How Document Control Software Helps You Meet the Requirements for ISO 9001:2015

Unlike previous iterations of ISO 9001, ISO 9001:2015 does not prescribe specific approaches to document governance. Instead, it is up to each organization to determine its approach to the maintenance, retention, and disposition of documentation.

ISO 9001:2015 eliminates the distinction between records, processes and manuals by using the category “documented information” to describe all of them. The phrase maintain documented information describes working documentation that requires regular updates, such as procedures and work instructions. The phrase retain documented information refers to document types such as records that provide evidence of past conformity with requirements.

ISO 9001:2015 has requirements for documented information throughout the standard. The table below collects all the references to required documented information.

Clause	Description
4.3 Scope of the QMS	Describe products and services covered and justify anything the organization decides is out of scope for ISO 9001:2015.
4.4.2 Operation of QMS processes	Maintain documents that support the operation of the QMS and retain documents that provide confidence and evidence that processes are being carried out correctly.
5.2.2 Communicating quality policy	Distribute and facilitate interaction with the quality policy.
6.2.1 Quality objectives	Maintain documentation of the quality objectives and their relevance to the QMS.
7.1.5.1 Resources	Maintain documentation that provides evidence of the suitability of monitoring and measuring resources for the QMS.
7.1.5.2 Measurement traceability	Maintain the basis for calibration or verification as documented information when no standards for these activities exist.
7.2 Competence	Retain documentation as evidence of the competence of all human resources supporting the QMS.
7.5.1 Documented information	Maintain documentation required by ISO 9001:2015 for the effectives of the QMS.
7.5.2 Creating and updating	Ensure that all documentation has appropriate identification, description, format, and review policies.
7.5.3 Control of documented information	Ensure documentation is available for use and adequately protected by effective information governance policies.

Clause	Description
8.1 Operational planning and control	Provide governance of documentation to demonstrate that processes, products, and services have met all requirements and expectations.
8.2.3.2 Requirements for products and services	Retain documentation to demonstrate reviews of the requirements for products and services and of any new or additional requirements.
8.2.4 Changes to requirements for products and services	Amend documentation to reflect changes to the requirements for products and services.
8.3.3 Design and development inputs	Retain documentation relating to design and development inputs.
8.3.4 Design and development controls	Retain documentation of the controls relating to the design and development process.
8.3.5 Design and development outputs	Retain documentation relating to the design and development of outputs.
8.3.6 Design and development changes	Retain documentation relating to any changes to the design and development controls.
8.4.1 Control of external processes, products and services	Retain documentation relating to externally provided processes, products, and services.
8.5.1 Control of production and service provision	Ensure the availability of documentation that defines the characteristics of the product, services, and activities, as well as the results of each.
8.5.2 Identification and traceability	Maintain documentation to ensure traceability of outputs and conformity of products and services.
8.5.3 Property belonging to customers or external providers	Retain documentation relating to any incident involving customer or external provider property while in the care of the organization.
8.5.6 Control of changes	Retain documentation describing the results of the review of changes.
8.6 Release of products and services	Retain documentation of the conformity of product and service release and the traceability of release authorization.
8.7.2 Control of nonconforming outputs	Retain documentation relating to nonconforming outputs.
9.1.1 Monitoring, measurement, analysis and evaluation	Retain documentation relating to the monitoring, measurement, analysis, and evaluation of the QMS.
9.2.2 Internal audit	Retain documentation relating to audits of the QMS.
9.3.3 Management review outputs	Retain documentation of results of management reviews of required changes and improvements.
10.2.2 Nonconformity and corrective action	Retain documentation on nonconformities and corrective actions taken.

Intelex can be used not only to support ISO 9001:2015, but also the Baldrige Excellence Framework. ISO 9001:2015 and Baldrige share several common elements, including a focus on achieving quality excellence for products and services that meet regulatory requirements.

Baldrige complements ISO 9001:2015 by moving beyond compliance and helping organizations achieve operational excellence and continuous improvement. Intelex can play an important role in achieving this strategic goal. The table below shows some of the common features between ISO 9001:2015 and Baldrige, as well as the Intelex applications that can support them.

The Baldrige Excellence Framework contains several elements that are not considered in ISO 9001:2015. These elements are critical to the complementary relationship between ISO 9001:2015 and Baldrige that will allow organizations to achieve operational excellence. Below is a description of these unique elements and how Intelex can help you meet the requirements found in ISO 9001:2015 and Baldrige.

