iso 9001:2015 overview: revisions & impact - part 1

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ISO9001:2015 Overview

Welcome

Revisions & Impact

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Jawaid.Mansour@us.dqs-ul.com

Joe Mansour Lead Auditor/ISO9001:2015

Program Manager

760-458-3879 (office/cell)

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www.ul-dqsusa.com

http://ul-dqsusa.com/iso-90012015/

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Today’s Presentation - ISO9001:2015

• Highlight Changes since October 2014

• Review Clause 0 of the Standard. Establish timeline for

three more webinars, each covering various sections of

the Standard

• Overall structure of the Standard

• Provide UL DQS’s transition plan for all registered clients

• Provide UL DQS’s Client Internal Auditor Training/

Certification Plan details.

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Roadmap ISO 9001:2015

Initial Release: based on BS5750

1994: element based - 20 sections.

2000: Radical Change:Process Based

2008: Minor Revisions

2015 2000 1994 1987

Significant

Changes

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Changes Since October 2014

• Development is on track for FDIS in June/July 2015.

• Standard to be published by September 2015.

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High Level Structure

1. Scope

2. Normative reference

3. Terms and definitions

4. Context of the organization

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards; some subclauses mandated as well.

Based on 7 Quality Management Principles

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9001:2008 ISO/DIS 9001

4 4 5.5.3 7.4 7.2.3 8.2.1 7.5.4 8.5.3

4.1 4.4 5.6 9.3 7.3 8.5 7.5.5 8.5.4

4.2 7.5 5.6.1 9.3.1 7.3.1 8.3, 8.3.1, 8.3.2 7.6 7.1.5

4.2.1 7.5.1 5.6.2 9.3.1 7.3.2 8.3.3 8 9.1

4.2.2 4.3, 7.5.1, 4.4 5.6.3 9.3.2 7.3.3 8.3.5 8.1 9.1.1

4.2.3 7.5.2, 7.5.3 6 7.1 7.3.4 8.3.4 8.2 9.1

4.2.4 7.5.2, 7.5.3 6.1 7.1.1, 7.1.2 7.3.5 8.3.4 8.2.1 9.1.2

5 5 6.2 7.2 7.3.6 8.3.4 8.2.2 9.2

5.1 5.1, 5.1.1 6.2.1 7.2 7.3.7 8.3.6 8.2.3 9.1.1

5.2 5.1.2 6.2.2 7.2 , 7.3 7.4 8.4 8.2.4 8.6

5.3 5.2 6.3 7.1.3 7.4.1 8.4.1,8.4.2 8.3 8.7

5.4 6 6.4 7.1.4 7.4.2 8.4.3 8.4 9.1.3

5.4.1 6.2 7 8 7.4.3 8.6 8.5 10

5.4.2 6, 6.1, 6.3 7.1 8.1 7.5 8.5 8.5.1 10.1, 10.3

5.5 5 7.2 8.2 7.5.1 8.5.1, 8.5.5 8.5.2 10.2

5.5.1 5.3 7.2.1 8.2.2 7.5.2 8.5.1 8.5.3 Clause removed

5.5.2 5.3 7.2.2 8.2.3 7.5.3 8.5.2 see 6.1

ISO9001:2008 vs. ISO/DIS 9001

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Notable Changes

- Quality Manual

- Management Representative

- Preventive Action

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Notable Changes

If a quality manual is currently written to reflect the ISO

9001:2008 standard, does it have to be re-written to

reflect the now 10 instead of 8 sections?

No, assuming that the Quality Manual does not provide any

contradictory information concerning the requirements of

ISO9001:2015. However, the requirements of the two

standards are significantly different. Upgrading the Quality

Manual to comply with the requirements of the new standard

may be a valuable effort to better identify the deficiencies

within the organization and to have them addressed prior to

the upgrade audit. Renumbering of the pages and/or

sections is not essential as the new standard does not

even require that a Quality Manual be maintained.

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Notable Changes

If a company has a manual based on standard

requirements, won’t they need to update to reflect process

approach?

