Imagine being the new owner of a factory with over 10,000 employees. How will you know who's in charge? Or what each person who received a monthly check is responsible for doing in your factory. Sure you might have managers in charge of different departments, but what if its those managers who aren't on the same page because no one ever told them which page to be on. That scenario sounds awfully chaotic and by implementing a quality management system like ISO 13485, its a start to have order restored.
"The two main reasons given for registration:
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Improved Operational Efficiency - Lower production costs due to fewer nonconforming products, less rework, lowered rejection rates, streamlined processes and fewer mistakes.
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Access to new markets - Some markets require ISO 13485 Registration, while other markets may only favor companies with ISO 13485 Registration. This was really the main objective in creating ISO 13485. If a company in Germany receives solicitations from companies in Italy and the UK, how can they compare quality without an expensive audit at both locations? A uniformed standard will at least give them a benchmark.
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What can you expect in return for your investment in an
ISO 13485 Quality Management System (QMS)?
Feedback from ISO 13485 Registered companies shows what you can expect as the payoff from all of your hard work.
Because of the responsibilities called out in the ISO 13485 Standard, organizations often see an increased involvement of top management with regards to the Quality Management System.
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This starts with the setting of the Quality Policy and Quality Goals and Objectives.
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It continues with Management Review looking at data from the QMS, and taking actions to make sure that Quality Goals are met
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New Goals are set, and continual improvement is achieved.
With the QMS in place and working for you, the organization is focused towards the Quality Goals.
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Management is provided with data on a continual basis and able to see progress or lack of progress towards goals and take appropriate action.
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The organized, scheduled process of conducting Management Review ensures that this evaluation takes place.
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It provides the mechanism of reviewing goals and performance against goals on a scheduled basis, and for taking action based on the evaluation.
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Increased productivity results from the initial evaluation and improvement of processes that occurs during the implementation process and from improved training and qualification of employees.
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Better documentation or control of processes leads to consistency in performance, and less scrap and rework.
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Managers experience fewer late night troubleshooting calls; employees have more information for troubleshooting problems on their own.
Customer satisfaction increases are seen as Goals and Objectives take the customer needs into account.
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Customer needs are better understood as customer feedback is sought, received and analyzed.
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Goals and objectives are adjusted based on the information and the organization becomes more customer driven.
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As goals focus on the customer, the organization spends less time focusing on individual goals of departments and more time working together to meet customer needs.
All of this leads to financial rewards, your reward for your hard work and investment in the Quality Management System. In a study conducted by researchers from UCLA results showed that “U.S. publicly held companies traded on the New York Stock Exchange that receive certification under the ISO 13485 Quality Standard show significant improvement in financial performance compared to those companies that have not pursued the standard.” *
So work with enthusiasm and optimism, knowing that your organization will be significantly improved by this ISO 13485 implementation project. You are contributing to the future success and profitability of your company." Source: the13485store