The PDF version of this presentation contains additional ...€¦ · conformity assessment services, including programs for certification of personnel, products and services, registration

Introduction to ISO 9001:2015Quality Management Systems

June 23, 2015National Arts Centre, Ottawa, ON

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Today’s Agenda

• Welcome and Introductions• What is ISO• What is ISO 9001• Upcoming changes in 2015• Why implement ISO 9001• Costs and benefits of implementation• Steps to implement• The registration process• Questions & answers• Feedback

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Canadian Public Sector Excellence NetworkMember-based non-profit volunteer organization dedicated to supporting Canadian public sector professionals in implementing organizational excellence.

Membership is free. Go to www.cpsen.ca and click on the membership tab in the top menu.

4 free NCR member morning networking events annually.

Annual NCR Canadian Public Sector Excellence Fair.

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Mandate

• The CGSB is mandated by an Order in Council and accredited by the Standards Council of Canada (SCC) to provide standards development and conformity assessment services, including programs for certification of personnel, products and services, registration of quality (ISO 9001) and environmental management systems (ISO 14001), as well as advisory services.

• These services are provided in support of socio-economic, regulatory, procurement, health, safety, trade and environmental interests of Canada.

Canadian General Standards Board

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Timeline

1934 The Canadian Government Purchasing Standards Committee (CGPSC) established in the National Research Council

1965 CGPSC transferred by order in council to the former Department of Defence Production (now PWGSC)

1980 CGPSC renamed the Canadian General Standards Board (CGSB)

1996 CGSB becomes a registrar for ISO 9001 and ISO 14001

1998 Re-confirmation of role and mandate through an order in council to provide services to the public and private sectors, nationally and internationally.

2012 Mandate shifts to focus service provision to public sector clients.

History

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• Staff on Strength : currently 30 FTE Indeterminate

• Network of more than 4,000 volunteers, providing subject matter technical expertise on active CGSB committees and review panels

• Charter participant of the National Standards System (NSS)

• CGSB is the only Federal Standards Development organization Accredited by the Standards Council of Canada (SCC)

• CGSB is the only Federal ISO 9001 and 14001 registrar Accredited by the Standards Council of Canada (SCC)

• CGSB is a unique centre of expertise within the Government of Canada on standards and certification of personnel, products and organizations

CGSB - Key Facts

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HUMAN

• ISO 9001 Implementation• Internal QMS Audit team training• Integrated Management Systems• Business Excellence Programs

• Strategic Planning• Process Improvements• Assessments and Evaluations• Customized Quality Workshops

Located in the National Capital Region

New job stressing you out?Awesome start to finish implementation guidanceat group rates

Coming this FallThe ISO 9001 Club

www.iso9001club.com

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Presenter

Presentation Notes

Based in Canada’s National Capitol Region, HUMAN has been helping organizations since 1997 with their quality management and business excellence needs. We provide expert facilitation, wise consultation, interactive workshops and other tools that bring about structure, awareness and success to whatever improvement initiative they plan. We think that it's important that you see the light at the end of the tunnel before you make any decisions. That's why we are offering a free 2 hour planning session, either at your location or via conference call. We'll help you by discussing your needs and expectations, and answer any question we can about the subject. Then we'll assist you and your team by advising what steps you could take to realize success. HUMAN provides start to finish ISO 9001 professional implementation guidance. For those on a very tight budget, you may want to consider joining the ISO 9001 Club, starting in the Fall of 2015. This will provide the next best thing to personal guidance, but as a group and at group rates.

http://www.iso9001club.com/

What Is ISO

International Organization for Standardization

® Registered Trademark of ISO

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Presenter

Presentation Notes

The International Organization for Standardization is responsible for developing international standards and is headquartered in Geneva, Switzerland. Independent, non-governmental membership organization since 1946. World's largest developer of voluntary International Standards. Members from 163 countries and 3 368 technical bodies to take care of standard development. The name “ISO” comes from the Greek word “ISOS”, which means “equal”.