There is no requirement for a quality manual in the draft for

2015. The new standard also requires that the processes be

identified and that their interaction be defined. The internal

audit process must use the “process approach”. The process

approach requirement has not changed. However, although

the “Process Approach” was noted in the ISO9001:2008

standard, the new standard explicitly requires the use of the

“Process Approach” when implementing the Quality

Management System.

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Notable Changes

If a company has a manual based on standard

requirements, won’t they need to update to reflect

process approach?

……….. Furthermore, the new standard requires the top

management to demonstrate leadership and commitment by

promoting awareness of the “Process Approach” within the

organization. Since a Quality Manual is no longer required,

the “documented information” required by the standard may

be in any media or format.

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Notable Changes

- Quality Manual

- Preventive Action

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Notable Changes

You mentioned that a management representative is

not required any more. How about MRM?

Although the requirement for having a management

representative has been removed, the new standard

now allows for multiple individuals to be responsible for

different aspects of the quality management system

(Process owners, instead of just one person for the

entire system). Management is now required to identify

the responsibility and authority of the personnel affecting

quality. Section 9.3 of the Standard clearly defines the

requirements for the Management Review Process. It is

an essential part of the PDCA cycle for performance

evaluation.

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Notable Changes

- Quality Manual

- Preventive Action

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Notable Changes

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Notable Changes

PROCESS INPUT OUTPUT

P-D-C-A ISO9001:2008 Preventive

Action

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Notable Changes

P-D-C-A

ISO9001:2015

Risk Based Thinking

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Notable Changes

P-D-C-A

ISO9001:2015

Risk Based Thinking

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Notable Changes

- New additions:

- “Documented Information” = Documented Procedure

(appears 17 times)

- “Documented Evidence” = Quality Records

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Notable Changes

- New additions:

- The explicit need to have the QMS use the Process

Approach (implement, maintain and audit the value-

added activities as a process)

- Managing the processes using the Plan-Do-Check-

Act cycle Using Risk-based thinking for

“establishment, implementation, maintenance and

continual improvement” of the quality management

system,

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Notable Changes

- New additions:

- Understanding the needs of the organization and

expectations of their interested parties and

stakeholders.

- Actions to address Risks and Opportunities. A formal

Risk Based program, such as the one defined in

ISO31000 may be suitable for some organizations,

but not mandated.

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Notable Changes

- New additions:

The overall emphasis on the stakeholders is

to ensure long term business success.

Internally, organizations can benefit from

these requirements as well by considering

the guidance set forth in ISO 9004.

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Upcoming Webinars

1. Scope

5. Leadership March 25, 2015

6. Planning

7. Support April 29, 2015

8. Operation

9. Performance evaluation May 26, 2015

10. Improvement

ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.

And, one more after FDIS is issued to discuss the changes. .

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Introduction “Forward” Section

- 0.1 General

- 0.2 The ISO Standards for Quality Management

- 0.3 Process Approach

- 0.4 Plan-Do-Check-Act Cycle (PDCA)

- 0.5 “Risk-Based Thinking”

- 0.6 Compatibility with other management system

standards.

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Introduction

0.1 – General

The adoption of a quality management system ought to be a

strategic decision for an organization.

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0.1 – General

a) its specific objectives

b) the risks associated with its context and

objectives

c) the needs and expectations of its customers and

other relevant interested parties

d) the products and services it provides

e) the complexity of processes it employs and

their interactions

f) the competence of persons within or working on

behalf of the organization

g) its size and organizational structure

Design & Implementation of QMS is influenced by the

context of the organization

Determine the issues and requirements that can impact on the planning of

the Quality Management System.

