A valuable aid to your developing a viable QMS Project Plan - to aid you start on time, finish on time and leave nothing vital out.
The ISO 9001 2015 Implementation Model developed by deGRANDSON Global
The 33 Steps to ISO 9001:2015 Implementation is the model we have developed for implementing a quality management system (QMS) to meet the requirements of ISO 9001:2015 and to securing accredited Certification.
It is the foundation on which our Lead Implementer is built.
Basis of the ISO 9001 33-Step Certification Process
The International Standards Organisation (ISO) has published two standards that focus on developing and implementing an organization's QMS:
- The quality management system standard: ISO 9001:2015. This standard is the specification for a QMS. It specifies the requirements of a quality management system for organizations seeking to establish implement and maintain a framework to consistently meet and exceed customer expectations.
- ISO/TS 9002: 2016, QMS - Guidelines for the application of ISO 9001:2015. This technical specification provides extensive guidance on implementing and maintaining a QMS, especially for Small and Medium-sized Enterprises (SMEs) and for Service Organizations.
To help make sense of it all from a QMS Implementer/Project Manager’s viewpoint we have developed this 33-Step Infographic.
33-Step ISO 9001 Certification Process
- Obtain management support (Clause 5.1)
- Assemble QMS project team
- Gap analysis and project plan
- Identify the quality context of the organisation (Clause 4.1)
- Identify Legal and Other Requirements (Clause 4.2 and 6.1.3)
- Other interested party's needs (Clause 4.2)
- Establish QMS and define processes (Clause 4.4)
- Define scope of QMS (Clause 4.3)
- Prepare quality policy (clause 5.2)
- Define key roles and responsibilities (Clause 5.3)
- Determine actions for risks and opportunities (Clause 6.1)
- Establish QMS objectives and plan to achieve them (Clause 6.2)
- Establish design and development processes (Clause 8.3)
- Operational planning and controls (Clause 8.1)
- Identify monitoring and measurement calibration (Clause 9.1.1)
- Establish operational controls and monitoring (Clause 9.1)
- Establish customer satisfaction methods (Clause 9.1.2)
- Develop plan for QMS changes (Clause 6.3)
- Develop mandatory and other documentation (Clause 4.4 and Clause 7.5)
- Determine and secure required resources (Clause 4.4 and Clause 7.5)
- Determine and secure required resources (Clause 7.1)
- Procurement provision
- Establish internal and external communication (Clause 7.4)
- Initial employee awareness (Clause 7.3)
- Finalise and issue QMS documentation (Clause 4.4 and Clause 7.5)
- Complete job specific training (Clause 7.2)
- Go Live! Implement procedures (Clause 7.5 and Clause 10.1)
- Determine customer requirements (Clause 8.2)
- Production and service provision (Clause 8.5)
- Establish product and service release processes (Clause 8.6)
- Conduct internal audits (Clause 9.2)
- Conduct management reviews (Clause 9.3)
- Implement continual improvement (Clause 10.2
For ease of understanding the 33 steps have been set out in a simple sequence. In reality, you will frequently be working on several steps simultaneously.
This will help reduce the overall timescale for the project. When project planning with your project team, you should seek out and document such opportunities.