ISO 9000 family of standards

• ISO 9000:2005 – Quality Management Systems- Fundamentals & Vocabulary – ISO 9000:2015 to be published same time as ISO 9001

• ISO 9001:2015 - Quality Management Systems– Requirements

• ISO 9004:2009 – Managing for the sustained success of an organization — A quality management approach

ISO 19011:2011 - Guidelines for auditing management systemsFriend of the family

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Presenter

Presentation Notes

Speaker notes ISO 9000 – Fundamentals and Vocabulary: Introduces the user to the concepts behind the management systems and specifies the terminology used. ISO 9000:2015 is scheduled to be published at the same time as ISO 9001:2015. ISO 9001 – Requirements: This sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain registration. ISO 9004 – ISO 9004:2009 – Managing for the sustained success of an organization — A quality management approach: This is designed to take you beyond ISO 9001 and takes into account the needs of not only customer, but all interested parties. ISO 19011 - Guidelines for auditing management systems: This defines the criteria for auditing management systems in general.

What is a Management System?

A management system represents the policies, procedures and practices that define an organization.

A quality management system provides focus on the quality of the product/service and the satisfaction of the customer/client.

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Presentation Notes

A quality management system provides a framework for good management practices. An “excellent organization” is all inclusive. You may consider removing the word “quality” from the title of your management system to ensure collaboration from ALL functions. All of the things that are instructional in nature make up a part of your management system (ex: mandate, mission, vision, values, policies, SOP’s, instructions, guidelines, forms, tags, practices, even the signs on the wall). A Social Principle called the Constructionist Principle states that the nature of an organization is based upon the beliefs and values of its stakeholders, past and present. You can use a quality management system to mold your organization’s culture into one of high performing best-in class.

ISO 9001 Standard

• International consensus on good management practices

• Focus on quality on the products or services delivered

• Focus on the customer• Available to use with all organizations, all sectors,

all sizes, anywhere in the world• Compliance audits• First published in 1987. Revised in 1994, 2000,

2008, and now 2015.

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Presentation Notes

ISO 9001 is an international standard defining the requirements for a quality management system and can be used by any organization, large and small, anywhere in the world. ISO 9001 promotes the use of clear, distinct processes that include inputs from suppliers and stakeholders and outputs to customers and stakeholders. It is not prescriptive and encourages organizations to use their own language and methodologies to achieve desired results. Although certification by a third party registrar is voluntary, it can provide worldwide recognition to an organization’s customers, stakeholders and partners of their level of professionalism and commitment to quality. You decide the scope of your organization that you want to apply itnto.

ISO 9001:2015 Development Timeline

© copyright ISO Technical Committee

June 2013 CD(Committee Draft)

May 2014 DIS (Draft International Standard)

July 2015 FDIS (Final Draft International Standard)

September 2015 Published International Standard

201520142013

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Presentation Notes

ISO 9001 is about to reach the Final Draft International Stage (FDIS ballot expected by July), the fifth stage of a six stage process, whereby the ISO subcommittee revising the standard will now go through all the comments received during the DIS vote in order to produce a final draft which will then be put forward to all ISO members for voting. Proposal stage - this first step is to confirm that a new International Standard in the subject area is really needed (this stage is skipped for revisions).. Preparatory Stage - usually a working group (WG) is set up by the parent committee to prepare the working draft. Committee Stage - during this stage the draft from the working group is shared with the members of the parent committee, and now called a Committee Draft (CD). The CD is circulated to the members of the committee who then comment and vote until consensus is reached on the technical content, at which point they have a Draft International Standard (DIS). Enquiry Stage - The Draft International Standard (DIS) is submitted to the ISO Central Secretariat by the committee secretary, and then circulated to all ISO members who get 3 months to vote and comment on it. If the DIS is approved the project goes straight to publication. Approval Stage - if the draft has been significantly revised following comments at the DIS stage, a Final Draft International Standard (FDIS) is created and submitted to ISO/Central Secretariat (ISO/CS) by the committee secretary, and then circulated to all ISO member for a two-month vote. Publication Stage - at this stage the secretary submits the final document for publication through the Submission Interface. Only editorial corrections are made to the final text. It is published by the ISO Central Secretariat as an International Standard.

