and value additions, to benefit the organization’s bottom line.
It is apparent that ISO 9001 QMS, with an effective internal audit process, can bring about significant improvement in any organization, achieving a competitive advantage with sustainable growth.
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