ISO 9000:2000 pdf free download.AMERICAN NATIONAL STANDARD Quality management systems – Requirements.
The adopion of a quality management system should be a strategic decision of an orgarazation. The design and inpiementation of an organization’s quality management system is influenced by varying needs. parlia.dar objectives the products provided, the processes employed and the size and structure of the organization. It is not the intent of ISO 9000 to imply uniformity in the structure of quality mariagemervt systems or uniformIty of documentation.
Th. quality management system requirements specified In ISO 9000 are complementary to requirements for products. Information marked NOTE Is for guidance In understanding or darifying the associated requirement
ISO 9000 can be used by internal and external parties. lndudlng certification bocbes, to assess the organization’s ability to meet customer, regulatory and the organization’s owi reqiirements.
The quality management pnnclples stated In ISO 9000 and ISO 9004 haire been taken into consideration donng the devetofsnent at ISO 9000
0.2 Process approach
ISO 9000 promotes the adoption of a process approach when developing, Implementing and Improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer reqtaremenls.
For an organization 10 function effectively, it has to identify and manage numerous linked actMties An activity using resources. and managed in order to enable the tranalomiatlon of inputs Into outputs, can be considered as a process. Often the output from one process citredly forms the input to the next
The application of a system of processes within an organization. together with the identification and Interactions at these processes, and their management, can be referred to as the process approacW
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system at processes, as well as over their combnahon and interaction.
When used within a quality management system, audI an approach emphasizes the importance of
a) understanding and meeting requirements,
b) the need Ia consider processes In temis of added value.
c) obtaining results of process performance and effectiveness, and
d) continual Improvement of processes based on objective measurement
The model of a process-based quality management system shown m Figure 1 illustrates the process linkages presented in clauses 4 to B. This Illustration shows that customers play a significant rote in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of Information relating to customer perception as to whether the organization has met Ihe customer requirements. The model shown In FIgure 1 covers all the raqulremenLs of this International Standard, but does not show processes at a detailed level,
1.1 General
ISO 9000 specifies requirements for a quality management system wnere an organizatton
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
b) aims to enhance customer sabstaction through the effectne application of the system. including procesees for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
NOTE In ISO 9000. the term product applies only to the product intended for, or required by, a customer.
1.2 Application
All requirements of ISO 9000 are generic and ar• Intended to be applicable to al organizattons regardiess of type, size and product provIded.
Where any requirement(s) of ISO 9000 cannot be applied due to the nature of an organization and its product, the can be considered for exclusion.
Where exclusions are made, dams of conformity to ISO 9000 are not acceptable unless these exclusions are bnlted to requirements wilt’sn clause 7, and such exclusions do not affect the organization’s abibty. or responsibility, to provide product that meets customer and applicable regulatory requirements
2 Normative reference
The following normative document contains provisions which, ilvough reference in this text, constitute provisions of the International Standard. For dated references, subsequent amendments to. or revisions of. any of these publications do not apply. However, pates to agreements based on ISO 9000 are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below, Foe undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.
ISO 9000:2000, Ouaflty management systems – Fundamenf aiPs and vocabuWy.
3 Terms and definitions
For the purposes of ISO 9000, the terms and definitions given in ISO 9000 apply
The following terms, used in this edition of ISO 9001 to desaibe the supply chain, have been changed to retied the vocabulary currently used:
7,5.5 Preservation of product
The organization shall preserve the conformity of product during internal processing and delrery to the intended destination. This preservation shal induda identification. haniuing, packaging, storage and protection. Preservation shalt also apply to the constituent paris of a product.
7.8 Control of monitoring and measuring devices
The organization shall determine the monitoring and measurement to be underlatcen and the monitoring and measuring devices needed Ic provide evidence of conformity of product to detemiined requrements (see 72.1).
The organization shall estabtish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that Is consistent MU, the monitoring and measurement reqiarements.
Where necessary to ensure valid results, measuring equipment shal
a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to International or national measurement standards; Miere no such standards exist the basis used for calibration or veriflcadon shall be recorded;
b) be adjusted or re-adjusted as necessary;
c) be identified to enable the calibration status to be determined;
d) be safeguarded from austments that would invalidate the measurement result,
e) be protected from demage and deterioration during handing, masitenance and storage.
In addition, the organization stial assess and record the validity of the previous measuring results Mien the equipment is found not to conform to requremenis. The organization shal take appropriate action on the equipment and any product affected Records of the results of calibration and verification shall be maintained (see 4.2.4).
When used in the monitoring and measurement of specified reqiarements. the ability of computer software to satisfy the intended application shall be conilmied The shall be undertaken pnor to initial use and reconfirmed as necessary.
NOTE See ISO 10012-1 and ISO 10012-2 for guidance. 8 Measurement, analysis and improvement
8.1 General
The organization shall plan and iriplement the monitoring, measurement, analysis and improvement processes needed a) to demonstrate conformity of the piockict.
b) to ensure conformity of the quality management system, and
c) to continualy improve the effectiveness of the quality management system.
This shall indude determination of applicable methods, Inducting statistical techniques, and the extent of their use.
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
As one of the measurements of the performance of the quality management system, the organization shall monitor Information relating to customer perception as to Miether the organization has met customer requirements The methods for obtaining and uemg the information shall be determined.