understanding of iso 9001:2015 - lapan · pt. catur daya solusi 1 understanding of iso 9001:2015...

PT. CATUR DAYA SOLUSI1

Understanding of ISO 9001:2015

Sabar Kembaren

Date: 01 March 2017

2

Agenda

Why Change to ISO 9001:2015

How to build QMS

Quality Awareness

Understanding requirements and implementation

Summary

01

02

03

04

05


INTRODUCTION

5

• Why Change

to ISO

9001:2015

01


• Decrease the emphasis on Documentation

• Increase the emphasis on Achieving Value for the Organization and

its customers

• Increase emphasis on Risk Management to achieve objectives

Reasons For The Changes (2)

Pre-Course

Discussion


Future Relevance of ISO 9001:2008 (9001 WW Survey Result)

Pre-Course

Discussion


World-wide Survey - Key User Inputs

• ISO 9001, as it is, must change to continue

be relevant

• Integrate with other MSS (EMS etc.)

• Provide one integral approach to the

management of the organization for

Leadership commitment & understanding,

strategic planning, management buy-in

• Need to work with ISO/CASCO and IAF to

ensure efficiency/effectiveness of audits and

address problems in certification audits

• Include tools and risk management

ISO InputFor Future

Pre-Course

Discussion


Summary Changes (Based on ISO9001:2015)

• New revision process for ISO 9001:2015 already underway

• Major changes likely

• Update ISO 9001 to reflect modern business practices, changing business

environment etc, since last major revision

• Provide more emphasis on achieving product conformity

• Simplification of language

• Improve compatibility with other management system standards

• Validation projects will be undertaken with users

• Scheduled publication date is September 2015

• We will be working closely with IAF to define transition policy at the

appropriate time


Competence The organization implementing a QMS would have to

identify the "competence" necessary for personnel doing work that

affects its quality performance, as well as ensuring that those

personnel are competent to do so. Competence would be defined as

the "ability to apply knowledge and skills to achieve intended results".

Documented Information The terms "document“ and "record" used in

ISO 9001: 2008 would both be replaced throughout the new

requirements by the phrase "documented information".

QMS ISO9001: 2015


External Provision of Goods and Services An organisation would be

required to take a risk based approach to determine the type and extent of

controls appropriate to all types of external provider (whether it is by purchasing

from a supplier, for example, or through the outsourcing of processes and

functions, etc.) and all external provision of goods and services.

Exclusions There would no longer be any requirement to identify any QMS

requirements that could not be applied due to the nature of the organisations

business (clause 1.2 in ISO 9001: 2008). This is because a different approach

has been taken to the way in which the requirements of the revised version of

ISO 9001 have been stated, so there would no longer be any reasons for an

organization’s QMS not to be able to meet all the requirements of the future

standard.

QMS ISO9001: 2015


Goods & Services Reference to "product" (as in ISO 9001 : 2008)

would be replaced by the phrase "goods and services".

lmprovement The term "continual improvement" would be changed to

just "improvement".

lnterested Parties An organization seeking to implement a QMS would

have to determine who are the "interested parties" relevant to its QMS,

as well as identifying what the requirements of those interested parties

are. An interested party (also referred to as a "stakeholder") would be

defined as any person or organization that can affect, be affected by, or

perceive themselves to be affected by a decision or activity of the

organization implementing the QMS.

QMS ISO9001: 2015


Preventive Action There would no longer be a specific requirement

for "preventive action". This main reason given for this is that one of

the key purposes of a QMS is to act as a preventive tool anyway.

Process Approach There would be a specific requirement for

organizations to apply a process approach to their QMS as well as a

list of requirements identifying the essential elements of such an

approach.

QMS ISO9001: 2015


Risks and Opportunities When planning for its QMS the organization

would have to identify the risks and opportunities that need to be

addressed to ensure that the QMS can achieve its intended outcome(s).

Having done this, the organization would have to plan actions to address

these risks and opportunities, integrate and implement them into its QMS

processes and evaluate the effectiveness of these actions.

ISO 9001: 2008 Transition The current intention is that the transition

period for users of ISO 9001: 2008 to transfer to the new version of this

Standard would be three years , though this has still to be formally

ratified.

