ISO 9001:2015

AWARENESS TRAINING

FEBRUARY 20, 2018

REV 0/ 15-02-19 APPROVED BY: CHECKED BY : PROVIDED BY:

ISO 9001:2015 PROJECT SCHEDULE SIGNS

PT. ANUGERAH MORTAR UTAMA
NAME HADI KASIM HERRY CHRISNANTYO HISAR SIMANJUNTAK
FEBRUARY MARCH APRIL MAY JUNE JULY AUGUST
NO ACTIVITIES TARGET DELIVERABLES DUE DATE PIC

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1 ISO 9001:2015 AWARENESS TRAINING All departments, Setion head Training material, 22/02/2019 H S I
(Supervisor) up Attendance list
2 DEVELOP ISO 9001:2015 PROJECT TEAM All departments are represented PT AMA ISO 9001:2015 01/03/2019 H R C
by at min section head level Project Team
3 DEVELOP BUSINESS PROCESS MAP All internal processes and external Business Process map. 01/03/2019 H S I
related parties are identified.

4 DEVELOP PROCESS VS PROCEDURE VS All ISO 9001:2015 requirements Matrix diagram 01/03/2019 H S I
ISO 9001:2015 REQUIREMENTS MATRIX are addressed.
5 DEVELOP DOCUMENT CONTROL Comply with ISO 9001:2015 Hard and soft copy 08/03/2019 H S I
PROCEDURE requirements. Both in softcopy procedure.
and hardcopy.
6 SOCIALISE DOCUMENT CONTROL All ISO Team undertand and have Minutes of meeting 15/03/2019 H S I
PROCEDURE the ability to create ISO
Documents
7 DEVELOP PROCEDURES REQUIRED -All processes as stated in Procedures. 29/03/2019 ISO Team
Company Business Process.
- All risks are identified
-Comply with ISO 2015:9001
requirements.
8 PROCEDURE REVIEW AND APPROVAL -Approved by Management and Approved procedures. 12/04/2019 H R C
related parties.
9 DEVELOP QUALITY MANUAL All ISO 9001:2015 requirements Approved Quality 26/04/2019 H S I
are addressed. Manual
10 DEVELOP COMPANY QUALITY Comply with Quality Policy Management 26/04/2019 H R C
OBJECTIVES AND DEPLOYMENT TO ALL Statement and Company Business dashboard : Quality
RELATED DEPARTMENT Planning and Management related KPI
Dashboard.
11 ISO 9001:2015 KICK OFF Formal ceremony and the Commitment sign 30/04/2019 H R C
commitment sign to implement all board.
ISO 9001:2015 procedures
consistently.
12 CONDUCT INTERNAL QUALITY AUDITOR - All departments represent 1 Traininng material and 14/05/2019 H S I
TRAINING internal quality auditor trainee. Attendance List.
13 INTERNAL QUALITY AUDIT - Cover All department & Internal Quality audit 04/06/2019 H S I
Management Findings Reports.
14 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and Internal Quality Audit 18/06/2019 H S I
FOLLOW UP provide corrective action. & Follow up.
- All verified and closed
15 MANAGEMENT REVIEW - ISO implementation are Management Review 02/07/2019 H R C
reviewed including Internal minutes of Meeting.
Quality Audit, Customer
satisfaction and improvements.
- New Initiatives are identified.
16 THIRD PARTY PRE-ASSESSMENT Gaps are identified by Pre assessment 16/07/2019 H S I
Certification body. findings.
17 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and Pre assessment 30/07/2019 H S I
FOLLOW UP provide corrective action. findings.
- All verified and closed
18 THIRD PARTY CERTIFICATION AUDIT ISO 9001:2015 certificate is ISO 9001:2015 14/08/2019 H S I
awarded certificate
 REV 0/ 15-02-19 APPROVED BY: CHECKED BY : PROVIDED BY:
FEBRUARY MARCH A
ISO 9001:2015 PROJECT SCHEDULE
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SIGNS
NO ACTIVITIES TARGET DELIVERABLES DUE DATE PIC b b pr
PT. ANUGERAH MORTAR UTAMA
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NAME HADI1KASIM 2 0 CHRISNANTYO
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2 SIMANJUNTAK
HISAR 0
FEBRUARY
1 ISO 9001:2015 AWARENESS TRAINING All departments, Setion head Training material,
MARCH 22/02/2019 H S IMAY
APRIL JUNE JULY AUGUST
NO ACTIVITIES TARGET DELIVERABLES DUE DATE PIC

