Documented information is the key to ISO 9001 requirements. Developing a list of documents and records that reflects your processes and procedures and implementing a quality management system as per ISO 9001 standards are part of ISO 9001 Requirements.
ISO 9001 Quality Manual: Different from previous versions of ISO 9001, a quality manual is not required as per ISO 9001 requirements. Although it is not a requirement, creating a quality manual will help you have a comprehensive picture of your organization and it is incredibly helpful.
ISO 9001 Quality Procedures: There are almost two dozen mandatory quality procedures as part of the ISO 9001 requirements. No Quality Management system can be successful without well-documented quality procedures.
Standard Operating Procedures: Standard Operating Procedures or SOP is simply the how-to procedure/instruction document of your organization about various facets of your company. Standard Operating Procedures are part of the ISO 9001 requirements.
List of documented information to be maintained as per the ISO 9001 requirements:
These are documents to be maintained by the organization such as their scope, policies, procedures, objectives, etc that are subject to change as part of ISO 9001 Requirements:
- Clause 4.3: The scope of the quality management system.
- Clause 4.4: Documented information necessary to support the operation of processes.
- Clause 5.2: The quality policy
- Clause 6.2: The quality objectives
List of documented information to be retained as per ISO 9001 Requirements:
These are documents that are to be retained and not to be changed after they are released as part of ISO 9001 Requirements:
- Clause 4.4: Documented information to the extent necessary to have confidence that the processes are being carried out as planned (ISO 9001 Documented Information)
- Clause 7.1.5.1: Evidence of fitness for the purpose of monitoring and measuring resources
- Clause 7.1.5.2: Evidence of the basis used for calibration of the monitoring and measurement resources (ISO 9001 Calibration of Measuring Devices)
- Clause 7.2: Evidence of competence of person(s) doing work under the control of the organization that affects the performance and effectiveness of the QMS
- Clause 8.2.3: Results of the review and new requirements for the products and services
- Clause 8.3.2: Records needed to demonstrate that design and development requirements have been met (ISO 9001 Design and Development)
- Clause 8.3.3: Records on design and development inputs
- Clause 8.3.4: Records of the activities of design and development controls
- Clause 8.3.5: Records of design and development outputs
- Clause 8.3.6: Design and development changes, including the results of the review and the authorization of the changes and necessary actions
- Clause 8.4.1: Records of the evaluation, selection, monitoring of performance, and re‐evaluation of external providers and any actions arising from these activities
- Clause 8.5.2: Evidence of the unique identification of the outputs when traceability is a requirement
- Clause 8.5.3: Records of the property of the customer or external provider that is lost, damaged, or otherwise found to be unsuitable for use and of its communication to the owner
- Clause 8.5.6: Results of the review of changes for production or service provision, the persons authorizing the change, and necessary actions taken
- Clause 8.6: Records of the authorized release of products and services for delivery to the customer including acceptance criteria and traceability to the authorizing person
- Clause 8.7: Records of nonconformities, the actions taken, concessions obtained, and the identification of the authority deciding the action in respect of the nonconformity
- Clause 9.1.1: Results of the evaluation of the performance and the effectiveness of the Quality Management System
- Clause 9.2.2: Evidence of the implementation of the audit program and the audit results (ISO 9001 Internal Audit)
- Clause 9.3.3: Evidence of the results of management reviews (ISO 9001 Management Review)
- Clause 10.2.2: Evidence of the nature of the nonconformities and any subsequent actions taken (ISO 9001 Non-Conformity and Corrective Action)
- Clause 10.2.2: Results of any corrective action
How to get ISO 9001 certification is a commonly asked question across various small scale and medium sized organizations across the globe. Developing a quality management system based on ISO 9001 requirements is the key to ISO 9001 accreditation.
FREE ISO 9001 CONSULTATION: Liberty Management Group (LMG) offers a free, onsite ISO 9001 consultation. Whether you are just starting out on building a quality management system from scratch or need to evaluate your existing system for ISO 9001 certification, our experienced consultants will be able to give advice and guide you through the entire process of implementation and certification of ISO 9001.
After the initial onsite visit, we will provide you with an estimate of the cost and time frame of the ISO 9001 implementation and certification process. No contract or commitment is required unless LMG is selected to provide any further service.
