Quality Management System Requirements (QMS) Part-1

Hello friends, 

Welcome to my Blog..

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. 

The purpose of a quality management system is to ensure every time a process is performed, the same information, methods, skills and controls are used and applied in a consistent manner. If there are process issues or opportunities, this is then fed into the quality management system to ensure continuous improvement.

Scope:

• Normative reference.
• Terms and co definitions.
• Quality management system General requirements.
• Management responsibility. 
• Resource management.
• Product realization. 
• Measurement, analysis and Improvement.

1. Scope

1.1 General

This international Standard specifies requirements for a quality management system where an organization.

1. needs  to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and

2. 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.

1.2 Application

• All requirement of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
• Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
• Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not effect the organization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

2. Normative reference

The following normative document contains provisions which, through reference in this text, constitute provisions of this international Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements  based on this International Standard are encouraged  to investigate the possibility of applying the  most recent edition of the normative document indicated below. For undated references,  the latest  edition of the normative document referred to applies of Members of ISO and IEC maintain registers of currently valid International Standard.

3. Terms and conditions

For the purpose of this International Standard, the terms and defi nation given in ISO 9000 apply.

The following terms, used in this edition of ISO 9001 to  describe the supply chain, have been changed to reflect  the vocabulary currently used.

Supplier ----- >          organization  -----  >            customer

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 accordance with the requirements of this International Standard.

The organization shall

• Identity the processes needed for the quality management system and their application throughout the organization. 
• Determine the sequence and Interaction of these processes.
• Determine criteria and methods needs to ensure that both the operation and control of those processes are effective,
• ensure the availability of resources and Information necessary to support the operation and monitoring of these processes.
• monitor, measure and analyse these processes, and
• Implement action necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes, Control of such outsourced processes shall be identified within the quality management system.

4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include

• Documented statements of a quality policy and quality objectives.
• A quality manual
• Documented  procedures required by this international Standard
• documented needed by the organization to ensure the effective planning, operation and control of its processes, and
• records required by this International Standard

4.2.2 Quality manual

• The organization shall establish and maintain a quality manual that includes. 
• The scope of the quality management system, including details of and justification for any exclusions 
• The documented procedures established for the quality management system, or reference to them and ,
• A description 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 special 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

• to approve documents for adequacy prior to issue,
• to review and update as necessary and re- approve documents,
• to ensure that changes and the current revision status of documents are identified,
• to ensure that relevant versions of applicable documents are available at points of use,
• to ensure that documents remains legible and readily Identifiable,
• to ensure that documents of external origin are identified and their distribution controlled, and
• to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.5 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of 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 end 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:

• communicating to the organization the Importance of meeting customer as well as statutory and regulatory requirements,
• establishing the quality policy,
• ensuring that quality objectives are established,
• conducting management review, and
• ensuring the availability of resources.

5.2 Customer focus

Top management shall ensure that Customer requirements are determined and are met with the aim of enhancing customer satisfaction.

5.3 Quality policy

Top management shall ensure that the quality policy 

• is appropriate to the purpose of the organization
• includes a commitment to comply with requirements and continually unaprove the effectiveness of quality management system
• provides a  framework for establishing and reviewing quality objectives,
• is communicated and understood within the organization, and
• is reviewed for continuing suitability.

You will find the next part of this post on QMS_2

That's all for today..

See you soon..