QMS ISO9001: 2015

15

• How to Build

QMS?

02


Key terms and definitions

Management ?“Coordinated activities to direct and

control an organization”

Quality Management ?“Management with regard to

quality”

Quality Management System ?“Management system with regard

to quality”


Key concepts (1): Process

With what?(resources)

Outputs? (what,to whom)

What results?(monitoring, measurements, performance indicators)

Inputs? (what, from whom)

How done?(criteria, methods/controlsdocumentation)

With who?(responsibilities,authorities)

PROCESS


Key concepts (2): Process Approach

A Coherent System:

Understanding

requirements

Intended

results

Consistent,

predictable results

Meeting requirements

Customer satisfaction

Activities

understood

and managed as

interrelated

processes

Processes adding value

Processes providing effective performance

Improvements (through evaluation) of data/information

PDCA (process) methodology

(Interactions)

(Outputs)

(Inputs)

Process


• Questions:

• Who is the owner of Process?


2

0 Process Classification

Core Process/

Realization Process

Supporting Process

Interested

Parties

/Customers

Management

Process

Interested

Parties

/Customers

Monitoring, Measure,

Analysis

and Improvement Process


Build your own Process for your organization


•Supporting Process

- Documented Information Process (prev. Control

of document and records)

- Control of infrastructure

- Corrective and preventive maintenance

- Recruitment

- Training & Human Development

- Waste control

•Management & Planning

- Setup Policy, Objective and Target

- Business Risk Analysis/SWOT

- Management Review

Common Process explore from ISO-MS

MMA Process

- NC Corrective Action

- Internal Audit

- Customer Satisfaction Measurement

- Accident Investigation

Realization Process (Depend of Organization)

- Production

- In-Process Inspection

- Final Inspection

- Warehouse

- Complaint Handling

- Etc.

23

• Quality

• Awareness

03


What is quality?

•Comply and Exceed expectation and need of customer and continuous improvement

William Edwards Deming (1900-1993)

•Quality mean Compliance with requirements Philip Bayard Crosby

(1926-2001):

•Quality mean Compliance with userJoseph Moses Juran

(1904 – 2008)

•Quality mean customer satisfactionKaoru Ishikawa (1915 – 1989)

• Degree to which a set of inherent characteristics (3.5.1) fulfils requirements (3.1.2)

ISO 9001


Quality Management System Evolution

Non Quality Culture

Quality Inspection

Quality Control

Time

Q Performance

ZERO DEFECT

ZERO DEFECT CONTINUOSLY

ZERO DEFECT CONTINUOSLY &

CUSTOMERS SATISFCATIONQuality

Assurance

CUSTOMERS SATISFCATION CONSISTENTLYQUALITY

MANAGEMENT

(ISO 9001:2008)

ZERO DEFECT CONTINUOSLY &

INTERESTED PARTIES SATISFCATION

(ISO 9001:2015)

SUSTANAIBILITY

COMPLIANCE

PERFORMANC E


ISO 9000 Series evolution

ISO 9001 historical change

1st edition :

ISO 9001:1987

ISO 9002:1987

ISO 9003:1987

2nd edition :

ISO 9001:1994

ISO 9002:1994

ISO 9003:1994

3rd edition :

ISO 9001:2000

4th edition :

ISO 9001:2008BS 5750

Part 2:1979

5th edition :

