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Documented information is a critical component of ISO 9001:2015, the international standard for Quality Management Systems (QMS). It encompasses policies, processes, procedures, and records that provide evidence of the QMS’s effectiveness and conformity to requirements. This guide explores the requirements for documented information under ISO 9001:2015, essential documents, and best practices for creating, controlling, and maintaining them.
Understanding Documented Information
Definition: Documented information refers to information required to be controlled and maintained by an organization and the medium on which it is contained. It includes documents and records necessary for establishing, implementing, maintaining, and continually improving the QMS.
Types of Documented Information:
Documents: Information that must be controlled and maintained (e.g., procedures, work instructions, policies).
Records: Evidence of conformity to requirements and effective operation of the QMS (e.g., audit records, inspection records, management review minutes).
Requirements for Documented Information
ISO 9001:2015 Clauses: Documented information requirements are specified throughout various clauses of ISO 9001:2015. Key clauses include:
4.3 Determining the Scope of the QMS: Documented information defining the scope of the QMS.
5.2.1 Leadership and Commitment: Documented information establishing the quality policy and quality objectives.
6.2 Quality Objectives and Planning to Achieve Them: Documented information relating to quality objectives and plans for achieving them.
7.5 Documented Information: Requirements for creating and updating documented information as necessary to support the operation of processes.
9.1.1 Monitoring, Measurement, Analysis, and Evaluation: Documented information necessary to support the operation of these processes and retain appropriate documented information as evidence of conformity.
Control of Documented Information:
Identification and Description: Documents must be identified and described to distinguish them from one another.
Format and Media: Ensure that the format and media of documented information are suitable for their intended purpose and remain legible, identifiable, and retrievable.
Review and Approval: Establish review and approval processes for new or revised documented information to ensure suitability, adequacy, and effectiveness.
Essential Documents in ISO 9001:2015
Quality Manual:
Purpose: Provides an overview of the organization’s QMS, including its scope, objectives, and interaction between processes.
Content: Typically includes the organization’s quality policy, objectives, description of the QMS, and documented procedures or references to them.
Documented Procedures:
Process Descriptions: Detailed descriptions of processes necessary for the QMS and their interactions.
Work Instructions: Detailed instructions for performing specific tasks or activities within processes, ensuring consistency and conformity to requirements.
Records:
Examples: Records of management reviews, internal audits, corrective actions, customer feedback, and supplier evaluations.
Purpose: Provide evidence of conformity to requirements and the effective operation of the QMS.
Best Practices for Creating Documented Information
Clear and Concise Documentation:
Simplicity: Keep documents clear, concise, and easy to understand to facilitate implementation and compliance.
Standardization: Use standardized formats, templates, and terminology to promote consistency across documents.
Process-Based Approach:
Mapping Processes: Document information that supports each process within the QMS, ensuring alignment with organizational objectives.
Integration: Integrate documented information into daily operations and decision-making processes to enhance efficiency and effectiveness.
Version Control and Distribution:
Controlled Copies: Ensure that controlled copies of documented information are readily accessible to personnel who need them.
Revision Control: Implement a system for managing revisions, ensuring that only current, approved versions of documents are used.
Maintenance and Retention of Documented Information
Storage and Accessibility:
Electronic Systems: Utilize electronic document management systems (EDMS) to store and retrieve documented information efficiently.
Security Measures: Implement security measures to protect sensitive or confidential information from unauthorized access or alteration.
Retention Periods:
Legal Requirements: Comply with legal and regulatory requirements regarding the retention and disposal of records.
Operational Necessity: Determine retention periods based on operational needs, ensuring that records are retained for the necessary duration.
Document Control Procedures
Documented Information Lifecycle:
Creation: Define procedures for creating new documented information, including requirements for content, format, and approval.
Distribution: Establish procedures for distributing controlled copies of documented information to relevant personnel.
Review and Update: Implement processes for reviewing and updating documented information as necessary to ensure its continued suitability and effectiveness.
Auditing and Continuous Improvement
Internal Audits:
Audit Trails: Use documented information as evidence during internal audits to verify conformity to ISO 9001:2015 requirements.
Non-Conformities: Address non-conformities identified during audits by updating documented information and implementing corrective actions.
Continuous Improvement:
Feedback Loop: Use documented information to capture lessons learned, feedback from stakeholders, and opportunities for improvement.
Benchmarking: Benchmark documented information practices against industry standards and best practices to drive continual improvement.
Training and Awareness
Employee Training:
Awareness Programs: Provide training and awareness programs to ensure that employees understand the importance of documented information and their role in its creation, use, and maintenance.
Competence: Ensure that personnel responsible for creating or managing documented information possess the necessary skills and knowledge to perform their duties effectively.
Compliance and Certification
Certification Audits:
Audit Readiness: Prepare for certification audits by ensuring that documented information is complete, accurate, and aligned with ISO 9001:2015 requirements.
Evidence of Compliance: Demonstrate compliance with ISO 9001:2015 by providing auditors with documented information that supports the effective operation of the QMS.
Conclusion
Documented information is essential for establishing, implementing, maintaining, and improving a robust Quality Management System in accordance with ISO 9001:2015. By understanding the requirements and best practices for creating, controlling, and maintaining documented information, organizations can enhance operational efficiency, ensure compliance with regulatory requirements, and achieve continual improvement. Leadership commitment, effective document control procedures, and a systematic approach to managing documented information are key to leveraging its benefits and demonstrating organizational excellence under ISO 9001:2015.