iso 9001:2015 the sticky clauses - asq...

ISO 9001:2015The Sticky Clauses

How to get unstuckwithout becoming unglued

By Charlie [email protected]

CAC © 2017 R5All rights reserved

CAC © 2017 R5all rights reserved 2

About Your Presenter: Charlie Cianfrani

o Business advisor with over 50 years of experience as an operations and quality executive

o Over 25 years as a participant in TC 176 and the US TAG to ISO TC 176—the committee responsible for ISO 9001

o Direct contributor to writing ISO 9001:2008, ISO 9001:2000, ISO 9004:2009 and ISO 9004:2018 and the latest publication of the QMP’s

o ASQ Fellow, ASQ CQE, CRE, CQA and an Exemplar Global-certified QMS auditor

Professional Experience


Disclaimers

o The information provided here today is meant to give an accurate picture of the meaning and intent of ISO 9001:2015.

o The content presented is not an “official” view of ISO/TC176 but rather based on my 50+ years of experience in P & L and quality management assignments domestically and internationally.

o Think carefully before making any changes to your system just to adhere to the perceived requirements of a Standard.

o The real questions to ask are “How does the process help the organization achieve its objectives and do the processes add value?”


• ISO 9001 Has Become a Global StandardResults from the 2015 ISO Survey

ISO 9001 Certifications by Country


The evolution of ISO 9001ISO has a requirement to review and reaffirm or update each Standard every 5 years

• ISO 9001 was first issued in 1987• Tweaked in 1994 (no major changes)• Major updating in 2000

– process approach introduced• Tweaked again in 2008• Major updating in 2015

– Annex SL format introduced (mandated by the ISO TMB)

5


ISO 9001:2015 journey to reality

FDIS was released for translation on 10 May 2015 . FDIS ballot opened on 9 July and closed on 9 September 2015

September 2015 International Standard published

June 2013 CDCommittee Draft

201520142013

June – October 2014 DIS Draft International Standard


Our Goal For This PresentationWe will address eight sticky clauses in ISO 9001:2015, their requirements, and possibleapproaches to address and comply with these requirements.

1. Understanding the Organization and its Context (Clause 4.1)

2. Needs and Expectations of Interested parties (Clause 4.2)

3. Leadership (Clause 5)

4. Actions to Address Risks and Opportunities (Clause 6.1 and others)

5. Knowledge, competence, and innovation (Clause 7.1.6, 7.2 and 10.1 note)

6. Understanding documented information requirements (clause 7.5)

7. Measuring customer satisfaction (Clause 9.1.2)

8. Alignment of objectives (Clauses 6.2, 7.3 and 7.4)


• ISO 9001:2015 was developed to be consistent with the Quality Management Principles (QMPs) See ISO 9000:2015 Clause 2.3

• The QMPs are

• Customer Focus• Leadership• Engagement of

People• Process Approach

• Improvement• Evidence-based Decision

Making• Relationship

Management

9

Think!


Sticky Clause #1: Understanding the Organization and its Context (Clause 4.1)

Clause 4.1: The Requirement

1. Determine relevant external and internal issues that can impact the strategic and tactical directions of the organization and that directly affect the achievement of the intent of the QMS

2. Monitor and review information about the relevant external and internal issues

Both positive and negative issues

External Issues can arise from legal, technological, competitive, market, cultural, social, and economic environments whether international, national, regional or local

Internal ssues may be related to values, culture, knowledge and performance of the organization.

