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One of the most critical elements of quality management is ensuring that "the right information is available to the right person at the right time." Documents such as procedures, instructions, forms, control plans, specifications, technical drawings, training content, audit reports, and measurement records constitute the information infrastructure that sustains an organization's quality system. However, if documents are outdated, versions are mixed up, or records are missing, the quality system exists only on paper; in the field, it becomes a disorganized implementation. Therefore, a modern Quality Management System (QMS) treats document and record management not merely as an "archiving" activity, but as a strategic module that standardizes processes, strengthens traceability, and ensures audit compliance.
Centra's QMS Document and Records Management solution helps you manage the entire lifecycle of documents under a single structure, from creation and review to approval and publication, revision management, access rights, and record storage/retrieval processes. The goal is not simply to say "the document exists," but to be able to prove that the document is being used correctly in the field and to create an auditable quality memory with each record.
Version & Revision Control
Separation of old and new documents, revision history, reason for change, and approval records.
Workflow and Approval
Managing the draft → review → approval → publication steps with role-based workflows.
Access Permissions & Distribution
Department/location-based authorization, controlled distribution of published documents to the field.
Records Management & Audit Evidence
Retention periods, archiving, searching, quick retrieval, and instant access during audits.
Why is Document and Records Management the "Backbone" of QMS?
ISO 9001 and similar quality standards consider the control of documented information as one of the fundamental requirements of the system. This is because standardization cannot be achieved without processes, instructions, and records; and without standardization, quality cannot be sustained. Document management defines "what is to be done"; record management proves "it has been done". When these two do not work together, the organization struggles during audits, employees work according to different versions of the process, information loss increases, and processes become dependent on individuals.
Document vs. Record: They Are Not the Same Thing
Documents (procedures, instructions, forms, plans, specifications, etc.) describe how processes are to be carried out and are generally subject to revision. Records (production lot records, inspection reports, training attendance lists, maintenance/calibration certificates, audit findings, etc.) show that an activity has taken place and its results; they are often not revised but preserved. This distinction is critical for both access control and retention/archiving logic. The QMS Document and Records Management module strengthens auditability by managing these two structures with separate rules.
Version Confusion: The Biggest Risk in the Field
A significant portion of quality problems arise from the use of outdated documents in the field or the failure of personnel to receive up-to-date instructions. The "this was the PDF in my folder" approach can very quickly lead to non-compliance. Document and record management creates a single source of truth. Ensuring that published documents are accessible from a single location, automatically deprecating outdated versions, and controlling who has access to which document significantly reduces this risk in the field.
What's Looked For in Audits: The Chain of Evidence
Audits don't just look at the existence of the document; they also examine whether the document is under control, its approval process, revision history, distribution, and the availability of related records. For example, if a process instruction changes, is there a change management record? Was training provided? Was the new control plan implemented? Are the measurement records consistent with the updated instruction? The answers to these questions depend on establishing the correct document-record chain. The module strengthens this chain with its linking logic.
Retention Periods and Privacy: Fine-Tuning Records Management
Records should be stored for specific periods, be easily accessible when needed, and have access restrictions applied to some records (e.g., customer documents, personnel training records, critical product test reports). Retention periods may also vary depending on industry/regulation requirements. Document and record management manages information security and compliance through classification, retention policies, and access permissions.
Process Standardization: Corporate Memory Shouldn't Be Dependent on Individuals.
When documentation is well managed, the organization's knowledge resides in the system, not on people's computers. Process information is not lost during personnel changes; new employees adapt more quickly by accessing up-to-date documents. This increases both quality and operational efficiency. Furthermore, because there is a clear answer to the question "how do we do it?", improvement activities are carried out more effectively.
Centra QMS Document and Record Management: End-to-End Lifecycle
Centra's approach is to establish a process infrastructure for managing documents, rather than simply storing them. Documents are created, reviewed, approved, and published; then kept up-to-date through periodic review and revision management. Records are generated using standard templates, linked to the relevant process/product/equipment, and archived in accordance with retention policies. This ensures that the quality system is audit-ready, traceable, and sustainable.
1) Document Creation and Template Standardization
Preparing procedures, instructions, forms, and plans within the organization in a specific format increases readability and consistency of application. The module enables the organization of documents into a structured library using templates, mandatory fields, and classification labels (department, process, product family, standard clause, etc.) according to document types.
2) Review and Approval Workflows
Uncontrolled document release is one of the riskiest aspects of a quality system. Workflows require draft documents to be reviewed by relevant units, revised if necessary, and approved by authorized personnel. Approval records (who, when, and for what reason) ensure auditability. Furthermore, multiple approval mechanisms (quality + production + EHS, etc.) can be used for critical documents.
3) Publication, Distribution and Access Control
Once approved, the document is published and distributed to relevant users in a controlled manner. Access permissions are managed by department/location/role, ensuring that everyone has access to the "necessary" document and that access to unnecessary documents is restricted. This enhances information security and guarantees the use of the correct version in the field.
4) Revision Management and Justification for Changes
Documents are living entities; as processes change, so do the documents. Revision management ensures that the rationale for the change is documented, a revision history is maintained, and older versions are phased out in a controlled manner. Training requirements or announcement mechanisms can be implemented to ensure the revision is reflected in the field. This allows document changes to progress synchronously with operational changes.
5) Creation, Association, and Archiving of Records
Records management requires that the correct records be kept in the correct place and in the correct context. For example, an inspection record becomes truly traceable when associated with the relevant product code, lot number, process step, measuring device, and operator information. The module helps to store records in this context. Furthermore, records remain organized through retention periods and archiving policies.
6) Audit Preparation: Quick Dial and Recall
When audit day arrives, the greatest need is to be able to quickly present the right evidence. The document and record management module, thanks to advanced search, filtering, and relationship maps, allows access to the desired record in seconds. This speed reduces audit stress and strengthens the organization's perception of maturity.
Need Common Problem Centra QMS Approach
Access to the current document Using the old version in the field. Single point of release, version control, locking down the old version.
Approval traceability The uncertainty surrounding "Who approved it?" Workflow, approval logs, role-based authorization.
Record availability Keeping records in scattered folders Central archive, tagging, association, and quick search.
Audit evidence The rush to gather evidence Document-chain, certificate and report attachments
Document and Record Management KPIs
- Percentage of documents reviewed on time (%)
- Revision cycle duration (days)
- Previous document usage case (number)
- Average approval time (days/hours)
- Time to access the evidence requested in the audit
- Record completeness rate (%)
- Compliance rate with retention policy (%)
- Document training completion rate (%)
When document and record management matures, the quality system ceases to be merely a "document burden" and transforms into an information infrastructure that accelerates decision-making. The correct version, the correct evidence, and the correct traceability significantly improve both audit success and the quality of daily operations.
Gather your corporate quality memory in one central location.
To take control of the document lifecycle, manage records in a traceable and auditable way, and eliminate version control issues, you can review the Centra QMS Document and Record Management page.
Focus: Version • Approval • Release • Access • Registration • Archive • Audit Evidence
