ISO 9001:2015 is an International Standard dedicated to Quality Management Systems (QMS). A Quality Management System is a set of policies, processes and procedures focused on consistently meeting the requirements and expectations of customers and other relevant interested parties and enhancing their satisfaction. These requirements specified in the Standard are complementary to the requirements for products and services.
The best way to implement an ISO 9001:2015 Quality Management System is by firstly understanding what the standard entails and how it can benefit your organisation. The focus should not be to gain more business as a ‘tick box’ exercise to comply and win more tenders but viewed as a holistic effort to increase business credibility. The risk of losing certification can be more harmful than attaining it. The maintenance of a Quality Management System is challenging and should be adopted in the culture of the organisation.
Educate yourself on ISO 9001:2015 through articles or an awareness training program. Consider a Gap Assessment because many organisations could partially conform to the standard without their knowledge as the definitions and terms used in ISO are not your typical business terms that may be used in your business/industry or country. Once the Gap Assessment is completed, determine whether you can close the gaps through Implementation Training or hiring a Temporary Consultant, or a Full-Time Quality Representative. The Process focuses on a Risk-Based approach conforming to Governance Frameworks best suited for the business and its Legal Requirements.
There are seven Quality Management Principles upon which ISO 9001 requirements for the QMS are based. These principles are in no particular order as they are seen as equally important to ensure that the Quality Management System is effective.
The seven quality management principles are:
- Customer Focus
- Leadership
- Engagement of people
- Process Approach
- Improvement
- Evidence-based decision making
- Relationship management
With these seven pillars firmly in place, implementing a quality management system will be much easier and the results will be more focused on your needs as an organisation.
The International Standard utilizes the Process Approach, which enables an organization to plan and put their processes in place and identify their interactions. This approach incorporates the Plan-Do-Check-Act (PDCA) Model and Risk-Based thinking. Below is the PDCA Model which can be applied to all processes and to the QMS as a whole.
Below is a brief description of the PDCA cycle:
- Plan – Identify activities that are required to be done. Set the objectives of the QMS, its processes. Identify and allocate resources needed to deliver these objectives.
- Do Put words into action. Implement what was planned.
- Check Monitor and measure the processes and the products/ services according to the plan which can be your policies, procedures, objectives and requirements and report and review the results.
- Act based on the acquired results, take measures and activities to improve performance.
Risk-based thinking enables an organisation to identify factors that could have a negative impact on the Quality Management System. An organisation is required to analyse and prioritise the risks and opportunities based on what they think is acceptable and what is unacceptable to the organisation. Preventive controls need to be in place to minimise any potential nonconformities and recurrence.