Notes of factors to consider


Why Do It?Understanding the Organization and its Context (Clause 4.1)

o Ensure QMS is structured for both the needs of today and tomorrow

o Integrate QMS processes into the organization strategic and tactical activities

o Explore interactions between processes that may be related to external and internal issues

o Discover, understand and plan to address threats, opportunities, and technology shifts


ExamplesUnderstanding the Organization and its Context (Clause 4.1)

o Define (and in most cases document) a process or processes for considering internal and external issues • Who should participate • When and how often to consider issues • How to document results

o Method of follow-up to assess status– who and with whom

o Consider implementation of a self-assessment process (not a requirement)

o Ensure integration into the strategic and tactical plans of the organization

o Make this integral to a strategic planning process


Understanding the EssenceUnderstanding the Organization and its Context (Clause 4.1 and 4.2)

External ScanSelf-Assessment

Internal Scan

Input:Threats &

Opportunities

Itemized Risks

Focus StrategyMissionVision

Execution MonitoringLearning

Strategic Risk Planning

Output:Action Plans & Objectives


Understanding the EssenceUnderstanding the Organization and its Context (Clause 4.1 and 4.2)

External ScanSelf‐AssessmentInternal Scan

Strategic Planning

Threats

MissionVision

Strategies

Ideas

PrinciplesInnovations

Issues

Action PlansObjectives

Identify Key Processes

AlignmentObjectivesPeople

System DevelopmentProcess Management

Optimization

Develop And Implement

New System

Risks


External ScanSelf‐AssessmentInternal Scan

Strategic Planning

Threats

MissionVision

Strategies

Ideas

PrinciplesInnovations

Issues

Risks

This is the essence of what is required byISO 9001 Clauses 4.1 and 4.2


Sticky Clause #2Needs and Expectations of Interested Parties (Clause 4.2)


1. Determine the interested parties that are relevant to the quality management system

2. Determine the relevant requirements of these interested parties

3. Monitor and review information about these interested parties and their relevant requirements

4. The results of the analysis of relevant interested parties should be used in planning the QMS (see also Clause 4.3)


o Risk avoidanceo “Interested parties” is new language in ISO 9001:2015o Needs of interests of parties beyond the direct customer may impact

the content of the QMS of the organizationo Ideas for new products or services that have marketplace relevanceo Consideration of relevant needs/requirements/interests of interested

parties can influence of product design, production or delivery processes

Why Do It?Needs and Expectations of Interested Parties (Clause 4.2)


o Define and deploy processes to determine if interested parties are impacted by the activities of the organization

o Document processes for identification of interested partieso Establish criteria for assessing relevanceo Keep records of identification and relevance decisionso Consider actions to lessen or eliminate the extent of any impact on

relevant interested parties o Examples of organizations that could potentially be considered

interested parties

ExamplesNeeds and Expectations of Interested Parties (Clause 4.2)


Process

Customer

The QMS of the organization

Providers

Regulators

Shareholders

Internal divisions

Design consultants

Customer feedback

The organization

Interested parties can impact process design


Sticky Clause #3Leadership (Clause 5)

Clause 5: The Requirement

1. Clause 5 which has 4 sub-clauses; Clause 5.1 is titled Leadership and commitment

2. Prime leadership requirements are in 5.1.1 General

• top managers are required to demonstrate leadership and commitment to the QMS by carrying out specific duties

• specific activities that are required are articulated in Clause 5.1.1


What are Top Managements’ Responsibilities?Leadership (Clause 5)

o Taking accountability for the effectiveness of the quality management system

o Ensuring that the quality policy and quality objectives are established for the organization and are compatible with the context and strategic direction of the organization

o Ensuring the integration of the quality management system requirements into the organization’s business processes

o Promoting the use of the process approach and risk-based thinkingo Ensuring that the resources needed for the quality management

system are available


What are Top Managements’ Responsibilities (Continued)?Leadership (Clause 5)

o Communicating the importance of effective quality management and of conforming to the quality management system requirements

o Ensuring that the quality management system achieves its intended results

o Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system

o Promoting improvemento Supporting other relevant management roles to demonstrate their

leadership as it applies to their areas of responsibility


Job 1Leadership (Clause 5)

Communicate

Communicate

Communicate


Establish Quality Policy




Establish Quality Policy

QualityObjective

QualityObjective

QualityObjective

Structure objectives that are aligned with

Policy


Management CommitmentLeadership (Clause 5)

