Before talking about the fundementals of ISO Audit we should firstly define ISO 9001 basic standards.If you are not aware of ISO standards than there is no way to be succesfull on ISO audit.So let’s start with ISO Standards.
What are ISO 9001 Standards?
The ISO 9000 is a set of international standards on quality management and quality confirmation created to help organizations effectively report quality system components to be actualized to keep up a productive quality framework. They are not particular to any one industry and can be connected to organizations of any size.
The ISO 9000 group of value management system standards is designed to help organizations ensure that they meet the issues of clients and different partners while meeting statutory and regulatory necessities identified with an item or program. The ISO 9000 standards also contains an individual standard named ISO 9000. This standard lays out the fundamentals and vocabulary of quality management systems (QMS).
The ISO 9000 can help an organization fulfill its clients, meet regulatory requirements, and achieve improvement. However, it should be considered to be a 1st step, the base level of a quality system, not a complete of the quality.
The ISO 9000 series standards can be listed as below;
• The ISO 9001:2015: Quality management system – Requirements -This is the Latest version.
• The ISO 9000:2015: Quality management system – Fundamentals and vocabulary.
• The ISO 9004:2009: Quality management system – Managing for a maintained achievement of an organization.
• The ISO 19011:2011: Guidelines for auditing management system
The ASQ (American Society Quality)is the main place to get the American National Standard deferents of these standards in the ISO 9000 family.
Fundamentals of ISO Audit
Now are aware of what are the basic standards of ISO and ready to talk about fundementals of ISO audit.We are all aware that ISO is not a system that will established quickly as it is complicated and should be assimilated by everyone in company.Therefore ISO Audit is complicated as well.There are fundemental things you should consider before ISO Aaudit.
1-Rationale for Quality Management System
This is one of fundamental of quality management systems. The organizations can employment Quality Management Systems to upgrade its consumer satisfaction. Clients want their items to fulfill their necessities and desires. These necessities and desires of the client can be referred to as client needs and can be organization’s item specification. The organization may decide client prerequisite by consumer loyalty overviews, client information on conveyed item quality, user opinion surveys, lost their business analysis, the compliments, warranty claims, and dealer report. The Client prerequisite may likewise be indicated in an agreement. At last, the client figures out if he needs to acknowledge the item. The organization needs to enhance consistently their items and procedure to upgrade consumer loyalty as client necessities continue changing as a result of focused weight and change in technology in general.
2-Quality Strategy and Quality Objective
Organization should set up quality strategy and quality objective to give a concentration and heading to the organization. Quality strategy and quality goals help the organization in using the assets to accomplish the fancied consequences of the organization.The quality arrangement ought to give a structure to building up the quality target of the organization which ought to be predictable with the quality objectives.The quality approach and quality destinations ought to demonstrate a pledge to constant change.
The quality Objective should be measurable and should have a positively affect item quality, operational effectiveness, and financial performance , in this way enhancing the fulfillment and certainty of invested individuals. Both quality arrangement and quality targets ought to be evaluated periodically.
The Requirements for quality management system are indicated in ISO 9001 standards. This is generic requirements.Generic means that similar standards can be applied to any organization, vast or little, whatever its item or management, in any area of movement, and whether it is a business undertaking, an open organization, or a management division. Nonexclusive likewise implies that regardless of what the organization’s extent of action on the off chance that it needs to build up a quality management framework, ISO 9001 standard gives the basic components. ISO 9001 won’t give necessities to the items. The prerequisites of the items can be determined by the clients, Regulators or the organization itself . The necessity of the item and its related procedure can likewise be gotten from specialized details, item benchmarks, prepare guidelines, administrative prerequisites, and authoritative assertions.
As a summary the fundementals of ISO Audit can are below;
• Evaluating quality management system
• Continual Improvement
• Rule of statistics strategies
• Quality management system approach
• The process approach
• Role of top management within Quality Management System
• Relationship between quality management system and brilliance models