ISO 9001:2015

28

• Understanding

Requirements

and

implementation

04


PLAN DO CHECK ACT

4 Context of the organization

Understanding of the organization and its context

Expectations of interested parties

Scope of the QMS

Quality ManagementSystem

5 Leadership

Leadership andcommitment

Policy

Roles, responsibilities and authorities

6 Planning

Actions to address risk and opportunity

Quality objectivesand planning to achieve them

7 Support

Resources

Competence

Awareness

Communication

8 Operation

Operationalplanning and control

Determination of market needs and interactions with customers

Operational planning process

Control of externalprovision of goods and services

Development of goods and services

9 Performance Evaluation

Monitoring, measurement, analysis and evaluation

Internal audit

Management review

10 Improvement

Nonconformity and corrective action

Continual improvement

Documented information

Planning Changes

Production of goods and provision of services

Release of goods and services

Nonconforming goods and services

High Level Structure Process Flow – QMS ISO9001: 2015

TEN CLAUSES


Context of the

Organization

1. Understanding the organization and its context

2. Understanding the needs and expectation of interested parties

3. Determining the scope of the quality management system

4. Quality management system (QMS)4Q:2008 : 4.1, 4.2.2, 5.2

“SO

LU

TIO

N F

OR

YO

UR

BU

SIN

ES

SCitizens

Customers

Distributors

Shareholders

Investors

Owners

Insurers

Government

Regulators

Recovery service suppliers

The Organization

Management

• Top Management

• Those accountable for Quality policy and implementation

Those who implement and maintain the QMS

• Those who maintain QMS and risk procedures

Other Staff

Contractors

Competitors

Media

Commentators

Trade groups

Neighbors

Pressure groups

Emergency services

Other response agencies

Transport services

Staff dependents

4.1. Understanding the organization and its context

4.2. Understanding the needs and expectations of interested parties

4.3. Determining the scope of the QMS4.4. QMS and its Processes


There will be many people, entities, and organizations which will be either

interested in or have an impact on, the environmental performance of the

organization and its activities.

It is important to consider who is affected or involved in the environmental

related activity

Understanding the needs and expectations of

interested parties

Organization

Employees

Competitors

Supply Chain

Government

Non-

governmental

organisationsCommunities

Customers

Owners and

Financial

Community

Company

Decision

MakersRecruitment and

retention

Access to

capital

Changing

markets

Informed

decisions

Social

license to

operate

Reputational

Risk

Regulatory

Constraints

Input Costs

Competitive

advantage


Understanding the needs and expectations

of interested parties

What are the stakeholder’s needs and expectations?

An organization is expected to gain a general (i.e. high-level, not detailed)

understanding of the expressed needs and expectations of those internal and

external interested parties that have been determined by the organization to

be relevant

Which ones become obligations?

Some interested party are mandatory because they have been incorporated

into laws, regulations, permits and licenses by governmental or even court

decision.

The organization may decide to voluntarily agree to or adopt other

requirements of interested parties


Determining the scope

The scope is - physical boundaries and organizational boundaries

It is not permissible to exclude activities, products and services from the

control of the EMS if included within the identified scope

When determining the scope, the organisation shall considered:

• External and internal issues

• Compliance obligations

• Organizational units, functions and physical boundaries

• Activities, products and services

• Authority and ability to exercise control and influence

A scope statement must be documented and made available to

interested parties


Leadership

1.Leadership and Commitment

2.Policy

3.Organizational role, responsibility and authoritirs5Q:2008 : 5.1, 5.3, 5.5


5. Leadership

5.1. Leadership and commitment

Leadership and commitment for the quality management

system

Customer focus

5.2. Policy

5.3. Organizational roles,

responsibilities and authorities


5.2 Policy

provides a framework for setting objectives

appropriate to the purpose

and context of the organization

communicated, understood and applied within the

organization

available to interested parties

maintained as documented information

Top management shall establish, implement and maintain an environmental policy

includes a commitment to fulfil

its compliance obligations

includes a commitment

to continual improvement


5.3 Organizational roles, responsibilities and authorities

Top management shall ensure that the responsibilities and authorities for relevant

roles are assigned and communicated within the organization.

Top management shall assign the responsibility and authority for:

a) ensuring that the management system conforms to the requirements of this

International Standard;

b) reporting on the performance of the management system, including

environmental performance, to top management

b) ensuring that the processes are delivering their intended outputs;

d) ensuring the promotion of customer focus throughout the organization;

e) ensuring that the integrity of the quality management system is maintained

when changes to the quality management system are planned and

implemented.