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0.2 - Additional Sections

0.2 – The ISO standards for quality management

• ISO9001:2015 Standard (one of the 3 core standards)

• ISO9000 – Fundamentals and vocabulary

• ISO9004 – Managing for the sustained success of an

organization (lead to continual

improvement of the organization)

• - ISO10000 numbered standards

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0.2 - ISO 10000 numbered standards

0.2 – GUIDELINES

ISO10001 Customer Satisfaction

Guidelines ISO10012 Management of

measurement processes

ISO10002 Customer Satisfaction –

handling complaints ISO10013 QMS Documentation

ISO10003 Customer Satisfaction –

External Dispute ISO10014 Realizing financial and

economic benefits

ISO10004 Monitoring and Measuring

Customer Satisfaction ISO10015 Guidelines for Training

ISO10005 Guidelines for Quality Plans ISO10017 Guidance on Statistical

Techniques

ISO10006 Guidelines for Quality

Management in Projects ISO10018 Guidance on People

Involvement & Competence

ISO10007 Guidelines for Configuration

Management ISO10019 Guidelines for the selection

of QMS consultants

ISO10008 Guidelines – Electronic

Commerce ISO19011 Guidelines for auditing

management systems

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0.3 – Process Approach

“set of interrelated or interacting

activities which transforms inputs

into outputs”

Document: ISO/TC 176/SC 2/N544R3 Guidance on the Concept and Use of the Process Approach

(http://www.iso.org/iso/04_concept_and_use_of_the_pr

ocess_approach_for_management_systems.pdf )

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0.3 - Benefits of Process Approach

Benefits of the process approach are:

• Integration and alignment of processes to enable achievement of

desired outcomes

• Ability to focus effort on process effectiveness and efficiency.

• Provision of confidence to customers, and other interested

parties, about the consistent performance of the organization.

• Transparency of operations within the organization.

• Lower costs and creation of shorter cycle times, through the

effective use of resources.

• Improved, consistent and predictable results.

• Provision of opportunities for focused and prioritized

improvement initiatives.

• Encouragement of the involvement of people and the clarification

of their responsibilities.

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0.3 - Definition of Process

• Production Processes (stamping, welding, painting)

• Management Processes (administration, audits, CAR, HR)

• Support Processes (maintenance, warehouse, purchasing)

• Customer Processes (sales, customer satisfaction)

activities which transforms inputs into

outputs”

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0.3 - Identification/Interaction of Processes

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0.3 - Process Map - Example

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0.3 - NOT A PROCESS MAP

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0.3 - Definition of Process

• Production Processes (stamping, welding, painting)

• Management Processes (administration, audits, CAR, HR)

• Support Processes (maintenance, warehouse, purchasing)

• Customer Processes (sales, customer satisfaction)

activities which transforms inputs into

outputs”

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0.3 - Process Approach

From Section 0.3:

This International Standard promotes

the adoption of a process approach

when developing, implementing and

improving the effectiveness of a quality

management system, to enhance

customer satisfaction by meeting

customer requirements.

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0.4 – Plan-Do-Check-Act Cycle

P-D-C-A

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STAMPING

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PROCESS

(DO) INPUT OUTPUT

STAMPING

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PROCESS

(DO) INPUT OUTPUT

Parts Per Million

Machine Up Time

Parts Per Hour

Cost of Quality -

rework

STAMPING

Process

Effectiveness

Internal Process

Efficiency

Internal Process

Efficiency

Internal Process

Efficiency

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PROCESS

(DO) INPUT OUTPUT

Parts Per Million

Machine Up Time

Parts Per Hour

Cost of Quality -

rework

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PROCESS

(DO) INPUT OUTPUT

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0.5 – “Risk Based Thinking”

0.5 – Risk-based thinking

- concept has always been implicit in ISO9001:2008

- ISO9001:2015 makes it more explicit

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Notable Changes

P-D-C-A

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a) Incorporated in requirements for the

establishment, implementation, maintenance and

continual improvement of the QMS.

b) May Use ISO31000 - but not required.

c) Not all processes represent the same level of risk.

d) Considering Risk “qualitatively” to define the

QMS, processes and activities.

Risk is the effect of uncertainty on

an expected result.

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Document N1222 published by ISO/TC 176/SC2.

