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Risk Management Procedure Sample

  September 09, 2023    

Here's a sample Risk Management Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how risks are identified, assessed, managed, and monitored to prevent issues and support continual improvement.
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Risk Management Procedure

Purpose:

This Risk Management Procedure is established to identify, assess, manage, and monitor risks within the organization to prevent issues, improve decision-making, and support the achievement of quality objectives in accordance with ISO 9001:2015 requirements.

Scope:

This procedure applies to all employees and departments within the organization responsible for identifying, assessing, and managing risks.

Responsibilities:

1. Risk Management Team: The Risk Management Team is responsible for coordinating and overseeing the risk management process.
2. Department Heads/Managers: Department heads and managers are responsible for identifying and assessing risks within their areas of responsibility.

Procedure:

1. Risk Identification:

a. Employees are encouraged to identify and report potential risks and opportunities within their areas of responsibility.
b. Department heads and managers regularly conduct risk assessments in their respective departments.

2. Risk Assessment:

a. Risks are assessed based on their potential impact and likelihood of occurrence.
b. Risk assessments may consider factors such as financial impact, operational disruption, safety, compliance, and customer satisfaction.
c. Risks are categorized as high, medium, or low based on their severity.

3. Risk Mitigation:

a. The Risk Management Team develops risk mitigation plans for high and medium-risk items.
b. Mitigation plans include specific actions, responsibilities, timelines, and resources required to reduce or eliminate the risk.

4. Risk Monitoring:

a. The status of risk mitigation plans is regularly reviewed by the Risk Management Team.
b. Progress is documented, and adjustments are made as needed to achieve risk reduction goals.

5. Risk Reporting:

a. Risk reports are prepared periodically to summarize the status of identified risks, mitigation efforts, and outcomes.
b. Reports are communicated to relevant stakeholders, including top management.

6. Risk Review:

a. The organization conducts periodic risk reviews to assess the effectiveness of the risk management process.
b. Reviews consider changes in the business environment, new risks, and the performance of existing risk mitigation efforts.

7. Documentation and Records:

a. All risk assessments, mitigation plans, and monitoring activities are documented and retained.
b. Records are maintained for a specified period as per the organization's document retention policy.

8. Continuous Improvement:

a. Lessons learned from risk assessments and mitigation efforts are used to drive continual improvement in risk management processes and decision-making.
b. The organization seeks opportunities to capitalize on identified opportunities.

Review and Audit:

This Risk Management 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 risk management.

  

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Customer Complaint Handling Procedure Sample

  September 09, 2023    

Here's a sample Customer Complaint Handling Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how customer complaints are received, documented, investigated, resolved, and analyzed to enhance customer satisfaction and identify areas for improvement.

Customer Complaint Handling Procedure

Purpose:

This Customer Complaint Handling Procedure is established to ensure that customer complaints are effectively and consistently managed to address customer concerns, improve customer satisfaction, and identify opportunities for continual improvement.

Scope:

This procedure applies to all employees and departments within the organization responsible for receiving, investigating, resolving, and analyzing customer complaints.

Responsibilities:

1. Customer Service Representatives: Customer service representatives are responsible for receiving and initially documenting customer complaints.
2. Quality Assurance Department: The Quality Assurance Department is responsible for overseeing the complaint-handling process, conducting investigations, and ensuring effective resolution.

Procedure:

1. Complaint Receipt:

a. Customer complaints may be received through various channels, including phone, email, website forms, or in person.
b. All complaints are recorded promptly, and the date of receipt is documented.

2. Initial Documentation:

a. Customer service representatives gather essential information from the complainant, including contact information, a detailed description of the complaint, and any relevant supporting documents.
b. Complaints are classified based on their nature and severity.

3. Complaint Registration:

a. Complaints are assigned a unique reference number for tracking purposes.
b. The complaint details are recorded in a central complaint management system.

4. Investigation and Analysis:

a. The Quality Assurance department conducts a thorough investigation of the complaint, involving relevant departments or personnel as necessary.
b. Root cause analysis is performed to determine the underlying reasons for the complaint.

5. Resolution:

a. Once the investigation is complete, the organization takes corrective actions to address the root causes of the complaint.
b. Corrective actions may include process improvements, product revisions, or other measures to prevent recurrence.

6. Communication with the Customer:

a. The organization communicates with the customer to inform them of the resolution or proposed corrective actions.
b. Customers are provided with a timeline for resolution if applicable.

7. Follow-up and Closure:

a. After corrective actions have been implemented, the organization follows up with the customer to ensure their satisfaction and verify that the complaint has been resolved to their satisfaction.
b. The complaint is marked as closed in the complaint management system.

8. Documentation and Records:

a. All details related to the complaint, including the investigation, corrective actions, and customer communication, are documented and retained.
b. Records are maintained for a specified period as per the organization's document retention policy.

9. Complaint Analysis:

a. Periodic analysis of customer complaints is conducted to identify trends, recurring issues, and areas for improvement.
b. The Quality Assurance department reviews complaint data to drive continual improvement efforts.

Review and Audit:

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

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 customer complaint handling.