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1 ISO 9001:2015 AWARENESS TRAINING All departments, Setion head Training material, 22/02/2019 H S I
2 DEVELOP ISO 9001:2015 PROJECT TEAM All departments
(Supervisor) up Attendance list are represented PT AMA ISO 9001:2015 01/03/2019 H R C
by at min
2 DEVELOP ISO 9001:2015 PROJECT TEAM All departments are represented PT AMAsection head01/03/2019
ISO 9001:2015 level H R C Project Team
by at min section head level Project Team
33 DEVELOP BUSINESS
DEVELOP BUSINESS PROCESS
PROCESS MAP MAP
All internal All internal
processes and external processes
Business Process map. and external
01/03/2019 HSI Business Process map. 01/03/2019 H S I
related parties are identified.
related parties are identified.
4 DEVELOP PROCESS VS PROCEDURE VS All ISO 9001:2015 requirements Matrix diagram 01/03/2019 H S I
ISO 9001:2015 REQUIREMENTS MATRIX are addressed.
45 DEVELOP PROCESS
DEVELOP DOCUMENT CONTROLVS PROCEDURE
Comply with ISO VS
9001:2015All ISO 9001:2015
Hard and soft copy requirements
08/03/2019 H S I Matrix diagram 01/03/2019 H S I
PROCEDURE requirements. Both in softcopy procedure.
ISO 9001:2015 REQUIREMENTS MATRIX
and hardcopy.
are addressed.
56 DEVELOP DOCUMENT
SOCIALISE DOCUMENT CONTROL CONTROL
All ISO Team undertand and Comply with
have Minutes ISO 9001:2015
of meeting 15/03/2019 H S I Hard and soft copy 08/03/2019 H S I
PROCEDURE the ability to create ISO
PROCEDURE Documents requirements. Both in softcopy procedure.
7 DEVELOP PROCEDURES REQUIRED -All processes as stated in and hardcopy.
Procedures. 29/03/2019 ISO Team

QMS DEVELOPMENT
Company Business Process.
6 SOCIALISE DOCUMENT CONTROL - All risks are identified All ISO Team undertand and have Minutes of meeting 15/03/2019 H S I
-Comply with ISO 2015:9001
PROCEDURE requirements. the ability to create ISO
8 PROCEDURE REVIEW AND APPROVAL -Approved by Management and Approved procedures. 12/04/2019 H R C
related parties.
Documents

PHASE 1
79 DEVELOP
DEVELOP QUALITYPROCEDURES
MANUAL REQUIRED -All processes
All ISO 9001:2015 requirements as stated
Approved Quality in
26/04/2019 HSI Procedures. 29/03/2019 ISO Team
are addressed. Manual
10 DEVELOP COMPANY QUALITY Comply with Quality Policy
Company Business Process.
Management 26/04/2019 H R C
- All risks
OBJECTIVES AND DEPLOYMENT TO ALL Statement and Company Business are: Quality
dashboard identified
RELATED DEPARTMENT Planning and Management related KPI
Dashboard. -Comply with ISO 2015:9001
11 ISO 9001:2015 KICK OFF Formal ceremony and the Commitment sign 30/04/2019 H R C
requirements.
commitment sign to implement all board.

