Organizations around the globe use the ISO 9000 family of standards to improve the quality of their products and services and more aptly meet their customers’ expectations. One of the more prominent ISO standards, ISO 9001, sets the criteria for a robust quality management system (QMS). If your company wants to stay ahead of the competition and streamline efficiency, receiving ISO 9001 certification is a great first step.
The table below demonstrates how the ENSUR Quality Management Software meets each requirement of ISO 9001.
| Requirement (informal interpretation) | ENSUR Document Control Software |
|---|---|
| The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. | Quality documents may be drafted, approved and controlled within ENSUR. They may additionally be secured with print controls and watermarking. |
| The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives. | ENSUR's Document Training enforces the reading and comprehension of documents in conjunction with an ENSURQuiz. |
| The business makes decisions about the quality system based on recorded data. | ENSUR's electronic Review cycle offers virtual collaboration. |
| The quality system is regularly audited and evaluated for conformance and effectiveness. | ENSUR's managed and scheduled periodic review cycles allow for the evaluation of documentation. |
| Records show how and where raw materials and products were processed to allow products and problems to be traced to the source. | ENSUR's Binder and BOM templates offer the ability to link documents together in order to produce a ‘where used’ look up. |
| The business determines customer requirements. | Requirements may be drafted, approved and controlled within ENSUR. They may additionally be secured with print controls and watermarking. |
| The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints. | ENSUR's configurable Distribution allows notifications and content to be emailed to users of ENSUR as well as external contacts. These emails are configured based on lifecycle events such as ‘upon Current and/or Historic’. |
| When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs. | ENSUR's comprehensive and configurable workflow allows for the incorporation of Action Items, Linking and Routing to allow for a full cycle of task initiations and completions. |
| The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits. | Internal Audit forms may be generated within ENSUR and electronically submitted for completion. This form data is then able to be extracted for reporting purposes. Additionally, Action Items and Periodic Reviews can tie into audit tracking. |
| The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness. | Incident tracking forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in Incident template. ENSUR offers multiple lifecycle options that may be utilized in order to incorporate multiple departmental approvals and the resolution and closing of an Incident. Additionally, Action Items can tie into reporting. |
| The business has documented procedures for dealing with actual and potential non-conformances (problems involving suppliers, customers, or internal problems). | NCR forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in CAPA template which includes a Non-Conformance section. ENSUR offers a multi-tiered CAPA lifecycle that may be utilized in order to incorporate multiple departmental approvals. Additionally, Action Items can tie into NCR reporting. |
The business:
| CAPA forms may be generated within ENSUR and electronically submitted for completion or users may work from the built in CAPA template. ENSUR offers a multi-tiered CAPA lifecycle that may be utilized in order to incorporate continuous improvement processes including Root Cause identification, Analysis, Implementation, Acceptance and Verification. Additionally, Action Items can tie into reporting. |
ISO 9001 FAQ:
- What are ISO 9001 document control requirements?
- ISO 9001 document control requirements refer to the criteria outlined in the ISO 9001 standard for effectively managing and controlling documents within an organization’s quality management system. These requirements ensure that documents are properly created, reviewed, approved, and updated to maintain the integrity of the quality management system.
- How do I get ISO 9001 certified?
- To get ISO 9001 certified, organizations need to follow a series of steps outlined in the ISO 9001 standard. These steps typically include:
- Develop your QMS: Implement a quality management system that aligns with ISO 9001 requirements.
- Internal Audit: Conduct an audit to ensure your QMS functions as intended.
- Select a Certification Body: Choose an accredited organization to perform the certification audit.
- Certification Audit: The certification body audits your QMS for compliance. If successful, they will issue a certificate.
- Maintain and Improve: Continue ensuring conformity with ISO 9001 and seek continuous improvement in your QMS.
For a more detailed guide, please visit: [Guide to Getting ISO 9001 Certified]
- To get ISO 9001 certified, organizations need to follow a series of steps outlined in the ISO 9001 standard. These steps typically include:
- Who is required to be compliant with ISO 9001?
- ISO 9001 compliance is not limited to a specific industry or type of organization. Any organization, regardless of its size or sector, can choose to implement and become compliant with the ISO 9001 standard. ISO 9001 is often adopted for these reasons:
- Customer Demands: Customers in certain industries might require ISO 9001 certification from their suppliers.
- Competitive Advantage: Demonstrating quality commitment through certification can provide a competitive edge.
- Internal Improvements: ISO 9001’s framework helps organizations improve efficiency, reduce errors, and increase customer satisfaction.
- ISO 9001 compliance is not limited to a specific industry or type of organization. Any organization, regardless of its size or sector, can choose to implement and become compliant with the ISO 9001 standard. ISO 9001 is often adopted for these reasons:
- How does ENSUR help with ISO 9001 compliance?
- DocXellent’s ENSUR Document Management System provides a robust platform to help organizations achieve and maintain ISO 9001 compliance. Here’s how:
- Centralized Document Control: ENSUR offers a secure, central repository for all your QMS documents. This ensures control, prevents the use of outdated documents, and streamlines access to the latest information.
- Automated Workflows and Version Control: ENSUR automates document review and approval processes, tracks changes, and maintains a clear version history. This aligns with ISO 9001’s requirements for proper document handling.
- Simplified Audits: ENSUR makes it easy to locate and retrieve documents for audits, demonstrating compliance and reducing audit preparation stress.
- Training Management: ENSUR can manage employee training records, ensuring staff stays up-to-date on relevant procedures and their competency is tracked.
- Corrective and Preventive Actions (CAPA): ENSUR helps track and manage non-conformances, improvement actions, and customer feedback, ensuring continuous improvement of your QMS.
- Reporting and Analytics: ENSUR provides reporting tools to track key quality metrics, monitor QMS performance, and identify areas for improvement.
ENSUR simplifies the often complex task of ISO 9001 compliance, helping you streamline processes, maintain control, and demonstrate your organization’s commitment to quality.
- DocXellent’s ENSUR Document Management System provides a robust platform to help organizations achieve and maintain ISO 9001 compliance. Here’s how: