Clause 4: Quality Management System

General Requirements
Sequences of the events are:
1. Establishing
2. Documenting
3. Implementing
4. Maintaining
5. Continuously Improving its effectiveness
6. Identifying the processes needed for the quality management system for the entire org
7. Making a process flow chart
8. Determining methods to ensure that the system established is effective
Problem: How will the system (management) avoid to have inadequacy of resources and control
of documentations from continuing to support the operation and monitoring of the processes?
 Processes must be monitored and the process parameters measured
 Ensure everything’s under control via stability of adequate resources
 Goal is important for every steps to be undertaken
 Never stop improving along the way
The processes above include the following:
 Processes for management activites
 Provision of resources
 Product Realization
 Measurement
Quality Management System requirements are as follows:
 Develop a QMS for the organization
o Identify processes needed for QMS
o Describe the QMS processes
 Implement the QMS
 Improve the QMS
o Monitor and improve process performance
Documentation Requirements
There are 5 types of documents given below:
1. Quality Policy and Quality Objectives
2. Quality Manual
3. Documented Procedures as required by the standard ISO 9001
4. Documents needed by the organization to ensure effective planning, operation, and
control of its processes
 5. Records
Documentation Structure – document should be in hierarchical manner
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Documentation Style – be prepared with a clear focus on the processes. Every document should
use a standard template. Some which add value to the documents, are:
 Unique Identification and Date of Issue
 Purpose
 Scope
 Controlled/Uncontrolled
 Applicable Specifications
 Reference to clause no. in the ISO 9001 Standard
 Persons Responsible for implementation
 Records
 Traceable to the quality manual
Quality Manual
An apex document for the quality management system. It should contain the following:
 Scope of the QMS
 Documented procedures
 Description of interaction between the processes of QMS
Control of Documents
There should be documented procedure to define the control of the documents. This procedure
should address the following:
a. To approve documents for adequacy prior to issue
b. To review and update as necessary and reapprove documents
c. To ensure that changes and current revision status are identified
d. To ensure that relevant versions of applicable documents are available
e. Documents are legible and readily identifiable
f. Documents of external origin are identified and their distribution controlled
g. Prevent unintended use of obsolete documents and apply to suitable identification to them
Control of Records
 Maintain quality system records
 Use the records collected to prove that requirements have been met
 Develop a procedure to control records
 Ensure that the records are useable
Clause 5: Management Responsibility
Management Commitment – be made visible through the following:
1. Communicating to the org the importance of meeting the customer
2. Establishing the quality policy
3. Ensuring the quality objectives
4. Conducting management reviews
5. Ensuring availability of resources
Customer Focus
ISO 9001 standard also gives the assurance of following the customer requirements and met with
the aim of enhancing customer satisfaction.
 Top Management should ensure that org
 Identifies customer requirements
 Meet customers
 Enhance customer satisfaction
Quality Policy – should include commitment to comply with the requirements of ISO 9001 and
continually improve the effectiveness of quality management system. Must provide a
FRAMEWORK and the QUALITY OBJECTIVES must be clearly understood by everyone in
the org
 Define the org’s quality policy
 Manage the org’s quality policy
o Communicate the policy to the org
o Review the policy to ensure that it is still suitable
Quality Planning
Quality Objectives
 Formulate org’s quality objectives
o Ensure that objectives are set for all functional areas
o Ensure that objectives are set for all org levels
o Ensure it facilitates product realization
o Support Quality Policy
o Measurable
Quality Management System Planning – whenever changes are made make sure that the orig
objectives are not affected by the changes of QMS
 Plan the QMS for the org
o Plant the following:
o Development, Implementation, Improvement, Modification as needed
Responsibility, Authority, and Communication
Management Representative
 Ensuring that the processes are established, implemented, and maintained
 Reporting to the top management and any recommendations for improvement
 Ensuring promotion of awareness of customer requirements
 Liaison with external parties
Management Review – planned intervals, MRB (Management Review Board) can be the
quality council itself or top management. Aim at improving and be maintained by the minutes of
meeting.
Review Input
a. Results of Audit
b. Customer Feedback
c. Process Performance and product conformity
d. Status of preventive and corrective actions
e. Follow-up actions from previous management reviews
f. Changes the affect QMS
g. Recommendations for improvement
Review Output
a. Give authorization or approvals in respect of the following: Quality Manual, Quality
Policy
b. Authorize corrective and preventive actions