Understanding Documented Information Requirements in ISO 9001:2015 Standards

Did you know nearly 70% of businesses struggle with effective documentation? Imagine a company where paperwork is chaotic, processes are unclear, and quality feels more like a distant goal than a reality. Welcome to the world of ISO 9001 documentation standards – your blueprint for organizational clarity and excellence! 

If you've ever felt like documentation is just another bureaucratic headache, prepare to have your mind changed. ISO 9001:2015 provides a clear roadmap, helping your business run smoothly, maintain quality, and ensure customer satisfaction – like a GPS for your processes.

In this blog, we'll break down complex standards into bite-sized, digestible insights that even your coffee-fueled brain can easily comprehend. From understanding what documentation truly means in the ISO world to practical strategies for implementing these requirements, we're about to turn complicated standards into your competitive advantage. Let's dive in!

Role of Documented Information in QMS

ISO 9001 documentation standards require documented information to be essential for the success of any Quality Management System (QMS). It ensures that processes are standardized, consistent, and compliant with ISO 9001:2015 standards. Here's why it's crucial:

• Ensures Consistency: Documented procedures and records standardize operations, making sure tasks are performed the same way each time.
• Supports Compliance: Accurate documentation is vital for meeting regulatory and ISO requirements, reducing the risk of non-compliance.
• Facilitates Continuous Improvement: It allows businesses to track performance, identify issues, and implement corrective actions for ongoing improvement.
• Provides Accountability: Clear records help assign responsibility and maintain transparency across all levels of operation.

Poor quality can cost businesses up to 30% of their annual revenue, underscoring the critical role of a well-maintained QMS and documentation in preventing costly mistakes. By maintaining organized, up-to-date documented information, organizations can ensure their QMS runs smoothly, supports quality goals, and is in line with industry standards. 

Documented information is the foundation of a robust QMS, helping businesses achieve consistency, compliance, and continuous improvement.

While ISO 9001 documentation standards ensure consistency and compliance, the beauty of ISO 9001:2015 is its flexibility. Let’s explore how you can tailor these documents to fit your organization’s unique needs.

Flexibility and Customization in Documentation per ISO 9001:2015

The ISO 9001 documentation standards provide organizations with the flexibility to tailor their documented information requirements to suit their specific processes and operational needs. This flexibility allows businesses to maintain compliance with the standard while avoiding rigid document formats. Here's how customization benefits organizations:

• Tailored to Unique Processes: While the standard specifies the types of documents and records that must be maintained, businesses can adapt these documents to reflect their specific workflows and industry requirements.
• Scalability: As organizations grow, they can modify their documentation to reflect changes in operations, ensuring that their QMS remains relevant and effective.
• Simplifies Compliance: By aligning documents with company-specific processes, businesses can achieve compliance without the need to adhere to overly strict or cumbersome document formats.
• Enhances Efficiency: Custom documentation allows for more efficient record-keeping and process management, as it is directly relevant to the company’s operations. 60% of organizations using document management software reported increased efficiency and improved compliance with industry standards.

Why Customization Matters

The ability to customize documentation is a significant advantage of ISO 9001:2015, offering several benefits:

• Improved Relevance: Custom documents ensure that your QMS is not just compliant but also practical and applicable to your business’s needs.
• Greater Flexibility: Companies can adjust documents over time as their operations evolve, ensuring ongoing compliance without excessive administrative burden.
• Better Alignment with Business Goals: Customization ensures that the QMS directly supports your organizational goals and quality objectives, making it easier to track performance and improvements.

McKinsey’s research shows that organizations with an effective QMS see up to a 15% boost in operational efficiency and a 10% reduction in operational costs. ISO 9001:2015 allows for flexibility in documentation, enabling businesses to create processes that are both compliant and tailored to their unique needs. Customizing your documentation is key to maintaining an effective, scalable, and relevant QMS.

Customization is key to making ISO 9001:2015 work for your unique processes. Want to make your QMS even more tailored to your needs? Book a demo now.

Now that we’ve covered how to make your documentation more relevant to your business, it’s time to dive into the specific mandatory documents that ensure compliance and keep your QMS in check.

Mandatory Documents and Records for ISO 9001:2015 Compliance

According to ISO 9001 documentation standards, organizations must maintain specific documents and records to ensure their Quality Management System (QMS) operates effectively and remains compliant with the standard. A report by ASQ states that businesses with ISO 9001 certification report 20% higher customer satisfaction than their non-certified counterparts, proving the framework’s effectiveness in driving quality outcomes. 

These documents and records provide the foundation for consistency, accountability, and continuous improvement.

Mandatory Documents to Maintain:

• Scope of the QMS: Defines the boundaries of your QMS, including the products, services, and locations it covers. It specifies what processes are included and how they are managed.
• Quality Policy and Objectives: The quality policy expresses your organization's commitment to quality, while the quality objectives set measurable goals to drive improvements and align operations with strategic targets.
• Criteria for Supplier Evaluation and Selection: Documents the criteria used for selecting suppliers to ensure they meet quality standards and regulatory requirements.

