What is ISO9001
ISO9001 is the world’s foremost recognised quality management standard. With over 1,000,000 certifications in over 170 countries, it is the most recognised quality management standard in the world.
ISO9001 sets out the essential requirements for a practical and effective quality management system (QMS) which is, in essence, a system for minimizing risk and maximizing opportunity.
Among the many benefits of ISO 9001, the Standard helps organizations to improve customer satisfaction levels, internal efficiency and employee involvement.
Who uses ISO9001?
ISO9001 is applicable to all organisations from service to manufacturing and from sole traders to large multi-nationals.
Why implement ISO9001?
Implementing a certified quality management system provides a range of benefits including:
- provides for clearly defined operational processes for staff, operations, communication etc.
- provides a framework for increased efficiency and continuous improvement
- potential direct reduction in the cost of scrap and rework
- increased competitiveness among industry rivals
- meets the requirements for public and private tenders
Is it compatible with other standards?
Based on a structure called Annex SL, ISO9001:2015 is fully compatible with ISO14001 (environmental management) and ISO45001 (health & safety management). What this means is that 3 systems can be seamlessly implemented together into a single integrated management system. Similarly, ISO14001 or ISO45001 can be easily integrated into an existing ISO9001 QMS.
ISO 9001 sets out seven key principles of quality management:
- Customer focus
- Engagement of people
- Process approach
- Evidence based decision making
- Relationship management
ISO 9001 is based on the PDCA cycle – Plan-Do-Check-Act – and its key elements are:
- Establish and document the quality management system
- Implement and maintain the QMS
- Monitor and measure the outputs from the QMS and its processes
- Review and analyse these results
- Identify areas for improvement
- Implement improvement programmes
Risk based thinking
The concept of “risk-based thinking” is prevalent throughout the ISO90012015 standard. The standard requires that companies:
- Identify all potential risks that could impact the effectiveness of the QMS
- Assess these risks
- Determine if the risks are acceptable
- If the company feels the risks need to be reduced, implement improvement programmes
Replacing “preventive action” from previous versions of ISO9001, risk based thinking is a practical and sensible approach to ensuring in so far as possible, that companies are prepared for adverse scenarios and prevent negative effects.