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Control of Nonconforming Products or Services Procedure Sample

  September 09, 2023    

Here's a sample Control of Nonconforming Products or Services Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how nonconforming products or services are identified, evaluated, and managed to prevent their unintended use or delivery.
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Control of Nonconforming Products or Services Procedure

Purpose:

This Control of Nonconforming Products or Services Procedure is established to ensure that non-conforming products or services are identified, evaluated, segregated, and properly managed to prevent their unintended use or delivery. The objective is to maintain the quality of products and services delivered to customers.

Scope:

This procedure applies to all employees and departments within the organization responsible for the production, inspection, and delivery of products or services.

Responsibilities:

1. Employee Responsible for Identification: Any employee who identifies a nonconforming product or service is responsible for reporting it immediately to their supervisor or the Quality Assurance department.
2. Supervisor: Supervisors are responsible for investigating nonconformities, ensuring segregation, and initiating corrective actions.
3. Quality Assurance Department: The Quality Assurance Department is responsible for overseeing the nonconforming product or service process, conducting root cause analysis, and ensuring corrective actions are effective.

Procedure:

1. Identification of Nonconforming Products or Services:

a. Any employee who identifies a nonconforming product or service during production, inspection, testing, or any other stage of the process must immediately cease further processing or delivery of the nonconforming item.
b. The employee completes a Nonconformance Report (NCR) providing details of the nonconformity, including its nature, location, and any relevant information.
c. The NCR is submitted to the supervisor and Quality Assurance department for further investigation.

2. Investigation and Evaluation:

a. The supervisor and Quality Assurance department review the NCR to determine the severity of the nonconformity and its potential impact on quality, safety, or compliance. 
b. They conduct a root cause analysis to identify the underlying reasons for the nonconformity. 
c. Based on the investigation, the supervisor and Quality Assurance department determine whether the nonconformity poses a risk to customers, regulatory compliance, or the organization's quality objectives.

3. Segregation and Control:

a. Nonconforming products or services are segregated from conforming items to prevent accidental use or delivery.
b. Segregated items are clearly marked as nonconforming and placed in designated storage areas.
c. Access to nonconforming items is restricted to authorized personnel only.

4. Corrective Action:

a. If necessary, corrective actions are initiated to address the root causes of nonconformities.
b. Corrective actions are documented, and responsible parties are assigned to implement them.
c. The effectiveness of corrective actions is monitored and verified.

5. Disposition:

a. Once corrective actions have been implemented and verified, the Quality Assurance department determines the disposition of nonconforming items.
b. Nonconforming items may be reworked, repaired, scrapped, or returned to suppliers, depending on the nature of the nonconformity and customer requirements.
c. All actions taken and decisions made regarding nonconforming items are documented for future reference and audit purposes. 

Record Keeping: 

The organization maintains records of all nonconformities, including Nonconformance Reports (NCRs), investigation findings, corrective actions, and disposition decisions. 

Review and Audit: 

This Control of Nonconforming Products or Services Procedure shall be reviewed and audited periodically to ensure its effectiveness and compliance with ISO 9001:2015 requirements.

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Please customize this procedure to align with your organization's specific processes and requirements. Additionally, ensure that you follow any relevant industry-specific regulations or standards that may apply to the control of nonconforming products or services.

  

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Document Control Procedure Sample

  September 09, 2023    

Here's a sample Document Control Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how documents are managed and controlled within the organization to ensure accuracy, consistency, and compliance with ISO 9001 requirements.

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Document Control Procedure

Purpose:

This Document Control Procedure is established to ensure that all organizational documents, including policies, procedures, work instructions, and records, are controlled, maintained, and updated to support the effective operation of the Quality Management System (QMS) in accordance with ISO 9001:2015 requirements.

Scope:

This procedure applies to all documents and records generated and used within the organization.

Responsibilities:

1. Document Owner: The author or creator of a document is responsible for its content and accuracy. The document owner is also responsible for initiating updates when necessary.
2. Document Controller: The Document Controller is responsible for overseeing the document control process, including document distribution, retrieval, and archiving.

Procedure:

1. Document Creation:

a. The Document Owner creates a new document or revises an existing one as necessary to meet organizational needs or ISO 9001 requirements.
b. The Document Owner ensures that the document is clear, accurate, and includes the appropriate format and content.

