Achieving accreditation as a Reference Material Producer (RMP) under the ISO 17034 standard requires a well-structured documentation system that ensures competence, consistency, and traceability in all processes. The ISO 17034 standard emphasizes the importance of documented information to demonstrate compliance, maintain quality assurance, and establish confidence in reference material production. To simplify the implementation and documentation process, organizations can rely on readymade ISO 17034 documents developed by experts. These documents cover every aspect of the quality management system required for ISO 17034 accreditation.
Below are the core ISO 17034 documents that form the foundation of a comprehensive documentation set for accreditation:
- ISO 17034 Manual
The ISO 17034 Manual serves as the top-tier document that defines the company’s quality management system and outlines how each requirement of the standard is addressed. It acts as a roadmap for implementation, internal audits, and external assessments. This manual provides an overview of the organization’s structure, management policies, quality objectives, and responsibilities for achieving RMP competence. For any laboratory or material producer, the manual is the cornerstone document that aligns operations with ISO 17034 requirements.
- ISO 17034 Procedures
Procedures are the backbone of the ISO 17034 documentation framework. They describe in detail how each process is carried out to maintain consistency, quality, and traceability in reference material production. The 31 documented procedures typically cover areas such as document control, internal audits, corrective actions, training, subcontracting, homogeneity testing, stability testing, and traceability of measurement results. Each procedure ensures that staff members follow standardized steps, reducing errors and ensuring compliance with accreditation bodies.
- Sample Exhibits
Exhibits provide visual and practical examples of how specific processes or controls are implemented within the organization. The four sample exhibits included in the ISO 17034 documents may illustrate workflows, sample handling systems, calibration hierarchies, or traceability chains. Exhibits act as supporting materials that help both staff and auditors understand the application of the standard in a clear, demonstrable manner.
- Work Instructions
Work instructions are detailed, step-by-step operational guides designed for personnel directly involved in production and testing activities. The 23 work instructions cover critical laboratory and production functions—such as preparation of reference materials, labelling, storage, sampling, calibration, and testing procedures. These documents ensure that tasks are performed consistently, reducing human error and maintaining product integrity. Work instructions are particularly valuable in training new employees and ensuring adherence to the organization’s quality framework.
- Templates to Retain Documented Information
Templates and blank forms are essential for recording and retaining evidence of compliance. The 55 readymade templates provided in the ISO 17034 documentation kit are designed to capture data related to quality checks, equipment calibration, staff training, audit findings, material traceability, and other operational records. These forms promote consistency in documentation and make it easier to track performance metrics over time. Proper record-keeping is a key requirement in ISO 17034 accreditation, as it provides tangible proof of conformity with standard clauses.
- ISO 17034 Audit Checklist
The ISO 17034 Audit Checklist is one of the most valuable tools in the documentation package. Containing more than 250 audit questions, this checklist allows organizations to perform thorough internal audits before applying for accreditation. It helps identify gaps, assess readiness, and ensure that all requirements of ISO 17034 have been implemented effectively. The audit checklist also assists management in evaluating the robustness of their system and preparing corrective actions where needed.
Conclusion
The journey toward ISO 17034 accreditation begins with the right documentation. Having a complete set of manuals, procedures, exhibits, work instructions, forms, and audit checklists ensures a solid foundation for a reliable and compliant system. These ISO 17034 documents not only simplify the implementation process but also help organizations demonstrate competence, consistency, and traceability in their operations. For organizations looking for a trusted source of readymade ISO 17034 documents, Global Manager Group provides comprehensive, expertly developed toolkits tailored to meet accreditation requirements efficiently and effectively.
