Assignment 2 (Chapter 8: ISO Series)

The need of quality system, basic concepts, main term in ISO 9000, the advantages and

disadvantages of ISO 9000, and also include quality management system for ISO 9000:2008.

GROUP MEMBERS:

1. NUR ANISA WASILAH BINTI MOHD NOOR SHAHRIN (212051542)

2. IMAN NUR HANIS BINTI EMAM MOHD TAWFEEK (212051071)

3. NUR SYAZWANA BINTI SHAHRIZAL HISHAM (212051549)

4. NUR SUHAILA BINTI SALIM (212051546)

Format Report:

1. Introduction ISO Series

The ISO 9000 family of international standards defines the requirements for a quality
management system (QMS) to help organizations establish, document, implement,
maintain, and continuously improve their processes and quality management practices.
Organizations need a quality system to guarantee that they consistently meet or exceed
customer expectations and deliver safe, reliable, and high-quality products and services.
The following are some basic concepts and key terms associated with ISO 9000:
1. Quality Management System (QMS): A QMS is a framework that an organization
uses to manage its processes, policies, and procedures to ensure that it consistently
delivers products and services that meet customer requirements and comply with
relevant regulations and standards.
2. Quality Policy: The quality policy is a document that outlines the organization's
commitment to quality. It should express the organization's mission and vision for
quality and be communicated and understood at all levels.
3. Quality Objectives: Quality objectives are specific, measurable goals that an
organization sets to improve its processes and performance. These objectives should
be consistent with the quality policy and help the organization work toward its
quality goals.
4. Process Approach: ISO 9000 encourages organizations to view their activities as
interconnected processes that collectively contribute to the achievement of quality
objectives. The process approach emphasizes understanding and managing these
processes to ensure consistency and efficiency.
5. Customer Focus: ISO 9000 emphasizes the importance of understanding and
meeting customer requirements and enhancing customer satisfaction. Customer
feedback and needs are critical drivers in the quality management process.
6. Continual Improvement: ISO 9000 places a strong emphasis on continually
improving the effectiveness of the quality management system. This involves regular
 monitoring and measurement of processes and making adjustments to achieve
better results.
7. Risk-Based Thinking: ISO 9000 promotes a proactive approach to identifying and
managing risks that could affect the achievement of quality objectives. Organizations
are encouraged to assess and address risks in their processes.
8. Documentation: ISO 9000 requires the creation and maintenance of documented
information, which includes documents and records, to ensure the effective
operation of the quality management system.
9. Nonconformity: When something does not meet specified requirements, it is
considered a nonconformity. Organizations must have processes in place to identify,
correct, and prevent nonconformities.
10. Audit and Review: Internal and external audits are used to assess the effectiveness
of the quality management system. Management reviews are conducted to evaluate
the system's performance and identify opportunities for improvement.
ISO 9000 is a set of standards that provide a framework for implementing a quality
management system within an organization. ISO 9001 is the most well-known standard
within the ISO 9000 family and contains the specific requirements for a QMS.
Organizations can seek ISO 9001 certification to demonstrate their commitment to
quality and compliance with these standards, which can enhance their reputation,
customer trust, and competitiveness in the marketplace.
2. Advantages & Disadvantages ISO series
ADVANTAGES

DISADVANTAGES

3. Differentiate ISO series

The International Organization for Standardization (ISO) has developed various series of standards to
cover a wide range of industries, processes, and systems. Here's a brief differentiation of some of
the most common ISO series:
1. ISO 9000 Series:

 ISO 9001: This series focuses on quality management systems. ISO 9001 provides
requirements for organizations to establish and maintain a quality management
system that ensures consistent product or service quality and customer satisfaction.

 ISO 9000: This includes the fundamentals and vocabulary used in the ISO 9001
series.

2. ISO 14000 Series:

 ISO 14001: These standards pertain to environmental management systems. ISO

14001 outlines requirements for organizations to establish, implement, and
maintain an effective environmental management system.

 ISO 14000: Similar to ISO 9000, this provides the fundamentals and vocabulary for
the ISO 14001 series.

3. ISO 27000 Series:

 ISO 27001: These standards relate to information security management systems

(ISMS). ISO 27001 specifies requirements for establishing, implementing,
maintaining, and continually improving an ISMS to manage information security
risks.

 ISO 27000: This series contains information security management system standards,
guidelines, and related vocabulary.

4. ISO 45000 Series:

 ISO 45001: This series deals with occupational health and safety management
systems. ISO 45001 specifies requirements for organizations to establish,
implement, and maintain a management system that improves occupational health
and safety performance.

 ISO 45000: Includes the fundamentals and vocabulary used in the ISO 45001 series.

5. ISO 22000 Series:

 ISO 22000: These standards focus on food safety management systems. ISO 22000
outlines requirements for organizations involved in the food chain to establish,
implement, maintain, and improve a food safety management system.

6. ISO 50000 Series:

 ISO 50001: These standards address energy management systems. ISO 50001
provides requirements for organizations to establish, implement, maintain, and
improve an energy management system, helping them achieve energy efficiency and
sustainability goals.

7. ISO 9000 Series (Continued):

 ISO 9002, ISO 9003, ISO 9004, and others: These are part of the broader ISO 9000
series but focus on specific aspects or provide guidelines for quality management.
For example, ISO 9002 outlines quality system model for quality assurance in
 production, installation, and servicing, while ISO 9004 provides guidelines for
performance improvement.

8. ISO 31000 Series:

 ISO 31000: These standards cover risk management. ISO 31000 provides principles
and guidelines for organizations to develop and implement a risk management
framework and process.

