BS 9100:2009 pdf download – Quality management systems — 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)
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
The organization shall coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements.
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection,retrieval, retention time and disposition of records.
The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers.
Records shall be available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.
NOTE See EN 9130 for guidance.
4.3 Configuration management
The organization shall establish, document and maintain a configuration management process appropriate to the product.
NOTE Guidance on configuration management is given in ISO 10007.
5 Management responsibility
5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.
5.2 Customer focus
Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1 ).
5.3 Quality policy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,
c) provides a framework for establishing and reviewing quality objectives,
d) is communicated and understood within the organization, and
e) is reviewed for continuing suitability.
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality management system planning Top management shall ensure that
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1 , as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.
5.5.2 Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes
a) ensuring that processes needed for the quality management system are established, implemented and maintained,
b) reporting to top management on the performance of the quality management system and any need for improvement,
c) ensuring the promotion of awareness of customer requirements throughout the organization, and
d) the organizational freedom to resolve matters pertaining to quality.
NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
5.5.3 Internal communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.