refers to the organization's structure for managing its processes, which meets the organization's objectives, such as: satisfying the customer’s quality requirements; complying with applicable regulations; and achieving continual improvement of results/ performances.
ISO 9001 is the most commonly used international standard that provides a framework for an effective quality management system.
Benefits of implementing a QMS: Policies and objectives set by 'top management’; Understanding the customer's requirements with a view to achieving customers and other interested parties satisfaction; Improved internal and external communications; Greater understanding of the organization's processes; Understanding how statutory and regulatory requirements impact on the organization, its customers and stakeholders; Clear responsibilities and authorities; Improved use of time and resources; Reduced wastage; Greater consistency and traceability of products and services; Improved morale and motivation
Key steps for implementing a QMS every organization should consider:
1. Purchase the standards: ISO 9000:2005 Quality Management Systems – Fundamentals and Vocabulary; ISO 9001:2007 Quality Management Systems – Requirements; ISO 9004:2000 Quality Management Systems – Guidance for Quality Improvement. Get a copy of the standards. 2. Purchase the guidelines in the field: IWA2: 2003 Quality Management Systems – Guidelines for the Application of ISO 9001:2007 in Education. ISO has developed Guidance Notes on the application of ISO 9001 of QMS in Education. 3. Review support literature and software: There are a wide range of quality publications and software tools designed to help you understand, implement and become registered to a QMS 4. Assemble a team and agree your strategy: Responsibility for a QMS lies with top management; therefore it is vital that top management is involved from the beginning of the process. Assemble a team for QMS documentation and implementation. 5. Consider training: There are a range of workshops, seminars and training courses that you should consider whether you are seeking to implement a QMS or would like to increase your general awareness of ISO 9001:2007 6. Review Consultancy Options: You can receive advice from independent consultants on how best to implement your QMS. They will have the experience in implementing a QMS and can ensure you avoid costly mistakes. 7. Choose a registrar. The registrar is the 3rd party who will assess the effectiveness of your QMS, and issue a certificate if it meets the requirements of the standard. Factors to consider when choosing a registrar include industry experience, geographic coverage, price and service level offered. 8. Document the QMS: Quality Manual Level A - Quality management system procedures Level B - Work instructions and other documents for quality management system Level C
8a. Define the Quality Policy and Objectives: The quality policy identifies the main goals of the QMS. The quality policy must be: Appropriate to the organization’s purpose; Include a commitment to meet customer, legal and regulatory requirements; Create a background for establishing quality objectives; Communicated throughout the organization; Reviewed for ongoing suitability to the needs of the organization and its customers. 8b. Develop a Quality Manual: A high level document that outlines your intention to operate in a quality manner. It outlines why you are in business, what your intentions are, how you are applying the standard and how your business operates. 8c. Develop support documentation: This is typically a procedures manual that supports the Quality Manual; It outlines what you do to complete a task; It describes who does what, in what order and to what standard. 9. Implement the QMS: The key to implementation is communication and training. During the implementation phase everyone operates to the procedures and collects records that demonstrate you are doing what you say you are doing.10. Consider a pre-assessment: A pre-assessment by your registrar normally takes place about 6 weeks into the implementation of the QMS. The purpose of the pre-assessment is to identify areas where you may not be operating to the standard. This allows you to correct any areas of concern you may have before the initial assessment. 11. Gain registration and certification: You should arrange your initial assessment with your registrar. At this point the registrar will review the QMS and determine whether the organization should be recommended for registration and certification. 12. Continual assessment: Once you have received registration and been awarded your certificate, you can begin to advertise your success and promote your business services. To maintain your registration, continue to use your QMS.
QMS Auditing – ISO 19011:2002: The review of QMS is called auditing. An audit represents a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled policies, procedures, standards, laws and regulations, management system requirements, contractual requirements, and industry codes of conduct. Audit objectives: Determination of the extent to which the requirements for certification to a management system standard are met; Evaluation of the capability of the management system to ensure compliance with statutory, regulatory and contractual requirements; Evaluation of the effectiveness of the management system in meeting its specified objectives; Identification of areas for potential improvement of the management system. Types: Internal audits (first-party audits) - conducted by the organization itself. // External audits: Second-party audits - conducted by parties having an interest in the organization, such as customers. Third-party audits - conducted by external, independent auditing organizations, such as those providing registration or certification. How long does it take? The common period - six to twelve months (depending on the size of organization, complexity of products offered, services provided, etc.)
RENAR (www.renar.ro) - provide confidence in the independence and technical competence of accredited bodies dealing in conformity assessment in Romania. May accredit testing/ calibration laboratories, clinical laboratories, inspection bodies in the field of conformity assessment, QMS certification bodies; product conformity certification bodies, personnel certification bodies, etc.
Management Systems in Europe
ISO 9001 Quality Management System provides a framework for managing quality in business operations
ISO14001 Environmental Management System provides a framework for managing environmental impacts of business operations
ISO17799 Information Security Management System provides a framework for managing sensitive business information so that it remains secure
OHSAS 18001 Occupational Health and Safety Management System provides a framework that promotes a safe and healthy working environment
ISO 22000 Food Safety Management System provides a framework that promotes food safety of consumers
ISO 26000 Social Responsibility provides a framework that promotes social responsibility in organization
ISO 16001 Energy Management System. Requirements and Guidelines provides a framework for managing energy consumption in organization
Other management systems: ISO 10006 for project management, ISO 10007 for configuration management, ISO 10012 for measurement systems, ISO 10013 for quality documentation, ISO/TR 10014 for managing the economics of quality, ISO/TS 16949:2002 Automotive Quality Management System, ISO 10015 for training, ISO 19011 for auditing.