The ISO 9001:2015 certificate is today a standard that most companies and organizations strive for. It not only increases the reputation and credibility in the eyes of customers, but also facilitates work and brings real benefits. One of the key requirements of ISO 9001:2015 is the documentation of information in the quality management system. This means that the plant must implement and maintain the documentation indicated in the content of the above-mentioned standard. Here are what documents are mandatory for ISO 9001:2015?
What is the ISO 9001:2015 standard?
ISO 9001:2015 is an international standard that contains a number of requirements that should be met by a quality management system (QMS) in a given organization.
Documented information in ISO 9001:2015.
According to point 7.5 of the ISO 9001:2015 standard, the company’s QMS should have documented information, which is a form of communication in the company, as well as the way we share knowledge or confirm compliance with the acceptability criteria. In practice, these will be paper or virtual documents that are required by the standard, as well as documentation internally defined by the company. The scope of documentation stored and transported will vary depending on the industry, the size of the organization, the complexity of processes and the competence of people.
Documents must be properly supervised, developed (properly identified and formatted), updated for usefulness and adequacy, and archived.
What documents are mandatory in ISO 9001:2015?
Mandatory documents for ISO 9001:2015 can be divided into procedures and records.
- Scope of the quality management system
- Quality Policy
- Organization goals
- Documented information necessary to support the functioning of processes.
- Supplier assessment and approval criteria
- Staff training, skills and experience
- Management review
- Internal audits – planning and results
- Corrective actions
- Performance monitoring and measurement
- Calibration of measuring equipment
- Overview of product or service requirements
- Design and development review
- Input and output to a product or service
- Design or development control
- Product or service properties
- Design or development changes
- Customer property register
- Monitoring of product or service changes
- Product compliance according to acceptability criteria
Why is documenting information important?
Documented information is essential to maintain the quality management system, especially if we care about compliance with the ISO 9001:2015 standard. In the case of an audit or certification, we can be sure that this aspect will not only not be omitted, but will be checked first.
Of course, the required documentation in ISO 9001:2015 should not be kept only with a view to obtaining a certificate, as well as related inspections and audits. It happens that companies keep documentation “because it is required by the norm”, while treating the documents produced as bureaucracy to be ticked off on the checklist. This approach not only does not lead to development, but also makes us spend time creating documents that serve no purpose. And that’s not the point.
The idea behind the ISO 9001:2015 standard, and at the same time the goal, is to introduce a flexible quality management system that will facilitate and improve our work. Which in turn will translate into high quality of products or services, customer satisfaction and development of the organization. Therefore, it is worth using the potential of documenting information, especially since the standard does not impose a procedure for developing and processing documents. Therefore, we can use any quality management system available on the market that will facilitate and optimize the work with documents, and above all, will allow you to do it in the right way – for the benefit of the company and its customers.
How to store and manage documents according to ISO 9001:2015?
The ISO 9001:2015 standard precisely defines which documents are mandatory for the QMS, but leaves freedom in terms of the data carrier, as well as tools for maintaining, supervising and securing data.
QMStorm is a comprehensive document management system that supports ISO 9001:2015 standards. The program provides constant access to documents, enables their processing and monitoring. It also gives the ability to control and supervise the work of individual users – we can assign tasks, track their progress and execution.
Thanks to QMStorm, documents are:
- in one place
- organized and secured
- only available to selected users
- easy to search.