ISO 9001:2015 Certification Transition Timeline

September 2015 start of 3 years transition period to September 2018• Certifications to ISO 9001:2008 will no longer be valid

after September 2018

2018201720162015

September 2015 Published International Standard

© copyright ISO Technical Committee 13

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Presentation Notes

Organisations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.

ISO 9001 - Requirements

2008 Version1. Scope2. Normative reference3. Terms and Definitions4. Quality Management System5. Management responsibility6. Resource Management7. Product realization8. Measurement, analysis and

improvement

2015 Version1. Scope2. Normative reference3. Terms and Definitions4. Context of the organization5. Leadership6. Planning for the QMS7. Support8. Operation9. Performance evaluation10. Improvement

© copyright ISO 14

Process approach

Customers& otherrelevant

interestedparties

CustomerSatisfaction

10. Continual improvement

7. Support processes

5. Leadership

8. Operations

4.1, 4.2, 4.3Establish contextDefine relevant interested parties& scope of QMS

RequirementsProducts &

services

4.4 QMS – Process Approach

Inputs Outputs

6. Planning 9. Performance evaluation

© copyright ISO – referenced from ISO/DIS 9001 2014-05-08 15

Presenter

Presentation Notes

ISO 9001:2015 continues to require organizations view themselves using a process approach, but is now more adamant. Processes are a high level view of the organization’s activities, where key tasks within the overall process are identified. ISO defines a process as a set of interrelated or interacting activities which transforms inputs into outputs. Procedures are the detailed steps that describe how a process step will be performed. Instructions are the detailed steps that describe how a procedure step will be performed. Forms, tags, signs, databases, etc. are used for a myriad of reasons, such as record collection or further instruction, and assist in the activities described in procedures and instructions. The process approach using the ISO 9001 standard and its requirements is based on the PDCA cycle.

4. Context of the organization

4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties4.3 Determining the scope of QMS4.4 Quality management system and its processes

Includes “justification for any instance where a requirement of (ISO 9001) cannot be applied”.


Presenter

Presentation Notes

The context of your organization us really a description of your business environment (from ISO 9001:2008), including its strategies to achieve policies and objectives. The activity of completing a context of your organization is sometimes called an environmental assessment, which should be completed and shared internally to benefit the organization’s strategic planning cycle. Identify the internal issues that can affect your organisation’s products, services, and interested parties. regulatory requirements strategies to achieve its policies and objectives relationship with its staff and stakeholders, including partners and suppliers resources and knowledge (e.g. capital, people, processes and technologies) internal risk appetite assets Products and/or services Standards, guidelines and models adopted by the organisation information systems Identify the external issues that can affect your organisation’s products, services, and interested parties. government regulations and changes in the law shifts in the organisation’s market the organisation’s competition (if any) events that may affect the organization’s image changes in technology Identify who are the interested parties and what are their requirements. Institute a system for regular review and monitoring of the internal issues, external issues and interested parties.

5. Leadership

5 Leadership5.1 Leadership and commitment 5.2 Quality policy5.3 Organizational roles, responsibilities and authorities


Presenter

Presentation Notes

Management commitment Customer focus Quality policy Responsibility and authority Role of Management Representative has disappeared

6. Planning for the QMS

6 Planning for the QMS6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes


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Presentation Notes

Strategic Planning (Management System) Quality (and other) Objective setting Review and action setting to mitigate risks and opportunities Change (and transition) management

7. Support

7 Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information


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Presentation Notes

Resource allocation Infrastructure Work environment Monitoring and measurement Calibration program Knowledge management Training, education and employee competency Quality orientation Internal and external communication plan Documentation (including external documents), document control, and records