9. ISO 26000 Series:

 ISO 26000: This series addresses social responsibility. ISO 26000 provides guidance
on integrating social responsibility into an organization's practices and strategies.

The ISO that studied in this chapter is ISO 9000 series consists of several standards, each with a
specific focus on quality management and related aspects. Here's a differentiation of the key
standards within the ISO 9000 series:

1. ISO 9001:2015:

 Title: Quality management systems - Requirements

 Focus: ISO 9001 sets out the requirements for a quality management system (QMS)
that organizations can use to demonstrate their ability to consistently provide
products and services that meet customer and regulatory requirements. It is the
most well-known standard in the ISO 9000 series and is often used for certification
purposes.

 Applicability: Suitable for any organization, regardless of its size, industry, or sector,
seeking to establish a QMS that meets international standards.

2. ISO 9000:2015:

 Title: Quality management systems - Fundamentals and vocabulary

 Focus: ISO 9000 provides the fundamentals and terminology used in the ISO 9000
series. It offers definitions and explanations of key concepts and terms related to
quality management.

 Applicability: Used to provide a common understanding of quality management

concepts within an organization and across different industries.

3. ISO 9004:2009:

 Title: Managing for the sustained success of an organization - A quality management

approach

 Focus: ISO 9004 provides guidance on extending the principles of quality

management from ISO 9001 to achieve sustained success in organizations. It
emphasizes the broader aspects of organizational performance.

 Applicability: Useful for organizations that have already implemented ISO 9001 and
wish to further enhance their quality management practices for long-term success.

4. ISO 9002:2016:
  Title: Quality management systems - Guidelines for the application of ISO 9001:2015

 Focus: ISO 9002 provides guidelines for the application of ISO 9001:2015 specifically
for organizations involved in production, installation, and servicing. It helps
organizations align their QMS with the requirements of ISO 9001.

 Applicability: Useful for organizations in manufacturing, installation, and servicing

industries that want to apply ISO 9001 requirements to their specific contexts.

3. Quality Management system for ISO 9000: 2008 (Audit management)

The ISO 9000:2008 standard refers to the fundamentals and vocabulary used in quality management
systems. It provides the basic principles and terminology related to quality management. It is
important to note that ISO 9000:2008 is not an auditable standard in itself, but it forms the
foundation for the ISO 9001 standard, which is used for the establishment of quality management
systems (QMS) and is audited. If you are looking to implement an audit management system within
the context of ISO 9000:2008, you would typically do so within the framework of ISO 9001:2008,
which is the standard that outlines the requirements for a QMS. Auditing is a crucial part of
maintaining and continually improving a QMS. Here's a general outline of how audit management
can be integrated into a QMS based on ISO 9001:2008:

1. Plan Audits: Establish an audit program that outlines the scope, frequency, and objectives of
audits. Determine the criteria, scope, and purpose of the audits.

2. Audit Criteria: Define the criteria for the audits, which may include compliance with ISO
9001:2008, legal and regulatory requirements, and internal quality standards.

3. Select Auditors: Appoint competent and qualified auditors who are independent and
impartial. They should have the necessary skills and training to conduct audits effectively.

4. Conduct Audits: Conduct audits as per the audit program. Auditors will review processes,
documentation, and records to assess compliance with the QMS and ISO 9001:2008
requirements.

5. Document Findings: Auditors will document their findings, which may include
nonconformities (instances of non-compliance), observations, and opportunities for
improvement.

6. Corrective Actions: Nonconformities identified during audits should be addressed through

corrective actions. The organization should take action to rectify the issues and prevent their
recurrence.

7. Audit Reporting: Provide audit reports to the relevant personnel, including top
management, and ensure that the findings are communicated effectively.

8. Follow-Up: Ensure that corrective actions are implemented and are effective in addressing
nonconformities.

9. Review and Continuous Improvement: Use the audit findings to drive improvements in the
QMS. Continually review and adjust the audit program and procedures as necessary.

10. Management Review: Present the results of audits during management review meetings, as
required by ISO 9001:2008, to assess the QMS's effectiveness and identify areas for
improvement.
3.1: Real situation (Food processing industry, manufacturing industry and
educational institute)
While ISO 9000:2008 has been largely replaced by ISO 9001:2015, there might still be organizations
that were certified under the older standard and continue to use its principles. Here are real-world
scenarios for different industries where ISO 9000:2008 may have been applied for
audit management:

1. Food Processing Industry:

A food processing company operating globally had obtained ISO 9000:2008 certification. They
continued to use the standard for audit management.

Audit Management: The company regularly conducted internal audits to ensure that its food safety
and quality management systems met the ISO 9000:2008 requirements. Auditors reviewed
processes such as raw material handling, hygiene practices, quality control, and traceability.

2. Manufacturing Industry:

An automotive parts manufacturer had a long history of ISO 9000:2008 certification. They
maintained their quality management system based on this standard.

Audit Management: The manufacturer performed regular audits of their manufacturing processes,
including aspects such as machine calibration, product testing, and supply chain management.
Audits were essential to meet the requirements of automotive industry customers and
maintain certification.

3. Educational Institute:

A technical institute offering vocational training was ISO 9000:2008 certified. They continued to use
the standard for audit management of their educational processes.

Audit Management: The institute conducted audits to ensure the quality and consistency of their
educational programs. Auditors assessed the adequacy of course materials, student assessment
procedures, and instructor qualifications, ensuring that the educational experience met ISO
9000:2008 standards.

4. Discussion & conclusion

DISCUSSION
CONCLUSION