| The main processes of the quality management system are to be documented within the quality manual or procedures. This is the main idea of any quality manual. In any case, do yourself a favor and present within the quality manual a list of the processes included under the quality management system. It would save some explanations during the Audits. The relations and sequences between the main processes must be defined, documented and implemented. First let's understand the basics |
Chapter 4.1 – Quality management system general requirements
ISO 9001
| ISO 13485
| The organization shall establish a quality management system documented and implemented within the organization. The organization is required to act continually to improve the effectiveness of its quality management system according to the requirements of the 9001.
While documenting its quality management system, the organization shall refer to the next issues:
| The organization shall establish a quality management system documented and implemented within the organization. The organization is required to maintain the effectiveness of its quality management system according to the requirements of the 13485.
While establishing the quality management system the organization shall refer to the next issues:
| | The main processes of the quality management system shall be identified and documented according to the application of the standard (chapter 1.2). The identified processes must be implemented. | The main processes of the quality management system shall be identified and documented according to the application of the standard (chapter 1.2). The identified processes must be implemented.
| | The relations and sequences between the processes are defined and implemented. | The relations and sequences between the processes are defined and implemented.
| Criteria for effective monitoring and control over the processes are defined.
| Criteria for effective monitoring and control over the processes are defined.
| Any resources and information required to support these processes shall be available and appropriate.
| Any resources required to support these processes shall be available and appropriate.
| The processes are controlled and monitored according to prior specifications.
| The processes are controlled and monitored according to prior specifications.
| Continual improvement is implemented to improve the processes.
| Continual improvement is implemented to improve the processes.
| When any process is submitted for outsourcing, and where the process has a direct affect on the product's quality, the process shall be included under the quality management system and shall be submitted to control and monitoring as well as for continual improvement.
| When any process is submitted for outsourcing, and where the process has a direct affect on the product's quality, the process shall be included under the quality management system and shall be submitted to control and monitoring as well as for continual improvement. |
Chapter 4.1 is a general chapter. In this chapter presented the general requirements for your quality management system. The main idea of the quality management system. The specific requirements appear throughout the following chapter 4.2. This chapter shall be regarded as a base for self evaluation whether the organization's quality management system follows the general requirements.
What is it "The relation and sequences between the main processes"? The best way to demonstrate it is too present you with an example for a definition for relation and sequences between the main processes: 
In this diagram one can see that there are four main processes required to realize the product:
- Customer's delivering order
- Production processes
- Processing purchase
- Delivering goods to the customers.
The purpose of the diagram is to present the relations between these processes and the quality management system processes: Within the organization - Management responsibility
- Resource management
- Measurement, analysis and improvement
Outside the organization
- Purchase evaluation
- Customer satisfaction measurement
While the ISO 9001 Standard requires improving continually the effectiveness of the quality management system, the ISO 13485 Standard requires maintaining the effectiveness of the quality management system.
What is it exactly effectiveness? Effectiveness is the extent to which planned activities are realized and planned results achieved. You planned something during your
So far, so good. This issue is repeated and repeated and repeated throughout the ISO 13485 Standard. The ISO 13485 Standard requires constantly maintaining the effectiveness of the quality management system. The organization is actually required to (in a general requirement) to maintain processes and documented systems that would allow the organization to study constantly whether its quality management system is effective or not. The ISO Standard (the explanation from the standard itself) claims that the reason for insisting on maintaining the effectiveness of the quality management system (rather than improving as his cousin the ISO 9001 Standard does) is that medical regulation around the world for medical devices insist that organizations would act to implement a quality management system that examines its effectiveness constantly in order to produce safe and effective product. We cannot argue with them. They read the regulations. We didn’t. We hadn’t the time and the regulations are boring. We trust the ISO organization.
The criteria for maintaining the effectiveness of the quality management system are required to be defined and documented. These are the quality objectives. These objectives shall achieve the improvement of the quality management system. Objectives may occur as schedules, defined time frame for responses, results of processes, goods' returns etc.
The organization is required to monitor and measure its processes in order to examine whether it achieves its quality objectives. It will do so, by defining the processes for monitoring and measurements. It is required both by the ISO 9001 Standard and the ISO 13485 Standard.
The ISO 13485 Standard requires maintaining the effectiveness while the ISO 9001 Standard requires "only" improving the effectiveness. The difference lays where maintaining the effectiveness must be implemented in the organization. Why there is a difference? The ISO organization provides an explanation that medical regulation, around the world, generally aims for an effective quality management system. We said that before.
How one can maintain the effectiveness of its quality management system?!?
A "Cockpit" system is a good example for maintaining the effectiveness of the quality management system. "Cockpit" system is a system that reports data in real time. The name derives from the allegory of the aviation world. The management can control in real time the objectives. Just like a pilot can control his parameters. "Cockpit" allows the management track in real time, defined quality management objectives (or other more interesting objectives that really matters to the top management) and determine whether the quality management system is effective or not.
Within this "Cockpit" systems, the quality objectives, the criteria, and processes (in some cases) are defined and being measured per product, per day per hour – according to the definition. This kind of system allows the management to detect, on real time, trends in product provision (services or goods) and react immediately to improve. As a result, the effectiveness of the quality management system is maintained continually instead of being analyzed once in every period.
A Highly recommended system. In fact, we here at 13485 Quality, believe that this is the future of management. No longer screams and anger once in a quarter when the reports arrive. From now on, shouts screams and anger every hour.
Resources and information needed to support the processes are required to be available. Resources are well covered in chapter 6 – Resources management.
Information, however, is divided into two types:
- The information required to perform activities and processes – shall be available to the relevant parties. Here we may encounter procedures, work instructions etc. Anything supports operations of processes. First you must define the processes and then document them. We will get there later on.
- The information flowing between the productive parties and decision making parties. The purpose is to ensure that the information required for the decision making party, regarding the quality management system is transferred.
These processes regarding information are required to be defined.
For outsourced processes, it is cleared that the organization is responsible for them as if the processes were conducted within the organization's facilities. Medical regulations, usually, hold the organization responsible for any parameters of the medical device (intended use, safety and effectiveness). That means that whether processes occurred within the organization or within its supplier's facilities – the organization is responsible. In order to submit the outsourced processes to the quality management system, the organization must define these processes as part of the quality management system. Just to be clear…
So, when organization is manufacturing a medical device, but the packaging is preceded by a supplier, outside the organization, it is required to document within the quality management system the processes of:
- Delivering the medical devices to the supplier – product preservation
- Delivering the medical devices for the supplier – product preservation
- The control over the packaging processes – product realization
- Validating and verifying the outsourced processes – product realization
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