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How to Implement the ISO 9001:2008 Quality System
Keys for Success
Implementing a new Quality System takes time and resources. Your new ISO 9001 Quality Manual and Quality System will become your road map to success. There are many resources that can help keep an implementation on the right track. The International Organization for Standards has a wealth of information at your disposal. ISO has some of the most valuable resources available in the form of guidance documents. Some of these resources are listed below:
- Guidance on ISO 9001:2008
- Guidance on the documentation requirements of ISO 9001:2008
- Guide to the Terminology used in ISO 9001 and ISO 9004
- Guidance on the concept and use of the process approach for management systems
- Guidance on “Outsourced processes”
- Implementation guidance for ISO 9001:2008
The following keys for success will help you keep on track to accomplish a successful implementation.
1. Management Commitment
Implementing a new quality system takes time, effort and resources. If you are launching a project to implement ISO 9001, make sure you have the full support form your Management Team. Commitment from the Management Team will not only help achieve your implementation schedule but will help sustain the cross functional ownership of the system once it is implemented. A single person cannot be responsible for implementation. Engage the Management Team early by defining a mission statement and quality policy.
Discuss the following benefits of ISO 9001 with the Management Team
- Improved Customer Satisfaction
- Improved Internal Communication
- Measurable Objectives
- Reduced Non-Conformances and Scrap
- System to correct and prevent problems
- World recognized standard for Quality
- Continuous Improvement objectives
2. Create a Project Team
The success of any project requires effective Project Management. Project Management will establish project priorities, time lines and resource allocation. The ISO 9001 Project Manager should be a member of the Management Team who is supported by the Management Team. The Project Manager should have the responsibility and authority to keep the team on track.
- Assign a cross functional team to the project to win buy in
- Assign members from each functional area in the company even though their contributions may be limited.
3. Launch the Project
The Project Manager should launch the project by announcing it to the company so that everyone in the organization is aware of the new Quality System requirements the company is implementing. Announce the team and set incentives like a company lunch, team certificates, etc. The monetary value is not as important as the recognition and satisfaction personnel will feel if they are involved along the way,
- Try to set up a training webinar or internal training session on ISO 9001 so that the team and/or company can get acquainted with the concepts.
- Post signs with updates on progress
- Have periodic meetings with employees to get their feedback
4. Conducting an ISO 9001 Gap Analysis
Conducting a Gap Analysis of a quality system is a formal way for a company to evaluate where they are and where they need to be. The goal is to understand how to improve the current quality system to meet the regulatory requirements of the ISO 9001 Standard. A Gap Analysis Checklist can be written or purchased to accomplish this task. Each section of the standard is checked to determine if the current system meets the requirements of the standard. Upon completion of the Gap Analysis, the scope of the project can be understood. ISO 9001 requires specific documented procedures and records to comply with the standard.
5. Team Meetings
Team Meetings should be planned around each quality system requirements as it relates to each functional area in the company. For instance, Supplier Controls and Purchasing requirements should be discussed with the Purchasing Team. Non-Conforming Material Control could involve manufacturing as well as receiving inspection. The system which will be implemented needs to work in both departments. The meetings should be short and to the point reviewing progress, time lines, and accomplishments. Ensure the time lines are realistic. Keep everyone informed with bulletins, or progress reports so the project does not loss its momentum.
6. Create the Quality System Documentation
The first document that should be written is the Quality Manual. The ISO 9001 Quality Manual is the overriding policy statement and the document which will identify the quality system requirements that your company will implement. The Quality Manual also documents exclusions and justification for not complying to a requirement. Some requirements are not relevant to your company’s business. The Quality Manual will be used moving forward as the upper level policy document which should be consistent with each Standard Operating Procedure written. Remember, ISO 9001 is a process approach.
Using the Gap Analysis, the project plan can be updated to include all the Standard Operating Procedures which need to be created or modified to comply with the standard. As the procedures are written, a central repository should be created to save the documents electronically. Each document will require review and approval to determine if the requirements have been met. As the project progresses, each procedures created will fill a gap identified during the gap analysis.
There are five sections in the standard that specify activities that need to be considered when you implement your system:
- Overall requirements for the quality management system and documentation
- Management responsibility, focus, policy, planning and objectives
- Resource management and allocation
- Product realization and process management, and
- Measurement, monitoring, analysis and improvement.
When creating a quality system from the ground up, Standard Operating Procedure Templates can be very useful and save a lot of time. There are various debates regarding if using a template is an effective way to implement a Quality System. Each company needs to evaluate the pros and cons. Using a good template can save thousands of dollars, establish a consistent format and give the company a solid foundation to build on. Remember, templates are to be modified to meet the company’s core competencies and organization structure.
7. Implement the System and Train Staff
A lot of work has been done to get to the point of implementation. The ISO 9001 Quality System will be successful once the company understands the new requirements, documentation and their new roles in complying with the standard. Training all personnel is the key to success. Although this process is cumbersome, if effective training is not accomplished the system will not be effective. It takes commitment from the company and the Management Team to make it a successful launch.
8. Verify the Effectiveness of the Quality System
Now that your system is in place and the company is using the system, it is time to verify the effectiveness of the system. The best way to verify effectiveness is to audit the new processes. This can be accomplished by using an external third party auditor or your own Internal Audit Team. Using your Internal Audit Team provides many benefits. It reinforces the understanding of the requirements and keep the employees working together on compliance. Creating an Internal Audit Checklist can be very helpful since the Internal Audit Team will have difficulty recalling all the requirements that need to be verified during an audit. The audit results should be discussed at Management Review to determine is corrective actions need to be taken to address any issues that may have been identified.
9. Manage the Quality System
Managing a new Quality System is challenging after a launch. The focus on customer satisfaction is critical as well as the core requirements of the ISO 9001 Quality System.
- Monitor and measure the progress of your Quality Management System
- Strive for continual improvement
- Consider implementing goals and objectives in the company operation
10. Find a Registrar
There are many companies that can certify organizations to the ISO 9001 Standard. Interview several registrars to determine which company is right for you. Consider their location, travel costs and other administrative fees. There are a lot of resources available, talk to other companies and ask for referrals.
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