ISO 9000:2000 pdf download – Quality management systems Requirements.
NOTE 2 The estent of the quality management system documentation can ffer from one organization to another due to a) the size of organization and type of acbvities,
b) the complexity of ocesses and their mieradions, and
c) the competence of personnel.
NOTE 3 The docixnenlabon can be in any form or type of medium
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, Induding 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 descnption 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 spedal 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,
b) to review and update as necessary and re-approve documents.
c to ensure that changes and the current revision status of documents are identified.
d) to ensure that relevant versions of applicable doctxnents are available at points of use.
e) to ensure that documents remain legible and readily identifiable,
1) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete doct,nents. and to apply suitable identification to them if they are retained for any purpose,
4.2.4 Control of records
Records shall be established and maintalned 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,
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 orgarzatlon the Importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy,
C) ensuring that quaty objectives are established.
d) conducting management reviews, and
a) ensuring the availability & 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 pdicy
a) is appropnate 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
a) is reviewed for continuing suitability
5.4 Planning
5.4.1 Quality objectives
Top management shall ensure that quality objectNes, including those needed to meet requirements for product 7.1 a)). are established at relevant functions and levels within the organization. The quality objectrves 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 lnlegnty 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 responsbilities 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 authonty that indudes
a) ensunng thai 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, and C) ensuring the promotion of awareness of customer requwements throughout the organization.