It seems that this development is not only about adapting to more modern forms of communication such as video, audio and other electronic recordings, but also about giving an organization the flexibility to reuse the appropriate information, facilitate the updating of current versions, allow wider access/distribution and reduce the costs associated with documentation. (Note: This change does not require a media change and allows an organization to reuse existing QMS documentation as long as it is compliant. See explanation below.) The final documents that must be generated are those that must cover each section of the standard that applies to your business. Once all the quality procedures are generated, you can start creating the work instructions, and once all the procedures and work instructions are generated, you can match them to your quality manual to ensure that the quality manual gives an accurate overview of your QMS. The final step is to maintain and improve QMS documentation throughout the product or service lifecycle. Maintenance is performed by ensuring that QMS documents are verified in accordance with the document control procedure and improvement is achieved through the analysis of QMS results and the taking of appropriate measures to continuously improve the effectiveness and efficiency of the QMS. ISO 9001 requires that different types of information be documented; However, not all information needs to be documented as separate documents. It is flexible so that the organization can decide on the scope of documentation and the level of detail documented. For example, small businesses may include procedures documented in the QMS manual. ISO 9001:2015 essentially allows the organization to adapt the completeness or complexity of the documentation to its own situation while achieving its overall objectives.
However, deferral does not reduce the need for proper documentation. As mentioned in the standard, “documented information” may be required: The ISO guidelines on requirements for documented information in ISO 9001:2015 contain these guidelines for the documentation of the following: It is true that the international standard for quality management systems (ISO 9001) requires specific documentation (see this article: List of mandatory documents for ISO 9001). The purpose and benefits of QMS documentation are manifold: it provides a clear framework for operations in an organization, enables process consistency and a better understanding of the QMS, and provides evidence of the achievement of goals and objectives. When designing QMS documentation, you need to focus on efficiency and create processes and documents that are applicable in your organization. The document control procedure describes the existing documentation system and how it is to be implemented. The existing system must ensure that all documents are verified, legible, easily identifiable, retrievable, available at points of use and regularly checked for their continued suitability throughout the product/service lifecycle. This procedure must be followed for all verified documents. The documents describe the structure, procedures, processes and resources of the organization and are needed as objective evidence of regulatory compliance and are verifiable, so the document control process is crucial, because if it does not work properly, you will have to encounter compliance issues very quickly and use expensive resources to resolve issues. Please note that the requirements of the Clinical Trials Regulations will only apply from the coming into force of the Regulations. The scientific requirements will apply from 26 April 2018. QmS documentation can consist of different types of documents.
As a rule, it contains documents such as quality policy, quality manual, procedures, work instructions, plans and quality files. QMS documentation can be represented as a hierarchy, as shown in the following diagram: However, this flexibility does not exempt the organization from demonstrating that it is meeting its quality management objectives. As mentioned earlier, the standard has many cases where it requires specific proof of compliance. The documentation must therefore be accurate, objective and up-to-date in this respect and, in practice, withstand the test that requires a properly conducted external audit. Although ISO 9001:2015 is more accommodating in terms of documentation guidelines, the discipline used to compile the quality management system requirements of the previous revision may still be a viable approach. The realization of the adequacy documentation is based on the PDCA cycle (Plan-do-Check-Act) and can be carried out in 5 steps, which are described below. The Usability documentation should be streamlined to facilitate implementation and maintenance, while the documents should clearly describe all QMS processes with simple, concise and unambiguous language to ensure that the processes are understood and can be easily implemented. A quality management system (QMS) is a formalized system that documents processes, procedures and responsibilities to achieve quality guidelines and objectives, thus constantly providing a quality product or service to the customer.
A QMS helps coordinate and manage an organization`s activities to meet client and regulatory requirements and continually improve its effectiveness and efficiency. QMS documentation should accurately and concisely document the organization`s structure, procedures, processes and resources. www.gmp-compliance.org/files/guidemgr/2012-05_quality_for_biological.pdf The quality policy defines the quality objectives that the organization aims to achieve. The quality objectives of organizations are defined by quantifying the quality objectives. Proper QMS documentation ensures that all processes are understood and executed consistently by employees, so that a quality product/service is delivered to the customer every time. If your company`s documentation does not meet this standard, it will lead to non-compliance with legal regulations, significant costs to your company in terms of resources to resolve issues and can affect your company`s reputation. B for example due to delays in processing customer orders or non-delivery of a high-quality product or service to your customer. In many cases, the information the QMS needs remains more convenient and accessible when it is collected, published and maintained in a traditional, high-quality manual format. Usually, when people think about documenting the quality management system, they imagine a lot of unnecessary documents and bureaucratic procedures. Indeed, companies often go too far when documenting their quality management systems.
However, this does not necessarily have to be the case. A one-size-fits-all approach will not work, each type of document must be tailored to the purpose so that it is easily understood by the employees involved and can be implemented effectively. Documentation also needs to be lightened, as too many documents make the processes and the respective QMS more difficult to operate and maintain and at the same time bureaucratic. Documentation is also required for regulatory purposes and must demonstrate the effective planning, operation and control of the organization`s processes, as well as the implementation and continuous improvement of the effectiveness of its QMS. It is obvious that good documentation is crucial for a functional QMS, in fact, it forms the basis of the organization`s QMS as it affects the QMS for the life cycle of the delivered product/service. A well-designed documented system has many advantages, it ensures that quality standards are regularly met, minimizes the risk of errors, reduces downtime in case of deviations because it can quickly access relevant data and allows easy monitoring of processes so that process results are analyzed and appropriate adjustments are made. QMS documentation performs many functions such as reporting, demonstrating compliance, and sharing knowledge, and as such, many different types and levels of documents are required, such as a quality manual, quality policy, documented procedures, and work instructions. .