8. Operation

8 Operation 8.1 Operational planning and control8.2 Determination of requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided products and services8.5 Production and service provision8.6 Release of products and services8.7 Control of non conforming process outputs, products and

services


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Presentation Notes

Planning of product and service provision Customer Related Processes Customer communications - enquiries, orders, views, perceptions, and complaints Contract (or internal) reviews - product and service requirements, statutory and regulatory requirements, delivery, post-delivery, needs and expectations. Customer property Design and Development – planning, inputs, controls, reviews, outputs, verifications, validations, changes. Purchasing – supplier evaluation and selection, controls, performance monitoring, verification, purchase orders and contracts (including reviews). Product/Service Provision – documented information (characteristics, activities, expected results, inspection), infrastructure and work area, monitoring and measurement, competent and qualified workforce, process validation (where output can’t be verified), product and service release, delivery, and post-delivery. Identification and traceability – including inspection status. Customer (and external provider) property – material, components, tools and equipment, customer premises, intellectual property and personal data. Preservation – identification, handling, packaging, storage, transmission or transportation, and protection. Post-delivery activities Control of changes Release of products and services – inspection at different stages Control of nonconformances – segregation, containment, returns, corrections, deviations and waivers, concessions, re-inspection.

9. Performance evaluation

9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review


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Presentation Notes

Customer Satisfaction – customer perception, views, opinions, surveys, compliments, complaints, customer data. Analysis and evaluation – product and service inspections, customer satisfaction, QMS audits, process measurement, supplier performance, improvements. Internal audit – internal audit program, planning, frequency, methods, responsibilities, reporting, and verification of previous audits – ISO 19011 for guidance. Management review – nonconformities and corrective actions, monitoring and measurement results, audit results, customer satisfaction, external provider issues, relevant interested parties issues, resources, process performance, conformity of product – rolling action status list.

10. Improvement

10 Improvement 10.1 General10.2 Non-conformity and corrective action 10.3 Continual improvement


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Presentation Notes

Improvement – continuous improvement program – processes, products and services, quality management system. Nonconformity and corrective action – nonconformance, containment actions, (root) causes, areas affected, corrective actions, verify effectiveness. Continual improvement – continual improvement program.

Changes in 2015 – Structure and terminology

ISO 9001:2008 ISO 9001:20158 sections 10 sectionsProducts Products and servicesExclusions Not usedDocumentation and records Documented informationWork environment Environment for the operation

of processesPurchased product Externally provided products

and servicesSupplier External provider


Changes in 2015 – Products and Services

“Products and services include all output categories such as hardware, services, software and processed materials”.

“The organization needs to take into account where a tangible product has some associated intangible service, or an intangible service has some associated tangible product”.


Changes in 2015 – Context of the organization

“4.1 Understanding the organization and its context”.

“4.2 Understanding the needs and expectations of interested parties”.

“….no requirement to consider interested parties….not relevant to the (QMS)….”


Changes in 2015 – Risk-based approach

Risk-based approach replaces Preventative Action.

“Although risks and opportunities have to be determined and addressed, there is no requirement for formal risk management or a documented risk management process”.


Presenter

Presentation Notes

Risk is the “effect of uncertainty on an expected result” It can be both detrimental, or an opportunity. The word “risk” shows up 15 times within the requirement sections 4 to 10, in 7 different sections and sub-sections A Failure Mode Effects Analysis (FMEA) is a common tool used to identify and prioritize risk in processes.

Changes in 2015 – Exclusions and Applicability

“….no longer makes specific reference to exclusions….”.

Where a requirement can be applied, it is applicable – where it cannot be applied, it is not applicable, but justification has to be stated.


Changes in 2015 – Documented information

“terms documented procedure and record have both been replaced by documented information”.

“….now expressed as a requirement to maintaindocumented information”.