Mandatory Records to Retain:

• Calibration and Maintenance Records: Demonstrate that equipment is regularly calibrated and maintained to ensure reliable and accurate results in production.
• Training, Skills, and Qualifications Records: Show that staff members have the necessary skills and training to perform their roles effectively, ensuring quality outcomes.
• Design and Development Records: Track progress in product or service development and ensure quality control is integrated into the design process.
• Customer Property Records: Ensure customer property is properly handled and protected during processing or storage.
• Nonconformance and Corrective Action Records: Document nonconformances and corrective actions to address and prevent future quality issues.
• Internal Audit Reports and Management Review Results: Demonstrate that regular reviews and audits are conducted to evaluate performance and identify opportunities for improvement.

Maintaining both mandatory documents (like scope and quality policies) and records (such as training and calibration logs) is critical for ensuring compliance with ISO 9001 documentation standards. These documents and records support the ongoing effectiveness of your QMS and drive continuous improvement efforts across your organization.

Staying compliant with ISO 9001:2015 means staying on top of key documents and records. Need help with managing them? Get in touch today.

With mandatory documents in place, effective document control is the next critical step. Let’s take a closer look at how you can maintain and manage these documents to keep your QMS operating smoothly.

Control and Maintenance of Documents

Effective document control and maintenance are crucial to ensure that your ISO 9001:2015-compliant Quality Management System (QMS) runs smoothly. The standard emphasizes the importance of managing documents systematically to maintain their accuracy, relevance, and accessibility. Proper control processes help minimize errors and ensure that only valid and up-to-date information is used in your operations.

• Processes for Document Approval and Updates: A structured process for document approval ensures that only valid, accurate documents are used. Documents should also be regularly updated to reflect changes in operations, regulations, or standards.
• Identification and Retrieval of Records: Documents must be easily identifiable and retrievable to ensure that staff can access the information they need quickly and accurately.
• Preventing the Use of Obsolete Documents: Obsolete documents must be clearly marked and removed from active use to avoid confusion or errors.

A BSI Group study found that nearly 20% of businesses struggle with document control when implementing ISO 9001:2015, underscoring the need for effective document management. By establishing clear approval processes, ensuring easy access to records, and eliminating outdated documents, you can maintain the integrity of your QMS.

Now that we’ve covered document control, it’s essential to understand the distinction between maintained and retained information. Both play a vital role in ensuring compliance and optimizing your QMS for operational efficiency. Let’s dive into how each impacts your system.

Understanding Maintained and Retained Information

ISO 9001:2015 makes an important distinction between two types of information within a Quality Management System (QMS): maintained and retained information. Understanding the difference between these two can help ensure that your QMS remains compliant, organized, and efficient.

Maintained Information

Maintained information includes documents that are regularly updated and used in daily operations to ensure consistency and compliance with ISO 9001:2015. These documents include:

• Procedures and Work Instructions: Guide employees in performing tasks consistently, ensuring quality across processes.
• Policies: Company-wide policies, like the quality policy, define the company’s approach to quality and compliance.
• Standard Operating Procedures (SOPs): Outline standardized methods for performing tasks, promoting uniformity across departments.
  Maintained information is regularly reviewed and updated to reflect changes in processes, standards, or regulations.

Retained Information

Retained information consists of records preserved for compliance, audit, or legal purposes, providing evidence of your QMS's effectiveness. Examples include:

• Calibration Records: Verify that equipment is properly calibrated to ensure accurate production.
• Audit Results: Demonstrate regular audits and highlight any non-conformances or improvements needed.
• Training Records: Show that employees are qualified for their roles, ensuring competency.
• Corrective and Preventive Action Records: Track non-conformances and actions taken to prevent recurrence.

Retained information typically has a longer retention period and must be accessible for review, inspections, or audits. It provides a historical trail of compliance and continuous improvement. The distinction between maintained and retained information is critical for ISO 9001:2015 compliance. Understanding this distinction ensures that you can both manage your day-to-day processes effectively and meet your long-term regulatory and compliance obligations.

Understanding the distinction between maintained and retained information sets the stage for exploring the flexibility of your QMS. While some documents are essential, others—though not required—can significantly enhance your system. Let’s take a look at non-mandatory documents that can elevate your operations.

Additional Documents to Boost Your QMS Effectiveness

Although not mandatory under ISO 9001:2015, certain non-required documents can help boost the effectiveness of your Quality Management System (QMS). Did you know that over 1.3 million businesses worldwide have embraced ISO 9001 certification? This widespread adoption highlights the growing recognition of the framework's value in ensuring quality and consistency across operations. By documenting processes like risk management, employee competencies, and equipment maintenance—even if not explicitly required—you can further strengthen your QMS and align with global best practices. These extra documents provide a competitive advantage by:

1. Risk Management and Opportunity Procedures: Documenting risk management and opportunity processes allows organizations to identify potential issues and capitalize on improvements. These procedures help:

• Assess and manage risks to ensure quality outcomes.
• Identify opportunities for enhancing processes and performance.

2. Competence and Training Records: By documenting employee competencies and training, you ensure that your team is always equipped to meet quality standards. This practice helps:

• Keep track of required skills and qualifications.
• Facilitate ongoing employee development and compliance.

