ISO 9001 Quality Management System Principles

The 8 Management Principles
Customer Focus
Organizations depend on their customers and therefore should understand current and future customer needs, should meet requirements and strive to exceed customer expectations.
Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
Involvement of People
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
Process Approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
System approach to management
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
Continual Improvement
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
Factual Approach to decision making
Effective decisions are based on the analysis of data and information.
Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

ISO 9001 Internal Auditing

The Audit Program
Writing the Internal Audit Procedure
A documented Internal Audit procedure is a requirement under Clause 4.2.4 of ISO 9001:2000. Clause 8.2.2 sets out the minimum requirements and purpose of the Internal Audit. When writing the Internal Audit procedure the following requirements may be taken into consideration. These will vary from industry to industry but most of them are generic. Where an integrated system is in place the requirements of the other standards, regulatory authority or other may be taken in to consideration to verify compliance, institute corrective, preventive action and continual improvement.
•    Customer requirements
•    Statutory requirements
•    Requirements of the Standard
•    Requirements of the organization
•    Requirements of the department
•    Regulatory requirements
•    Requirements of the shareholders
•    Product requirements
•    Employee requirements
•    Process requirements
•    ISO  19011:2000
•    Ensure consistent application of procedures across the organisation

ISO 9001 Top Management Processes

 ISO 9001 and Top Management

The revised versions of the quality management system starting from ISO 9001:2000 and ISO 9001:2008 have sought to change the tradition of leaving the quality management system to the quality assurance manager or some junior manager to Top management. Even then often times when the implementation of a quality management system is customer driven the organization pursues certification not as a business improvement system but to obtain a certificate. In such instances once a management representative has been appointed, top management pays lip service to the quality management system. This is aggravated by the fact that customers in most industries except the aerospace and automotive industries among the few do not audit their suppliers but relies on third party audits and often the supplier chooses its own registrar.
The result is that there is a lot of dissatisfaction with the system and often employees have two jobs ISO and their daily jobs.
 
A successful quality management system is one that involves every one in the organization starting with top management regardless of the reasons of implementing a quality management system. Who is top management depends on the company’s structure. This must be determined at the start of the project as top management buy in is absolutely necessary for an effective quality management system.
The response of top management to ISO 90001 is also reflected in middle and junior management behavior. If top management is negative or just tolerate or don’t care about ISO 9001, no matter how hard you try no one is going to care. The battle is thus lost before it is even begun. The involvement of top ensures success and commitment through out the organization.