UNIT-IIIQUALITY AUDIT
Quality audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
TYPES OF QUALITY AUDIT
1.Internal Audits Internal audits ensure that an organization is meeting its own quality standards or contractually required standards. This is also called a first party audit. Internal audits may be done by auditors who work for the company being reviewed. They may also be hired by the company to audit its own functions. However, auditors must be independent of the function they are auditing.
2.External Audits External auditors are separate from the company they are auditing because they are independent. They may be hired by a supplier or customer to ensure that the audited company meets their quality standards. They may be audited by the government to verify that they meet military specifications.
3.Third Party Audits External quality audits done by an organization that has no contract with the company it is auditing is called a third party audit. A third party external audit can be done to attain or maintain certification in a quality standard. A third party audit by an independent auditor can also be mandated by law to qualify for government contracts. A third party audit of a company can also be done at the request of a supplier or customer who would be considered a second party audit if they performed the quality audit themselves.
4.Process Audits A process audit verifies that a documented process meets quality standards. This process could be a manufacturing process or service process.
5.Product Audits
A product quality audit verifies that a physical product meets design specifications and other quality measurements. Product audits may require measuring physical dimensions, product testing, or destructive testing. A product audit can involve checking the calibration and test equipment used to verify that the product meets quality standards.
6.System Audits A system audit is a review of the quality system used by a company. It is a review of how quality standards are measured and met by the company. It verifies the procedures used to measure the quality of the product, how defects are recorded, and how the company ensures that failed product is not passed.
QUALITY STANDARDS
Quality standards are defined as documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.
 Procedures of Quality Standards
Ensuring their products and services are safe
Complying with regulations
Meeting environmental objectives
Importance of Quality Standards
 Standards are important to the bottom line of every organization. Successful companies recognize standards as business tools that should be managed alongside quality, safety, intellectual property, and environmental policies. Standardization leads to lower costs by reducing redundancy, minimizing errors or recalls, and reducing time to market.
For the global economy:
Businesses and organizations complying to quality standards helps products, services, and personnel cross borders and also ensures that products manufactured in one country can be sold and used in another.
For consumers
Many quality management standards provide safeguards for users of products and services, but standardization can also make consumers’ lives simplier. A product or service based on an international standard will be compatible with more products or services worldwide, which increases the number of choices available across the globe.
ISO
The International Organization for Standardization is an  international standard-setting body composed of representatives from various national standards organizations. In contrast to many international organizations, which utilize the British English form of spelling, the ISO uses English with Oxford spelling as one of its official languages along with French and Russian.
Founded on 23 February 1947, the organization promotes worldwide proprietary, industrial, and commercial standards. It is headquartered in Geneva, Switzerland,[3] and works in 164 countries.[1]
ISO 9000
ISO 9000 is defined as a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements needed to maintain an efficient quality system. They are not specific to any one industry and can be applied to organizations of any size.
ISO 9000 principles of Quality Management
1.Customer focus Understand the needs of existing and future customers Align organizational objectives with customer needs and expectations Meet customer requirements Measure customer satisfaction Manage customer relationships Aim to exceed customer expectations Learn more about the customer experience and customer satisfaction
2.Leadership Establish a vision and direction for the organization Set challenging goals Model organizational values Establish trust Equip and empower employees Recognize employee contributions Learn more about leadership
3.Engagement of people Ensure that people’s abilities are used and valued
Make people accountable
Evaluate individual performance
Enable open discussion of problems and constraints
Learn more about employee involvement
4.Process approach Manage activities as processes
Measure the capability of activities
Identify linkages between activities
Prioritize improvement opportunities
Deploy resources effectively
Learn more about a process view of work and see process analysis tools
5.Improvement
Align improvement activities
Measure improvement consistently
Learn more about approaches to continual improvement
6.Evidence-based decision making Ensure the accessibility of accurate and reliable data Use appropriate methods to analyze data Make decisions based on analysis Balance data analysis with practical experience See tools for decision making
7.Relationship management Identify and select suppliers to manage costs, optimize resources,
and create value Establish relationships considering both the short and long term Share expertise, resources, information, and plans with partners Collaborate on improvement and development activities Recognize supplier successes
DISADVANTAGES OF ISO 9000
Owners and managers do not have an adequate understanding of the ISO 9000 certification process or of the quality standards themselves.
Funding for establishing the quality system is inadequate.
Heavy emphasis on documentation.
Length of the process.
ISO 9000 series of quality management ISO 9000 Quality management systems – Fundamentals and
Vocabulary, referenced in all ISO 9000 Standards.
ISO 9001 Quality management systems – Requirements, contains the requirements an organization must comply with to become ISO 9001 certified.
ISO 9002 – Guidelines for the application of ISO 9001:2015
ISO 9004 – Managing for the sustained success of an organization, provides guidelines for sustaining QMS success through evaluation and performance improvement.
ISO 9000 CERTIFICATION
RELIABILITY AND MAINTAINABILITY
Reliability and maintainability management is the management of failure. Maintainability is related to reliability because when a product or system fails, there may be a process to restore the product or system to operating condition.
MAINTENANCE
80-20 PRINCIPELS
The 80-20 rule maintains that 80% of outcomes (outputs) come from 20% of causes (inputs).
In the 80-20 rule, you prioritize the 20% of factors that will produce the best results.
A principle of the 80-20 rule is to identify an entity's best assets and use them efficiently to create maximum value.
THANK YOU
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ISO 9000 CERTIFICATION