Penjelasan KLAUSUL ISO 9001:2015

Mitra Berdaya Optima

31 Jul 202217:54

Summary

TLDRThe script provides a detailed explanation of ISO 9001:2015, focusing on its clauses and structure, particularly high-level structure (HLS). It covers internal and external factors affecting businesses, stakeholder needs, and quality management system scope. Key clauses discussed include leadership responsibility, customer focus, risk management, operational planning, monitoring, and continual improvement. The script also emphasizes the importance of documented information, competency, and communication in maintaining an effective quality management system. Additionally, the audit process and opportunities for improvement are highlighted to ensure the organization meets customer expectations and regulatory requirements.

Takeaways

📋 The High-Level Structure (HLS) in ISO 9001:2015 provides a standardized framework for organizing the requirements or clauses across different ISO standards.
🏢 Internal issues refer to company-specific factors, such as vision, mission, goals, and strategies, that can impact business processes if not evaluated.
🌍 External issues include factors like laws, politics, social dynamics, and regulations, which also affect business processes and must be assessed.
⚖️ Clause 4.2 emphasizes the need for organizations to consider relevant interested parties that may impact their quality management system.
📊 Clause 6 requires organizations to plan for risks and opportunities and integrate these considerations into their quality management processes.
🏗️ Clause 7 addresses the resources needed for quality management, such as infrastructure, human resources, competence, and training.
📝 Documented information must be maintained to support the operation of processes and provide evidence of their effectiveness.
🎯 Clause 5 focuses on leadership responsibilities, including ensuring customer requirements are consistently met and fostering a customer-focused culture.
🔄 Continuous improvement is a key element of ISO 9001:2015, requiring organizations to enhance the effectiveness of their quality management systems over time.
📈 Monitoring and measuring performance, including customer satisfaction and internal audits, are critical for maintaining and improving the system's effectiveness.

Q & A

What is the High-Level Structure (HLS) in ISO 9001:2015?
-The High-Level Structure (HLS) is a standardized structure for organizing the requirements or clauses of ISO standards. It serves as the main table of contents, ensuring all ISO requirements are grouped uniformly, making it easier for organizations to implement multiple ISO standards.
What are internal and external issues according to ISO 9001:2015?
-Internal issues are those arising from within the company, such as the company's vision, mission, and strategic direction, which can impact its business processes. External issues are factors like legal, social, political, or regulatory changes that can affect the business from outside.
What is required in Clause 4.1 of ISO 9001:2015 regarding the organization's context?
-Clause 4.1 requires organizations to identify internal and external issues that are relevant to their strategic goals and can affect the achievement of the desired outcomes of the quality management system.
How should an organization manage risks and opportunities according to ISO 9001:2015?
-An organization must plan actions to address risks and opportunities by integrating these actions into its quality management processes and evaluating their effectiveness. The actions should be proportional to the potential impact on product and service conformity.
What is the role of top management in ISO 9001:2015 as per Clause 5.1?
-Top management is responsible for demonstrating leadership and commitment to the quality management system by ensuring its effectiveness, setting policies and objectives, integrating it with business processes, and promoting continual improvement.
What are the key elements of the quality policy under Clause 5.2?
-Clause 5.2 requires top management to establish, implement, and maintain a quality policy that aligns with the organization's purpose and supports the strategic direction. The policy must also be communicated and understood within the organization.
What does Clause 7.1.6 of ISO 9001:2015 address?
-Clause 7.1.6 addresses organizational knowledge, requiring organizations to determine the knowledge necessary for their operations and ensure it is maintained, accessible, and preserved, especially when personnel leave the organization.
How does ISO 9001:2015 ensure customer satisfaction?
-ISO 9001:2015 requires organizations to monitor customer perceptions to determine if their needs and expectations are being met. This includes using methods such as customer surveys, feedback sessions, and analyzing customer satisfaction data.
What is the purpose of internal audits under Clause 9.2?
-The purpose of internal audits is to ensure that the quality management system conforms to the planned arrangements and is effectively implemented. Internal audits are conducted periodically to assess compliance and identify areas for improvement.
What is meant by continual improvement in ISO 9001:2015?
-Continual improvement refers to the ongoing effort to enhance the quality management system's effectiveness, driven by the use of the quality policy, objectives, audit results, data analysis, and corrective actions, aiming to improve customer satisfaction and performance.

Outlines

00:00

🔍 Overview of ISO 9001:2015 and Organizational Context

This paragraph explains the high-level structure (HLS) of ISO 9001:2015, which is a standardized framework for grouping requirements or clauses. It emphasizes internal and external issues affecting an organization's business processes, such as vision, mission, and strategic direction, and highlights the need for monitoring these issues. The clause also requires the organization to identify stakeholders relevant to the quality management system and to determine the scope of the system based on external and internal issues, stakeholder needs, and organizational products and services.

05:01

⚖️ Risk Management and Quality Objectives

The paragraph discusses the importance of planning for risks and opportunities within the quality management system (QMS). It highlights the necessity of identifying, assessing, and managing risks that may affect organizational objectives. Actions must be proportional to the potential impact on the conformity of products and services. It also describes setting quality objectives at various levels of the organization and the resources required for their achievement, including determining responsibility, timelines, and methods for evaluating results.