8 PROCEDURE REVIEW ANDISO 9001:2015 procedures

APPROVAL
consistently.
-Approved by Management and Approved procedures. 12/04/2019 H R C
related
12 CONDUCT INTERNAL QUALITY AUDITOR - All departments represent 1 parties.
Traininng material and 14/05/2019 H S I
TRAINING internal quality auditor trainee. Attendance List.
913 DEVELOP QUALITY
INTERNAL QUALITY AUDIT MANUAL
- Cover All department & All ISO 9001:2015
Internal requirements
Quality audit 04/06/2019 H S I Approved Quality 26/04/2019 H S I
Management Findings Reports.
are addressed. Manual
14 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and Internal Quality Audit 18/06/2019 H S I
10 DEVELOP
FOLLOW UP COMPANY QUALITY
provide corrective action. Comply with
& Follow up.Quality Policy Management 26/04/2019 H R C
- All verified and closed
15 OBJECTIVES AND DEPLOYMENT
MANAGEMENT REVIEW TO ALLare Statement
- ISO implementation andReview
Management Company Business
02/07/2019 HRC dashboard : Quality
RELATED DEPARTMENT reviewed including Internal
Quality Audit, Customer
minutes of Meeting.
Planning and Management related KPI
Dashboard.
satisfaction and improvements.
- New Initiatives are identified.
1116 ISO
THIRD9001:2015 KICK OFF
PARTY PRE-ASSESSMENT Gaps are identified by Formal
Preceremony
assessment and 16/07/2019
the HSI Commitment sign 30/04/2019 H R C
Certification body. findings.
commitment sign to implement all board.
17 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and Pre assessment 30/07/2019 H S I
FOLLOW UP provide corrective action. ISO 9001:2015
findings. procedures
- All verified and closed
consistently.
18 THIRD PARTY CERTIFICATION AUDIT ISO 9001:2015 certificate is ISO 9001:2015 14/08/2019 H S I
awarded certificate
12 CONDUCT INTERNAL QUALITY AUDITOR - All departments represent 1 Traininng material and 14/05/2019 H S I
REV 0/ 15-02-19 are addressed. Manual APPROVED BY: CHECKED BY : PROVIDED BY:

ISO10
9001:2015
DEVELOPPROJECTCOMPANYSCHEDULE
QUALITY Comply with Quality Policy Management
SIGNS 26/04/2019 H R C
PT. ANUGERAH MORTAR UTAMA
OBJECTIVES AND DEPLOYMENT TO ALL Statement and Company Business dashboard NAME
: QualityHADI KASIM HERRY CHRISNANTYO HISAR SIMANJUNTAK

NO
RELATED
ACTIVITIES
DEPARTMENTTARGET
Planning
DELIVERABLES DUE DATE
and
PIC
Management
FEBRUARY MARCH
related
APRIL
KPI MAY JUNE JULY AUGUST

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1 ISO 9001:2015 AWARENESS TRAINING All departments, Setion head Training material, 22/02/2019 H S I

11 ISO 9001:2015 KICK OFF

(Supervisor) up
2 DEVELOP ISO 9001:2015 PROJECT TEAM All departments are represented
Attendance list
Formal
PT AMA ISO 9001:2015
ceremony and the
01/03/2019 H R C
Commitment sign 30/04/2019 H R C
3 DEVELOP BUSINESS PROCESS MAP
by at min section head level Project Team
commitment
All internal processes and external Business Process map. 01/03/2019 H S I
sign to implement all board.
related parties are identified.
ISO 9001:2015 procedures
4 DEVELOP PROCESS VS PROCEDURE VS All ISO 9001:2015 requirements Matrix diagram consistently.
01/03/2019 H S I
ISO 9001:2015 REQUIREMENTS MATRIX are addressed.
5 DEVELOP DOCUMENT CONTROL Comply with ISO 9001:2015 Hard and soft copy 08/03/2019 H S I
12 CONDUCT INTERNAL
PROCEDURE QUALITY
requirements. Both in softcopyAUDITOR
procedure. - All departments represent 1 Traininng material and 14/05/2019 H S I
and hardcopy.
TRAINING internal quality auditor trainee. Attendance List.

QMS IMPLEMENTATION
6 SOCIALISE DOCUMENT CONTROL All ISO Team undertand and have Minutes of meeting 15/03/2019 HSI
PROCEDURE the ability to create ISO
13 INTERNAL QUALITY AUDIT
Documents - Cover All department & Internal Quality audit 04/06/2019 H S I
7 DEVELOP PROCEDURES REQUIRED -All processes as stated in Procedures. 29/03/2019 ISO Team
Company Business Process.
- All risks are identified
Management Findings Reports.
-Comply with ISO 2015:9001
14 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and
requirements. Internal Quality Audit 18/06/2019 H S I

PHASE 2
FOLLOW UP
8 PROCEDURE REVIEW AND APPROVAL
-Approved by Management and
related parties.
provide
Approved procedures.
corrective action.
12/04/2019 H R C
& Follow up.
9 DEVELOP QUALITY MANUAL All ISO 9001:2015 requirements
are addressed.
Approved Quality
Manual
- All verified and closed
26/04/2019 H S I

