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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

QMS Auditor / Lead Auditor course ( A 17929)

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

QMS Auditor / Lead Auditor course ( A 17929)

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

QMS Auditor / Lead Auditor course ( A 17929)

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

QMS Auditor / Lead Auditor course ( A 17929)

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

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


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

QMS Auditor / Lead Auditor course ( A 17929)

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)

QMS Auditor / Lead Auditor course ( A 17929)

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

QMS Auditor / Lead Auditor course ( A 17929)

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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

QMS Auditor / Lead Auditor course ( A 17929)

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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.

QMS Auditor / Lead Auditor course ( A 17929)

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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

QMS Auditor / Lead Auditor course ( A 17929)

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