2. Document Review:

a. The Document Owner submits the document to the Document Controller for review and approval.
b. The Document Controller reviews the document for conformity with established document control procedures, format, and content.
c. If revisions are required, the Document Owner is notified and requested to make the necessary changes.
d. Once the document is deemed satisfactory, the Document Controller approves it for distribution.

3. Document Distribution:

a. The Document Controller is responsible for distributing approved documents to relevant personnel.
b. Documents may be distributed in both hard copy and electronic formats, depending on the nature of the document and the preferences of recipients.

4. Document Retrieval:

a. All employees are responsible for using the most current version of documents when performing their work.
b. Outdated documents are to be immediately returned to the Document Controller for disposal.

5. Document Updates:

a. The Document Owner is responsible for identifying the need for document revisions, which may arise due to changes in regulations, processes, or identified improvements.
b. The Document Owner initiates the update process by making the necessary changes to the document.
c. The revised document is submitted to the Document Controller for review and approval, following the same process as outlined in Section 2.

6. Document Archiving:

a. Obsolete documents are archived by the Document Controller to maintain historical records.
b. Archived documents are retained for the period specified in the organization's document retention policy and in accordance with legal requirements.

Record Keeping:

The Document Controller maintains a record of all documents, their revisions, and distribution history. Records include the document's title, version, date of approval, and distribution list.

Review and Audit:

This Document Control Procedure shall be reviewed and audited periodically to ensure its effectiveness and compliance with ISO 9001:2015 requirements.

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Please note that this is a sample document control procedure, and you should tailor it to your organization's specific needs, structure, and processes. Additionally, consult with legal and regulatory requirements that may apply to document retention in your industry.

  

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Documented procedures required by ISO 9001

  September 09, 2023    

Introduction 

ISO 9001 is a globally recognized standard for quality management systems (QMS) that helps organizations ensure the consistent delivery of high-quality products and services. To achieve ISO 9001 certification, an organization must adhere to a set of mandatory procedures that form the foundation of its quality management system. These procedures are essential for meeting the requirements of ISO 9001 and demonstrating a commitment to continual improvement. In this article, we will explore the key mandatory procedures that organizations need to establish and maintain to attain ISO 9001 certification. 

1. Document Control Procedure 

Effective document control is crucial for maintaining the integrity of the quality management system. This procedure outlines how documents, including policies, procedures, and records, are created, approved, updated, and archived. It ensures that employees have access to the most current and relevant information necessary for their roles. Please take a look at an example of the Document Control Procedure sample. 

2. Control of Records Procedure 

ISO 9001 requires organizations to maintain records to demonstrate compliance with the standard's requirements. The Control of Records Procedure defines how records are identified, stored, protected, retained, and disposed of. This procedure ensures that records are available for audit purposes and that they are preserved for the required retention periods. 

3. Management Review Procedure 

Top management is responsible for overseeing the QMS and ensuring its effectiveness. The Management Review Procedure outlines how management reviews are conducted at planned intervals. These reviews assess the QMS's performance, suitability, adequacy, and opportunities for improvement.

4. Internal Audit Procedure

Internal audits are a critical part of maintaining and improving a QMS. The Internal Audit Procedure outlines how internal audits are planned, conducted, and reported. Auditors, typically from within the organization, assess processes and procedures to identify non-conformities and areas for improvement.

5. Corrective and Preventive Action (CAPA) Procedure

The CAPA Procedure defines how an organization addresses non-conformities, corrective actions to eliminate their causes, and preventive actions to prevent recurrence. It ensures that issues are addressed promptly, root causes are identified, and preventive measures are put in place. 

6. Control of Nonconforming Products or Services Procedure 

This procedure outlines how an organization deals with nonconforming products or services to prevent their unintended use or delivery. It includes the identification, segregation, evaluation, and disposition of nonconforming items, helping to maintain the quality of delivered products and services. Please take a look at an example of the  Control of Nonconforming Products or Services Procedure

7. Training and Competence Procedure 

To ensure that employees are qualified to perform their roles effectively, organizations need to establish a Training and Competence Procedure. This procedure identifies training needs, defines training plans, and monitors employee competence to ensure they have the skills and knowledge required for their positions. Please take a look at an example of the Training and Competence procedure.