10 DEVELOP COMPANY QUALITY Comply with Quality Policy Management 26/04/2019 H R C

15 MANAGEMENT REVIEW
OBJECTIVES AND DEPLOYMENT TO ALL
Statement and Company Business - ISO implementation are
dashboard : Quality Management Review 02/07/2019 H R C
RELATED DEPARTMENT Planning and Management related KPI
Dashboard. reviewed including Internal minutes of Meeting.
11 ISO 9001:2015 KICK OFF Formal ceremony and the Commitment sign 30/04/2019 H R C
commitment sign to implement all board. Quality Audit, Customer
ISO 9001:2015 procedures
consistently. satisfaction and improvements.
12 CONDUCT INTERNAL QUALITY AUDITOR - All departments represent 1 Traininng material and 14/05/2019 H S I
TRAINING internal quality auditor trainee. Attendance List. - New Initiatives are identified.
13 INTERNAL QUALITY AUDIT - Cover All department & Internal Quality audit 04/06/2019 H S I
16 THIRD PARTY PRE-ASSESSMENT
Management Findings Reports. Gaps are identified by Pre assessment 16/07/2019 H S I
14 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and Internal Quality Audit 18/06/2019 H S I
FOLLOW UP provide corrective action.
- All verified and closed
& Follow up. Certification body. findings.
17 CORRECTION AND
15 MANAGEMENT REVIEW
CORRECTIVE ACTION
- ISO implementation are
reviewed including Internal
-All findings
Management Review
minutes of Meeting.
02/07/2019 H R C
are corrected and Pre assessment 30/07/2019 H S I
Quality Audit, Customer
FOLLOW UP satisfaction and improvements. provide corrective action. findings.
- New Initiatives are identified.
16 THIRD PARTY PRE-ASSESSMENT Gaps are identified by Pre assessment
- All 16/07/2019
verified HSI
and closed
Certification body. findings.
18 THIRD PARTY CERTIFICATION AUDIT
Pre assessment ISO 9001:2015
17 CORRECTION AND CORRECTIVE ACTION -All findings are corrected and
30/07/2019 H S I certificate is ISO 9001:2015 14/08/2019 H S I
FOLLOW UP provide corrective action.
findings.
awarded
- All verified and closed certificate
18 THIRD PARTY CERTIFICATION AUDIT ISO 9001:2015 certificate is ISO 9001:2015 14/08/2019 H S I
awarded certificate
ISO 9001:2015 PROJECT TEAM
 SETIAP DEPARTMENT MENUNJUK TIMNYA – MIN LEVEL SUPERVISOR
(SECTION HEAD) SEBAGAI ANGGOTA TEAM PROJECT
 ANGGOTA TEAM BERTUGAS UNTUK MENGEMBANGKAN DOKUMEN DAN
MENSOSIALISASIKAN DOKUMEN YANG SUDAH SUDAH DISAHKAN KE
SELURUH ANGGOTA DEPARTMENT
 MEMAHAMI PERSYARATAN ISO 9001:2015 DI DEPARTMENTNYA
 MENJADI INTERNAL QUALITY AUDITOR SETELAH MENGIKUTI PELATIHAN
 MENGIKUTI BRIEFING DAN MEETING TIM ISO SETIAP:
 SENIN : FULL DAY
Facts about ISO 9001

1. ISO 9001 is being implemented in

175 countries around the world
2. Over 1.2 million certificates issued
worldwide
3. ISO has 163 member countries
What is ISO 9001?
 It’s a quality management system that can be adopted
by any kind of organization
 The system is focused towards the meeting of customer
requirements and enhancing of customer satisfaction

Keywords:
1. Quality
2. Management system
3. Customer requirements
4. Customer satisfaction
What is quality…. Satisfied Dissatisfied

How was it? 3



4
1 REQUIREMENTS

PRODUCTS/ SERVICES 2

Characteristic
Improve
5

“Degree to which a set of inherent characteristics fulfils requirements”

What is Quality Management
System….
Policies
Objectives

Processes

Quality Management
System

“a system to direct and control an organization with respect to quality!!!”