10:01

📊 Operational Control and Documentation

This paragraph covers the operational aspects of ISO 9001:2015, focusing on planning and controlling processes to meet product and service requirements. It outlines the need for criteria for product and service provision, as well as maintaining documented information to ensure consistent process outputs. It also details requirements for product and service design, production, and the control of nonconforming outputs. The importance of preserving customer property, monitoring customer satisfaction, and documenting information for conformity evaluation is also emphasized.

15:02

📈 Internal Audits and Continuous Improvement

This paragraph explains the requirements for conducting internal audits to ensure that the QMS is effectively implemented and maintained. It describes the frequency, criteria, and methods of internal audits, which aim to verify conformity with both ISO 9001:2015 and regulatory requirements. Additionally, it emphasizes management reviews and the ongoing evaluation of the QMS. The organization should identify opportunities for improvement and implement actions to enhance customer satisfaction, including corrective and preventive measures, while maintaining compliance with quality policies and objectives.

Mindmap

Keywords

💡ISO 9001:2015

ISO 9001:2015 is a standard that outlines the requirements for a quality management system (QMS). In the context of the video, it refers to the structure and processes an organization must follow to meet customer and regulatory requirements consistently. It serves as a foundation for systematic quality control and continual improvement in business operations.

💡High-Level Structure (HLS)

High-Level Structure (HLS) refers to the common framework for management system standards, making it easier to integrate multiple standards. The video explains that it acts as a uniform 'table of contents' that organizes requirements consistently across ISO standards, which simplifies implementation and understanding within organizations.

💡Internal Issues

Internal issues are factors originating from within the organization that can affect its quality management processes, such as its vision, mission, and strategic goals. The video emphasizes the importance of evaluating and monitoring these internal issues to ensure they do not negatively impact business performance.

💡External Issues

External issues are external factors like legal, social, political, or technological changes that could impact an organization’s operations. The video highlights the need for organizations to evaluate these external issues to mitigate potential risks and adapt their quality management system accordingly.

💡Stakeholder Requirements

This term refers to the expectations and needs of parties who are relevant to the organization's quality management system. The video explains that organizations must identify and understand these stakeholders' requirements to ensure that their QMS aligns with external and internal demands and maintains business efficacy.

💡Risk-Based Thinking

Risk-based thinking involves identifying, evaluating, and managing risks that could affect the organization’s ability to meet its goals. The video highlights how ISO 9001:2015 encourages proactive planning to address risks and opportunities in order to prevent negative outcomes and improve business performance.

💡Documented Information

Documented information refers to all records and documents needed to support the effective functioning of the quality management system. The video details how organizations should maintain documented information to ensure processes are performed as planned and to provide evidence of compliance with standards.

💡Customer Satisfaction

Customer satisfaction is a key measure of an organization's ability to meet the needs and expectations of its customers. The video explains that customer satisfaction must be monitored and evaluated regularly to ensure the organization’s products or services are fulfilling customer requirements.

💡Audit Internal

Internal audit is a systematic process to evaluate the effectiveness of the quality management system and ensure compliance with ISO 9001:2015 standards. The video explains that internal audits are necessary for identifying gaps in processes and implementing improvements to ensure continuous compliance and enhancement.

💡Continual Improvement

Continual improvement is the ongoing effort to enhance products, services, or processes to better meet customer needs. The video stresses that organizations should focus on continuous improvement through various methods, such as data analysis, corrective actions, and ongoing evaluations of their QMS.

Highlights

HLS (High-Level Structure) standardizes ISO 9001:2015 clauses into a uniform structure, simplifying the understanding and implementation of the standard.

Internal issues originate from within the company and can affect business processes if not evaluated, such as vision, mission, and strategic direction.

External issues, such as legal, social, and political factors, must also be evaluated to ensure they do not impact business processes.

Clause 4.1 requires organizations to determine issues that may affect the planning of the Quality Management System (QMS).

Clause 4.2 emphasizes the need to identify stakeholders and understand their requirements relevant to the QMS.

Clause 4.3 involves defining the scope of the QMS, considering both internal and external issues and stakeholder requirements.

Clause 4.4 focuses on the QMS structure, requiring organizations to establish, implement, maintain, and improve the system, ensuring effective interaction between processes.

Top management must demonstrate leadership and commitment to the QMS, integrating it with business processes and promoting continuous improvement.

Clause 5.1.2 highlights the importance of customer focus, ensuring that customer needs and expectations are consistently met.

Risk-based thinking is essential in ISO 9001:2015, requiring organizations to plan actions to address risks and opportunities to achieve QMS objectives.

Clause 6.2 addresses quality objectives, requiring organizations to define how they will achieve these goals, including resources, responsibilities, and timelines.

Clause 7.2 emphasizes the need to ensure personnel competence through education, training, or experience, and to take actions to address competency gaps.

Clause 7.4 requires organizations to establish effective internal and external communication related to the QMS, ensuring clarity in what, when, and how to communicate.

Clause 8.1 covers operational planning and control, ensuring processes meet product and service requirements and maintain conformity.

Continuous improvement is a fundamental requirement in ISO 9001:2015, with organizations expected to improve the effectiveness of the QMS based on audit results, data analysis, corrective actions, and management reviews.