ISO 9001:2008- Quality Management Systems- Requirement

ISO 9000:2005 Quality Management Systems –Fundamentals & vocabulary

ISO 9004:2000 Q M S –Guidelines for performance improvement

It is a generic standard

It relates to Quality system and not product

It is process based

INTENTION

Quality is built into every stage of activity

And to improve continually by
learning from experience by
examining reasons for
complaints, discrepancies and failures
and there after
building corrective actions and preventive actions into systems to
avoid recurrence

DOCUMENTATION

Level 1: Quality Manual-- Quality policy, Organization, Responsibility

& Authority, and cross reference to procedures.

Level 2: Departmental procedures covering all clauses

(what needs to be done)

Level 3: Detailed work instructions – operations, inspection, testing

(How it is to be done)

Level 4: forms and formats, tags, labels, follow up cards

(Objective evidence of meeting requirement)
“INTRODUCTION- 0.2 Process approach:
when used within a Quality Management System, such an
approach emphasises the importance of
a) Understanding and meeting requirement,
b) The need to consider processes in terms of added value
c) Obtaining results of process performance& effectiveness,
d) continual improvement of processes based on objective
measurement”
“Clause 4.1- General requirements
The organization shall
a) Identify the processes needed for the QMS and their
application throughout the organization

b) Determine the sequence and interaction of these processes,

c) Determine criteria and methods needed to ensure that both

the operation and control of these processes are effective,

d) Ensure that availability of resources and information

necessary to support the operation and monitoring of these
processes,

e) Monitor, measure and analyse these processes and,

f) Implement actions necessary to achieve planned results and

continual improvements of these processes.

These processes will be managed by the organization in

accordance with the requirements of this international
standard.”
PROCESS APPROACH

A process converts input into output.

INPUT PP OUTPUT
(INPUT of next process)

WASTE

The characteristics of a process are:

1) A defined purpose

2) A defined objective

3) Inputs in the form of machinery, material, people, tools, information,

money

4) Constraint in the form of rules, regulation, laws and policies

5) Activities in a sequence from start to finish

6) Controls in the form of standards, measurement and feedback loop

7) Interfaces with other processes feeding input or taking output

8) Output in the form of product, information, decision, people

9) Outcomes in the form of effects on people, environment, society,

business performance

10) Results as a measure of adequacy of output

11) Results as a measure of efficiency and effectiveness

In process approach, People

1) Define the objectives of the Organization’s processes

2) Define a process that will achieve specific objectives

3) Establish clear responsibility, authority and accountability

for managing the process

4) Determine the stages in the process necessary to achieve the

results

5) Determine the activities required to accomplish each process

stage

6) Determine the competence required of the people performing

these activities.

7) Identify the Input and Output of the process

8) Determine the measurements required to verify process

Inputs & outputs
9) Determine the information & resource requirements needed
to achieve the Objective

10) Determine the sequence & interaction of activities within

the process

11) Taking action to prevent use or delivery of

nonconforming inputs or outputs until remedial action has
been affected

12) To eliminate cause of nonconforming Inputs or Outputs

13) Evaluating possible risks, consequences and impacts of

processes on customers, suppliers and other stake holders of
the process

14) Determine the measurements required to establish

process efficiency and effectiveness

15) Measuring process outputs, efficiency and effectiveness

16) Aware of the results the process is achieving

4 Quality management system
4.1 General requirements
4.2 Documentation requirements- Quality manual (4.2.2), control of
documents (4.2.3), control of records (4.2.4)
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning- Quality objectives (5.4.1)
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource management
6.1 Provision of resources
6.2 Human resources- competence, training and awareness
6.3 Infrastructure
6.4 Work environment
7 Product realization
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design and development
7.4 Purchasing
7.5 Product and service provision
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
 QUALITY AUDIT
“A systematic, independent and documented process for obtaining
audit evidence and evaluating it objectively to determine the extent
to which audit criteria are fulfilled”
Audit evidence: Records, statements of fact or other information
which are relevant to the audit criteria and verifiable
Audit criteria: Set of policies, procedures or requirements used as
reference- ISO 9001 standard, Requirements of external origin,
statutory or regulatory requirements
Types of Audits:
External: 2nd party, 3rd party
Internal: 1st party
Adequacy audit
Compliance audit
Product audit
Process audit
System audit
Assessment is collection & compilation of several audits
Certification is awarded on successful completion of assessment
Accreditation is awarded to certification body by National Board
Surveillance audit
OUTPUT: Report stating 1. Note worthy efforts
2. Observation for improvements
3. Nonconformities