How Intelex Docment Control Software, Other Apps, Support Common Elements Between ISO 9001:2015 and Baldrige Excellence Framework 

ISO 9001:2015		Baldrige Excellence Framework		Intelex App
Clause	Description	Clause	Description
4. Context of the organization	Understand the internal and external issues that impact strategic direction.	Organizational profile	Consider requirements and expectations of stakeholders.    Understand organizational mission, vision, values and core competencies for strategic planning and innovation.	Bulletins  Document Control  Training Management  Nonconformance (NCR)  Customer Complaints  Audits/Supplier Audits (with Checklists)  Management Review (MR)  Meetings Management  Action Plans  Risk Assessments  Monitoring and Measurement
6. Operations	Design, manage and improve key products and work processes.  Create processes for managing innovation.
4. Measurement, analysis and knowledge management	Consider measures to improve operational performance.  Collect data from multiple sources and share best practices throughout the organization.
5. Leadership	Understand the role of leadership in supporting the QMS and engaging the people in the organization.    Demonstrate commitment to customer satisfaction.	1. Leadership	Consider the role of leadership in creating an environment for success and communicating with the workforce.  Create opportunities for intelligent risk and innovation.    Communicate with and engage key customers and stakeholders in and beyond the organization.	Bulletins  Document Control
3. Customers	Listen to and engage with customers to develop a long-term relationship that exceeds customer expectations.    Determine methods of listening to and engaging with customers to achieve customer satisfaction.
6. Planning	Address risks, opportunities and objectives.	2. Strategy	Understand the development and implementation of strategy.    Understand strategy development process and key strategic objectives.	Action Plans  Document Control  Management of Change (MoC)
7. Resources	Consider work environment, monitoring, organizational knowledge and workforce competence.	5. Workforce	Build and engage an effective and capable workforce.	Document Control  Monitoring & Measurement  Training Management  Risk Management  Bulletins  EHS applications  Nonconformance (NCR)  Customer Complaints  Audits/Supplier Audits (with Checklists)  Management Review (MR) (Meetings Management, Action Plans)   Risk Assessments  Dashboards  Supplier Relationship Management  Product Management  Shipping, Receiving & Inspections  Management of Change (MoC)
4. Measurement, analysis and knowledge management	Consider measures to improve operational performance.    Collect data from multiple sources and share best practices throughout the organization.
6. Operations	Design, manage and improve key products and work processes.    Create processes for managing innovation.
8. Operations	Monitor operations and internal and external information.
3. Customers	Listen to and engage with customers to develop a long-term relationship that exceeds customer expectations.  Determine methods of listening to and engaging with customers to achieve customer satisfaction.
9. Performance evaluation	Manage and evaluate the QMS for operational performance and customer satisfaction.	4. Measurement, analysis and knowledge management	Consider measures to improve operational performance.    Collect data from multiple sources and share best practices throughout the organization.	Document Control  Monitoring & Measurement  Training Management  Risk Management  Bulletins  EHS applications  Nonconformance (NCR)  Customer Complaints  Audits/Supplier Audits (with Checklists)  Management Review (MR) (Meetings Management, Action Plans)   Risk Assessments  Dashboards  Supplier Relationship Management  Product Management  Shipping, Receiving & Inspections  Management of Change (MoC)
3. Customers	Listen to and engage with customers to develop a long-term relationship that exceeds customer expectations.    Determine methods of listening to and engaging with customers to achieve customer satisfaction.
1. Leadership	Consider the role of leadership in creating an environment for success and communicating with the workforce.    Create opportunities for intelligent risk and innovation.    Communicate with and engage key customers and stakeholders in and beyond the organization.
7. Results	Analyze results for product performance, customer-focused performance, workforce performance and leadership performance.
10. Improvement	Address nonconformity, corrective action and continuous improvement.	6. Operations	Design, manage and improve key products and work processes.    Create processes for managing innovation.	SRI (Shipping, Receiving, and Inspections)  Nonconformance (NCR)  Corrective Action Reporting  Root Cause Analysis  Action Plans
4. Measurement, analysis and knowledge management	Consider measures to improve operational performance.    Collect data from multiple sources and share best practices throughout the organization.
Baldrige Scoring System	Apply Baldrige rubric for assessment of organizational performance maturity.

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