3. Document Control and Equipment Maintenance: Clear procedures for document control and equipment maintenance enhance QMS efficiency by:

• Managing document revisions, approvals, and access.
• Ensuring equipment is regularly maintained to avoid disruptions.

While optional, including risk management, competence tracking, and document control procedures can improve your QMS by supporting continuous improvement and ensuring compliance with industry standards.

Ready to take your document management to the next level with digital tools? Let’s explore how BPRHub can help streamline your ISO 9001:2015 compliance and improve your QMS.

While non-mandatory documents can enhance your QMS, managing them effectively becomes increasingly challenging as your organization grows. This is where digital solutions for document management come into play, offering the scalability and automation needed to streamline and simplify your documentation processes.

Digital Solutions for Document Management

Adopting a digital Quality Management System (QMS) is a game changer for managing ISO 9001 documentation standards. It simplifies processes, ensures consistency, enhances accessibility, and reduces errors. Deloitte’s research found that digital QMS systems improve accessibility, reduce errors, and provide real-time insights, empowering businesses to proactively address quality issues and stay compliant. Here's how digital tools can transform your approach to managing documented information:

Why Digital Solutions Matter in ISO 9001:2015 Compliance

Digital solutions are a game-changer when it comes to ISO 9001:2015 compliance, helping businesses centralize documentation, improve efficiency, and reduce manual complexities. Here’s how they make a difference:

• Centralized Documentation: All records are stored in one place, making it easier to access and reducing the time spent searching for critical information.
• Real-time Access: Employees can access the latest document versions from anywhere, ensuring consistency and reducing errors across the organization.
• Automation: By automating repetitive tasks like document approval and updates, businesses can reduce human error and ensure compliance without the hassle of manual processes.

Digital solutions enhance document security and accuracy for ISO 9001:2015 compliance. With encrypted storage, secure access, and automated audit trails, businesses reduce risks and ensure accountability. By minimizing manual processes, these solutions also help eliminate errors, ensuring documents stay accurate and up-to-date.

Manage ISO 9001:2015 Documentation the Right Way with BPRHub

BPRHub provides a comprehensive digital solution designed to simplify the management of your ISO 9001 documentation standards. BPRHub supports your compliance efforts by storing all documents in one secure platform for your team to easily access. You can even create and manage ISO 9001-compliant documents with BPRHub’s customizable templates.

By using BPRHub, you can ensure that your ISO 9001:2015 documentation is always up to date, secure, and compliant with minimal manual effort.

Ready to take control of your documentation and streamline your QMS? Explore how BPRHub can simplify your ISO 9001:2015 compliance with seamless document management solutions. Start today and ensure your organization is always aligned, efficient, and compliant.

FAQ’s

1. What is documented information in ISO 9001:2015?

Documented information in ISO 9001:2015 refers to the documents and records that are essential for the effective operation of your Quality Management System (QMS). This includes both maintained documents, such as procedures and work instructions, and retained records, such as audit results and training records. These documents help ensure consistency, compliance, and continuous improvement within the organization.

2. What is the difference between maintained and retained documented information in ISO 9001:2015?

Maintained Information are documents that are regularly updated and used for ongoing activities within the QMS. Examples include procedures, work instructions, and policies that guide daily operations. Records that need to be kept for legal, audit, or compliance purposes. Examples include training records, audit results, and calibration logs. These documents serve as evidence of compliance and QMS effectiveness.

3. How many documents are required for ISO 9001:2015 compliance?

ISO 9001:2015 does not prescribe a specific number of documents that must be maintained. The number and type of documents depend on the organization's processes, size, and complexity. However, the standard requires key documents to ensure effective operation, including a Quality Policy, scope of the QMS, procedures for risk management, and records of internal audits and corrective actions.

4. Can ISO 9001:2015 documentation be customized to suit the needs of my business?

Yes, ISO 9001:2015 allows for customization of documentation. The standard provides flexibility, meaning businesses can tailor their documented information to fit their unique processes, operational needs, and industry requirements, as long as the core principles of consistency, compliance, and continuous improvement are maintained.

5. What happens if I don’t maintain properly documented information in my QMS?

Failure to maintain properly documented information can lead to non-compliance with ISO 9001:2015 standards, which may result in the loss of certification, increased risk of operational inefficiencies, and a lack of accountability. Additionally, without proper documentation, it becomes difficult to track quality metrics, implement corrective actions, or demonstrate compliance during audits.

6. How does digital document management help with ISO 9001:2015 compliance?

Digital document management systems help streamline the process of storing, updating, and retrieving documented information. These systems centralize documents in one secure location, ensure real-time updates, and provide automated workflows for document approvals. 

7. How can BPRHub assist with ISO 9001:2015 documentation management?

BPRHub offers a fully integrated digital solution that simplifies the management of ISO 9001:2015 documentation. It centralizes all your QMS documents, ensures that they are always up to date, and automates approval workflows. With robust security features like encrypted storage and audit trails, BPRHub ensures compliance while reducing manual effort. Whether it’s maintaining work instructions, records, or policies, BPRHub streamlines the entire documentation process for your business.