Presenter

Presentation Notes

No longer any requirement for a documented quality manual or specific procedures. 19 sections and sub-sections where records (or groups of records) are required to be retained. Required to have a documented scope and quality policy. Allude to the requirement of operational work instructions and work criteria.

Changes in 2015 – Organizational knowledge

“Organizational knowledge addresses the need to determine and maintain the knowledge obtained by the organization….to ensure that it can achieve conformity of products and services”.

“The balance between knowledge held….and knowledge made available….is at the discretion of the organization….”.


Presenter

Presentation Notes

Knowledge management (KM) is the process of capturing, developing, sharing, and effectively using organizational knowledge. It refers to a multi-disciplined approach to achieving organisational objectives by making the best use of knowledge. Determine the knowledge necessary for the operation of processes and for achieving conformity of products and services Maintain knowledge and make it available to the extent necessary Consider the current organizational knowledge and compare it to changing needs and trends Acquire the necessary additional knowledge.

Changes in 2015 – Control of externally provided products and services

• Purchasing from a supplier• Arrangement with an associate organization• Outsourcing of processes and functions• Any other means

“The organization is required to take a risk-based approach to determine the type and extent of controls appropriate….”.


Presenter

Presentation Notes

Regardless of whatever products or services that are outsourced, the organization is responsible to their customer.

Why Implement ISO

1. Make organization more efficient and effective

2. Provide perceptible value to current and potential customers (promotion)

Why did (or does) your organization want to implement ISO 9001?

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Cost To Implement ISO

Normal Roles

ISO 9001

Specific

External Costs• External Guide – if required, may reduce internal times• Registrar – if decision to become certified• Additional training – if required, ISO 9001 related, job related

Internal Costs• Management Representative• Administration• Implementation Team• Management Team• All Staff

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• More structured and discipline• Proactive rather than reactive• Opportunities to do more with less• Increased process efficiencies• Increased employee morale• Increased confidence from your market

Benefits of implementing ISO 9001

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Benefits of Implementing ISO 9001Quality Award Winners perform better

© copyright Excellence Canada 35

Steps to Implement1. Planning

• Gap analysis• Implementation team setup• Management team setup• Find your registrar

2. Documentation and Development• Quality policy manual• Procedures• Instructions• Forms and templates

3. Training & Implementation• Train employees• Follow your documented system• Develop what’s not there

4. Assessment & Monitoring• Departmental monitoring• Management reviews• Internal audits• Certification audit

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The Registration Process

1. Organization selects a registrar and completes a profile

2. Nature of registration services are selected for a 3 year period, initial dates are agreed upon, and a contract for services signed

3. Registration is a two stage process:1.Document Review (on-site or off-site)2.Implementation Audit (on-site)

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4. Depending upon results:a) If minor nonconformities found, organization is

asked to email acceptable corrective actionsb) If major nonconformities found, organization asked

to correct and schedule a follow-up visit

5. When nonconformities corrected and/or acceptable corrective actions sent, organization is recommended for registration

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6. Sample maintenance audits completed annually or semi-annually

7. Re-registration audit re-applied every 3 years

Note: Registrars are themselves accredited by standard making bodies around the world and bound by an international accreditation process. In other words, even the auditor is audited.

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Questions & Answers

Ask Us – we’ll stick around

Want to know more about CGSB and certification to ISO 9001?

Donald FultonTeam Leader, Conformity AssessmentTelephone: 819-956-3825E-mail: [email protected]: http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.html

Want to know more about HUMAN and implementation guidance for ISO 9001?

Michael HartPresidentTelephone: 613-297-6362E-mail: [email protected]: www.human.ca

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mailto:[email protected]

http://www.tpsgc-pwgsc.gc.ca/ongc-cgsb/index-eng.html

mailto:[email protected]

http://www.human.ca/

• Please fill out the CPSEN feedback form before you leave.

• You’re welcome to stick around and network.• Don’t forget – the best way to learn about

future CPSEN events is to sign up as a member at www.cpsen.ca.

Thank you for coming

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