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-- QualitySystemManual - 02 Jul 2008

7 Support

7.1 Resources

7.1.1 General

The organization has implemented a Quality Management System that complies with the AS 9100 Rev. D and ISO 9001:2015 standards. The implementation was achieved with management commitment and with sufficient resources for the implementation.

Management determines and provides the resources needed

  • to implement and maintain the quality management system and continually improve its effectiveness, and
  • to enhance customer satisfaction by meeting customer requirements.
Resource allocation is done with consideration of the capability and constraints on existing internal resources, as well as needs deriving from customer expectations. Resource allocation is assessed during management reviews.

7.1.2 People

Management ensures that it provides sufficient staffing for the effective operation of the management system and identified processes.

7.1.3 Infrastructure

Kreis Tool determines, provides, and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:

a) buildings, workspace and associated facilities;

b) process equipment, hardware and software;

c) supporting services such as transport/logistics;

d) information and communication technology.

7.1.4

Kreis Tool provides a clean, safe and well-lit working environment. Management governs the work environment needed to achieve conformity to product requirements. Specific environmental requirements for products are determined during quality planning and are documented in subordinate procedures, work instructions, or job documentation. Where special work environments have been implemented, these shall also be maintained per 6.3. (See also Level 3 - task level instructions WorkInstructions).

Human factors are considered to the extent that they directly impact on the quality of outputs.

7.1.5 Monitoring and Measuring Resources

Where equipment is used for critical measurement activities, such as inspection and testing, these shall be subject to control and either calibration or verification; see the procedure MeasurementComponent.

7.1.6 Organizational Knowledge

Kreis Tool determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This may include knowledge and information obtained from:

a) internal sources, such as lessons learned, feedback from subject matter experts, and/or intellectual property;

b) external sources such as standards, academia, conferences, and/or information gathered from customers or suppliers.

This knowledge shall be maintained, and made available to the extent necessary.

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.

7.2 Competence

Personnel performing work effecting conformity to product requirements are competent to process the work on the basis of appropriate education, training, skills and experience.

  • To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality.
  • Qualifications include requirements for education, skills and experience. Appropriate qualifications, along with required training, provide the competence required each position.

Note: Conformity to product requirements may be affected directly or indirectly by personnel performing any task within the quality management system.

The organization:

  • determines the necessary competence for personnel performing work affecting conformity to product requirements,
  • where applicable, provides training or takes other actions to achieve the necessary competence,
  • evaluates the effectiveness of the actions taken,
  • ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
  • maintains appropriate records of education, training, skills and experience (see 4.2)

Note: Training and evaluation are directed by or conducted by the manager or supervisor of the department. Records of training are maintained by each department manager.

Supporting documentation:

7.3 Awareness

Training and subsequent communication ensure that staff are aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the management system, including the benefits of improved performance;

d) the implications of not conforming with the management system requirements,

e) relevant quality management system documented information and changes thereto;

f) their contribution to product or service conformity;

g) their contribution to product safety;

h) the importance of ethical behavior.

7.4 Communication

Management ensures internal communication takes place regarding the effectiveness of the management system. Internal communication methods include:

a) use of corrective and preventive action processes to report nonconformities or suggestions for improvement

b) use of the results of analysis of data

c) meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS

d) use of the results of the internal audit process

e) regular company meetings with all employees

f) internal emails

g) memos to employees

h) Kreis Tool’s “open door” policy which allows any employee access to the Management Team as well as the QMS for discussions on improving the quality system

7.5 Documented Information

The management system documentation includes both documents and records.

Documents required for the management system are controlled within the "CONTROLLED DATA" file storage on-site. The purpose of document control is to ensure that staff have access to the latest, approved information, and to restrict the use of obsolete information. All documented procedures are established, documented, implemented and maintained.

Records are to be maintained for 7 years within the management system.

These controls are applicable to those records which provide evidence of conformance to requirements; this may be evidence of requirements, contractual requirements, procedural requirements, or statutory/regulatory compliance. In addition, quality records include any records which provide evidence of the effective operation of the management system.

Topic revision: r36 - 21 May 2019 - JohnKreis
 
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