Seeking an ISO 9001 certification might be overwhelming because of its processes. However, it doesn’t have to be that complicated if your organization has a good understanding of ISO 9001. The next part is to follow a simple step-by-step guide.
The ISO management standards are designed to be generic and relevant to sectors of all sizes. Regardless of your organization’s products and services, the standards provide a structure for good management training. Remember, ISO 9001 focuses on the effectiveness of an organization’s processes and delivery of services.
Step 1: Identify key drivers.
It is advisable for the top management to formally review your organization’s key drivers for enforcing a Quality Management System. Those factors should incorporate distinct client requirements, enhanced awareness of your key processes’ performance, and the need for perpetual improvement.
Determine whether the reasons for implementation are aligned to your organization’s business plan and strategies. The QMS serves as a succinct framework in specifying the outcomes your organization wants to achieve. This practical and process-based method is a good chance to improve.
Step 2: Acquire the standard.
Your organization must buy a copy of the standard. Allot time for research to gain knowledge about ISO 9001 associated with your particular industry. There are several sources available, including the International Organization for Standardization’s handbooks and articles from the internet.
Make sure your organization can differentiate the facts from the myths. For instance, IS0 9001 is the global standard for quality management systems across all sectors, not just in manufacturing. Meanwhile, ISO 9001:2015 is the latest version of the standard.
Step 3: Design your strategy.
Goals and actions make up a strategy, which the senior management should be committed to using so the organization can successfully enforce a Quality Management System. Formal documentation of the quality policy and objectives based on ISO 9001’s requirements is an essential step.
The strategic plan must consider how your organization operates and secures quality policy requirements. It must also be accessible to manifest infinite improvements. The strategy must be effectively communicated to all employees to have a collective effort in managing, achieving, and maintaining quality.
Step 4: Allocate resources for the Quality Management System’s development.
An internal quality manager doesn’t have to carry out all responsibilities. The organization must assure that all responsibilities and tasks are shared within all levels. The organization must provide resources such as budget and impose realistic timelines. A formal project plan is a sensible way of identifying needs and progressing implementation, but it isn’t an actual requirement of ISO 9001.
The top management should be kept updated about the system’s development so they can examine the plan. Similarly, they should clearly set out the responsibilities for the Quality Management representative, who will serve as the organization’s ISO 9001 expert and point person.
Furthermore, hiring a consultant is a cost-effective way of assisting the system’s development. Independently sourced consultants can give advice, so they must have total awareness and understanding of your organization.
Step 5: Understand your processes.
IS0 9001 obliges an organization to properly describe the interaction between the processes within the management system. A simple process map specified to your organization can help you obtain this. It should indicate the resources, key processes, controls, records, and documentation essential to meet the requirements of clients.
The process map must be validated throughout the organization to ensure no interactions or areas were left out. It should be used and reviewed as the system develops. In this manner, the process map could be updated until its consequent inclusion in the Quality Manual.
Step 6: Invest in a concise training program.
ISO 9001 requires proper identification of competence requirements for staff coming within the scope of the QMS. Employees, team leaders, and internal auditors will all need to undergo a range of seminars, workshops, and refresher courses in order to meet the requirements of competence.
This could sometimes include external training, which can provide assurance and authentic skills to help the execution process. An organization must also define how to demonstrate the effectiveness of training.
Step 7: Develop an extensive management system documentation.
Your organization doesn’t have to go overboard by preparing tons of files and loads of unnecessary documents. ISO 9001 only requires six specific documented procedures, including those identified and needed by the organization.
Controlled documentation of procedures, records, policies, work instructions, and company manual is another requirement of ISO 9001. The documentation aims to give a clear framework of the organization’s operations and consistency of processes.
Your QMS documentation should focus on documents that show the efficiency and create processes applicable to your organization. It gives better evidence for attaining objectives and goals.
Step 8: Execute your Quality Management System.
Internal audits should periodically measure and record the proper implementation of the Quality Management System’s requirements. It’s recommendable to conduct a management review to guarantee efficiency, continuing suitability, and adequacy of the system.
The management review is a key aspect of proving the effective application of the ISO management system. Company-based evaluations are also helpful during the ISO 9001 enforcement phase.
The organization must supply detailed checklists and position-specific work instructions. Likewise, preventive and corrective actions should be determined, improved, and recorded.
Inform your employees why the organization is aiming for certification, including the procedures, timeline, and benefits. A proper explanation will attain a company-wide goal and assure consistent effort. Communication and buy-in are vital for a successful implementation.
Step 9: Perform a pre-assessment audit and gap analysis.
Consider a pre-assessment audit at any stage. Moreover, a certification body gap analysis report will identify which ISO 9001 requirements your organization is already meeting. Any gaps that exist between the current processes of your organization and the standard’s requirement can help in the creation of a project plan.
In addition, audits should monitor whether seminars or training were being applied. This will give you the capacity to estimate timelines and set a date for the actual certification.
Step 10: Get Certified.
It is significant for organizations to choose a nationally accredited certification body to audit the management system. The certification body will decide if your management system complies with ISO requirements.
Initial certification is a two-stage process. The first stage involves a review of active processes at an organization’s head office. It aims to check whether the processes meet the requirements of ISO management systems.
An accredited certificate will be rewarded to your organization following the second stage audit’s successful completion. The on-site audit should see that your organization is following its own processes.
Hence, it is crucial to have an early dialogue and forward planning with your organization’s chosen certification body because it can add value to your organization. It will also help in continuously improving your organization’s processes.
The ISO 9001 Quality Management System aims to maximize your organization’s performance and ensure continuous development.
It looks like a complicated process, yet your organization can make it simpler by preparing employees and processes in implementing an ISO 9001 QMS. Once your organization earns the ISO 9001 certification, you must continue to apply the QMS in day-to-day operations in order to maintain certification and improve QMS if needed.