In order for organizations to successfully implement an ISO 9001 Quality Management System (QMS) that provides confidence to customers and serves as an instrument for continuous improvement, the implementation process should be taken up as a project, following these steps and recommendations:
Step 1: Nominate a Team.
- A small team consisting of a senior person from each department should be appointed by management for system development.
- A coordinator must be designated.
- The team should undergo awareness and documentation training on the ISO 9000 family of standards with a professional training organization.
Step 2: Carry out a gap analysis
- Start with a flow chart showing how information currently circulates, from order placement by the customer to delivery of the product or service.
- Follow with a flow chart of activities in each department.
- Formulate a list of existing procedures and work instructions for the most relevant activities in each department.
- Other activities and processes that are considered relevant at this point can be added.
- Identify gaps throughout this process.
- A time-bound action plan to close the gaps identified during this exercise should be prepared and action taken as planned.
Step 3: Prepare documentation
- Procedures should be limited the documentation that is required.
- Additional procedures and records should be devised only if they add value to the system.
- Involve all personnel concerned in the development of the procedures and work instructions applicable to their areas.
- Documentation should reflect current practice and not ideas of what should be implemented.
- New forms and checklists should be created if necessary; otherwise adopt existing ones to the extent possible.
Step 4: Train and implement
- Train all employees. Everyone should know their responsibilities in order to successfully implement and maintain the QMS.
Step 5: Conduct Internal audit and improvement
- Some managers and staff members should be trained by a professional trainer to carry out internal auditing.
- Conduct the first internal audit approximately three months from implementation.
- Correct any gap found during the audit.
- Once the system stabilizes, internal audits should be conducted at planned intervals.
- To improve the system internal audits, customer feedback data, process and product monitoring data, evidence of the attainment or not of quality objectives, corrective actions taken, etc. should be used.
- Management should provide financial and other resources for improvement projects and monitor the progress of improvement.
Step 6: Management review
- Top management should review the QMS.
- As a result of this review, management may decide to set new targets for quality objectives and to make the improvements needed in the QMS.
Step 7: Certification
- Certification is voluntary; therefore the need for it should be decided by management.
- Once the system has been in operation for a few months, organizations may consider making an application for certification.
An action plan for developing QMS covering the above activities should be prepared. The plan should define the responsibilities of team members and management and set target dates. Full implementation may require six to nine months.