0.1D.overview-Clauses 0.1 To 3-Aug 2015

0.1D.
Overview of ISO 9001:2015

Clauses 0.1 to 3
0.1 General
Adoption of QMS is a strategic decision

Implementation of QMS is to help organizations to improve its overall
performance & part of sustainable development
Many factors can influence the design of QMS
Context of an organisation
Risks associated with its context and objectives
Requirements of QMS are complementary to those of products
Standard can be used by many parties
Delegates are required to study the respective clauses of the standard in more details
for a better understanding of the concepts
Aug 2015
QMS Auditor / Lead Auditor course ( A 17929)
0.2 Quality Management Principle
9001:2015
From ISO 9000:2005
Customer focus
Customer focus
Leadership
Leadership
Involvement of people
Engagement of people
Process approach
Process approach
System approach to management
Improvement
Continual improvement
Evidence-based Decision making
Factual approach to decision making
Relationship Management
Mutual beneficial supplier relationships
Aug 2015
0.3.1 Process approach
Consistent and predictable results are achieved when activities are

managed as processes.
Process Approach=systematic definition and management of

processes and their interactions to achieve intended results
Controls
(e.g.procedure)
(e.g.procedure)
Input
Process
Activities
+
Resources
Output
Process
A
Process
C
Process
B
Process
D
Name the parameters needed to identify a process
Aug 2015
0.3.1 Process approach
The process approach ensures:
understanding the process and consistency in meeting

requirements.
Consideration of processes in terms of added value
The achievement of effective process performance
Aug 2015
Improvement of processes based on evaluation of data and

infrmation
Consistent and predictable results
0.3.2 Model of a process based QMS

4.1,4.2 &4.3
Context &
Scope
Improvement
Leadership
4.4 QMS-General & Process
Approach
Customer
& Other
relevant
Interested
parties
Planning
Performance
evaluation
Customer
Satisfaction
Products
Products&
&Services
Services
Input
Operations
Requirements
Output
Satisfaction
Support Processes
Aug 2015
0.3.2 PDCA cycle
ACT incorporate
improvements as
necessary
PLAN - the process
(Extent of planning depends

on RISK)
DO carryout the process
OUTPUTS
CHECK monitor/measure
process performance
Schematic representation of a single process within the system

Aug 2015
0.3.3 RISK- based thinking
Risk based thinking has been always an intent of the standard
Now made more explicit and part of the requirements
Organisations may choose to adopt more extensive risk based

approach than required by the standard.
Aug 2015
Level of risk may vary between various processes and the context
Risk based thinking means considering risk qualitatively while
planning for the QMS
0.4 ISO 9000 standards for QMS

Annexes A & B for
information only
Quality management
systems Fundamentals &
vocabulary
ISO
ISO
ISO
ISO
10012
10012
10012
10012
Measurement
ISO
ISO
9000:
9000:
2015
2015
Audits
ISO
ISO
19011
19011
Guidelines
Managing for the

sustained success of
an organisation
A QMS approach
ISO
ISO
9004:
9004:
2009
2009
ISO
ISO
9001:
9001:
2015
2015
Technical
Technical
Reports
Reports
Aug 2015
Quality management
systems Requirements
as needed
(e.g. ISO/TR 10013)
0.4 ISO Standards for QMS

ISO
ISO
9004:
9004:
2009
2009
ISO
ISO
9001:
9001:
2015
2015
Focuses on effectiveness
Focuses on sustained success
and is certifiable
and is not certifiable
Focuses on customers
Focuses on interested parties and

goes beyond requirements of
9001
Both focus on quality management approach

Both are based on 7 principles
Aug 2015
10
0.4 relationship with other management system standards

Adoption of high level structure has enabled:
ISO to improve alignment among its international standards for

management systems
(Annex A of this standard provides key elements of high level structure)
Level of risk may vary between various processes and the context of the
organization
This standard defines requirements in an order that is in line with
organizations planning and process management. i.e.,
Understanding the context of the organization. Its quality management system & processes (Clause 4)
Leadership, policy and responsibilities (Clause 5)
Processes for planning & consideration of risks and opportunities (Clause 6)
Processes for support, including resources, people and information (Clasue 7)
Operational processes related to customers, products and services ( Clause 8)
Processes for performance evaluation (Clause 9)
Processes for improvement (Clause 10)
Aug 2015
11
1.Scope
The standard specifies requirements for a QMS when an organization:
a) needs to demonstrate its ability to consistently provide product or

service that meets customer and applicable statutory and regulatory
requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for the improvement of
the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.
Note:
Aug 2015
Product & Service = products & services intended for, or required by, a
customer.
Statutory and regulatory requirements can be expressed as legal requirements.
12
2 Normative Reference
ISO 9000:2015 Quality management systems- Fundamental s&
vocabulary is the normative reference
3 Terms & Definitions

Terms and definitions given in ISO 9000:2015 apply
Aug 2015
13

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0.1D.

Overview of ISO 9001:2015

Adoption of QMS is a strategic decision

Many factors can influence the design of QMS

Risks associated with its context and objectives

Requirements of QMS are complementary to those of products

Standard can be used by many parties

QMS Auditor / Lead Auditor course ( A 17929)

0.2 Quality Management Principle

QMS Auditor / Lead Auditor course ( A 17929)

0.3.1 Process approach

Consistent and predictable results are achieved when activities are

Process Approach=systematic definition and management of

Name the parameters needed to identify a process

QMS Auditor / Lead Auditor course ( A 17929)

0.3.1 Process approach

The process approach ensures:

understanding the process and consistency in meeting

Consideration of processes in terms of added value

The achievement of effective process performance

Improvement of processes based on evaluation of data and

QMS Auditor / Lead Auditor course ( A 17929)

0.3.2 Model of a process based QMS

QMS Auditor / Lead Auditor course ( A 17929)

0.3.2 PDCA cycle

PLAN - the process

(Extent of planning depends

DO carryout the process

Schematic representation of a single process within the system

QMS Auditor / Lead Auditor course ( A 17929)

0.3.3 RISK- based thinking

Risk based thinking has been always an intent of the standard

Now made more explicit and part of the requirements

Organisations may choose to adopt more extensive risk based

QMS Auditor / Lead Auditor course ( A 17929)

0.4 ISO 9000 standards for QMS

Managing for the

QMS Auditor / Lead Auditor course ( A 17929)

0.4 ISO Standards for QMS

Focuses on sustained success

and is not certifiable

Focuses on interested parties and

Both focus on quality management approach

QMS Auditor / Lead Auditor course ( A 17929)

0.4 relationship with other management system standards

ISO to improve alignment among its international standards for

Leadership, policy and responsibilities (Clause 5)

Processes for planning & consideration of risks and opportunities (Clause 6)

Processes for support, including resources, people and information (Clasue 7)

Operational processes related to customers, products and services ( Clause 8)

Processes for performance evaluation (Clause 9)

Processes for improvement (Clause 10)

QMS Auditor / Lead Auditor course ( A 17929)

a) needs to demonstrate its ability to consistently provide product or

QMS Auditor / Lead Auditor course ( A 17929)

vocabulary is the normative reference

3 Terms & Definitions

QMS Auditor / Lead Auditor course ( A 17929)