8. Supplier Evaluation and Control Procedure 

To maintain the quality of purchased products and services, organizations must establish a Supplier Evaluation and Control Procedure. This procedure outlines how suppliers are selected, evaluated, and monitored to ensure they meet the organization's quality requirements. Please take a look at an example of the Supplier Evaluation and Control Procedure

9. Customer Complaint Handling Procedure

Customer satisfaction is a key element of ISO 9001. The Customer Complaint Handling Procedure details how customer complaints are received, documented, investigated, resolved, and analyzed. It helps organizations identify areas for improvement and enhance customer satisfaction. Please take a look at an example of the Customer Complaint Handling Procedure

10. Risk Management Procedure

While not explicitly mandated in ISO 9001, many organizations include a Risk Management Procedure to identify, assess, and mitigate risks that could affect the achievement of quality objectives. This proactive approach aligns with the principles of ISO 9001 and helps prevent issues before they occur. Please take a look at an example of the Risk Management Procedure

Conclusion

ISO 9001 certification requires organizations to establish and maintain a set of mandatory procedures that ensure the effective implementation and continual improvement of their quality management systems. These procedures cover key aspects such as document control, record management, internal audits, corrective and preventive actions, and more. By adhering to these procedures, organizations can enhance their quality processes, meet customer expectations, and demonstrate a commitment to delivering high-quality products and services.

Reading Sources:
  • ISO 9001:2015 Standard: This is the primary source to understand the ISO 9001 requirements. You can access and purchase this standard from the ISO website or ISO certification bodies.
  • "ISO 9001 for Small Businesses" by Ray Tricker: This book provides a practical guide on how to implement ISO 9001 in small and medium-sized businesses.
  • "ISO 9001:2015 Handbook for Small and Medium-Sized Businesses" by Robert W. Peach: This book is specifically aimed at small and medium-sized organizations and offers a step-by-step guide to complying with ISO 9001.
  • "The ISO 9001:2015 Implementation Handbook" by Milton P. Dentch: This book reviews how to implement ISO 9001:2015 within organizations and includes numerous case examples.
  • "Internal Auditing to ISO 9001:2015" by Fred Dobb: This is a useful guide to understanding and conducting internal audits in accordance with the ISO 9001 standard.
  • "ISO 9001:2015 in Plain English" by Craig Cochran: This book provides easily understandable explanations of the ISO 9001:2015 requirements without excessive technical jargon.
  • "ISO 9001:2015 for Small Enterprises – What to do?" by Lars Albinsson: This guide offers insights into how small businesses can comply with ISO 9001:2015 with limited resources.
  • "ISO 9001:2015 Explained" by Charles Cianfrani: This book helps you understand the ISO 9001:2015 requirements with clear examples and explanations.
  • "ISO 9001:2015 Internal Audits Made Easy" by Ann W. Phillips: This book focuses on how to efficiently conduct internal audits in line with ISO 9001:2015.
  • "ISO 9001:2015 for Small Businesses" by Robert D. Brown: This book provides a specific guide for small organizations looking to comply with ISO 9001:2015.
  • "ISO 9000 Quality Systems Handbook" by David Hoyle: This is a comprehensive reference on quality management systems, including ISO 9001.
  • Your Organization's Documentation: In addition to the above sources, make sure to refer to your organization's internal documentation, including the mandatory procedures you've created in accordance with ISO 9001.
Please check the availability of these books at your local bookstore or library. By reading these sources, you will be able to develop a better understanding of ISO 9001 and how to implement it within your organization.

  

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More about "E. Communication and Alignment"

  September 03, 2023    

Effective communication and alignment are critical components of a successful ISO 9001 certification process. This step involves ensuring that all relevant stakeholders within your organization are informed, engaged, and aligned with the ISO 9001 implementation efforts. Clear communication and alignment facilitate cooperation, understanding, and commitment to the certification process. Here's why communication and alignment are crucial, along with specific requirements for this step:

1. Stakeholder Engagement:

Engaging stakeholders, including employees, managers, and process owners, is essential for the success of ISO 9001 implementation. Their involvement ensures a collective effort and a shared commitment to quality.

