Developing a well-documented Quality Management System (QMS) based on the ISO 9001 standard and implementing it throughout your organization are the major steps in the ISO 9001 implementation process. Once the Quality Management System has been developed, it should be implemented throughout your organization.
ISO 9001 implementation can be a simultaneous process as you develop sections of the quality management system. You can start training your staff and implementing it. Implementation of the standard’s requirements can be monitored by doing internal audits.
ISO 9001 implementation is one of the most important steps in the ISO 9001 Quality Management System process. The operational effectiveness of the ISO 9001 Quality Management System is based on how well you implement it. Implementing a well-documented Quality Management System throughout your organization can significantly improve the business performance of your organization. The following are the key elements of ISO 9001 requirements in the ISO 9001 certification lifecycle:
ISO 9001 IMPLEMENTATION PROCESS
- GAP Analysis: Conducting a thorough analysis of your existing Quality Management System in relation to the ISO 9001 requirements is the beginning of the ISO 9001 implementation process. Organizations can use a gap analysis to evaluate the extent to which their organization is already ISO 9001 compliant. Once you recognize the gap in your existing quality management system, it becomes more apparent what is required to achieve and maintain ISO 9001 Certification.
- ISO 9001 Documented Information: Preparing ISO 9001 Documentation and Records is a key part of the ISO 9001 implementation process. Documentation is the road map that provides the organization with procedures to follow, objectives to achieve, and policies to adhere to. ISO 9001 implementation cannot be achieved without appropriate documents such as a Quality Manual, Quality Procedures and Standard Operating Procedures, or Work Instructions.
- ISO 9001 Training: ISO 9001 Awareness and Education are integral parts of the ISO 9001 implementation process. Comprehensive training and education of your employees about your company’s quality policy, quality objectives, and quality procedures are critically important. No Quality Management System can be successfully implemented without your employees being aware of it.
- ISO 9001 Standard Operating Procedures: SOP or standard operating procedures are part of ISO 9001 Requirements. It is the how-to procedure document of your company about various facets of your company. ISO 9001 implementation cannot be successful without having well-written Standard Operating Procedures.
- ISO 9001 Internal Audit: It is through internal audit, that organizations identify non-conformities related to the ISO 9001 requirements. Auditing is an ongoing element of the ISO 9001 Quality Management System lifecycle. ISO 9001 implementation cannot be completed without internal audits.
- ISO 9001 Management Review Meetings: Management Review Meeting or MRM is part of ISO 9001 Implementation where the performance of your quality management system is reviewed to see if it is bringing the desired outcome. It should be conducted by the top management at planned intervals based on the size and nature of your organization. Evidence of periodically scheduled Management Review Meetings is a requirement for certification of the ISO 9001 Quality Management System.
- ISO 9001 Corrective and Preventive Actions: Corrective and Preventive Actions or CAPA are root cause analyses of a problem by defining them, determining its cause, and taking appropriate action to prevent it from happening again. This is a structured, formalized process taken to investigate and address non-conformities that are part of the ISO 9001 Implementation Process. Corrective Action is reactive and deals with the problem after that occurs and Preventive Action is proactive and deals with the problem before that happens.
- Certification Body Selection: ISO 9001 Quality Management System Certification is provided by Certification Bodies or Registrars. They are third-party external auditors who perform audits of your quality management system and issue certification. The selection of a registrar is an important step in the ISO 9001 implementation and certification process.
- ISO 9001 Audit: Your ISO 9001 implementation process is not completed until it is certified that your quality management system is effective and meets the requirements of ISO 9001 by a third-party Certification Body or Registrar. The ISO 9001 Certification Cost is based on the scope of your Quality Management System and the kind of certification body you choose.
- ISO 9001 Surveillance Audit: ISO 9001 certificates are valid for three years. Surveillance audits are required to be conducted every year by the Certification Body until recertification is completed after three years.
- Continual Improvement: Continual Improvement is an integral part of the ISO 9001 implementation process. It is an ongoing effort over time to improve your organization’s quality management system. The assumption here is that there is always room to improve your products, services, and/or processes. The ISO 9001 Quality Management System uses The Plan-Do-Check-Act (PDCA) cycle tool which involves planning, implementing, monitoring, and correcting any potential problems.
FREE ISO 9001 CONSULTATION: Liberty Management Group (LMG) offers a free, onsite ISO 9001 consultation. Whether you are just starting out on building a quality management system from scratch or need to evaluate your existing system for ISO 9001 certification, our experienced consultants will be able to give advice and guide you through the entire process of implementation and certification of ISO 9001.
After the initial onsite visit, we will provide you with an estimate of the cost and time frame of the ISO 9001 implementation and certification process. No contract or commitment is required unless LMG is selected to provide any further service.