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.
How to Get ISO 9001 Certification
- Obtain management support (ISO 9001 Clause 5.1)
- Assemble QMS project team
- Make a Gap analysis and project plan
- Identify the quality context of the organisation (ISO 9001 Clause 4.1)
- Identify Legal and Other Requirements (ISO 9001 Clause 4.2 and 6.1.3)
- Identify Other interested party's needs (ISO 9001 Clause 4.2)
- Establish QMS and define processes (ISO 9001 Clause 4.4)
- Define the scope of QMS (ISO 9001 Clause 4.3)
- Prepare quality policy (ISO 9001 Clause 5.2)
- Define key roles and responsibilities (ISO 9001 Clause 5.3)
- Determine actions for risks and opportunities (ISO 9001 Clause 6.1)
- Establish QMS objectives and plan to achieve them (ISO 9001 Clause 6.2)
- Establish design and development processes (ISO 9001 Clause 8.3)
- Operational planning and controls (ISO 9001 Clause 8.1)
- Identify monitoring and measurement calibration (ISO 9001 Clause 9.1.1)
- Establish operational controls and monitoring (ISO 9001 Clause 9.1)
- Establish customer satisfaction methods (ISO 9001 Clause 9.1.2)
- Develop plan for QMS changes (ISO 9001 Clause 6.3)
- Develop mandatory and other documentation (ISO 9001 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.
- [Infographic] The route to ISO Certification explained
- Free ISO 9001 Implementation Handbook (100+ pages)
- [Update] Seventeen official ISO 9001 Guidance Documents
- ISO 9001 & IATF 16949 Certification: What's the Difference?
- ISO 9001 Training Courses Overview
deGRANDSON Global is an ISO Certified Educational Organization
We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment. It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.