2. Awareness and Understanding:

Clear communication helps raise awareness and understanding of ISO 9001 requirements and objectives. When employees understand the purpose and benefits of certification, they are more likely to actively support the process.

3. Consistency:

Alignment ensures consistency in practices and processes across different departments or teams within your organization. It helps create a unified approach to quality management.

4. Risk Mitigation:

Effective communication and alignment also help identify and address potential risks or obstacles that may hinder ISO 9001 certification efforts.

Requirements for Communication and Alignment:
  • Stakeholder Identification: Identify all relevant stakeholders, both internal and external, who are impacted by the ISO 9001 certification process.
  • Communication Plan: Develop a comprehensive communication plan that outlines how and when information will be shared with stakeholders. This plan should include regular updates, progress reports, and opportunities for feedback.
  • Training and Education: Provide training and educational resources to employees to ensure they have the knowledge and skills necessary to support ISO 9001 compliance. This includes awareness training, as well as specialized training for specific roles.
  • Two-Way Communication: Encourage two-way communication to foster engagement and feedback. Create channels for employees to ask questions, provide input, and raise concerns.
  • Alignment with Objectives: Ensure that all stakeholders understand how ISO 9001 certification aligns with your organization's strategic objectives and goals.
  • Regular Updates: Provide regular updates on the progress of ISO 9001 implementation. Celebrate milestones and achievements to maintain motivation and engagement.
  • Feedback Mechanisms: Establish mechanisms for collecting feedback from employees and other stakeholders. Use this feedback to make necessary adjustments to the implementation process.
  • Leadership Support: Ensure that top management actively supports and communicates the importance of ISO 9001 certification. Their commitment sets the tone for the entire organization.
  • Documentation: Document all communication efforts, including meeting minutes, emails, training materials, and feedback received. This documentation can be valuable during audits.
  • Integration with QMS: Integrate communication and alignment efforts with your organization's existing Quality Management System (QMS) processes and documentation.

Conclusion

Effective communication and alignment are the glue that holds your ISO 9001 certification efforts together. By engaging stakeholders, creating a communication plan, providing training, encouraging two-way communication, aligning with objectives, providing regular updates, collecting feedback, securing leadership support, documenting your efforts, and integrating them with your QMS, you ensure that your organization is not only compliant with ISO 9001 but also operating as a cohesive, quality-focused unit. This approach not only facilitates the certification process but also promotes a culture of quality, continuous improvement, and excellence within your organization.

  

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More about " D. Implementation Strategy"

  September 03, 2023    

Developing a well-structured implementation strategy is a pivotal step in achieving ISO 9001 certification. This strategy outlines the systematic approach your organization will take to implement the necessary changes and align with ISO 9001 requirements. It helps ensure that the certification process is organized, efficient, and effective. Here's why an implementation strategy is crucial, along with specific requirements for this step:

1. Systematic Approach:

An implementation strategy provides a clear and systematic plan for achieving ISO 9001 compliance. It prevents ad-hoc or disorganized efforts.

2. Resource Allocation:

It helps allocate resources, including human, financial, and time resources, effectively to ensure a smooth implementation process.

3. Risk Mitigation:

The strategy should include risk assessment and mitigation plans to address potential challenges that may arise during the implementation process.

4. Timeframe and Milestones:

A well-defined strategy includes a timeframe with milestones and deadlines, ensuring that progress is tracked and that the project stays on schedule.

5. Clear Responsibilities:

Roles and responsibilities for various team members and stakeholders should be clearly defined in the strategy to avoid confusion and ensure accountability.

Requirements for Implementation Strategy:
  • Compliance with ISO 9001: Ensure that your implementation strategy is aligned with the ISO 9001 standard and its requirements.
  • Stakeholder Involvement: Involve relevant stakeholders, including top management, process owners, and quality professionals, in the development of the implementation strategy.
  • Detailed Plan: Create a detailed plan that outlines the steps and actions required to implement ISO 9001. This should include a timeline, responsibilities, and specific tasks.
  • Risk Assessment: Identify potential risks and challenges that may hinder the implementation process. Develop strategies to mitigate these risks.
  • Resource Allocation: Allocate resources, both human and financial, to support the implementation efforts. Ensure that necessary tools and training are provided.
  • Communication Plan: Develop a communication plan to keep all stakeholders informed about the implementation process, progress, and any changes.
  • Documentation: Document the implementation strategy, including all plans, procedures, and risk assessments. Maintain records of all actions taken during the implementation.
  • Monitoring and Review: Regularly monitor and review the progress of the implementation strategy. Adjust the plan as needed based on feedback and changing circumstances.
  • Training: Provide training to employees to ensure they understand their roles in the implementation process and are equipped with the necessary knowledge and skills.
  • Integration with QMS: Integrate the implementation strategy with your organization's existing Quality Management System (QMS) processes and documentation.