  

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Supplier Evaluation and Control Procedure Sample

  September 09, 2023    

Here's a sample Supplier Evaluation and Control Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how suppliers are selected, evaluated, and monitored to ensure they meet the organization's quality requirements.
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Supplier Evaluation and Control Procedure

Purpose:

This Supplier Evaluation and Control Procedure is established to ensure that suppliers are selected, evaluated, and monitored to ensure they consistently provide products or services that meet the organization's quality requirements and standards.

Scope:

This procedure applies to all departments within the organization responsible for supplier selection, evaluation, and monitoring.

Responsibilities:

1. Procurement Department: The Procurement department is responsible for supplier selection, evaluation, and ongoing supplier management.
2. Quality Assurance Department: The Quality Assurance Department is responsible for conducting supplier audits and assessments as needed.

Procedure:

1. Supplier Selection:

a. The Procurement department identifies potential suppliers based on the organization's needs and requirements.
b. Supplier selection criteria are established, considering factors such as product or service quality, price, delivery capabilities, reputation, and compliance with relevant standards and regulations.
c. Suppliers are assessed for their ability to meet the organization's quality requirements and standards.

2. Initial Supplier Evaluation:

a. The Procurement department conducts an initial evaluation of potential suppliers, which may include reviewing supplier documentation, quality certificates, and conducting interviews.
b. Initial supplier evaluations are documented, and a decision is made regarding whether to engage the supplier.

3. Supplier Performance Metrics:

a. Key performance metrics are established to assess supplier performance, including quality, delivery, responsiveness, and reliability.
b. Supplier performance metrics are communicated to the supplier and are included in supplier agreements or contracts.

4. Regular Performance Evaluation:

a. Supplier performance is regularly evaluated based on established metrics.
b. Performance evaluations may include quality audits, on-time delivery assessments, and feedback from internal stakeholders.
c. Performance evaluations are documented and tracked over time.

5. Supplier Development:

a. If a supplier's performance falls below acceptable levels, the organization may work with the supplier to identify and address areas for improvement.
b. Supplier development plans are created and implemented as needed.

6. Supplier Audits:

a. Periodic supplier audits may be conducted to assess compliance with quality requirements, standards, and regulations.
b. Supplier audits are typically conducted by the Quality Assurance department or a designated auditing team.

7. Communication and Feedback:

a. Open communication channels are established with suppliers to address any issues, concerns, or improvement opportunities.
b. Feedback from internal stakeholders, such as production, quality, and procurement teams, is collected and considered when evaluating supplier performance.

8. Supplier Rating:

a. Supplier performance is rated based on established criteria and performance metrics.
b. Supplier ratings may influence decisions regarding the continuation of the supplier relationship.

Review and Audit:

This Supplier Evaluation and Control 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 supplier evaluation and control.

  

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Training and Competency Procedure Sample

  September 09, 2023    

Here's a sample Training and Competency Procedure that you can use as a starting point for your organization's quality management system. This procedure outlines how training needs are identified, training plans are developed, and employee competency is monitored to ensure that all employees have the skills and knowledge required for their roles.
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Training and Competency Procedure

Purpose:

This Training and Competency Procedure is established to ensure that employees receive the necessary training, development, and assessment to perform their job functions effectively and in compliance with ISO 9001:2015 requirements. The objective is to enhance employee skills and maintain a competent workforce.

Scope:

This procedure applies to all employees and departments within the organization responsible for identifying training needs, planning training programs, and assessing employee competencies.

Responsibilities:

1. Department Heads/Supervisors: Department heads and supervisors are responsible for identifying training needs, developing training plans, and ensuring employees receive the necessary training.
2. Human Resources (HR) Department: The HR department is responsible for maintaining training records and coordinating training activities.
3. Employees: Employees are responsible for actively participating in training programs and seeking opportunities for professional development.

Procedure:

1. Training Needs Identification:

a. Department heads and supervisors regularly assess the skills and knowledge required for each job function within their department. 
b. Training needs are identified based on job requirements, changes in technology, regulatory updates, and employee performance evaluations. 
c. Training needs are documented, and a training plan is developed for each employee.

2. Training Plan Development:

a. Training plans outline the training objectives, methods, duration, and resources required to address the identified training needs.
b. Training plans are tailored to individual employees, taking into consideration their roles and responsibilities.
c. The HR department maintains a master training plan that tracks all planned training activities.

3. Training Delivery:

a. Training is delivered through various methods, including classroom sessions, online courses, on-the-job training, workshops, and external training programs.
b. Trainers or instructors are selected based on their expertise and experience in the subject matter.

4. Training Records:

a. The HR department maintains records of all training activities, including training dates, topics, attendees, and results.
b. Training records are periodically reviewed to ensure compliance with training plans.

5. Competency Assessment:

a. Competency assessments are conducted to evaluate employees' knowledge and skills after completing training.
b. Assessment methods may include written tests, practical demonstrations, or on-the-job evaluations.

6. Competency Monitoring:

a. The competency of employees is monitored regularly through performance evaluations, feedback, and observation.
b. If competency gaps are identified, additional training or support is provided to address these gaps.

7. Training Effectiveness Evaluation:

a. The effectiveness of training programs is periodically evaluated to ensure they meet their intended objectives.
b. Feedback from employees and supervisors is collected and considered for continuous improvement.

Review and Audit:

This Training and Competency 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 training and competency.

  

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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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