What is the Documented Information?
Documented information describes the requirements of ISO 9001: 2015 for the QM documentation of processes and evidence. The relief was in part clearly noticeable when, in the first drafts of ISO 9001, the requirements for the specification documents, in the new “wording” for the “documented information to be maintained”, were significantly reduced. Even after the final version of the standard, an organization no longer needs a quality management manual and does not necessarily have to map six standard specifications in documented procedures. Have all the dams been broken and a company can do without specification documents entirely?
Definitely no, because there are also specific requirements of ISO 9001 for specification documents in the new standard and what needs to be documented must now be determined by the company itself. However, if specification documents have been determined to be necessary, they must meet the requirements of DIN EN ISO 9001: 2015 for their content and format. Since these standard requirements for documented information have been made more concrete and in some cases expanded compared to the 2008 revision, a company should check the conformity of its documents. The following text names the points that could possibly create a need for action.
What does ISO 9001 require with regard to the scope, content and format of documented information?
“It is the greatest folly not to say anything with too many words.” This insight comes from Martin Luther (1483-1546), German theologian and reformer. However, DIN EN ISO 9001 certainly cannot be blamed for this. The standard contains a great deal of information in a small space, which must be taken into account when reading the standard. If we want to meet the standard requirements for documented information, we have to carefully analyze its text.
This analysis should cover the following three levels:
What scope is required? At which points does the standard require aspects to be documented?
What content has to be documented? What is the subject of the documented information here?
Which format is required by the standard? How should the required content be presented in the sense of the standard?
In the following, the relevant ISO 9001 requirements for the documented information to be maintained are considered in relation to these three levels.
Documented information according to ISO 9001 in the scope of the QM system
In subsection 4.3, the standard requires the documentation of the scope of the quality management system with its limits. To make this compliant, the following format should be considered:
Designation of the product types (categories) or services with an assignment of the locations at which the production or service takes place.
Indication of which processes may have been outsourced and are provided externally.
In the event that standard requirements cannot be applied, a plausible justification must be provided
Documented sequence and interactions of the processes
The sentence “We cannot apply Subsection 8.3 because we are not developing” would not be a sufficient justification for its inapplicability. For example, it would be better: “As a consequence of our strategic orientation as a B-to-B subcontractor, we cannot carry out any product development to only offer manufacturing services for products that our customers as interested parties have developed.” In subsection 4.4, the standard requires the structure a quality management system including the presentation of the sequence and interactions of the processes. Documented information must be maintained to the extent necessary to support the implementation of the processes. The organization itself determines which processes are to be documented. however, every organization must meet the requirements of ISO 9001 for the format of process descriptions. Documents must describe or visualize the following aspects:
- Inputs into the processes and expected results of the processes.
- The sequence (flow) of a process and its interactions with other processes.
- The criteria or procedures and performance indicators for monitoring and measuring a process.
- The responsibilities and authorities in the context of process implementation.
- The way in which identified process risks and opportunities are dealt with. Each organization can decide for itself whether and how this is visualized or just verbalized. In any case, the above-mentioned aspects must be appropriately addressed and mapped in the documents. If this is not the case, the format of the process descriptions must be adapted!
Documented information on quality policy and quality objectives
In order to meet the requirements of subsection 5.2, an appropriate quality policy for the organization must be defined, implemented and maintained. The requirements of the standard for the format for the document defining the quality policy of the organization are less specific than those for the process documentation. The quality policy must provide the framework for setting quality objectives. In terms of content, however, the quality policy must contain the obligation to meet the applicable ISO 9001 requirements and to continuously improve the quality management system. The standard becomes very specific when defining the format of the quality objectives and planning the achievement of the quality objectives in subsection 6.2. In subsection 6.2.1, the standard requires for the target format:
Measurability and reference to applicable requirements of ISO 9001, which are relevant for the conformity of products and services as well as customer satisfaction.
In subsection 6.2.2, the standard hardly leaves any leeway when planning to achieve the quality objectives by requiring the determination of the following aspects:
- What is being done, ie what measures are being planned.
- The presentation of the resources required to achieve the goal.
- The assignment and naming of responsibility.
- Setting a closing date.
- The method of evaluating results with regard to the achievement of objectives. The documented information on the quality objectives must contain these aspects in order to be compliant with the standard.
Documents according to ISO 9001 required for the effectiveness of the QM system
The last subsection of the quality management standard, which contains ISO 9001 requirements for specification documents, is subsection 8.5.1 Control of production and service provision. The standard requires that the documented information has the content that guarantees controlled conditions in production and service provision. Controlled conditions exist when there are no systematic errors or disruptive influences in the process and the process results are reproducible. This content is very dependent on the type of production or service. The ISO 9001 requirements for documented information on the format of these specification documents therefore extend to the following two aspects:
Indication of the characteristics of the products, services or activities that are decisive for the quality. Quality assurance refers to these characteristics as acceptance criteria
The associated results (values) that are to be achieved for the status OK. Quality assurance lists these features in a specification
Definitions related to document control according to ISO 9001
Documented information, QM documentation, specification and verification documents. With all the different terms, it is not always easy to keep track of things. Therefore, we would now like to give you an understanding of the definition of basic terms and procedures in connection with QM documentation.
This generic term summarizes data with meaning that must be controlled and maintained by an organization. The term includes the format or medium. Documented information can be understood as a “document” (information including the carrier medium) or “record” (evidence indicating the results achieved or the activities carried out).
Specification document – document
Specification documents have the task of conveying information in the quality management system, which serve as instructions for action. This type of quality management documentation has an instructive or teaching character. Finally, DIN EN ISO 9001 specifies, in particular, requirements for the “maintenance” of specification documents.
Evidence document – recording
As part of quality management, it is necessary to recognize and / or prove that activities have been implemented in accordance with the specifications. These so-called evidence documents have the character of a certificate. DIN EN ISO 9001 specifies in particular the requirements for the “storage” of evidence documents.
Relationship between specification and verification documents in the QM documentation
In addition to the records, it may also be necessary for certain reasons to keep documents (e.g. archiving of older work instructions in order to prove that activities were carried out earlier). If the quality management standard ISO 9001 requires “information to be monitored and checked” (e.g. in section 4.1), the respective process owners can decide for themselves whether it is appropriate to create documents. When determining which QM documents – in addition to those required by DIN EN ISO 9001 – are to be maintained in the quality management system, the respective process owners should use the following questions:
Is a document required so that we can be confident that our processes are going as planned?
Do we need documents in order to obtain controlled conditions that ensure that
– all characteristics of the products to be produced, the services to be provided or the activities to be performed are clearly defined?
– the results to be achieved are clearly specified?
In addition to that required by DIN EN ISO 9001 , other documented information on the quality management system can also be stored in the case of verification documents. The following question supports the respective process owners in deciding which evidence documents are additionally required:
Is a record required so that we can be confident that our products and services conform to requirements?
A recording can be written down or stored on a data carrier. Other specific reasons for recording (process) data are:
- legal or regulatory requirement
- Use of the recording as a control tool in the company
- proof of process stability
- Determination of customer satisfaction
- Determination of improvement potential
Depending on the type of reason, the management or the person responsible for the process determines:
- how and to what extent the data is recorded
- on what basis these are evaluated
- at what time cycle the evaluation takes place
Recorded data must be legible and its origin and context must be easily identifiable. Archiving must ensure that data can be easily found again during the retention period.