“IMPORTANCE OF AUDITING ISO 9001: 2015”€¦ · At the end of this session, you will able to understand: About 3FOLD Education Centre 7 Quality Management Principles Brief on

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“IMPORTANCE OF AUDITING ISO 9001: 2015”


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Learning Outcomes

At the end of this session, you will able to understand:

About 3FOLD Education Centre

7 Quality Management Principles

Brief on ISO 9001:2015

Purpose of Audit

Types of Audit

Auditing ISO 9001:2015

Clarifications / Questions.



7 Quality Management Principles


PROCESS APPROACH –CONTINUAL IMPROVEMENTS OF PROCESS

PDCA Cycle

Processes in terms

Of Added Value

DO

Continual improvements

of Processes based on

objective measurements

ACTION

Measure results of process

Performance and effectiveness

- Objective Measurements

CHECK

Understandings &

meeting requirements

PLAN


1. Scope 2. Normative references

3. Terms and definitions 4. Context of organization

5. Leadership 6. Planning

7. Support 8. Operation

9. Performance evaluation 10. Improvement

I N T R O D U C T I O N

Standard Overview

8

Date:

ISO

/TC

176/S

C 2

/ N

1282

8

Do Check ActPlan

4 Context of

organization

5 Leadership

6 Planning

8 Operation

9 Performance

and Evaluation

10 Improvement

4.1 Understanding

context

4.2 Interested parties

4.3 Scope

4.4QMS

5.1 Leadership and

commitment

6.1 Actions to

address risks and opportunities

6.2 Quality objectives

and planning

9.1 Monitoring,

measurement, analysis and evaluation

10.2 Nonconformity and corrective

action

10.3Continual

improvement

5.3Organizational

roles, responsibilities and authorities

9.2Internal audit

9.3 Management

review

8.1 Operational

planning and control

5.2 Policy

6.3 Planning of

changes

9.1.2Customer

satisfaction

9.1.3 Analysis and

evaluation

See next slide

7 Support

7.1 Resources

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence

7.1.4 Environment for the

operation of processes

7.1.5 Monitoring and

measuring resources

7.1.2 People

7.1.3 Infrastructure

7.1.6 Organizational

knowledge

10.1General


CLAUSES BASED ON QUALITY MANAGEMENT PRINCIPLES

CUSTOMER FOCUS- 4,6,9 & 10

LEADERSHIP- 4,5,7 & 10

ENGAGEMENT OF PEOPLE- 4,5,6,7

PROCESS APPROACH- 6,8 & 9

IMPROVEMENT- 6,8,9 & 10

EVIDENCE BASED MANAGEMENT- 7,8,9 & 10

RELATIONSHIP MANAGEMENT- 4,5 & 8


➢ To determine conformity to requirements

➢ To determine effectiveness of the system

➢ For improvement of the system

➢ To meet regulatory requirements

➢ To meet contract requirements

➢To gain registration for marketing and customer assurance purposes

Purpose of Management System Audit


Types of Audits

Third Party Audit

Audit by independent body seeking conformance to a standard such as ISO 9001(certification/ registration

body)

First Party Audit

Undertaken by an organization on its own quality system - to

seek conformance and improvement Self-audit (Client,

auditor and auditees are Internal or company appointed

consultant)

Second Party Audit

Undertaken by an organization on an existing or potential

supplier usually relating to a contract of supply Audit by an

interested body (like a customer, vendor,

subcontractor)


The Quality audit is define as “ a systematic & independent examination to determine whether Quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives”.

(1) Adequacy audit:- (System or Management audit)

determine the extend to which the documented

information adequately meet the requirements

of standard.

(2) Compliance audit:-

Which seeks to establish the extent to which the

documented system is implemented and

observed by the work force.

Audit - Quality Audit


Important Terms relating to Documented information

The following terms to be considered

Term Details

Documented information

Information and its support medium and guidelines or evidences

Guideline Document stating recommendations or suggestions

Record Documented information stating results achieved or providing evidence of activities performed

Specification Documented information stating requirements



Documentation, Manual, documented procedures, record


Auditing Questions


Auditing Questions

INPUTS

OUTPUTS

ProcessOperators

PEOPLE

MATERIALS

METHODS

ENVIRONMENT

INFRASTRUCTUREAdmin

Corrective actions Customer FeedbackManagement Supervision

Non-conformance

Records

Monitor


Important Auditing Elements of ISO 9001:2015309 ISO 9001 REQUIREMENTS

4 Context of organisation (24)4.1 Context (2)4.2 Interested parties(3)4.3 Scope(7)4.4 QMS and processes (12)

5 Leadership (26)5.1 Leadership and commitment(13)5.2 Policy(7)5.3 Responsibilities (6)



6 Planning (27)6.1 Actions to address risks(8)6.2 Quality objectives(14)6.3 Planning of changes (5)7 Support (43)7.1 Resources(17)7.2 Competence(4)7.3 Awareness (4)7.4 Communication(5)7.5 Documented information(13)



8 Operation (128)8.1 Operation control(9)8.2 Requirements(19)8.3 Design and development (36)8.4 External providers (21)8.5 Production service provision(26)8.6 Release of product and services(5)8.7 Non conforming output(12)



9 Performance (43)9.1 Monitoring measurement(16)9.2 Internal audit(10)9.3 Management review (17)

10 Improvement (18)10.1 General(4)10.2 Corrective action(12)10.3 Continual improvement(2)


Context of organisation

Internal Context

Addressed consideration of Strengths and Weakness that would generate opportunity or risk or Threat to the company

(SWOT)

Organisation Core Values

• Business strategic risk

• Organization capability

• Resources

• Financial capability

• Workplace safety

• Employees

• Services


Context of organisation

External Context

External factors that may relate to Opportunity or challenges or Threats from the elements analysed

(SWOT)

Elements• Political

• Economic

• Social

• Technological

• Legal

• Environmental

• Competitor


Auditing Questions

Interested Parties

• Have you identified interested parties?

• Their needs and expectations

• Priority to meet needs and expectation of interested parties

Scope and QMS

• Have you defined scope of QMS?

• Processes involved?

• Their interconnection?

• Risk and opportunity analysis


Auditing Questions

Man

• Roles and responsibilities?

• Organisational Knowledge

• Competence

• Training need analysis

• Training plan

• Conduction of training

• Training effectiveness analysis, etc

Machines

• Calibration of tools and equipment's

• Maintenance policy

• Breakdown maintenance records

• Preventive maintenance records

• Maintenance log book

• Production planning, etc


Auditing Questions

Materials

• Approved suppliers/vendors/contractor list

• Procedure for the same

• Performance evaluation

• Re evaluation basis

• Inspection/Quality assurance of supplies, etc

Customer

• Customer requirements analysis

• Validation of product or services

• Customer feedback

• Performance evaluation

• Customer focus

• Customer complaints register, etc


Auditing Questions

Leaders

• Context

• Policy

• Objectives

• Commitment

• Interested parties

• Resources

Management Appointee, if any.

• Internal audit programmes

• Conduct of audits

• Management Review details

• Non conformities

• Corrective actions, Improvements


Clarifications


Upcoming Training Schedule for QMS

ISO 9001:2015

• Batch Start Date: 9/2/2018

• Batch End Date: 9/3/2018

• Frequency: Every Friday

Product ManagerMr. [email protected] – 1036364


END OF THE SESSIONPlease return the feedback form at the reception!

Documents

“IMPORTANCE OF AUDITING ISO 9001: 2015”€¦ · At the end of this session, you will able to understand: About 3FOLD Education Centre 7 Quality Management Principles Brief on