How to manage the transition successfully ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS TECHNICAL GUIDE. Move Forward with Confidence

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Move Forward with Confidence

TOP MANAGEMENT - QUALITY MANAGERS

TECHNICAL GUIDE

ISO 9001:2015

How to manage

the transition

successfully

.fr Photos: fotolia.com

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CONTEXT OF THE ORGANIZATION Leadership and commitment Needs & expectations of interested parties Planning of changes Scope of the QMS Introductory clauses Basic clauses, common to all management systems standards Documented information Management

review inprovementContinuous Quality policy

Resources Competence

Awareness Internal audit

Communication Roles, responsibilities & authorities PLANNING PLAN IMPROVEMENT OPERATION PERFORMANCE EVALUATION SUPPORT LEADERSHIP 4 SCOPE Clause Clause Clause Clause Clause Clause Clause Clause 1 NORMATIVE REFERENCES 2

TERMS AND DEFINITIONS

3

CONTEXT OF THE ORGANIZATION 4 PERFORMANCE EVALUATION 9 LEADERSHIP 5 Clause 8 OPERATION IMPROVEMENT 10 PLANNING 6 Clause 7 SUPPORT 5 6 8 9 10 7 DO CHECK ACT Quality objectives & planning Actions to address risks and opportunities Operational planning & control Non conformity & corrective actions Monitoring, measurement analysis & eval. Production & service provision Release of products & services Determination of requirements for prod. & services Design & devel.

of products & services Control of externally proc.prod. & services Non conforming processes prod. & services Understanding the organization and its context

QMS & its processes

WHAT ARE THE MAIN CHANGES

IN ISO 9001?

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS TECHNICAL GUIDE

2

The high-level structure proposed in Annex SL for all ISO management systems includes, in addition to the usual 3

introductory clauses, 7 basic clauses common

to all management system standards. They are: context of the organization, leadership, planning, support, operation, performance evaluation and improvement. For ISO 9001, they will replace current clauses 4, 5, 6, 7 and 8. It follows the well known PDCA cycle and the process approach from section 4 to 10, in an order that is consistent with organizational planning and process management.

The new model is similar to the previous one. Although the intention is not to

recommend the sequence of activities that an organization follows

in the implementation of a management system, each organization is free

to interpret the model as it sees fit.

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INTENDED R E S U LT S INTERNAL ISSUES CULTURE TECHNOLOGICAL • ECONOMIC • MARKET • COMPETITIVE • • CULTURAL • LEGAL • SOCIAL VALUES KNOWLEDGE PERFORMANCE EXTERNAL ISSUES BUSINESS ENVIRONMENT

ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS TECHNICAL GUIDE 3

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 QMS

_STAKEHOLDERS

BUSINESS

Annex SL has introduced two new clauses related to the context

of the organization: Both clauses require the organization to

determine issues and requirements that may have an impact on the planning of the QMS and can serve as input for the development of the system. Although reference is made to the determination of requirements of relevant stakeholders, there are no additional requirements to ensure that goods and services meet the needs and expectations of external entities other than those already identified in ISO 9001:2008. The organization’s top management must be involved directly and actively in the clarification of its mission and vision, considering both the internal and external issues that may affect its ability to achieve the desired results. The requirements include the consideration of changes

and trends, relationships, perceptions and values of stakeholders, strategic priorities, the availability of

resources, and other issues which could have an impact on the

objectives of the organization.

The context of the organization refers to the business

environment it is operating in. To do this, it must first decide what

are the intended results of its QMS and then determine the

relevant internal and external issues that affect its ability to

achieve those results.

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. Understanding the internal

context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

This requirement goes beyond what is covered by current clause 7.2, because it does not include only the direct customers but also the

end-users, suppliers, distributors, retailers and others involved in

the supply chain, regulators and any other relevant interested party. The intention is also to anticipate current and future needs, because it could lead to the identification of opportunities for improvement and innovation. The organization is required to monitor and review the information about these interested parties and their relevant requirements.

DESCRIBED IN TERMS OF:

• products and services • main processes involved

• sites where processes are operated

EXCLUSIONS

This term is not used in ISO 9001:2015. However, the organization must review the standard requirements and decide which, if not addressed, would affect their ability to achieve conformity of products and services.

Note : The concept of context of the organization is equally applicable to not-for-profit or public service

organizations as it is to those seeking profits.

