Documents help to pass across information, enable knowledge sharing and provide proof of conformity. They could be presented in several forms, for instance as images, electronics or paper.
ISO 9001 document control requires a company to establish, document, execute and uphold a quality management system and continuously improve its efficiency. ISO 9001 document includes: documented quality policy, quality objectives, procedures/processes, quality manual, documents required for efficient planning and several other documents as mandated by the international standard. The international standard also explicitly requires the organisation’s processes to be established, recorded, executed and maintained.
The scope of the quality management system might differ from one company to the other as a result of the size of the company and its activities as well as the complexity of their processes.
The ISO 9001 document control is important for every document which form a part of the quality management system.
The Benefits of ISO 9001 Document Control
The ISO 9001 document control is an important part of an organisations QMS. It might not be a glamorous activity however; ISO 9001 document control is an important preventive action to make sure that only current and approved documentation is made use of in the organisation. Accidental use of obsolete documents can have major negative effects on costs, customer satisfaction and quality.
Because of its significance, organisations usually invest greatly in detailed processes, specialized software programs and dedicated staff to manage their QMS and other various business documents. Both internal and external auditors also focus on ISO 9001 document control disciplines thereby causing repeated audit non-conformances if not implemented efficiently. It is appropriate that the people with the responsibility of managing their company’s QMS should design an ISO 9001 document control process which is easy to use and monitor, and is efficient in the prevention of the use of wrong documentation.
ISO 9001 Document Control Requirements
Below is an overview of the ISO 9001 document control requirements.
Quality Policy and Objectives
ISO requires the quality policy and objectives are documented.
Quality Manual
The quality manual also has to be controlled if available. Even though the quality manual no longer is required in the ISO 9001:2015 standard, the majority of organisations use that format to documents their quality management system.
Documents Required for Efficient Planning, Operation and Management
Other documents might be required to demonstrate an efficient QMS. These documents also have to be controlled. Some of them are; quality objectives, quality policy, quality plans, quality manual, specifications, internal communications documents, process descriptions, process maps or process flowcharts, work and test instructions, production schedule, organisation charts, test and inspection plans and approved suppliers list.
Some other records might be added as a requirement to demonstrate the conformity of products, processes and the QMS according to ISO. Although, the ISO 9001 document control requirements of such records vary from that of other documents, however, ISO mandates that they must be controlled.
ISO 9001 Document Control Software
The software provides the necessary capabilities for document control according to ISO principles. The software controls the access to certain information, enables the automation records of management policies, and secures the whole history of every document activity for the process of auditing. Some examples are, security, revision control, audit logging, review of workflow and approvals.
Approving Documents for ISO 9001 Document Control
The approval procedures for ISO 9001 document control defines the files that are approved and the person who made the approval. The acceptance of polices, work instructions, documents handbook and others are recorded. Document approval steps are designed with the software to support the requirements of the business.
Giving Access for ISO 9001 Document Control
The ISO 9001 document control software gives a controlled but flexible access to the documents in the organisation’s quality management system. Security decides who gets access to which documents what they can do on it. Access to the files is gained through the windows explorer, via a web browser or perhaps on a mobile phone.
