ISO 9001:2015 Transition

Key Changes and IssuesWelcome and Thanks for Attending

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Manufacturer’s Edge Mission:To strengthen and grow the manufacturing community

in Colorado

• Provide coaching,

consulting, training

and programs to

Colorado

manufacturers

• Public/private

partnership hosting

the Colorado

Manufacturing

Extension Partnership

(a Department of Commerce

program)

Colin Gray

• 30 years auditing, training and consulting

with ISO

• MBA Middlesex University

• Professional Lead Auditor IRCA, EG, PECB

• IRCA ISO 9001:2015 Lead Auditor instructor

and training designer

• colin@cavendishscott.com

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Agenda

• Introduction and Speakers

• The need for change

• Annex SL

• New Processes

• Changed Processes

• Impacts

• Why its great!

• Questions

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The Need for Change

• Customer Survey

• Problems with ISO

– Documents that are not used/meaningful

– A system that is defined around the standard

– The absence of management

– Illogical mandatory documents

– Some requirements poorly addressed e.g. change, communication

– Lack of flexibility

• Poorly audited (lack of requirements?)

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Solutions

• Process based system

• Integration with business systems

• Leadership responsibilities, no Mgmt Rep.

• Limited documentation specified

• Flexibility in demonstration of conformance

• Expanded requirements (for some e.g. change, objectives, communication….but others e.g. people)

• Flexibility throughout with risk

• Poorly audited – now specific requirements

– No accreditation training reqs (EG 2 hours online)

– No more audit time (MD5)

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Management System Structure - Annex

SL

• Common structure– 4 QMS

– 5 Leadership

– 6 Planning

– 7 Support processes

– 8 Operations

– 9 Measurement and analysis

– 10 Improvement

• Common terminology/definitions

• ALL management system standards

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Substantive Change

• Leadership Involvement

• Alignment of management system with strategic direction, – organizational context, interested parties, strategic direction

reflected in management system planning

• Risk based approach/thinking - opportunities

• Integration with business systems

• Process approach

• Flexibility in demonstration – Down to the organization to determine how to demonstrate

conformance – no mandated procedures and few mandated records

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5.1 Leadership & commitment

• 5.1.1 General

• Top management shall demonstrate leadership and commitment with respect to

the quality management system by:

• a) taking accountability for the effectiveness of the quality management system;• b)ensuring that the quality policy and quality objectives are established for the quality management system and are

compatible with the context and strategic direction of the organization;

• c) ensuring the integration of the quality management system requirements into

the organization’s business processes;

• d) promoting the use of the process approach and risk-based thinking;• e) ensuring that the resources needed for the quality management system are available;

• f) communicating the importance of effective quality management and of conforming to the quality management system

requirements;

• g) ensuring that the quality management system achieves its intended results;• h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;

• i) promoting improvement;

• j) supporting other relevant management roles to demonstrate their leadership as

it applies to their areas of responsibility.

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4.1/2

• 4.1 Context of the Organization

• 4.1 Understanding the organization and its context

• The organization shall determine external and internal issues that are

relevant to its purpose and its strategic direction and that affect its ability

to achieve the intended result(s) of its quality management system.

• The organization shall monitor and review information about these

external and internal issues.

• NOTE 1 Issues can include positive and negative factors or conditions for consideration.

• NOTE 2 Understanding the external context can be facilitated by considering issues arising

from legal, technological, competitive, market, cultural, social and economic environments,

whether international, national, regional or local.

• NOTE 3 Understanding the internal context can be facilitated by considering issues related to

values, culture, knowledge and performance of the organization.

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4.1/2

• 4.1 Context of the Organization

• 4.2 Interested Persons and their Requirements

• 4.2 Understanding the needs and expectations of interested

parties

• Due to their effect or potential effect on the organization’s ability to

consistently provide products and services that meet customer and

applicable statutory and regulatory requirements, the organization shall

determine:

– the interested parties that are relevant to the quality management system;

– the requirements of these interested parties that are relevant to the quality

management system.

• The organization shall monitor and review information about these

interested parties and their relevant requirements

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• Risk and Opportunities

• 6.1 Actions to address risks and opportunities

• 6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:– give assurance that the quality management system can achieve its intended result(s);

– enhance desirable effects;

– prevent, or reduce, undesired effects;

– achieve improvement.

• 6.1.2 The organization shall plan:

• actions to address these risks and opportunities;

• how to:– integrate and implement the actions into its quality management system processes (see 4.4);

– evaluate the effectiveness of these actions.

– Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

• NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

• NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organization’s or its customers’ needs.

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Risk

• Risk and Opportunities

• Strategic Approach

• (and) Applies throughout the organization

• No approach mandated (KISS)

• Changes in environment affect risks and

opportunities

• Are opportunities different from risks

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Strategic Approach

• SWOT

• Strengths (internal +ve)

• Weaknesses (internal –ve)

• Opportunities (external +ve)

• Threats (external –ve)

• PESTLE

– Political, economic, social, technical, legal,

environmental

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Significant Changes

• Objectives

• Change Management

• Communication

• Knowledge

• People

• Control of externally provided processes,

products and services

• Integration – to risk, opportunities, context

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Objectives

• 6.2 Quality objectives and planning to achieve them

• 6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

• The quality objectives shall:– be consistent with the quality policy;

– be measurable;

– take into account applicable requirements;

– be relevant to conformity of products and services and to enhancement of customer satisfaction;

– be monitored;

– be communicated;

– be updated as appropriate.

• The organization shall maintain documented information on the quality objectives.

• 6.2.2 When planning how to achieve its quality objectives, the organization shall determine:– what will be done;

– what resources will be required;

– who will be responsible;

– when it will be completed;

– how the results will be evaluated.

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Change Management

• 6.3 Planning of changes

• When the organization determines the need for changes to the quality management system, the changes shall be carried out in a planned manner (see4.4).

• The organization shall consider:

• the purpose of the changes and their potential consequences;

• the integrity of the quality management system;

• the availability of resources;

• the allocation or reallocation of responsibilities and authorities.

• 8.5.6 Control of changes

• The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

• The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

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Communication

• 7.4 Communication

• The organization shall determine the internal and external communications relevant to the quality management system, including:

• on what it will communicate;

• when to communicate;

• with whom to communicate;

• how to communicate;

• who communicates.

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Knowledge

• 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:

• 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);

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

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People

• 7.1 Resources 7.1.1 General

• The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

• The organization shall consider:

• the capabilities of, and constraints on, existing internal resources;

• what needs to be obtained from external providers.

• 7.1.2 People

• The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.

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Externally….

• 8.4 Control of externally provided

processes, products and services

• Same…

• Changes to “scope”

• Emphasis on control of externally provided

“processes”

– Corporate

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The Requirement for Documentation

• 4.4.2 To the extent necessary, the organization shall:

– A) maintain documented information to support the operation of its processes;

– B) retain documented information to have confidence that the processes are being carried out as planned.

• 8.1 Operational planning and control

• E) determining, maintaining and retaining documented information to the extent necessary:

• to have confidence that the processes have been carried out as planned;

• to demonstrate the conformity of products and services to their requirements.

• 1 Scope

• This International Standard specifies requirements for a quality management system when an organization:

• needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and…

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Key Issues• Less Prescriptive to demonstrate conformance

– What procedures, records

– What will satisfy an auditor

– What do we need to make sure we are effective

– How will verbal evidence be treated

• How do you demonstrate Leadership and Commitment

– Not all verbal

– Engagement

• Auditing leadership – are internal auditors going to be comfortable challenging the

CEO on his/her strategy?

• Integration with business processes. Quality Manager promoted to top

management? Attending senior meetings?

• Interrelationships within the new structure

• Process Based mandatory

• Don’t focus on “getting ISO” (focus on a great QMS and it will get ISO for you)

• Always do an Document Review so you know you meet the requirements.

• Full Internal Audit – don’t cut corners,.

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Why So Good?

• Accountability of Leadership

• Involvement of Leadership

• Integration with strategic and business processes (new role for quality)

• More comprehensive and successful QMS

• Annex SL – common, consistent and a lot less likely to change

• Fix poor processes – Preventive Action, Change, etc.

• Deliberately Successful

• Auditing – to be seen

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Certification Transition

• It’s a new standard – many additional

requirements – losing 3 very minor requirements –

Its going to take more time

• You have to maintain conformance to 2008 until

you are 2015 certified (in case there are issues)

• Best at recertification

• Deadlines

– Sept 1 2017 No new certifications to 2008

– Sept 1 2018 standard withdrawn

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QMS Transition

• Why wait

• Transition and hold on certification

For Information and Next Steps

• Contact Colin Gray

• colin@cavendishscott.com

• 303 4800111

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Questions

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