Foundations of ISO 9001
Foundations of ISO 9000 – knowing the concepts that make ISO 9001 work.
If you’ve been asked to get the company ISO certified, but you’re new to the world of ISO, here are some core concepts to get you started.
ISO 9001 is a basic set of requirements which ,when implemented consistently, help a company function consistently and effectively. It is a management methodology that supports the provision of quality goods and services consistently. It starts with commitment by top management to define company vision and policies, provide resources and promote a process-based approach to achieving objectives. Every company has quality-promoting activities of some sort, but a formal Quality Management System accurately reflects the organization’s culture, and provides a structure for planning, executing, monitoring and ongoing improvement of those activities.
There are 7 quality management principles that underlie all quality management systems. These are each explained in greater detail in ISO 9000 (the fundamentals and vocabulary resource supporting ISO 9001), section 2.3, with rationale, benefits, and possible actions.
Customer Focus – understanding the needs and challenges of the customers and markets you serve, as the foundation of being able to meet and exceed expectations, which drives customer satisfaction and loyalty.
Leadership – defining and communicating direction and purpose creates an environment where all people can help to achieve company objectives.
Engagement of people – recognition, empowerment and ongoing growth in competence helps keep staff engaged in achieving company objectives.
Process Approach – every company functions as a set of interrelated processes. Your results come from your processes, so defining and consistently following them, and then monitoring the results, helps you achieve objectives.
Improvement – this is essential to maintain performance, react to changes and create new opportunities. A culture of improvement encourages staff to stay engaged and contributing, includes a commitment to learning from mistakes, and supports change and innovation where it is needed.
Evidence-based decision-making – since decisions often include multiple types and sources of information which can be subjective, the use of facts, evidence and data analysis can provide greater objectivity and confidence when making decisions.
Relationship management – sustained success is more likely when the company prioritizes strong relationships in both customers and suppliers. This is done by focusing on understanding the opportunities and constraints of each partner, sharing knowledge and having shared values.
Process Approach - viewing the way a company functions as a set of interrelated processes helps to achieve goals effectively and efficiently. Defining the activities, interactions, and expected results within each process and as an overall system, helps management identify opportunities that will add value, and implement improvements when objectives are not met.
Plan-Do-Check-Adjust - Management systems function best when they are based on this cycle of improvement. This is explained in detail in ISO 9001, clause 0.3.2.
Plan includes identifying the context of the organization, the interrelated processes in operation at the company, and how they are monitored, and expected performance goals.
Do includes implementing the plan, operating according to your processes and recording results
Check is how management identifies needs and opportunities by reviewing performance compared to goals and the results of audits (both internal and external)
Act (Adjust) is driven by those performance results, and includes Corrective Actions and process changes when objectives were not met, or Improvement actions like upgrades to infrastructure, equipment, or staff competence.
Interested parties - requires identifying those who pose a significant risk to the company if their needs and expectations are not met (customers, suppliers, competitors, regulatory, financial, and employees). Knowing the needs and expectations of your interested parties helps you ensure that your system meets those that are relevant to the company.
Risk Based Thinking – although a part of every day life (“don’t touch that, it’s hot”) risk based thinking can get forgotten in a QMS. In 9001 an organization is required to identify both risks and opportunities, and to implement actions to address them. Risks can come from internal sources like process gaps, infrastructure needs and culture, and from external sources like customer, supply chain and interested party pressures. Opportunities can come from sources like access to new markets, new or upgraded products or services, improved productivity and reduced waste. Developing a culture of improvement is easier when management leads the way by modeling risk based thinking and listening to the risks and opportunities identified by staff at all levels of the company.
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