The ISO/IEC 9001 standard stands as the global benchmark for quality control. ISO 9001 zeroes in on two pivotal elements: fulfilling customer demands and elevating customer contentment. To achieve these objectives, ISO 9001 delineates specific facets that are enshrined in its requirements.
Phase 1: The initial stage of ISO 9001 implementation commences with delineating the scope. This scope encompasses the quality management system tailored to meet customer requisites and enhance customer satisfaction.
Deliverable: ISO 9001 Scope
Phase 2: In the second phase, the organization is tasked with crafting a comprehensive quality management policy. This overarching policy encompasses core aspects, such as the organization’s characteristics, the characteristics of its services and products, inputs and expected outputs, as well as the requisite resources for processes, responsibilities, and authorities.
Within the policy, the following are included:
- A description of the risk framework, which may involve selecting from various options like COSO 2013 or ISO 31000. The risk framework is detailed from a quality control perspective.
- A framework for handling laws, regulations, requirements, and guidelines established by the organization in terms of quality.
- Demonstration of alignment with the existing risk management framework, such as COSO 2013. This also covers how the organization manages the implementation and oversight of the quality management system, including the methods and controls required to ensure the effective execution of procedures.
- Identification of processes designated for evaluating and enhancing the quality management system.
- Approval of the policy by the organization’s management or leadership.
Deliverable: Policy Document
Phase 3: Phase three entails executing a risk analysis in the realm of quality management. It encompasses describing processes and procedures in response to the risks pinpointed in Phase Three. Following this, the procedures and processes are introduced within the organization, ultimately culminating in the creation of a quality management manual that is accessible to all employees.
Deliverable: Risk Analysis & Quality Management Handbook
Phase 4: After documenting the manual, the fourth phase involves conducting a pre-audit or walkthrough. During this phase, all control measures and ISO 9001 procedures are scrutinized, and potential issues are unearthed in preparation for the final audit.
Phase 5: Phase five, stemming from insights gleaned in the pre-audit, revolves around enhancing control measures and the quality management system. Solutions are devised and implemented to address the identified problem areas.
Phase 6: In the culminating sixth phase, an ISO 9001 audit is carried out by a certifying institution, leading to the acquisition of the ISO 9001 certificate.