 QMS Model….
Quality Management System (4)

Support and
Organization Operation
and its (7,8)
context (4)
CUSTOMER
PLAN DO SATISFACTION

Performance
Customer Leadership RESULT OF
Planning (6) evaluation
requirements (5)
(9) QMS

ACT CHECK PRODUCT &

Needs and
expectation SERVICES
of relevant
interested Improvement
parties (4) (10)
Quality Policy….
Part of Quality Manual

Published on intranet

Expresses Top Management’s

commitment towards quality

All employees MUST understand and

apply the quality policy
Why do we need ISO 9001?
 To be effective in whatever we do, we need a system of
doing things to be consistent. Just like craftsmen,
managers need a good management tool to get the
job done.
 There are too many activities in any organization. Easy
to lose track of things and focus. Easy to get distracted.
Managers need a good system to keep things in order.
 Systemizing of activities is a natural phenomenon. We
do it all the time – privately, publicly or commercially
 A business faces great risks – big investments, customer
expectations, jobs, credibility, etc. The business owner must do all he
can to ensure success, or he/she will fail.
 Every major economy in the world adopts it! Governments give
recognition to it. Because it works.
You already have a system of
doing things too!
 But is it effective? If you keep doing what you always
do, you will always get the same result.
 ISO 9001 is an option, a good one. It requires your
organization to document your business processes
(QMS), monitor, measure, analyze and improve it.
 Business owners and top management need to make
a strategic decision on whether to implement the ISO
9001 QMS.
Biggest benefit
 The ISO 9001:2015 Standard provides managers with a
tool that is designed to continually improve their
business performance.
 ISO 9001 requires you to:
– Plan what you want to do,
– Follow that plan,
– Monitor, measure and analyze your execution of the
plan, and
– Improve the plan.
What is ISO 9001:2015?
 ISO - International
Organization for
Standardization
 isos - Greek - equal
 9001 - unique ID number
 2015 = Year it was published
ISO 9001 History
YEAR STANDARDS TITLE
1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS
1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS
1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE
1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION,
INSTALLATION AND SERVICING
1987 ISO 9001:1987 Model for quality assurance in design, development, production,
installation, and servicing
ISO 9002:1987 Model for quality assurance in production, installation, and servicing

ISO 9003:1987 Model for quality assurance in final inspection and test
1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE
2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
2015 ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
ISO 9001:2015….
International Standard published by ISO

Prescribes set of requirements related to a

quality management system

Conformity can be assessed internally as

well as by external parties

World’s first certifiable QMS standard

“Quality Management System - Requirements”

Global Issuance of ISO 9001
Certificates
 A well-designed and well-
implemented quality management
system can and should eliminate
 Ineffectiveness
 Inefficiencies
 Problems
 Errors
 Inconsistencies
 Malicious practices
 Uncertainties
 Bad culture
ISO 9000 Family
a) ISO 9001:2015 Quality Management Systems – Requirements
b) ISO 9000:2005 Fundamentals and vocabulary
c) ISO 19011:2011 Guidelines for auditing management
systems
d) ISO 9004:2009 Managing for the sustained success of an
organization — A quality management approach

 The term “ISO 9000” is frequently used to refer to the ISO 9001
standard
 Only ISO 9001 is auditable. The rest serves as references only.
ISO 9001 provides common ground
Quality management systems (QMS) standards for which ISO 9001 is
a normative reference also require use of ISO 9000.

SAE ISO TS ISO QUEST

AS9100C:2009 16949:2009 13485:2003 TL9000

Aerospace Automotive Med. devices Telecom

ISO 9001

ISO 9000
What is ISO 9001:2015 Quality
Management Systems - Requirements?
 Quality - degree to which customer requirements have
been met
 Management - coordinated activities to direct and control
an organization
 System - set of interrelated or interacting elements
 Quality management system - a system to direct and
control an organization with regard to quality
 Requirements - a set of management parameters for your
QMS
More about quality
 How do you know requirements have been met?
– Review = confirm that requirements are accurate
– Verify = measure accuracy of output against requirements
– Validate = Get feedback from customer/end-user
 Nonconformance = failure to fulfill requirements
 Nonconformance = error
 All forms of nonconformance require corrections and corrective action to
prevent recurrences
 Correction = Elimination of error
 Corrective action = Elimination of the root causes of the error (Ask WHY 5 times)
Understanding “interested parties”
When determining the scope of the organization, we shall consider
the expectations of “relevant interested parties.”
All of the following can be "interested parties”:

Person having an
Organization that
interest in the Person that can affect
perceives itself to be
success of an an activity
affected by a decision
organization

Person having an
interest in the Providers’ regulators
Stakeholder
performance of an
organization

Opposing pressure
Competitors There are more!
group
Understanding “risk”
The term “risk” has been added to ISO 9001:2015 and is noted in
many places throughout the standard.

