The type and extent of documentation required for an ISO Quality Management System (QMS) can vary depending on the size and complexity of your organization, as well as the specific ISO standard to which you are seeking certification, such as ISO 9001. However, some fundamental types of documents are generally required for an effective QMS:
Mandatory Documents for ISO 9001:2015
-
Scope of the QMS: A document that specifies what parts of your organization’s activities are covered by the QMS.
-
Quality Policy: A document that outlines your organization’s approach to quality, including objectives and commitments.
-
Quality Objectives: Specific, measurable goals related to quality performance.
-
Procedures for Internal Audits: Guidelines or instructions for conducting internal audits of the QMS.
-
Procedure for Control of Nonconforming Output: Instructions for identifying, isolating, and managing nonconforming products or services.
-
Procedure for Corrective Actions: Guidelines for identifying, analyzing, and correcting problems in the QMS to prevent recurrence.
Contact Adapt Management Consulting to help with your Documentation Requirements.
Additional Documents
-
Process Maps, Process Flow Diagrams and Work Instructions: These describe how specific tasks are performed and processes are carried out.
-
Records of Monitoring and Measurement: Evidence that processes are being controlled, and measurements are being taken where required.
-
Management Review Minutes: Records of management review meetings where the QMS performance is discussed.
-
Training Records: Documents showing who has been trained, what training they’ve received, and when.
-
Supplier Assessments: Documentation evaluating the performance and quality of suppliers.
-
Customer Feedback, Complaints and Returns: Records of customer interactions, including feedback, complaints, and any returns.
-
Document Control Records: A register or similar to show how documents are controlled within the QMS.
-
Calibration Records: Information on the calibration of any monitoring or measuring equipment used.
-
Competence Records: Proof that employees doing work affecting product or service quality are competent, usually through education, training, or experience.
-
Risk and Opportunities Assessment: Documents outlining the risks and opportunities affecting the QMS and actions to address them.
-
External and Internal Audit Reports: Reports generated by internal and external audits.
-
Corrective Action Reports: Documentation detailing how corrective actions were implemented and their effectiveness.
Best Practices
-
Documented Information: Ensure that all documents are properly stored, readily accessible, and controlled.
-
Regular Updates: Keep all documentation up-to-date and review it regularly for accuracy and relevance.
-
Conformity and Consistency: Ensure that the documents comply with ISO requirements and are consistent in format and style for ease of use.
Note that the ISO 9001:2015 standard places greater emphasis on "documented information" rather than strictly "documented procedures," allowing for greater flexibility in how organizations achieve compliance. It's essential to consult the specific ISO standard to which you're certifying to understand the full documentation requirements.
