- The management representative is a central part of the ISO 13485 quality system. QMS Management Representative Responsibilities. Top management must appoint a member of management who has the authority and responsibility to ensure the processes that are needed for the QMS are documented, report to top management on the effectiveness of the QMS.
- Top management involvement and active participation in the QMS implementation process. Identification of ISO representative(s) / ISO in charge and core team and issuance of appointment letter with responsibilities. Quality policy displayed and known to everybody. If required, translated in local language.
- All terms that could describe the critical role of the Management Representative (MR) in an ISO 9000 quality management system. Just as the point guard on a basketball team is responsible for setting up plays for his teammates, the MR is an enabler of the quality system.
Many people have a problem figuring out what additional responsibilities a quality management representative has. Although many roles are defined in the standard, the standard also states that the responsibilities required should be given to a management representative, although they might have another job in the organization.
The question then arises on which quality management representative responsibilities are not mentioned in ISO 9001. There are a number of functions that are commonly done by QM representatives in addition to duties required by ISO 9001.
The QM
Smaller companies can often not justify having the role of a quality management representative as a separate position and then define a manager within the company to take on the additional responsibilities. Anonymox firefox.
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Many people don’t realize that a quality manager does not need to be the QM rep for an ISO 9001 QMS. These two jobs are not the same. If the role of QM rep is added to the responsibilities of a manager that already exists, the quality manager is often the first and logical choice.
A common duty held by many management representatives is being the quality manager. This is most likely because when management decides who the quality management representative should be, the obvious choice is that the QMS should be managed by a manager whose job it is to manage other quality functions in the company.
A quality manager has the responsibility of managing the employees working for the quality department, i.e. inspectors. This includes everything else, e.g. salary reviews, performance reviews, budgets, staffing levels, etc. The QM will also, for example, manage the quality department planning, who deals with non-conformances and when inspections should be done. This also means that the QM will be the owner of all the department’s processes, and as such, is responsible for making sure they are integrated with the internal customer and internal supplier processes.
Liaison with external parties
Customers like to have a single point of contact when they have comments or complaints, especially if the quality manager is also the management representative. The key to the role is to make sure that being a liaison is not the only thing that the management rep does, as contact with customers could easily surpass other important focus points of the management rep’s job.
Iso 9001 2015 Management Representative
The 2nd most common group of extra responsibilities given to the role of QM rep are the responsibilities mentioned in the ISO 9001 standard: the function of liaising with outside parties. The certification body for the QMS has to have someone to contact when arranging reports, audits and corrective action correspondence. This is most often done by the quality management representative.
Management review data analysis
To be able to report on the performance of the quality management system, could be done by looking at raw data, but as the management review needs to look at a list of 7 inputs (customer feedback, results of audits, product conformity and process performance, follow-up of previous management review actions, status of corrective and preventive actions, changes that will have to be made to the QMS and improvement recommendations), it is easier if the data is presented in an understandable format.
The data that has been identified need to be examined so that it becomes easy to use. The QM representative will often have the task to review the data that should be discussed at the review meeting, assess data and make it presentable by using charting and statistical analysis and then formatting it to a suitable format for the review.
The QM rep will also likely be responsible for taking minutes and controlling the actions flowing from the management review.
QM rep responsibilities should be first
The list described is a summary of common additional responsibilities added to those mentioned in ISO 9001 and includes reporting on the management system performance, QMS process maintenance and promoting customer requirements. The key is to make sure that other managerial responsibilities are still performed, but at the same time, the additional responsibilities of the QM rep should not be affected when the rep ensures the oversight of the QMS. Like with any other function within an organization, monitoring and reviewing the workload of employees against job responsibilities are crucial to make sure enough time and resources are available to give enough attention to every aspect of the job. Remember that when monitoring the tasks that have been assigned, it is okay to change the manager given the role as the quality management rep if it is needed. If there is no oversight, the expense of designing and implementing the system could be wasted, as the QMS will not add the improvements and value that top management expects. The QMS is not about wasting resources, but it is about building a framework to improve and adding value.
Iso 9001 Management Representative Appointment Letter Sample
ISO 9001 quality management systems (QMS) are implemented using MyEasyISO software in Fes (Morocco), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with MyEasyISO in Auckland (New Zealand).