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 Compliance with the requirements of this International Standard.

The organization must:

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.

The organization should manage these processes [hidepost = 3], in accordance with the requirements of this International Standard.

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

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

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

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

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

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

c) ability to carry out [/ 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 be different for organizations depending on:

a) the size and type of organization

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 interaction between the processes of quality management system.

4.2.3 Control of documents

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

Should be implemented documented procedure, which establishes rules governing:

a) approve documents for adequacy prior to release,

b) Review, revise as necessary and re-approval

c) To ensure that changes and current revision status of documents

d) providing current versions of relevant documents users

e) to ensure clarity and ease of identification,

f) for the planning and management documents of external origin are identified and their distribution controlled, and

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

4.2.4 Quality Control protocols

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

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

Entries must be clear, identifiable and retrievable.

6. Resource Management

6.1 Provision of resources

The organization shall determine and provide the resources needed to:

a) implement and maintain the QMS and continual improvement of its effectiveness, and

b) increase customer satisfaction through the implementation of its requirements.

6.2 Staff

6.2.1 General Provisions

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, awareness and training

The organization shall: [hidepost = 3]

a) determine the necessary competence for personnel whose work affects the quality of the product,

b) where applicable, provide training or take other actions to achieve the required competency

a) evaluate the effectiveness of actions taken

d) ensure that employees understand the significance and importance of its activities and its contribution to the achievement of quality objectives,

e) maintain appropriate records [/ hidepost] education, training, skills and experience (see 4.2.4).

6.3 Infrastructure

The organization shall determine, provide and maintain the infrastructure necessary to meet product requirements. Infrastructure includes, as applicable:

a) buildings, workspace and associated services

b) equipment for the process (as part of the material and software), and

c) supporting services (such as transport, communication and information system).

6.4 Operating Environment

Organization [hidepost = 3] shall determine and manage the work environment needed to achieve conformity to product.

NOTE. The concept of "working environment" refers to conditions under which work is performed including physical and environmental factors (such as noise, temperature, humidity, lighting or weather [/ hidepost] conditions)