Clause

SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 COMMUNITY

GOVERNMENT

EMPLOYEES

CUSTOMERS

PARTNERS

EMPLOYEES

FAMILIES

INVESTORS

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4

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES

NEW REQUIREMENT:

• Determination of risks and opportunities • Plan & implement actions to address them

• Change to ‘documented information’ lets the organization decide necessity, type and media. But previous terms, such as quality manual, procedure, record can still be used if the organization prefers them

5.1 LEADERSHIP AND COMMITMENT

This clause replaces the current clause on management responsibilities. The elimination of the role of ‘management representative’ now requires a more proactive leadership role and greater involvement

of top management in identifying risks that can affect the

conformity of products, services, customer satisfaction and integrating QMS requirements into its business processes.

Top-level commitment and empowerment of senior

management has been raised up by the new standard, which

means that the responsibility will not lie on one person. The quality policy must include a commitment to improve all relevant aspects of the

QMS, not just its effectiveness, and it must provide a framework (that is, a process) for “setting” the quality objectives.

IMPORTANT CHANGES:

• Top management to establish, implement and maintain quality policy

• Appropriate to the purpose and context of the organization • Available to relevant interested parties, as appropriate • Commitment to improve the QMS

• Communicated, understood and applied within the organization

• Maintained as documented information

Clause

SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 RIBBONS BANNERS

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rutrum mattis mauris nec mollis.

RIBBONS BANNERS

ORIGAMI BANNERS

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NEW DESCRIPTION OF RESPONSABILITIES

TOP MANAGEMENT INVOLVED IN:

• clarification of mission and vision

• consideration of changes and trends

• relationships, perceptions and values of stakeholders • strategic priorities and

availability of appropriate resources

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6.1 ACTIONS TO ADDRESS RISKS

AND OPPORTUNITIES

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

RESOURCES

7.1.6 ORGANIZATIONAL KNOWLEDGE

6.3 PLANNING OF CHANGES

The clause on Planning is much broader than the current one. In clause 6.1 the emphasis is on the planning of actions to address

risks identified as per clauses 4.1 and 4.2 . In a ‘note’, it is suggested

that the options to address these risks may include avoidance of risk, taking the risk in order to pursue an opportunity, eliminating the source of risk, changing the likelihood or consequences of risk or acceptance of risk by informed decision. Reference to preventive actions is now removed from the standard.

Management of all resources is covered under the Support clause. It extends what is covered by the current clause with the same title by adding outsourced products and services, monitoring

and measuring equipment and, very important, people and organizational knowledge as a resource. The organization

shall provide the necessary manpower for the effective operation of the QMS and its processes. When addressing changing needs and trends it shall consider current knowledge and how to acquire or access additional necessary knowledge.

It also makes clear that considerations of work environment is limited to the operations of processes.

Undertake changes in a planned and systematic manner by considering:

• Potential consequences of change • Integrity of the QMS

• Availability of resources

• Allocation or reallocation of responsibilities and authorities

Clause

SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 RIBBONS BANNERS

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nteger is nec mollis. rutrum mattis maur

RIBBONS BANNERS

ORIGAMI BANNERS

nteger

rutrum mattis maur is nec mollis. COULD INCLUDE AVOIDANCE, MITIGATION, ELIMINATION OR ACCEPTANCE

7.2 COMPETENCE

7.4 COMMUNICATION

This clause limits competence to those doing work that

affects its quality performance. Competence is achieved by

appropriate education, training OR experience. There is no mention of skills as in the current standard. A note suggests different

ways to acquire the necessary competence through provision of

training, mentoring, re-assignment of currently employed people or hiring or contracting of competent people.

ORGANIZATION NEEDS TO DETERMINE: • Internal and external communication needs • On what it will communicate

• When to communicate • With whom to communicate • How to communicate

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EXPORTING

TRACKING & TRACING

BUSINESS RULES & STANDARDS ISO 9001:2015 TOP MANAGEMENT - QUALITY MANAGERS

TECHNICAL GUIDE

6

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION

9.1.1 GENERAL

• Determine what to monitor and measure

• Determine methods for monitoring, measurement, analysis and evaluation

• Evaluate the quality performance and effectiveness of the QMS

This new clause covers all monitoring, measurement, analysis and evaluation activities required by the QMS, describing the requirements in more detail. Monitoring of the customer’s perceptions of the degree to which requirements have been met, now must include

customer views and opinions of the organization and its

products and services. The use of the output of analysis and evaluation is listed in detail and includes input to management reviews.

