4. Quality Management System

4.1 General requirements

The organization documents, implements and maintains a quality management system and continually improves its effectiveness in accordance with the requirements of AS9100 Rev. B and ISO9001:2008.

The organization:

• determines the processes needed for the quality management system and their application throughout the organization (see 1.2),
• determines the sequence and interaction of these processes ,
• determines criteria and methods needed to ensure that both the operation and control of these processes are effective,
• ensures the availability of resources and information necessary to support the operation and monitoring of these processes,
• monitors, measures where applicable and analyzes these processes, and
• implements actions necessary to achieve planned results and continual improvement of these processes. These processes are managed in accordance with the requirements of AS9100 Rev. B and ISO9001:2008.

Where the organization chooses to outsource any process that affects product conformity to requirements, the organization ensures control over such processes. The type and extent of control to be applied to these outsourced processes are defined within the quality management system.

Note 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis, and improvement.

Note 2: An "outsourced process" is a process that the organization needs for its quality management system and whih the organization chooses to have performed by an external party.

Note 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as

• the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,
• the degree to which the control for the process is shared,
• the capability of achieving the necessary control through the application of clause 7.4.

4.1.1 Process Approach

• Quality System Overview Picture:

Quality Management System Overview (printable version)

The Kreis Tool & Mfg. Quality System is designed as a system of interrelated processes. All main activities in the company are defined as Quality System Processes are grouped into the following categories (refer to the System Overview diagram at the top):

• Customer Requirements
• Product Realization
• Measurement Analysis and improvement
• Management Responsibility
• Resource Management
• Continual Improvement

The sequence and interrelation between processes are illustrated in this diagram.

Quality System Processes and sub-processes are documented in the system as Quality procedures and Work instructions.

4.1.2 Resource and Information
Quality Assurance manager is responsible for determining resource and information requirements necessary to support the operation and monitoring of quality system processes, and for communicating these requirements to the top management. The top management is responsible for ensuring the availability of necessary resources and information. Quality Manual Section 6.1, Provision of Resources, explains in more detail how resource requirements are identified and satisfied.

4.1.3 Monitoring and Measurement

• Performance of quality system processes is systematically monitored. This is to ensure their effectiveness and identify opportunities for improvement.

• Performance of quality system processes is monitored through internal quality audits. The overall performance of the quality system is monitored by measuring customer satisfaction. (Quality Manual Section 8.2, Internal audits, Customer Satisfaction)

• Quality system processes are reviewed and analyzed by the management review of the quality system. (Quality Manual Section 5.6, Management Review)

4.1.4 Continual Improvement
Quality Management system processes are regularly reviewed by the top management to identify any possible failures or breakdowns, as well as opportunities for improvement. Actions necessary to address actual or potential problems and to improve the quality system are implemented through corrective and preventive actions and through quality objectives.
In Quality Manual Section 8.5 Management Review, Quality Objectives, and Corrective and Preventive Actions, define how the quality management system itself ensures its own compliance and continual improvement.

4.1.5 Sub-Contracted Processes
When processes that affect product conformity are outsourced, special controls are implemented to ensure that these processes meet specified requirements. Such controls may include, as appropriate:

• Evaluation and pre-qualification of suppliers
• Assess of supplier realization processes and quality system
• Flow-down of customer (contract) requirements,
• Monitoring of supplier quality performance;
• Requirements for process control, inspection, testing or other records demonstrating product conformity;
• Verification of the supplied product.

Quality Manual Section 7.4 Supplier Evaluation, Purchasing and Verification of Purchased Product defines the policy related to Sub-contracted work.
Ensuring control over outsourced processes does not absolve Kreis Tool & Mfg. of the responsibility of conformity to all customer requirements.

4.2 Documentation requirements

The quality management system documentation includes:

• documented statements of quality policy and quality objectives,
• a quality policy manual,
• documented procedures and records required by AS9100 Rev. B and ISO9001:2008,
• documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
• quality system requirements imposed by applicable regulatory authorities.

NOTE 1: Where the term “documented procedure” appears within AS9100 Rev. B and ISO9001:2008, means that a procedure is established, documented, implemented and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.

NOTE 2: Documentation can be in any form or type of medium.

NOTE 3: Personnel have access to quality management system documentation and are aware of relevant procedures and instructions. Customers and/or regulatory authorities also have access to quality management system. All users of the system (Customers, Employees and Suppliers) can view the controlled system at any time via internet access www.kreisquality.com . This easy reference to the entire system facilitates delivery of products which meet customer specifications.

4.2.2 Quality System Manual

The organization establishes and maintains a quality system manual that includes

• the documented statements of a quality policy and quality objectives,
• the scope of the quality management system including details of and justification for any exclusions,
• the documented procedures established for the quality management system, or reference to them, and
• a description of the interaction between the processes of the quality management system.

Supporting Documentation:

AS 9100 Rev. B Defined Process Cross Reference

AS 9100 Rev. B Clauses vs Processes Matrix

4.2.3 Control of documents

Documents required by the quality management system are controlled. The organization recognizes quality record as a special type of document and they are controlled according to the requirements given in 4.2.4.

A documented procedure is established to define the controls needed:

• to approve documents for adequacy prior to issue,
• to review and update as necessary and re-approve documents,
• to ensure that changes and the current revision status of documents are identified,
• to ensure that relevant versions of applicable documents are available at points of use,
• to ensure that documents remain legible and readily identifiable,
• to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and controlled, and
• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
• to coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements when applicable.

Supporting Documentation:

DocumentControlProcedures

4.2.4 Control of records

Records are established to provide evidence of conformity to requirements, and or the effective operation of the quality management system.

A documented procedure is established to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.

Records remain legible, readily identifiable and retrievable.

Controls are in place for records that are created by and/or retained by suppliers. Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.

Supporting Documentation:

• RecordControlProcedures
• Document/Record Control Matrix

4.3 Configuration Management

All of Kreis Tool's products are entirely defined by customer specifications and broadly accepted reference standards. The configuration management aim of the system is to ensure that products are produced to the configuration as specified by our customer. The product realization processes describe how we maintain appropriate configuration.

The organization does not engage in any design activity related to its products.

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