Q1.
What is Quality
A1. Degree to which the requirements are met such as:
a. Requirements of Customers
b. Requirements of Statutory & Regulatory Bodies
c. Requirements of management/internal customers
Q2. What is ISO 9001?
A2. ISO means International Organization for Standardization. It’s a body of almost 130
countries. They make standards. 9000 is the series allocated for Quality, hence standard is
called ISO 9001.
Q3. What is Quality Management?
A3. Quality Management System includes management activities such as providing direction and
control for ensuring Quality requirements are fulfilled. Such activities includes:
a. Quality Planning: The planning for meeting requirements
b. Quality Control: The control of operations to meet requirements
c. Quality Improvement: The improvements done to enhance capability to meet
requirements.
Q4. What is Quality Management System?
A4. The establishment of combination of following aspects of Quality Management is termed as
Quality Management System:
a. Organization Structure to ensure clear reporting relationships
b. Clear Responsibilities
c. Clear Authorities
d. Systems of mailing, circulars, meetings for effective internal communication
e. System of acquiring and developing competent human resources
f. System for acquiring required infrastructure
g. Systems of monitoring and improvement of processes
h. Procedures and standard way of performing activities
Q5. What are Quality Management Principles?
A5. ISO 9001 is based on following Quality Management Principles:
a. Customer Focus
b. Leadership
c. Involvement of People
d. Mutually beneficial Suppliers’ relationship
e. Process Approach
f. System Approach
g. Facts based decision making
h. Continual Improvement
Q6. What is PDCA approach for Quality Management?
A6. PDCA approach is:
a. Plan: Identify what is expected?
b. Do: Work as per plan
c. Check: Monitor the activities to find any gaps
d. Act: Take actions on the identified/anticipated gaps
Q7. What is Quality Policy?
A7. Overall intentions of management to provide direction and motivation to all members of
organization to meet the requirements as well as to improve the ability to meet the
requirements during operations.
Q8. What are Quality Objectives?
A8. Measurable indicators that requirements are fulfilled as well as improvements are happening
in enhancing abilities to meet requirements. For e.g.:
a. Customer Satisfaction Index
b. On time Schedule index
c. Cost of deviations
Q9. What is Correction?
A9. Correction is actions taken to come out of a problem situation. For e.g.:
a. Use the product or service with deviation
b. Providing discount to customer to use the product or service
c. Rework to meet the requirement
d. Keep aside and find an alternate use of not OK product
Q10. What are Corrective Actions?
A10. Actions taken to ensure problems do not repeat again. For e.g.:
a. Training after a complaint
b. Changes in systems/methods after an identified compromise of requirements
Q11. What are Preventive Actions?
A11. Actions taken to ensure that problems to not occur at all. For e.g.:
a. Regular trainings
b. Regular reviews
c. Plans for contingency
d. Preventive maintenance
Q12. What are Key element of ISO 9001?
A12. ISO 9001 covers systems related to following:
a. Understanding requirements
b. Design and Development related issues
c. Purchasing
d. Project Management
e. Storage
f. Traceability
g. Inspection and Testing
h. Calibration
Above systems are supported by:
a. Management’s direction
b. Systems for work flow
c. Analysis, Reviews and Communication
d. Human Resources and Trainings
e. Maintenance of facilities
