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ISO 9001 Requirements

The ISO 9001 Requirements  has the following clauses
0 Introduction to ISO 9001 Requirements
1 Scope
1.1 General
1.2 Application
2 Normative references
3 Terms and definitions
4 Quality management system
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, training and awareness
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

Introduction to ISO 9001 Requirements

The implementation of a QMS should be a strategic decision of the  organization implementing QMS. Various factors influence the design and implementation of  QMS. These include – diverse needs and risks of organizations; particular goals and objectives; complexity of products and services provided; number of and complexity of processes employed; and size and structure of the organization. As a result of these and other underlying factors, the ISO 9001 standard does not require uniformity of QMS structure or documentation.
The QMS requirements specified in ISO 9001 are complementary to requirements for product. The standard specifies requirements for organization’s QMS, whereas requirements for  product come from customers and regulatory authorities. ISO 9001:2008 standard can be used by internal and external parties, including certification bodies, to assess an organization’s ability to meet customer, regulatory and the organization’s own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration in developing this standard.The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of quality management system standards, which have been designed to complement each other, but can also be used independently. Although the two standards have different scopes, they have similar structures in order to assist their application as a consistent pair.
PLAN-DO-CHECK-ACT (PDCA) – is a very effective tool for business management and the ISO 9001 standard strongly recommends its use. PDCA is a dynamic cycle that can be applied to each of the organization’s processes, and also to the system of processes as a whole. It may be used to plan, implement, control and continually improve both product realization and other QMS processes. Maintenance and continual improvement of QMS processes can be achieved by applying PDCA to processes at all levels within the organization – from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.
Plan:Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.
Do: Implement the processes
Check: Monitor and check processes and product against policies, objectives and requirements for the product and report the results
Act:Take actions to continually improve process performance
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organization’s overall efficiency, as well as effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.
This Standard has been aligned with ISO 14001 in order to enhance the compatibility of the two standards for the benefit of the user community. This Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements.

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Pretesh Biswas

Pretesh Biswas