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 in conforms to the requirements of this International Standard.

The organization shall:

a) identify the processes needed for quality management systems and their application throughout the organization (sm.1.2)

b) determine the sequence and interaction of these processes,

c) establish criteria and methods to ensure that management and control of these processes are carried out effectively,

d) Ensure that the tools and information needed to support the implementation and monitoring of these processes,

e) monitor, measure and analyze these processes, and

f) implement actions necessary to achieve planned results and continual improvement of these processes.

Organization must manage these processes [hidepost = 3], in accordance with the requirements of this International Standard.

If the organization uses processes subcontract affecting the product meets the requirements, the organization shall ensure control of these processes. The type and quantity control of subcontracted processes must be defined within the quality management system.

NOTE 1 Processes needed for quality management system referred to above should include processes for management, sourcing, product creation, measurement, analysis and improvement.

NOTE 2: "Outsourced processes" - is necessary in a system of quality management processes, but for better performance outsourced.

NOTE 3: Warranty management "outsourcing" process does not relieve the organization from liability for compliance with customer requirements, regulatory, and legislative. The type and quantity controls applicable to the "outsourcing" of the process may be due to factors such as

a) the potential impact of "outsourcing" process on the organization's ability to deliver compliant product

b) the extent to which the control process is divided,

c) ability to exercise [/ hidepost] applying the necessary controls 7.4

4.2 Documentation requirements

4.2.1. General Provisions

Quality management system documentation shall include:

a) documented statements of policy and quality objectives,

b) Quality Manual

c) documented procedures and records required by this International Standard,

d) documents, including records needed by the organization to ensure effective
planning, management and control of its processes.

NOTE 1 The term "documented procedure" in this International Standard, means that the procedure should be developed, [hidepost = 3] documented, implemented and maintained. One document can contain the requirements for one or more procedures.
Requirements documented procedure may be contained in several documents.

NOTE 2 The value of QMS documentation may differ for organizations depending on:

a) the size and type of activity,

b) the complexity of processes and their interactions,

c) the competence of personnel.

NOTE 3 The documentation can be on a carrier [/ hidepost] of any shape and type.

4.2.2 Quality Manual

The organization shall establish and maintain a quality manual that includes the following:

a) the scope of the QMS, including details of and justification for any exclusions (see 1.2.)

b) the documented procedures established for the quality management system or links to them, and

c) a description of the interaction between the processes of quality management system.

4.2.3 Control of documents

Documents of quality management system shall be [hidepost = 3] controlled. Protocols (records) - a special type of document management is regulated in paragraph 4.2.4.

Should be put in a documented procedure, which establishes rules governing:

a) approve documents for adequacy prior to release,

b) Review, revise as necessary and re-approval

c) Ensuring the identification of changes and current revision status of documents

d) To provide current versions of relevant documents users

e) to ensure clarity and ease of identification,

f) for the planning and control documents of external origin determined and their distribution controlled, and

g) prevent the unintended use [/ hidepost] date documents, and their respective
designation if they are retained for any purpose.

4.2.4 Control of quality protocols

Record set for the demonstration of compliance and effective management of the QMS must be controlled.

The organization shall implement a documented procedure to control the rules relating to: identification, storage, protection, restoration, specifying the period of storage and destruction.

Entries must be clear, identifiable and retrievable.