When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.
System documentation required by the ISO 9001 standard, including a quality manual, and the six “system” procedures required by the ISO 9001 standard – the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.
Read more on ISO 9001 Standard at http://www.iso9001-standard.us
Sunday, July 1, 2012
What Is The Benefits Of ISO 9001 Certification
ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there a number of system requirements which an organisation needs to fulfill in order meet customer, regulatory and statutory requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard.
The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement. In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing.
Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.
Read more on ISO 9001 Certification at http://www.iso9001-standard.us
The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement. In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing.
Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.
Read more on ISO 9001 Certification at http://www.iso9001-standard.us
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