From ISO 9000:2015, clause 3.7.9:

risk
effect of uncertainty…positive or negative….
Often characterized by reference to potential events….
Often expressed in terms of the consequences of an event …
and the associated likelihood of occurrence

This may apply, for example, to a product, service,

process, provider, customer, consumer, environment,
employee, and the competition.
System approach
 Quality must be managed by a system to be
effective
 This system is done for you, as represented by the ISO
9001:2015 standard
 Recall: A system is a set of interrelated or interacting
elements
 System approach is described in Clause 4.1
 Combination of all Clause matches the PDCA
approach to process management - Plan, Do,
Check, Act
System and process approach
 Quality must be managed by a system
 The
system must be managed using the process
approach because the system is made up of
processes
 These processes are linked to each other
A process has inputs , resources, activities,
outputs and customers. Manage them all.
Process approach
Output
requirements

Satisfaction
Input

Customer
Customer

Product
realization our
Or service product

Can be applied to any other

process that we manage

Input Your process Output

Process approach

 Every process require specific inputs, resources, activities, outputs and

customers
 What you can do now is:
 Define and document the inputs
 Define and document the kinds of resources that your process use
 Define and document the activities and their interactions
 Define and document the responsibilities
 Define and document the outputs
 You can name this document as Department Control Plan
 Then execute this plan, and monitor, measure, analyze and improve its
performance (KPI)
 Thus, Plan – Do - Check – Act (Edward Demmings)
Anatomy of a process

Inputs

Resources Process Activities

Every process
Outputs
has an owner
Process management

Input Process Output

Monitor Measure Analyze Improve

PLAN DO CHECK ACT

 General
requirements
Quality
Management
System
Documentation
requirements
Leadership

Support and
OUR QMS
operation

Performance
evaluation

Improvement
Good records management

Enables you to
a) conduct business in an orderly, efficient and accountable manner
b) support and document decision making
c) provide continuity in the event of a disaster
d) meet legislative and regulatory requirements
e) protect the interests of customers, employees and stakeholders
Types of records/ documented
Information to maintain
 through the ISO 9001 standard or your Quality Manual
 Identify the following phrases where they appear: “Documented Information ……
shall be maintained”
 Most of the records requirements are readily available, such as product planning
records, product design records, purchasing records, production records,
monitoring records, analysis records, employee performance appraisal and
training records, job descriptions, organization chart, infra maintenance records,
contract/sales records, marketing records, customer complaints records, etc.
 Records pertaining to the mandatory SOP’s and quality objectives shall be
created.
What to do
 Read quality policy and quality manual
 Establish a Quality Policy for your own Business
 Appoint a Management Representative
 Establish a QMS Committee
 Establish your Quality Manual
 Establish the procedures
 Establish your Quality Plan
 Establish your Department/Process Control Plans
 Establish and document your quality objectives
 Establish your KPI’s and start collecting data
 Implement all the procedures
Key Performance Indicators

 Ask this question when Financials

determining KPI’s:
 As the employee of this
organization, what data will
instantly give me the ability to
Human Balanced
assess overall performance at Capital scorecard
Process

any given point of time?

 Then list all them down and
select your desired KPI’s.

Customers
Quality objectives

 Can be used to benchmark performance based on input

requirements (customer wants 100 units per month, so give them 100
units per month)
 Can be used to improve KPI performance levels – decision must be
based on past performance data and existing capacity to be
realistic
 You can use existing performance levels to establish your quality
objectives
 Use quality objectives to improve on productivity levels, decrease
errors, improve speed, reduce costs, reduce complaints, etc.
Employee responsibility

 Know the Quality Policy

 Aware of the relevance and importance of their activities and how
they contribute to the achievement of the quality objectives
 Comply with the requirements of the QMS, as stated in the Quality
Manual, procedures, Quality Plan, etc.
 Provide feedbacks or ideas about the QMS
 Report any nonconformities
Types of resources

 Determine , provide and manage the following:

 a) Competent human resources (competency assessment, training
needs analysis)
 b) Suitable and well-maintained infrastructures (maintenance of
buildings, hardware, software, transportation, utilities)
 c) Suitable and well-maintained work environment (5S program)
 d) Consider including financial management in your QMS to ensure
product conformity
Why monitor and measure?