Provide Resources

EstablishEstablishQuality PolicyQuality Policy

QualityQualityObjectiveObjective



ManagementManagementReviewReview

ensure that the resources needed are available


The Quality Hierarchy*Leadership (Clause 5)

Organizational Sustainability

Prevent defectsMeet minimum requirements

Conform to customer requirements

ISO 9001Foundation

Worldclass

performance

EFQM, Baldrige

Beyond minimum requirements

ISO 9004

* Concept developed by Joe Tsiakals and used with permission


Quality Policy• Be the leading supplier of

hi-tech bicycles as viewed by our customers

• Be proactive in listening to and communicating with customers

• Achieve 99% delivery to customer commitment date

• Ship replacement parts in 24 hours

• Maintain a competent staff

Quality Objective - MD• Hold quarterly meetings with key

customers

• Visit 3 customers each quarter to solicit customer input (Quality and design)

Quality Objective - Marketing VP• Conduct market research to determine

who is perceived as the leading supplier

Quality Objective - Design• Complete titanium disk brake project on time and w/in budget

Quality Objective - Production Manager• 99.5% on time delivery to customer commitment date


Engagement of Top Management? Why? How?

• Important to know what can and should not be delegated

• What gets measured gets done (follow the process approach!!)

• Engagement is a critical component of sustainability

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Why do it?Leadership (Clause 5)

o Facilitate top management strategic engagement with the QMSo Ensure responsibilities, accountabilities and authorities are clear and

unambiguouso Enhance communication with and involvement of all staff

throughout the organizationo Enhance risk assessment and exploration of opportunitieso Emphasize customer satisfaction throughout the organizationo Integrate quality management into the tactical activities of the

organizationo Ensure alignment of processes and objectives with strategic and

tactical plans


ExamplesLeadership (Clause 5)

o Help determine what top managers should and should not delegate and how the delegation will work

o Practice and learn to speak in the language of management ($$$$)o Design and deploy a Cost of Quality processo Provide management with actionable information


Sticky Clause #4Risks and Opportunities (Clause 6.1)


1. Consider issues relevant to the organization2. Determine the risks and opportunities that need to be

addressed in planning the QMS related to the issues that are considered

3. Consider risks and opportunities that impact the organization’s ability to achieve intended results, prevent or reduce undesired effects, and achieve improvement

4. Address actions to be taken and how to integrate the actions into the QMS

5. Determine how to evaluate effectiveness of actions taken6. Balance actions taken to address risks and opportunities to

the potential impact of the risk on conformity of products and services


Risk and Opportunities (Clause 6.1)

o Synopsis of the intent of the requirement is:

• Consider risks and opportunities that impact the organization’s ability to achieve intended results, prevent or reduce undesired effects, and achieve improvement

• Address actions to be taken and how to integrate the actions into the QMS

• Determine how to evaluate effectiveness of actions taken• Balance actions taken to address risks and opportunities to

the potential impact of the risk on conformity of products and services


Why do it?

o Mitigate liability exposureo Enhance sensitivity to safetyo Mitigate financial exposure related to riskso Enhance customer satisfactiono Meet requirements of clause 6.1.1 o Expand breadth and depth of the QMSo Important to enhance sustainabilityo Improve product development cycle timeso Prevent costly situations

CC1

CC1 Need words around next to last bulletCharlie Cianfrani, 10/14/2016


Internal Risks to Consider

o Implement internal audit and self-assessment processeso Gather and analyze of quality cost datao Analysis of technology trend informationo Competitive analysiso Analyze results of customer reviews and feedbacko Assess actual vs intended internal values and cultureo Analyze operational and financial data to assess performanceo Implementing processes to consider best practices and

comparisons with industry benchmarks o Analyze performance and interactions of processes


