1. Leadership Buy-In:
It is important that the leadership of an organization shows their full commitment to quality management system (QMS) implementation in order to ensure success. This requires that the leadership team develops a clear understanding of ISO 9001 requirements, and communicates this understanding throughout the organization. It also includes providing resources to support the development of the QMS.
2. Perform a Gap Analysis:
A gap analysis is necessary to identify where an organization’s current practices and processes differ from ISO 9001 requirements. This helps organizations create an implementation plan that addresses any deficiencies.
3. The Scope:
Organizations must define the scope of their ISO 9001 certification, which should include all areas of their operations that will be subject to the QMS standards.
4. Implement the QMS and Create the QMS Manual:
Organizations must create documents outlining their quality management system, including procedures, policies, roles and responsibilities, as well as forms and records needed to support quality management activities within the organization or across its product or service range.
5. Internally Communicate:
Organizations must ensure that the implementation of their QMS is communicated effectively throughout the organization so that all personnel understands their roles and responsibilities in regard to quality management activities.
6. Create an Audit Plan:
Organizations should create an audit plan which outlines who will be responsible for conducting internal audits, when they will occur, and what areas they should cover. Internal audits help organizations identify any non-conformances with ISO 9001 requirements.
7. Identify Roles and Responsibilities:
Organizations must identify the various roles involved in implementing their quality management system, including who is responsible for managing each component of the system and overseeing its overall effectiveness.
8. Refine the QMS and Implement System Changes:
Organizations must continually review their quality management system, refine it where appropriate and make changes as needed to ensure that they are meeting ISO 9001 requirements. This includes making adjustments to procedures, forms and records, or adding new ones as necessary.
9. Internally Audit:
Regular internal audits are necessary to identify and correct any non-conformances with ISO 9001 requirements before an external audit occurs. Organizations must have documented procedures for conducting these audits, including what areas should be covered and how corrective action will be taken when necessary.
10. Apply for Stage 1 Audit:
When organizations feel confident that their QMS is compliant with ISO 9001 standards, they can submit an application for a Stage 1 audit. This audit is conducted by an external certification body to assess the organization’s QMS and make sure that it is compliant with ISO 9001 requirements.
11. The External Audit:
The final stage of ISO 9001 certification is the external audit. Once an organization passes this audit, it will be officially certified against ISO 9001 standards. This certification demonstrates to customers and other stakeholders that the organization has implemented quality management practices across their operations, and provides assurance that its products or services meet specific requirements.