In ISO 9001:2015, document and record control is handled in a new way.

There has been a lot of discussion over how the new ISO 9001 standard will change how documented information is used. Can we do without our protocols as written down? Is there no longer any need for paperwork or records? There is a new requirement for documented information that is meant to include both the documents and the records, even though it appears from all advanced draughts of the new 2015 version of ISO 9001 that the explicit requirements for documented processes and records have been abolished. I'll explain what is meant by "documented information" in greater detail below.

What is documented information?

Information that is documented according to ISO 9001:2015 must be controlled and maintained by the organization and the media it is stored on. Documented information may refer to the Quality Management System's (QMS) procedures, records, and documentation, according to notes to this definition.

Section 7.5 of the draught standard contains the standards for documented information, many of which are similar to those already in place for records and documentation. Both the documented information needed by the ISO 9001 standard and the documented information required for the QMS to function effectively must be included in the QMS. The QMS must also take into account the people's competency, the complexity of interactions and processes, and the scale and nature of the organization's activities.

What type of documentation is mandated by ISO 9001:2015?

Here are the components in the standard's requirements that are noted as requiring documented information, working from the most recent draught:

• Dimensions of the QMS
• anything required to ensure the operations run smoothly
• Anything required to ensure that the processes are carried out according to the plan
• Quality Guidelines
• The Goals for Quality
• Proof that monitoring and measurement tools are appropriate
• When there are no internationally accepted standards, calibration standards are used
• evidence of ability
• Proof that procedures have been followed as intended
• Evidence that the items and services meet the requirements
• the conclusions of a review of the requirements for goods and services
• Definition of the features of the goods and services, along with the actions to be taken and the outcomes desired
• Information needed for maintaining traceability is crucial
• Effects of production and service provisioning changes
• Product or service delivery to the client, along with the person who authorized the release
• Taking action against nonconforming process outputs, goods, and services, including obtaining concessions
• Results of actions for monitoring and measurement
• Evidence of the audit program's execution and audit findings
• Evidence of the management review's findings
• Evidence of the nonconformities and corrective measures performed, as well as their outcomes

Does the new strategy need you to adjust?

There is an intriguing statement in the annex to the draught of the new standard that notes that it is not necessary for an organization to change the terms it currently uses with those in the standard, such as replacing records or documentation with information that has been documented. Please refrain from confusing people by switching everything over to written information right away if your staff can easily understand the terminology that is already in place.

But now is the perfect opportunity to replace two procedures for controlling documentation and controlling records with one procedure that has fewer criteria if you see an advantage in doing so. Keep in mind that the goal of a quality management system is for you to effectively manage your operations and look for methods to enhance them; the ISO 9001 criteria are not meant to stand in the way of these advantages.