Clause

SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 8.1 RELEASE OF PRODUCTS AND SERVICES

9.3 MANAGEMENT REVIEW

9.2 INTERNAL AUDIT

• Implement planned activities at appropriate stages to verify that product and services requirements have been met

• Delivery shall not proceed until the planned arrangements verify

conformity, unless otherwise approved by a relevant authority and, where applicable, by the customer

• Documented information shall provide traceability to the

people authorizing release of products and services for delivery to the customer

The audit program must take into account quality objectives,

customer feedback and changes impacting the organization, in addition to the importance of the processes and

the results of previous audits. Documented information must be retained as evidence of implementation of the audit programs and audit results, but there is no requirement for a documented procedure. A note refers to ISO 19011 for guidance.

• Planned and carried out, taking into account the changing business

environment and the strategic direction of the organization.

• Consider information on the quality

performance, including trends and indicators for:

- Non-conformities and corrective actions - Monitoring and measurement results - Audit results

- Customer satisfaction

- Issues concerning external providers & interested

parties

- Adequacy of resources

- Process performance and conformity of products & services • Effectiveness of actions to address risks &

opportunities

• New potential opportunities for continual improvement

Clause

SCOPE

1 NORMATIVE REFERENCES

2 TERMS AND DEFINITIONS

3 CONTEXT OF THE ORGANIZATION

4 PERFORMANCE EVALUATION

9 LEADERSHIP

5 OPERATION

8 IMPROVEMENT

10 PLANNING FOR THE QMS

6 SUPPORT

7 RIBBONS BANNERS

RIBBONS BANNERS

ORIGAMI BANNERS

EMPHASIS ON PLANNING

RIBBONS BANNERS

ORIGAMI BANNERS

NEW REQUIREMENTS

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WHAT IMPACT TO EXPECT

ON YOUR MANAGEMENT SYSTEM?

WHAT IS THE TRANSITION PROCESS?

During the 3-year-transition period, the organization decides when it transitions.

An organization can still be recertified to the old standard during this period.

Current certificates remain valid until the end of the transition period.

GET THE NEW CERTIFICATION ISO: 2015

STARTING DATE

TO PREPARE TRANSITION

2

ND

_{QUARTER 2015}

DEAD-LINE TO MOVE TO

ISO 2015 CERTIFICATE

3

RD

_{QUARTER 2018}

THE TRANSITION PROCESS TAKES 6 TO 18 MONTHS

TRAIN YOUR CORE TEAM (QUALITY MANAGERS, INTERNAL AUDITORS, CEO)

ADAPT YOUR MANAGEMENT PROCESSES TO MAKE

THEM COMPLIANT INTEGRATE PARTS OF OTHER

MANAGEMENT SYSTEMS & UPDATE DOCUMENTATION

MONITOR THE NEW PROCESSES, PRODUCE & ANALYSE NEW KPIs.

ACT ACCORDINGLY

CHANGES ARE MORE SIGNIFICANT THAN FOR THE PREVIOUS REVISION

THE IMPACT OF THE CHANGES DEPENDS ON:

• The Management System current maturity

• The organization strategic decision to integrate

more the different Management Systems

LOW

IMPACT

MEDIUM

IMPACT

MEDIUM

IMPACT

HIGH

IMPACT

More advanced

Management System

Keep the same level of integration of the Management system

Maturity of the Management system

Towards more integration of Management systems

Increase integration of the Management systems More simple

Management System

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WHAT ARE YOUR BENEFITS

OF THE TRANSITION?

Better and timely

decisions based

on relevant and

pertinent information

You have more

freedom to develop

your own way

to address the

requirements

of the standard

Higher efficiency

of the QMS due

to higher involvement

of your employees

and stakeholders

Clients’ confidence

in your products

and services will be

strengthened

Responsibility

for quality issues

will be shared between

several employees

Fewer

prescribed

requirements

The QMS will be

closely aligned with

the Core Business

Processes to

facilitate an effective

implementation

HLS makes it

easier for you to

integrate more than

one standard in

your management

system

You will ensure

long-lasting customer

satisfaction due

to improved

‘risk-management’

The creation of

a knowledge-database

will ensure the effective

internal exchange of

company-owned

knowledge

Quality Management

is placed at the

very core of business

governance

You will establish

sustainable relationships

with all relevant

stakeholders

You will assure

to deliver high quality

products and

services

Less directive

requirements

Increasing ability

to meet customer and

other relevant interested

parties requirements

Continual

improvement

It allows all types

of businesses and

activity sectors to

better benefit from

ISO 9001

Limiting the risks

involved in the

operation of relevant

processes

It will be easier

for you to meet

the mandatory

requirements from

your customers

QMS will be

closely taillored

to each organization

specificities

Greater

motivated

employees

Anticipation

of future and current

needs from your

stakeholders will lead

to an early identification

of business

opportunities

Less emphasis

on documents

Simplified

language

and text

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ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE

BUSINESS CHALLENGE

In a world of ever changing economic, technological and environmental challenges, companies need to constantly transform themselves to stay ahead. The international standard for Quality management, ISO 9001 is being revised in 2015 to help drive this competitive advantage.