 If you cannot measure it, you

cannot improve it. Lord Kelvin
 Measurements provide you
with a baseline to improve
upon.
What do you measure?
1. Customer satisfaction (Survey, returns rate,
complaints, lost business, etc)
2. Process conformance and effectiveness
(internal audit.
3. Process performance (Key Performance
Indicators and quality objectives)
4. Product characteristics (QC inspection
before release to customer) where
nonconforming products must be controlled
Internal audit process
Establish
Distribute Follow-
annual Perform Report
Audit up
audit Audit Findings
Plan actions
schedule

 Purpose is to verify whether your QMS

 a) Conforms to your Quality Plan,
 b) Conforms to ISO 9001 requirements,
 c) Conforms to your QMS requirements, and
 d) is effectively implemented and maintained.
Audit defined
 Audit is a systematic and documented process for gathering
audit evidence and evaluating it against the audit criteria to
determine whether it has been fulfilled
 Audit criteria is a set of policies, procedures or requirements
 Audit evidence is records, statements of fact or other
information which are relevant to the audit criteria and
verifiable
 Audit conclusion is the outcome of an audit provided by the
audit team after consideration of the audit objectives and all
audit findings
  What to ask?
 What records to inspect?
 What activities to observe?
Audit methodology
a) Interviewing the
1. Remember your purpose is to verify conformance and
auditee
effectiveness against a specific requirement.
b) Inspection of
2. That requirement may come from the ISO 9001
ducuments and
Standard, your Quality Manual, SOP, etc.
records, etc.
3. So the answer depends on what audit criteria you
c) Observation of
want to verify
ongoing
4. Remember, your job as an auditor is to look for the
activities
audit evidence, that’s all
5. So use the ISO 9001 Audit Checklist and start auditing.
What do you analyze?

Analyze what you measured:

a) Customer satisfaction levels
b) Internal audit results
c) Product QC inspection results
d) KPI results
e) Suppliers’ performance.
 How do you analyze?
 Line Chart/Trend Chart/Control Chart
 used to detect trends and unusual activities within the data set,
 Pareto Chart Analysis - used to analyze the different components that make up the data value in a
descending order, complete with the cumulative percentage line superimposed on it,
 SWOT Analysis - used to analyze process strengths, weaknesses, opportunities and threats based on
the characteristics of the data set - whether internal or external,
 Arithmetic average or mean - used to identify the average performance value of the process,
 Median - used to identify the actual middle value of the data set,
 Mode - used to identify the most frequent value occurring within the data set,
 Range - used to identify the difference between the lowest and highest values ,
 Standard deviation – used to identify the SD from the mean
 Cause and Effect Analysis - used to analyze the causes and effects of a given data set,
 Risk Analysis - used to identify potential risks given the data set
 Pareto Principle
20% of the causes contributes to 80% of the effects

 Identify and classify all  Analyze your sales figures

problems and identify the
 Calculate cumulative contributors
occurrences up to 80%  Focus your efforts on
customers who contribute
 Focus on solving those
80% of those sales
problems
 Continually improve the  Focus your efforts on the
management of those sales personnel who are
causes managing those customers
What to improve?
 The organization shall continually improve the
effectiveness of the quality management system
through the use of the quality policy, quality
objectives, audit results, analysis of data,
corrective and preventive actions and
management review.
 All nonconformities require corrective actions
 All potential nonconformities require preventive
actions.
Corrective action process
Review
Detect Report
nonconformity
nonconformity Nonconformity
against criteria

Evaluate need
Perform root
fore corrective Issue CAR
cause analysis
action

Implement Record the Verify

corrective results of effectiveness of
action actions taken actions taken.
Risk analysis
Performing a risk analysis on your business Score ratings
processes can help you detect potential
nonconformities 1 = very low
 Describe the risk 2 = low
 Describe the potential effects
3 – moderate
 Quantify likelihood of occurrence
(consider frequency) 4 = high
 Quantify severity of consequence 5 = very high
(consider harm or damage)
 Assign risk rating (likelihood x severity)
 Risk rating > 4 shall be controlled (ALARP
= as low as reasonably practicable)