This team should be made up of managers from different areas of your business. An implementation team will ensure the success of your transition to the new Quality Management System. The implementation team should be headed by the Management Representative that will oversee all parts of the implementation process. This person should hold a perfect understanding of the ISO standard. They will be the line of communication between the implementation team and the ISO registrar that will eventually certify your business.
The Management Representative should be a member of management that is respected and has a passion for managing and maintaining the Quality Management System far into the future. It will be much easier to map out a plan for meeting the standards when you are aware of which processes within your organization coordinate with which requirements. It's extremely helpful to use flow charts and turtle diagrams to figure out exactly how your business gets from Point A to Point B when it comes to creating new products for customers.
You can do something as sophisticated as using computer software to define each step of the process, or simply use post-it notes on a wall. Once you can see the entire process in front of you, it's time to decide which of the items is a core process and which is a support process.
Examples of core processes are things such as design and delivery. These are the processes which contribute directly to getting the customer what they want. Support processes are not directly responsible for it but do help the core processes to do their job. These processes are things like training and facility maintenance. In order to keep the transition to ISO running smoothly, there should be a structured plan set into place.
Using the to-do list created from your analyses in step one, the implementation team should create milestones and deadlines to get things done. Having a plan in place is key in implementing any system in a timely and effective manner. Without ensuring things are done at specific times under controlled conditions, they may get pushed aside and take much longer. With a plan set out before you, it's time to let everyone in on the change. Every single person that works within your organization should be aware that change is coming.
Hold seminars to let them in on the way things are going to change and why. Make sure when you introduce the concept of such a large change that you tell your employees how it will affect them. Include research that supports why implementing ISO is a good thing for the business and for them. Let them know how their work might be changed in the process so that they are prepared.
Communication is key in implementing change. Keep everyone in the loop so that they don't feel they are being jilted in any way. Set up displays on notice boards that show the progress being made. Listen to any concerns or complaints.
Make everything feel included. The Quality Policy within your company is an integral part of keeping your business committed to meeting objectives and focusing on customer satisfaction. Your Quality Policy is one of the key things that will be used to measure your organization when determining the success of your Quality Management System. There is no set definition of quality that applies to all businesses. Your definition of quality is one that is agreed upon by your Top Management team.
It should build on your current values and identify objectives that are able to be measured to determine quality. Quality Objectives are the way that the quality of your products will be measured. There isn't a specific way that ISO asks for objectives to be documented. Your quality objectives can be related to budget, business plans, or management review. It's important that these objectives suit both your business and your customers.
Once you have your Quality Policy in place you need to communicate it effectively to all members of your organization. You don't have to force the entire thing down their throat verbatim, but make sure they know where they can find a copy of the document if they should need it. Try to shorten the key concepts of your Quality Policy into a few short sentences or a handful of keywords that make sense to employees at all levels.
Do this for each department depending on what part of the Quality Policy directly correlates to the work they are doing. Put this shortened version up on notice boards so that they are always aware of it. Every area of your organization should have managers and staff who are directly responsible for quality-related tasks and upkeep. You can create entirely new roles for these people or change already existing job descriptions to include the needed responsibilities.
You should have staff in each department that is capable of performing audits, maintaining documentation, conduct management reviews, and implement any needed changes.
Make sure the people you choose to undertake these responsibilities are fully aware of what the job entails and how it relates to the Quality Management System. There are certain documents you are required to keep and others which may just be helpful in keeping everything running as it should. Organizing and preparing your documentation is usually done according to the importance of the documents. At the top, you have your Quality Manual. This includes your companies quality policy and objectives as well as how your quality system functions.
It will have descriptions of all of the processes within your system and how they interact. You should always go back and refer to your Quality Manual as you implement changes to ensure all process descriptions are up to date.
Second, there are procedure documents. These documents detail all of the individual business processes and how they operate. They will show how each process is designed and controlled, including what checks are carried out to keep them in line. Third, there are work instructions. These are very specific documents that detail the necessary instructions required to perform every task within the business.
Last, you have your forms and records. These are exactly what they sound like. Forms are used to collect information for record-keeping purposes. Records are required to show how your Quality Management System is operating and if it is up to standard. The Template includes everything you need for ISO documentation - quality policy, scope, what procedures you're planning to implement, flow charts, objectives and forms that ISO certification may require. Your business probably already has extensive documentation going over processes and procedures, as well as forms and records.
It would benefit you to make a list of all of the documents that already exist and note their current status. Many of these documents may not be completed or up to date or might be lacking specific details required by the ISO standard. This list will give you a good idea of where to start in moving forward. All of the documentation within your Quality Management System should be uniform in style and format so they are easy to navigate and read.
Be sure to check what each type of document is required to have in it so that you can include these things in your template. Having ready-made templates will make the daunting task of documenting your Quality Management System a lot easier to handle for everyone involved. It is required that all documentation associated with your Quality Management System is well controlled and up to date.
