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The QMS requirements in the ISO 9001:2000 standard are complimentary to requirements for products.
The ISO 9001:2000 standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a QMS, to enhance customer satisfaction by meeting customer requirements.
Note: A model of the process-based QMS is shown in Figure 1 in the ISO 9001:2000 standard and illustrates the process linkages presented in clauses 4 to 8 of the standard.
Relationship with ISO 9004
The present editions of ISO 9001:2000 and ISO 9004:2000 have been developed as a consistent pair of QMS standards which have been designed to compliment each other. They can however be used independently.
ISO 9001 specifies requirements for a QMS and focuses on the effectiveness of the QMS in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a QMS than does ISO 9001, particularly for the continual improvement of an organizations performance and efficiency as well as its effectiveness.
Compatibility with other management systems
The ISO 9001:2000 standard has been aligned with the ISO 14001:1996, Environmental Management Systems standard.
Quality Management Systems - Requirements
The ISO 9001:2000 standard specifies requirements for a quality management system where an organization:
needs to demonstrate their ability to consistently provide product that meets customer and applicable regulatory requirements).
aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
Note: The term “product” applies only to the product intended for, or required by, the customer.
The requirements of the ISO 9001:2000 standard are generic requirements for a quality management system.
ISO 9000:2000, Quality management systems – Fundamentals and vocabulary
Terms and definitions
The terms used to describe the supply chain in the standard are as follows:
supplier → organization → customer
The term “product” can also mean service.
Quality management system
Where the term “shall” occurs in the standard it means that it must be done.
The organization shall establish, document, implement and maintain a QMS and continually improve its effectiveness” in accordance with the ISO 9001:2000 standard.
The organization shall:
identify the processes needed for the QMS and their application throughout the organization.
Also look at points b) to f) under this clause.
Note: “Processes” needed for the QMS should include processes for:
management activities (see clause 5)
provision of resources (see clause 6)
product realisation (see clause 7)
measurement (see clause 8)
The QMS documentation shall include:
documented statements of a quality policy and quality objectives,
a quality manual,
documents needed by the organization to ensure the effective planning, operation and control of its processes,
records (see 4.2.4).
Note: The “documentation” can be in any form or type of medium.
The organization shall establish a quality manual that includes:
the scope of the QMS,
the documented procedures or reference to them,
a description of the interaction between the processes of the QMS.
Control of documents
Documents required by the QMS shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4 of the ISO 9001:2000 standard.
A documented procedure shall be established to define the controls needed (refer to points a) to g) in the ISO 9001:2000 standard).
Note 1: There are six types of documented procedures that must be included in the QMS:
Control of documents (clause 4.2.3)
Control of records (clause 4.2.4)
Internal audits (clause 8.2.2)
Control of nonconforming product (clause 8.3)
Corrective action (clause 8.5.2)
Preventive action (clause 8.5.3)
Note 2: Examples of documents include but are not limited to the following:
Documents necessary to maintain the QMS
Procedures for data approval and control
Master list of documents and data sheets
Procedure to control quality records
Index of records
Retention schedule for records
Quality records and documents defined as quality records
Work or job instructions
Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS. 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 disposal of records.
Note: Examples of records include but are not limited to the following:
Management reviews (e.g minutes of the management review meeting)
Project reviews (e.g. minutes of the project review meeting)
Quality audit reports
Corrective action requests
Record of disposition of documents
Figure 1 below shows an example of a typical quality system document hierarchy.
Other quality documents
(work instructions, forms, reports, etc.)
Describes the quality system in accordance with the stated quality policy and objectives and the applicable standard
Describes the activities of individual functional units needed to implement the quality system elements
Consists of detailed work documents
Note: Any document level in this hierarchy may be separate, used with references, or combined.
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