ISO 9001 REVISION - ALSIalsi.or.id/wp-content/uploads/2015/02/1-ALSI_DIS-9001-2015.pdf · ISO/DIS...

2015-02-17 Asosiasi Lembaga Sertifikasi Indonesia 1

ISO 9001 REVISION Introduction to DIS 9001:2015

by

Titiek S. Sudarti

ALSI

Research & Development

AGENDA

� Introduction

� Annex SL

� Changes to ISO 9001

� Summary

Asosiasi Lembaga Sertifikasi Indonesia

2

INTRODUCTION

� ISO/DIS 9001

� Issued May 2014

� Only the latest stage in the revision process

�Final Draft (FDIS) to follow [current status per

Feb 2015: 90% approval for FDIS]

�Final Publication scheduled for 2015


3

ANNEX SL

� The ISO Technical Management Board (TMB) has produced Annex SL (previously ISO Guide 83) of the Consolidated ISO Supplement of the ISO/IEC Directives

� Annex SL describes the framework for a generic management system

� Framework for all new and revised ISO Standards

� Standardized structure format

� Common text and requirements in many areas

� Will be used for ISO 9001 revision


4

ANNEX SL

� All management system standards will:

� be based on the structure and format set out in Annex SL

� have the same high-level structure, identical core text and common terms and core definitions.

� have discipline-specific requirements concentrated in scope, normative references and clause 8 – Operation

� will be consistent and compatible

� will migrate to this structure and format


5

CHANGES TO ISO 9001

� Structure and Terminology

� Clause structure and some terminology have been changed to

align with other management system standard

� BUT consequent changes on structure and terminology do not

need to be reflected in the organization’s management system

documentation

� Organizational context

� QMS requirements


6

CHANGES TO ISO 9001

STRUCTURE

� ANNEX SL FRAMEWORK:

1. Scope

2. Normative references

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement


7

CHANGES TO ISO 9001

� Terminology: Major changes


8

ISO 9001: 2008 ISO/DIS 9001:2015

‘Products’ ‘Products and services’

‘Documentation’ ‘Records’ ‘Documented information’

‘Work environment’ ‘Environment for the operation of processes’

‘Purchased product’ ‘Externally provided products and services’

‘Supplier’ ‘External provider’

‘Preventive Action’ N/A

‘Exclusions’ N/A

CHANGES TO ISO 9001

ORGANIZATIONAL CONTEXT

� A Quality Management System cannot exist in isolation

� internal and external issues

� needs and expectations of interested parties

� scope of applicability of the QMS

� opportunities and risks these present


9

CHANGES TO ISO 9001

QUALITY MANAGEMENT SYSTEM CONCEPT

� PROCESS APPROACH

� PLAN-DO-CHECK-ACT CYCLE

� RISK BASED THINKING


10

5 Leadership5 Leadership

6 Planning6 Planning9 Performance

evaluation9 Performance

evaluation

10 Continual improvement

CustomerCustomers and other relevant interested

parties

8 Operations

Satisfaction

RequirementsInput Output

Products and services

7 Support processes

4.1, 4.2, 4.3

Establish context, define interested

parties & scope

4.4 QMS

General & process

approach

PROCESS APPROACH

A SINGLE PROCESS MANAGED USING THE

PDCA CYCLE

Act:

Incorporate

improvements

as necessary

Plan the process:

(Extent of

planning depends

on risk)

Do:

Carry out the process

Check:

Monitor / measure

process / performance

Inte

raction w

ith o

ther

pro

cesses

Inte

ractio

n w

ith o

ther

pro

cesses

� One of key purpose of QMS is to act as PREVENTIVE TOOLS.

� The concept of Preventive Action is expressed through RISK BASED APPROACH

� Reduction in some PRESCRIPTIVE REQUIREMENTS, and replaced by PERFORMANCE BASE REQUIREMENTS

� RISK and OPPORTUNITY shall be determined and addressed

BUT

� NO REQUIREMENT for A DOCUMENTED RISK MANAGEMENT PROCESS

RISK BASED THINKING

Quality Management Principles

� Customer focus

� Leadership

� Engagement of people

� Process approach

� Improvement

� Evidence-based decision making

� Relationship management

� Applicability

� Competence

� Organizational knowledge

� Performance evaluation

OTHER CHANGES / NEW

ISO 9001:2015 DIS version; clause 4


16

4Context of the organization

4.1Understanding

the organization and

its context

4.2 Understanding the needs and expectation of

interested parties

4.3 Determining the

scope of the QMS

4.4QMS and its processes



17

5 Leadership

5.1 Leadership and commitment

5.2 Quality policy 5.3 Organizational roles,

responsibilities and authorities



18

6Planning for the quality

management system

6.1Actions to address

risk and opportunities

6.2 Quality objectives and planning to achieve them

6.3Planning of changes



19

7Support

7.1Resources

7.2 Competenc

e

7.3Awareness

7.4 Communicati

on

7.5

Documented information

7: Support

7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring of resources

7.1.6 Organizational knowledge

ISO 9001:2015 DIS VERSION;

CLAUSE 7.1

ISO 9001:2015 dis version; clause 7.5

7.5Documented information

7.5.1General

7.5.2 Creating and updating

7.5.3Control of documented

information


8: Operation

8.1 Operational planning and control

8.2 Determination of requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided products and services

8.5 product and service provision

8.6 Release of products and services

8.7 Control of nonconforming process outputs, products and services

ISO 9001:2015 DIS version; clause 8.2


23

8.2 Determination of requirements for products and services

8.2.1 Customer communication

8.2.2 Determination of requirements

related to products and services

8.2.3 Review of requirements

related to products and services

ISO 9001:2015 DIS version; clause 8.3

8: Operation

8.3 Design and development of products and services

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes


8.4 Control of externally provided products and services

8.4.1 General8.4.2 Type and

extent of control of external providers

8.4.3 Information for external providers


8: Operation

8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.3 Property belonging to customers or external providers

8.5.4 Preservation

8.5.5 Post-delivery activities

8.5.6 Control of changes


9 Performance evaluation

9.1 Monitoring.

Measurement,Analysis and

evaluation

9.2Internal Audit

9.3Management

review

9.1.1 General

9.1.2 Customer satisfaction

9.1.3 Analysis and evaluation


10 Improvement

10.1

General

10.2

Nonconformity and corrective action

10.3

Continual improvement

SUMMARY

ISO/DIS 9001 encourages organizations to use more

external focus in a broader risk-based approach to

Quality Management


29


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Thank you

(Indonesia Certification Body Association)

c/o PT TUV Rheinland Indonesia,

Menara Karya 10th Floor

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Jakarta 12950, Indonesia

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http://www.alsi.or.id

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