ISO 9001
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▷ Reasons for Adoption
The widespread adoption of ISO 9001 can be attributed to several factors. Many major buyers now require their suppliers to be ISO 9001 certified. In addition to the benefits for various stakeholders, multiple studies have highlighted substantial financial gains for organizations with ISO 9001 certification. For example, a 2011 survey by the British Assessment Bureau revealed that 44% of their certified clients won new business. Corbett et al. (2005) found that certified companies experienced higher returns on assets compared to similar organizations without certification. Heras et al. (2002) observed similar superior performance, which was statistically significant and independent of company size. Naveh and Marcus (2007) showed that ISO 9001 implementation led to enhanced operational performance. Sharma (2005) linked improved operating performance to superior financial outcomes. Chow-Chua et al. (2002) found that companies in Denmark achieved better overall financial performance. Rajan and Tamimi (2003) showed that ISO 9001 certification resulted in stronger stock market performance, suggesting that shareholders benefit significantly from investments in an ISO 9001 system.
While the link between superior financial performance and ISO 9001 is evident, there is no definitive proof of direct causation. However, studies like Corbett et al. (2005) suggest a correlation. Other researchers, like Heras et al. (2002), have pointed out that this improvement may be partly driven by the tendency for high-performing companies to pursue ISO 9001 certification.
Research has also explored how results improve. Lo et al. (2007) identified operational improvements, such as reduced cycle times and lower inventories, as outcomes of certification. Buttle (1997) and Santos (2002) indicated that internal process improvements lead to observable external results. Hendricks and Singhal (2001) found that firms exceeded control groups post-implementation, with effective adoption of total quality management principles leading to substantial wealth creation. Alcorn states that the benefits of increased international trade, expanded domestic market share, and improvements in internal areas like customer satisfaction, interdepartmental communication, and customer/supplier relationships outweigh any initial investment.
▷ History
ISO 9000 was first published in 1987, based on the BS 5750 standards series proposed by BSI in 1979. Its roots trace back to 1959 when the U.S. Department of Defense released its MIL-Q-9858 standard, which was later revised into NATO AQAP standards in 1969. These were further updated into the BS 5179 guidance series in 1974 and then into the BS 5750 requirements series in 1979 before being submitted to ISO.
BSI began certifying organizations for their quality management systems in 1978. The first certification (FM 00001) is still held by Tarmac, the successor of the original certificate holder. Currently, BSI certifies organizations at nearly 70,000 sites worldwide.
▷ Process-Oriented Quality Management System
This International Standard encourages adopting a process-based approach to developing, implementing, and improving the effectiveness of a quality management system, aiming to enhance customer satisfaction by meeting their requirements. Key requirements for implementing a process-based approach are outlined in section 4.4.
Understanding and managing interrelated processes as a system enhances organizational effectiveness and efficiency in achieving desired outcomes. This approach enables the organization to control the interrelationships and interdependencies between processes, improving overall performance.
The process approach involves the systematic definition and management of processes and their interactions to achieve intended results in line with the organization’s quality policy and strategic direction. Process management is achieved using the PDCA cycle (see section 0.3.2), with an emphasis on risk-based thinking (see section 0.3.3) to capitalize on opportunities and prevent negative outcomes.
Implementing the process approach in a quality management system leads to:
- A clearer understanding and consistency in meeting requirements
- A focus on processes in terms of added value
- Effective process performance
- Ongoing improvement based on data analysis and evaluation
▷ Plan-Do-Check-Act Cycle
The PDCA cycle can be applied to all processes and the quality management system as a whole.
The PDCA cycle is summarized as follows:
- Plan: Establish objectives for the system and its processes, allocate resources to meet customer requirements, and identify risks and opportunities.
- Do: Implement the planned actions.
- Check: Monitor and measure processes and resulting products/services against policies, objectives, and requirements; report the findings.
- Act: Take corrective actions to improve performance where needed.
▷ Risk-Based Thinking
Risk-based thinking (see Clause A.4) is crucial for achieving an effective quality management system. Although implicit in earlier editions, it includes preventive actions to eliminate potential nonconformities and responses to actual nonconformities to prevent recurrence.
To comply with this Standard, organizations must plan and implement actions to address risks and opportunities. Managing both allows organizations to improve their quality management system’s effectiveness, achieve better results, and avoid negative impacts. Opportunities can emerge from favorable situations, like attracting new customers, developing new products, or enhancing productivity. Risk can present both positive and negative effects, where positive deviations may create opportunities.
▷ ACQ9001:2015 Requirements
4. Context of the Organization
- 4.1 Understanding the organization and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system and its processes
5. Leadership
- 5.1 Leadership and commitment
- 5.1.1 General
- 5.1.2 Customer focus
- 5.2 Policy
- 5.2.1 Establishing the quality policy
- 5.2.2 Communicating the quality policy
- 5.3 Organizational roles, responsibilities, and authorities
6. Planning
- 6.1 Actions to address risks and opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
7. Support
- 7.1 Resources
- 7.1.1 General
- 7.1.2 People
- 7.1.3 Infrastructure
- 7.1.4 Environment for process operation
- 7.1.5 Monitoring and measuring resources
- 7.1.6 Organizational knowledge
- 7.2 Competence
- 7.3 Awareness
- 7.4 Communication
- 7.5 Documented information
8. Operation
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.3 Design and development of products and services
- 8.4 Control of externally provided processes, products, and services
- 8.5 Production and service provision
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
9. Performance Evaluation
- 9.1 Monitoring, measurement, analysis, and evaluation
- 9.2 Internal audit
- 9.3 Management review
10. Improvement
- 10.1 General
- 10.2 Nonconformity and corrective action
- 10.3 Continual improvement
▷ Factors Affecting Audit Time Adjustments for Management Systems (QMS and EMS)
1. Increase in Audit Time
Audit time may increase due to several factors:
- Complex logistics with multiple locations
- Staff speaking multiple languages (requiring interpreters)
- Large sites relative to the number of personnel
- Highly regulated industries (e.g., food, aerospace, nuclear power)
- Complex systems or numerous unique activities
- Outsourced functions or processes
For QMS-specific reasons:
- High-risk activities or environments
- Sensitive receiving environments
- Views of interested parties
2. Decrease in Audit Time
Audit time may decrease for several reasons:
- Client is not “design responsible”
- Small site for the number of personnel
- Maturity of the management system
- High level of automation
- Low-risk or simple activities