QMS

Common


Planning

1.Actions to address risk and

opportunities

2.QMS Objectives and planning to

achived them

3.Planning Change6Q:2008 : 4.1, 5.4.1, 5.4.2, 6.4,

7.1, 7.2, 7.3, 7.4, 7.5


Clause 6: Planning

Plan actions to address risks and opportunities

Determine risks and opportunities

4.1

9.2

6.1

6.1

Issues

6.1. Actions to address risks and opportunities6.2. Quality objectives and planning to achieve them6.3. Planning of changes


Control It

Share orTransfer It

Diversify orAvoid It

RiskManagement

ProcessLevel

ActivityLevel

Entity Level

RiskMonitoring

Identification

Measurement

Prioritization

RiskAssessment

Risk Analysis


Risk assessment tools

Likelihood of loss

Severity of loss

Slight Moderate Extreme

Very unlikely Very low risk Very low risk High risk

Unlikely Very low risk Medium risk Very high risk

Likely Low risk High risk Very high risk

Very likely Low risk Very high risk Very high risk

Simple risk estimator

Copyright © 2013 BSI. All rights reserved.

Organization

objectives

progressing

Current

Situation

OBJECTIVE AND EFFORT OF THE WHOLE

INSTITUTION

Future

Situation

Risk Analysis

Vision

Mission

Performance

indicators

Risk A

Objectives A

Risk B

Objectives B

Risk C

Objectives C


• Planning/implementing QMS changes (6.3),

• Controlling operational changes, planned and unintentional (8.1)

• Addressing unplanned changes affecting products & services (8.5.6)

• See also 7.1.6 Organizational knowledge - for addressing changing needs

and trends, with respect to knowledge

6.3. ‘Planning of Changes’


Support

1.Resources

2.Competence

3.Awareness

4.Communication

5.Documented information7Q:2008 : 4.2, 5.5.1, 5.5.3, 6.1, 6.2, 6.3, 7.2.3


7.1 Resources

Human resources - specialized skills and knowledge

Natural resources

Infrastructure - organization’s buildings, equipment,

underground tanks and drainage system

Technology and financial resources.


7.1.6 Organizational knowledge

The organization shall determine the knowledge necessary for the operation of its

processes and to achieve conformity of products and services.

This knowledge shall be maintained and be made available to the extent

necessary.

When addressing changing needs and trends, the organization shall consider its

current knowledge and determine how to acquire or access any necessary

additional knowledge and required updates.

NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by

experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2 Organizational knowledge can be based on:

a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from

failures and successful projects; capturing and sharing undocumented knowledge and experience; the

results of improvements in processes, products and services);

b) external sources ( e.g. standards; academia; conferences; gathering knowledge from customers or

external providers).


7. 2 Competency

The organization shall:

a) determine the necessary competence of person(s) doing work under

its control that affects its environmental performance and its ability to

fulfil its compliance obligations; person(s) doing work under its

control that affects the performance and effectiveness of the QMS

b) ensure that these persons are competent on the basis of appropriate

education, training or experience;

c) determine training needs associated with quality management

system;

d) where applicable, take actions to acquire the necessary

competence, and evaluate the effectiveness of the actions taken.


7.3 Awareness

The organization shall ensure that persons doing work under the organization’s

control are aware of:

a) the quality policy;

b) their contribution to the effectiveness of the environmental management

system, including the benefits of enhanced quality performance; effectiveness

of QMS,

d) the implications of not conforming with the quality management system

requirements, including not fulfilling the organization’s compliance obligations


Interaction

Job roles-Competency-Training-Promotion

Standard of

Competency

Level

Competency

Level

Measurement

Gap of

Competency

analysis

Training Need

Analysis

Company

Business

Planning

Training

Execution

Training

Effectiveness

Evaluation

Suggestion

from

Department

Training

Plan

Job Roles,

Responsibility

and Authority

Promotion &

Career

developmentImpact, Risk &

Opportunity

evaluation

result

Applicable

Legal

Organization

Structure


7.4 Communication

Internal communication and

External communication

Equal treatment

Decide on communicating significant aspects

externally

Consistent and reliable communications

The organization shall determine the internal and external communications

relevant to the IMS management system, including:

a) on what it will communicate;

b) when to communicate;

c) with whom to communicate;

d) how to communicate;

e) who communicates.


7.5 Documented information

Focus on the implementation of the quality management

system and on quality performance, not on a complex

documented information control system.

Documented information does not require manual, and

may be integrated with other information management

systems implemented by the organization.