You want to manage your company transition to ISO 9001:2015 in a fully secure manner and want to know what areas of your quality management system have to be adapted to ISO 9001:2015?

SOLUTION

What is ISO 9001:2015 GAP ANALYSIS TOOL AND GAP ANALYSIS ON SITE ?

With the gap analysis tool you can review your current quality management system against the requirements of ISO 9001:2015. With the Verification on Site, a qualified Bureau Veritas auditor will then verify and validate the gaps you have identified in your current QMS.

What are the key benefits?

It helps to identify the gap between your current situation and the future state you want to reach to be compliant to ISO9001:2015.

HOW CAN BUREAU VERITAS SUPPORT

YOU IN YOUR TRANSITION?

E-LEARNING

COURSES

NOW AVAILABLE!

Get trained to the transition at your own pace and without engaging in travel expenses.

AVAILABLE IN DIFFERENT LANGUAGES

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REQUEST A PRE-AUDIT

WHAT IS IT ABOUT?

• An optional overview and validation audit of ISO 9001:2015 requirements against their current compliance in an ISO 9001:2008 quality management system and the new changes coming from the revision of the standard.

WHAT VALUE DOES IT BRING TO YOUR TRANSITION:

• An opportunity to fully understand the new requirements and their impact on your existing management system. This can then clarify the actions you need to take to achieve transition successfully.

BUT:

• A pre-audit is completely independent from the transition audit. It does not grant 9001:2015 or 14001:2015 certification

AUDIT OF TRANSITION DURING PLANNED AUDITS

WHAT IS IT?

• The transition requirements are audited as part of one of the ensuing planned audits such as the surveillance or Recertification audit

• During this audit, conformance with the revised standard is assessed along with other requirements

WHEN TO DO IT:

• Whenever you are ready with implementation of all changes • Whenever you are planning for your next surveillance or Recertification whichever is due at that time

Beware: from End of Sept2018, your certificate will no longer be valid.

WHAT ARE THE BENEFITS FOR YOUR COMPANY? • There is no need of a separate audit.

Beware: If the organization is found not conform to all the requirements, non conformities will be raised requiring for closure before a new certificate can be issued.

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A WIDE RANGE OF

SPECIALIZED TRAINING

AWARNESS

SEMINARS AND

WORKSHOPS

This course will help you find out

what you need to know about transitioning to the new ISO 9001:2015 standard.

You will discover more about the changes and how these will affect your organization so you can start putting transition arrangements in place.

This course will enable you to

identify the core changes and requirements of ISO. It will assist

you with the implementation of

the changes within your business.

On completion of the course, you will be able to apply your knowledge of the amended requirements to ISO 9001:2015 to develop

an action plan to aid your

implementation processes.

This course will help you stay at the forefront of QMS strategy. By attending you will transform your existing auditor skills to ISO 9001:2015.

Building on your knowledge you will develop the skills to audit against the changing landscape of ISO 9001:2015 Quality Management System (QMS).You’ll gain the practical knowledge

needed to build your auditing skills.

A series of deep dive workshops, which focus on auditing risk, leadership, external provision and facilitated action are also available for you to attend.

This workshop will help you identify the requirements of ISO 9001:2015 with regard to process risk management and identify the tools and techniques to implement a risk based approach within your management system.

On completion of the course, you will be able to apply your knowledge to identify, classify, quantify and treat risks and develop an action plan to implement a risk your organizations.

INTERNAL

AUDITOR

TRAINING

REVISED 2015

STANDARDS

TRAINING

RISK

MANAGEMENT

TRAINING

TO FIND OUT MORE ABOUT TRAINING AVAILABILITY AND TIMES, PLEASE CONTACT YOUR LOCAL BUREAU VERITAS PARTNER

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TECHNICAL GUIDE ISO 14001:2015 How to manage the transition successfully .fr Photos: fotolia.com