Document:ISO/TC176/SC2/N1222Guidance on the Concept and Use of the Process

Approach

http://isotc.iso.org/livelink/livelink/open/tc176SC2public

Look for presentation on “ISO9001 and Risk” at the end of

section 7. Also, article N1221 in section 1.

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0.6 – Compatibility

- ISO/IEC Directives, Part 1, Consolidated ISO

supplement, 2013, Annex SL,

High level structure and common text is public information and can be

found in Annex SL of the www.iso.org/directives

Organizations implementing multiple management

systems (e.g. quality, environmental, information

security) can achieve better integration and easier

implementation

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High Level Structure

1. Scope

5. Leadership

6. Planning

7. Support

8. Operation

9. Performance evaluation

10. Improvement

ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards; some subclauses mandated as well.

Based on 7 Quality Management Principles

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Transition Plan

UL DQS

TRANSITION

PLAN ISO9001:2008 TO ISO9001:2015

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Transition Plan

September 2015: Start of 3 years transition period to September 2018

2018 2017 2016 2015

September 2015: Published International Standard

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An organization may be upgraded to

ISO9001:2015

- as part of its scheduled Recertification

Audit;

- in a planned manner through the

Continuous Assessment process with

additional audit time, or

- through a Special Transition Audit.

Transition Plan

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The most cost-effective way is to

upgrade during the normally

scheduled Recertification Audit.

Upgrade audits done as part of the

Continuous Assessment and Special

audits will be carried out for the same

number of days as a recertification

audit (including Stage 1 and Stage 2)

2008 to 2015 Transition

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Topics to be verified during readiness review: (in addition to verification of fulfillment of changed requirements)

Resonsibilities / actions

Knowledge about the changed requirements

Identification of gaps and action needs

Action plan / responsible persons

Awareness building in the organization

Focus:

Context of the organization, leadership, and planning

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Is a complete MR and internal audit expected

before certification against ISO 9001:2015?

Yes; Management review and internal audit on the

basis of ISO 9001:2015 have to be completed before

a certificate on ISO 9001:2015 can be issued. Stage

1 (readiness review) can be carried out before

management review and a complete audit but the

need to complete it before stage 2 will be addressed

in the audit report.

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Stage 1 Stage 2

Newly Implemented

< 3 years

Maintained / Monitored

Effective / Mature (including Process Approach and

Risk-Based Thinking)

On Site On Site

Off Site On Site

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Please let your Customer Service

Representative know well in advance

of your audit when you are ready to

upgrade.

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Client Internal Auditor Training Plan

ISO9001:2008 to ISO 9001:2015

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On Site Overview

Webinar

Client Internal Auditor Certification

Program

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On Site Overview

One Day on-site presentation

Provide Overview of the Standard

No Certificate Issued

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Webinars:

Done By Cindy Soltis - October 2014

February 18 2015 (provide update,

announce the transition plan, the

Internal Auditor Certification program

and section 0 of the Standard)

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Webinars: In-depth review of the

requirements

March 25, 2015 Sections 1-6

April 29, 2015 Sections 7-8

May 26, 2015 Sections 9-10

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Internal Auditor Certification Program

Internal Auditor Certification

Program

Partner up with the clients

Let you know what we know!

Complete the UL DQS on line training

module and test.

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Internal Auditor Certification Program

Client Certification

Attend a 2 day Training Session in

person (locations to be determined)

and participate in case studies.

Get a Certificate of Training.

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Please let your Customer Service

Representative know well in advance

if you are interested in receiving

Internal Auditor Training from

UL DQS

http://ul-dqsusa.com/iso-90012015-training

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Questions?

ISO9001_2015_Questions@us.dqs-ul.com

Please send your questions to:

Next Webinar: March 25, 2015

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Questions?

Contact me:

Joe Mansour

ISO9001:2015 Program Manager

ISO9001_2015_Questions@us.dqs-ul.com

Please send your questions to:

Next Webinar: March 25, 2015

iso 9001:2015 overview: revisions & impact - part 1

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