Documented information can include:

paper

electronic documents maintained on computers and

remote servers.


Operation

1. Operational Planning and Control

2. Determination of market needs and interactions with customers

3. Operational planning process

4. Control of external provision of goods and services

5. Development of goods and services

6. Production of goods and provision of services

7. Release of goods and services

8. Nonconforming goods and services

9.

8Q : 6.4, 7.1, 7,3, 7.5.1, 7.5.2,

8.2, 8.3


Operational Planning and Controls

Operational Planning and Controls should:

1. Plan, implement and control the processes (see 4.4) needed to meet

the requirements for the provision of products and services (QMS)

2. To implement the actions identified in 6.1 and 6.2, by:

– — establishing operating criteria for the process(es);

– — implementing control of the process(es), in accordance with the

operating criteria.

3. The organization shall control planned changes and review the

consequences of unintended changes, taking action to mitigate any

adverse effects, as necessary.

• The organization shall ensure that outsourced processes are

controlled or influenced. The type and extent of control or influence to

be applied to the process(es) shall be defined within the environmental

management system.


Performance

Evaluation

1.Monitoring, measurement, analysis and

evaluation

2.Internal Audit

3.Management Review9Q: 2008 : 5.6, 8.2, 8.3, 8.4


Performance evaluation

Determine

monitoring

required

Global performance

indicators

Performance

indicators specific to

an activity or piece of

equipment

Compliance

obligations

Commitment

confirmation

and authority to

act

Objectives

Evaluated

performance

Non-conformity

management

Results analysis

and performance

evaluation

Conformity

evaluation to

operational

requirements

“SO

LU

TIO

N F

OR

YO

UR

BU

SIN

ES

SINTERNAL AUDITS

Confirm:

QMS confirms to the requirements of the standard

QMS Properly implemented and maintained

QMS Effectiveness

Provide information to management

Identify opportunities for improvement

!!! Selection of auditors and conduct of audits shall ensure

objectivity and impartiality


Management review

Involve Top Management

• Determine if QMS is

• Continuingly Suitable

• Adequate

• Effective

• Determine if QMS needs to be CHANGED

NEED:

- Management Review Schedule

- Documented Minutes

“SO

LU

TIO

N F

OR

YO

UR

BU

SIN

ES

SMANAGEMENT REVIEW

Previous actions/status

External/internal issues

N/C’s,corrective actions

Monitoring/Measurement

Audit results

Customer satisfaction

External providers

Adequacy ofresources

CONSIDER:

REVIEW

QMS performance

Risks andopportunities

Continual improvement (C.I)

Opportunities (C.I)

Changes to QMS

Resource needs

Doc. Information

WHAT NEEDSTO CHANGE?

! !

Communication


Improvement

1.Nonconformity and corrective action

2.Continual Improvement10Q : 8.5.1, 8.5.2, 8.5.3


Improvement: Nonconformity and

corrective action


Nonconformity and corrective actions

“React” to the non-conformity:

Actions to control it

Deal with the “consequences

Eliminate the cause

Review

Determining their cause

Other similar nonconformities do or potentially could exist

Implement actions

Review the effectiveness

Changes if necessary to the QMS

63

• Summary

05


Summary• Building process of organization based on organization needed

• New management system standard based on HLS

• Context organization to sustainability of organization

• Leadership engagement

• Planning including risk and opportunity and in aligned with objective, target

and program

• Support process deeper in organizational knowledge management,

managing of work environment, awareness, communication, and

documented information

• Operation: control all aspect influence quality to meet quality by clearly

determined requirement of process, proper operational control,

preservation and after services)

• Performance evaluation on QMS including quality performance,

achievement of target, management performance

• Improvement including control of NC


Any Questions?


TERIMA KASIH

PT. CATUR DAYA SOLUSIHead Office:

The CEO Building Level.12Jl. TB Simatupang No. 18c Jakarta 12430

Operasional Office:Kawasan Citragrand Blok R3 No 30, Jl. Alternatif Cibubur Km 3

Telp.021-84300011

understanding of iso 9001:2015 - lapan · pt. catur daya solusi 1 understanding of iso 9001:2015...

Documents