WHAT IS QUALITY

It could be fitness for use or it could mean customer satisfaction. In contractual situations it means "conformance to requirements." Quality requirements and expectations can be applied to materials, but they also apply to services and information that we may supply. All of these are products.
Our Company is a supplier of products to our Customers. Every company, as a supplier, has groups of stakeholders such as its Customers, its employees, its owners, and its sub-suppliers. We must address the expectations and needs of our stakeholders.
This Quality System is primarily concerned with meeting the requirements of our Customers, but it is also designed to contribute to fulfilling the expectations of our other stakeholders (customer, employee, owner and supplier).
Here are some descriptions commonly used:

• Get it right - first time, every time
• Customer satisfaction
• Fit for use, conforms to requirement / expectation
• Buyer and seller confidence in the product or service to be provided
• The fitness of a product for the purpose for which it was intended - customer’s perception what the customer expects.
• degree to which a set of inherent characteristics fulfils requirements 

Signs of Non-Quality

Why Have a Quality System?

THE BENEFITS OF ISO 9001
Over 350,000 companies world are registered to ISO 9001. The benefits they find include:

1. Improved consistency of service and product performance
2. Higher customer satisfaction levels.
3. Improved customer perception 
4. Improved productivity and efficiency
5. Cost reductions
6. Improved communications, morale and job satisfaction 
7. Competitive advantage and increased marketing and sales opportunities.

ISO 9001 HISTORY

ISO 9001 Standards;
- define the required elements of an effective quality management system
- can be applied to any company
- adopted by the United States as the ANSI/ASQC Q90 series.

Creator of ISO Standards
International Organization for Standardization – Geneva, Swiss ISO tech committee - TC 176 started in 1979
Standards created in 1987

• To eliminate country to country differences
• To eliminate terminology confusion
• To increase quality awareness

1906 - International Electro-technical Commission
1926 - International Federation of the National Standardizing Associations (ISA)
1946 London - delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards
1947 - ISO began to officially function
1951 - The first ISO standard was published
 "Standard reference temperature for industrial length measurement".

ISO Organization Structure

ISO 9000 Consist of Three Areas;
ISO 9000 Quality Management Systems: fundamentals and vocabulary
ISO 9001 Quality Management Systems – Requirements (required for certification)
ISO 9004 Quality Management Systems –Guidelines for performance improvement

ISO 9001 INITIAL AND REVISION HISTORY

1987 version
ISO 9001:1987 had the same structure as the UK Standard BS 5750, with three 'models' for quality management systems, the selection of which was based on the scope of activities of the organization:
• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
• ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
• ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.

ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management—which was likely the actual intent.

1994 version
ISO 9000:1994 emphasized quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality system.

2000 version
ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001. Design and development procedures are required only if a company does in fact engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing the concept of process management front and center ("Process management" was the monitoring and optimizing of a company's tasks and activities, instead of just inspecting the final product). The 2000 version also demands involvement by upper executives, in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal is to improve effectiveness via process performance metrics — numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.
2008 version
ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO14001:2004. There are no new requirements. A quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

2015 version
In 2012, ISO TC 176 - responsible for ISO 9001 development - celebrated 25 years of implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the next 25 years. This is why commenced the official work on big revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as “beginning of a new era in the development of quality management systems”. As a result of an intensive work of this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed. However the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.
The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
Some of the key changes include:

• Greater emphasis on building a management system suited to each organization’s particular needs
• A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
• Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement
• Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in
• Alignment with other key management system standards through the use of a common structure and core text.

TERMS AND DEFINITIONS

Terms relating to Quality and Management (refer to ISO 9000:2015 Fundamentals and Vocabulary)
• Quality Management System: part of a management system with regard to quality
• Quality Policy: policy related to quality.
Policy is intentions and direction of an organization as formally expressed by its top
Management.

• Quality Objective: objective related to quality.
• Objective is result to be achieved.
• Top Management: person or group of people who directs and controls an organization at the highest level
• Continual Improvement: recurring activity to enhance performance
• Effectiveness: extent to which planned activities are realized and planned results are achieved.
• Efficiency:  relationship between the results achieved and resources used.
• Audit criteria: set of policies, procedures or requirements used as a reference against which objective evidence is compared
• Audit evidence: records, statements of fact or other information which are relevant to the audit criteria and verifiable.
• Non conformity : Non fulfilment of a requirement
• Correction: action to eliminate a detected nonconformity
• Corrective action: action to eliminate the cause of a nonconformity  and to prevent recurrence. 
• Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable situation