Conclusion

An implementation strategy is the roadmap that guides your organization towards ISO 9001 compliance. By ensuring alignment with ISO 9001, involving stakeholders, creating a detailed plan, assessing and mitigating risks, allocating resources, developing a communication plan, documenting your strategy, monitoring progress, providing training, and integrating it with your QMS, you establish a solid foundation for certification success. This strategy not only ensures a structured and efficient implementation process but also demonstrates your organization's commitment to delivering quality products or services and achieving excellence in its operations.

  

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More about "C. Setting Objectives and Targets"

  September 03, 2023    

Setting objectives and targets is a pivotal step in the ISO 9001 certification process. It involves defining specific, measurable, achievable, relevant, and time-bound (SMART) goals that align with your organization's quality management system (QMS) and ISO 9001 requirements. These objectives and targets serve as a roadmap for continuous improvement and demonstrate your commitment to quality. Here's why setting objectives and targets is crucial, along with specific requirements for this step:

1. Focus on Improvement:

Objectives and targets provide a clear focus for your organization's improvement efforts. They direct your energy and resources toward achieving specific quality-related goals.

2. Align with ISO 9001:

Setting objectives and targets ensures that your QMS aligns with ISO 9001 requirements. It demonstrates your commitment to meeting the standard's criteria.

3. Measurable Progress:

Objectives and targets are measurable, allowing you to track your organization's progress over time. This measurement provides valuable data for decision-making and demonstrates compliance during audits.

4. Motivation and Accountability:

Clear objectives and targets motivate employees by giving them a sense of purpose and direction. They also create accountability as individuals and teams work towards achieving these goals.

5. Continuous Improvement:

ISO 9001 emphasizes the importance of continuous improvement. Objectives and targets are a practical way to implement this principle, as they are regularly reviewed and adjusted to reflect changing circumstances.

Requirements for Setting Objectives and Targets:
  • Alignment with ISO 9001: Ensure that your objectives and targets align with the ISO 9001 standard and its requirements. They should directly contribute to improving the quality of your products or services.
  • SMART Criteria: Objectives and targets should be Specific, Measurable, Achievable, Relevant, and Time-bound. This ensures clarity and practicality.
  • Consideration of Risks and Opportunities: Identify risks and opportunities that may impact your organization's ability to achieve its objectives. Develop strategies to address these factors.
  • Involvement of Relevant Parties: Involve relevant stakeholders, including top management and process owners, in the development of objectives and targets. This fosters ownership and commitment.
  • Documentation: Document your objectives and targets, including details such as the responsible parties, timeframes, and key performance indicators (KPIs) for measurement.
  • Monitoring and Review: Regularly monitor and review progress towards objectives and targets. Make adjustments as necessary to stay on track and respond to changing circumstances.
  • Communication: Communicate your objectives and targets throughout the organization to ensure that all employees are aware of and aligned with the goals.
  • Training: Provide necessary training and resources to employees to support the achievement of objectives and targets.
  • Integration with QMS: Integrate objectives and targets into your organization's QMS processes. Ensure that they are reflected in your documentation, internal audits, and management reviews.

Conclusion

Setting objectives and targets is the compass that guides your organization toward ISO 9001 compliance and continuous improvement. By aligning with ISO 9001, using SMART criteria, considering risks and opportunities, involving relevant parties, documenting your goals, monitoring progress, communicating objectives, providing training, and integrating them into your QMS, you create a dynamic framework for quality excellence. These objectives and targets not only demonstrate your commitment to quality but also drive measurable improvements in your products or services, customer satisfaction, and overall organizational performance.

  

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