This ensures that your employees only have access to the most recent version of all documents. Now it's time for the biggest step.
You've done all of the work required to set up your business for success in transitioning to ISO , all you have to do is launch your plan. You will start to see changes come into action and you will have to be mindful to ensure they go as planned.
Every employee is crucial to keeping your Quality Management System running as it should. It's time to train all of them on the parts of the system that are specific to their area of work. When they understand how their work affects the system they will be helping to move your business in the right direction.
Always go into training with a plan to equip each and every member of your team with the tools they require to be an effective part of your new Quality Management System. Use your structured plan to begin putting your Quality Management System into action. Keep a close eye on every part of the plan as it begins to make sure things are moving forward. Monitor process performance and start internal audits to check that all standard requirements are being met.
It's essential to keep your implementation team on task. The Management Representative should have a checklist on hand at team meetings to review with everyone. Any problems that arise during the implementation process should be handled as promptly as possible. This is also a good time to make sure documentation is being developed properly. Work instructions and forms should all be written and available to employees.
Two to three months after the documentation has been prepared and things have started being implemented, you should conduct internal audits to identify any problems within the scope of your Quality Management System. Any corrective measures that need to be taken should be taken without any delays.
If needed, documentation should be revised. Auditors will ensure that all procedures are well implemented, documented, and understood by the staff carrying them out. They will check that the system meets standard requirements, is effective, and is showing improvement.
Never spring an audit on your employees. They should not feel surprised or like they aren't being involved in the entire transition process. Always plan the audits well in advance. Let everyone know when the audit will take place and what departments will be audited. After you have done your internal audit and your Quality Management System has been up and running for six months or so, you should review the progress your business is making.
This review will help your team identify any underlying issues and the corrective actions that need to be taken to get everything in line with requirements. Ideally, this course should be provided by a registered training organization with expertise in this area. If a staff member has to conduct the training session, they must have a sound and demonstrated background in the subject matter combined with, wherever possible, formal training skills.
Involve employees in developing and improving the system, through awareness sessions, flowcharting, team reviews and experience feedback. Review all existing management system practices, controls and documentation using the requirements of ISO as the criteria.
Try to understand each business process in context of each of the requirements of the standards by comparing different activities and processes with what the standards requires. A gap analysis is a technique to clearly identify which clauses of ISO are currently not being fully addressed or not addressed at all and to develop remedial actions.
Gap analyses should be conducted with small groups of staff, including the process owner of each process. Establish the strategic direction of your company and implement the risks and opportunities procedure. The organization has to establish its vision consistent with its mission and identify the strategic directions and interested party requirements consistent to its context.
Identify the processes needed for the QMS. The scope must set out what your company does and what it delivers. It should include products and services. It must be done with consideration to the context.
Ensure staff understand the risks and opportunities that affect their work. Review the quality policy to determine whether it is appropriate to the context of the organization and its purpose.
Ensure the quality objectives are consistent with the quality policy. Set objectives per function and identify measurable performance indicators to enable tracking of their status. Staff must know the quality policy and how the objectives relate to their work. Adjusting the QMS documents should also be expected as staff become accustomed to the requirements and begin to suggest improvements in usability.
Meet and discuss the requirements of ISO clause 7. Meet and discuss the requirements of ISO clause 9. Meet and discuss the requirements of ISO clause 8. Top Management to perform a review of progress and to identify areas of weakness and take corrective action as required. Certification Body selection criteria may include:.
Meet and discuss the process requirements of ISO clause 8. If your operational procedures are effective and define how your key processes operate, keep them! Implement the purchasing and procurement procedure. Meet and discuss the process requirements of ISO clauses 7. Meet and discuss the process requirements of ISO clause 7. Members of Top Management should assist the Management Representative in drafting the quality management system manual and preparing its scope. If your existing quality manual fits your business and your customers require it, keep it!
Top management to perform a review of progress and to identify areas of weakness and take corrective action as required. Discuss the requirements for internal auditing and teach the participants on how to audit a QMS. Based on education and experience auditors must pass 1-or 2-day external auditor course and exam. Perform an elemental internal audit of selected functions and areas using the audit programme and audit checklists. Ensure that the auditors do not audit their own functions or processes.
All staff should be provided with adequate lead time to prepare for the audit. Assist the process owners in determining root-causes and finding solutions through workshops and training on 5-Whys analysis, Fishbone Diagrams, or 8 Dimensions 8D analysis techniques. The process owners should implement the corrective actions to address the audit findings. The documented corrective actions must be submitted to the Management Representative for approval.
Top Management should ensure that corrective action is undertaken on any adverse 1st stage audit findings without delay. Make any necessary changes to the quality management system and the documentation information.
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