BS EN 09100:2009 pdf download
BS EN 09100:2009 pdf download.Aerospace series一 Quality management systems一 Requirements (based on ISo 9001:2000) and Quality systems Model for quality assurance in design, development, production, installation and servicing (based on ISO 9001:1994).
3.4 Key characteristic
An attribute or feature whose variation has a significant effect on product fonn. fit, function. performance, service life or producibility, that requires specific actions for the purpose of controlling variation.
NOTE Special requirements and critical Items are new terms and, along with key characteristics, ar interrelated. Special requirements are Identified when determining and reviewing requirements related to the product (see 7.2.1 and 7.2.2). SpecIal requirements can require the Identification of critical Items. Design output (see 7.3.3) can include ldentthcat Jon of critical Items that require specific actions to ensure they are adequately managed. Some caltlcal Items will be further classified as key characteristics because their variation needs to be controJied.
4 QUALITY MANAGEMENT SYSTEM
4.1 General requirements
The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness m accordance with the requirements of this International Standard.
The organization’s quality management system shall also address customer and applicable statutory and regulatory quality management system requirements.
The organization shall
a) determine the processes needed for the quality management system and thew application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes.
C) determine critefla and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the avaability of resources and information necessary to support the operation and morntoring of these processes,
e) monitor, measure where applicable, and analyse these proces5es, and
I) implement actions necessary to achieve planned results and continual Improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this
International Standard
Where an organization chooses to outsource any process that affects product conformity to requirements. the organization shall ensure control over such processes The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
NOTE I Processes needed for the quatoy management system referred to above include processes for management actii1ies, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An ‘outsourced process Is a process that the organization needs for Its quabty management system and Mvch the organization chooses to have performed by an exlemot party.
NOTE 3 Ensunng control over outsourced processes does not absolve the organization of the responsibility of conlormify to ii o,islomer, statutory and regulatory requlrements The type and extent of control to be applied to the outsourced process can be Influenced by factors such as
a) the pofenbal impact of the outsourced process on the organizations capability to provide product that conforms to requirements.
b) the degree to which the control for the process is shared,
C) the capabiMy of actwewg the necessary ontrl through the application of 7.4.
4.2 Documentation Requirements
4.2.1 G.n.ral
The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives.
b) a quality manual,
C) documented piocedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes,
Th. organization shall ensure that personnel have access to, and are aware of, relevant quality management system documentation and changes.
NOTE I Where the term documented procedur& appears within this International Standard, this means that the procedie is established, documented, implemented end rnartained. A single document may address the requirements for one or more procedures A requirement for a documented procedure may be covered by more than one docwnent.
NOTE 2 The extent of the quality management system documentation can cellist from one organization to another due to
a) the size of organization and type of activities,
b) the complexity of processes and them rnteractons, and
c) the competence of personnel,
NOTE 3 Th documentation can be ii any form or type of medum,
4.2.2 Quality Manual
The organization shall establish and marntain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and c) a descflption of the interaction between the processes of the quality management system.
4.2.3 Control of Documents
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue.