External Risks to Consider

o Deploy processes to consider:• The economic environment• International trade conditions, processes and barriers.• Competitive products and services• Technology trends• Regulatory changes• Opportunities and conditions related to a wide variety of

outsourcing strategies


Examples of how to do it - Tool Examples

o SWOT (strengths, weaknesses, opportunities, threats) analysiso Process mapping and flow chartingo FMEA (failure modes and effects analysis)


SWOT (strengths, weaknesses, opportunities, threats) analysis

SWOT

ISO

requirement

Strength Weaknesses Opportunities Threats Process Actions

Determine external/internal

issues relevant to org purpose

Monitor info re issues

Determine interested parties

Requirements of interested

parties

Review info re interested

parties

Simple SWOT analysis format example for considering requirements of Clauses 4 and 6


Process mapping and flow charting


FMEA (failure modes and effects analysis)


Risk Based Thinking

o Teach Everyone• Always consider risk• Think about the positive aspect of risk (the risk of not taking action)• Promote awareness and encourage personal involvement• Reward risk input to reinforce the management desire for contribution

from ALL employees


Sticky Clause #5: Understanding Knowledge, Competence and Innovation Requirements (Clause 7.1.6, 7.2 and 10.1 Note)

Knowledge Requirements ‐ Clause 7.1.6

1. A new requirement ISO 90012. Somewhat vague and subject to a wide

spectrum of understanding 3. Determine the knowledge necessary for

the operation of processes4. Maintain necessary knowledge and make it

available5. Determine how to acquire or access the

necessary additional knowledge to address changing needs and trends


Why do it? Knowledge

o To ensure the availability of the information needed to establish, implement, maintain and improve the quality management system

o To ensure that currently required organizational knowledge is obtained

o To plan to acquire any necessary additional knowledge and required updates for anticipated future needs

o To ensure QMS is effectively implemented o To capture tacit knowledge


Examples of how to do it - Knowledgeo Identify the processes of the QMSo Consider resource requirements for processes (personnel, time,

buildings, equipment, utilities, materials, supplies, instruments, software, transport facilities, other infrastructure)

o Deploy processes to codify, embed and communicate knowledge required to satisfy customer requirements

o Ensure knowledge needed to meet requirements is available when and where it is needed

o Consider short and long term resource needs; timing may be critical

o Integrate longer-term needs into the organization’s strategic and capital plans


Sticky Clause #5: Understanding Competence Requirements (Clause 7.2)

1. Determine the competence required for persons doing work that affects the performance and effectiveness of the QMS

2. Ensure that everyone has the capability to provide product that meets customer requirements based on appropriate education, training, or experience

3. Take actions to acquire necessary competence4. Evaluate effectiveness of actions taken5. Retain appropriate documented information as

evidence of competence to effective implementation of the QMS


Why do it - Competence

To Ensure That:

o People have the capability to satisfy customer requirements o The capability exists to make the QMS effective o Continual improvement of the effectiveness of the QMS processes

occurso Competence is maintained when transferring workerso Competence is maintained when utilizing temporary staffo Competence is maintained under changing conditions o HR establishes job requirements when hiring


Examples of How to Do It - Competence

o Use some form of written job requirements (i. e. job descriptions) o Competencies required should make sense for each job type; find

the right combination of education, training, skill and experience o Some job requirements may be only a performance standard (for

example, to produce a quantity of conforming product per day) o Establish processes to ensure newly hired or transferred personnel

have the competence to perform assigned tasks to requirementso Train supervision to ensure staff competence, especially in a

dynamic work environmento Engage HR in ensuring competence of staff for assignments


Sticky Clause #5: Understanding Innovation Requirements (note to Clause 10.1)

1. No requirements in ISO 9001:2015 2. There is note 1 in Clause 10.1 listing innovation as

an example of improvement


Why do it - Innovation

o Innovation is a vital component of sustainabilityo Innovation is a vital component of improvemento Competition is not statico Customer demands are always changingo Cost reduction is continually an issueo Technology is continually unveiling better ways to implement

process activities


How to Do It - Innovation

o Define a processo Requires periodic attentiono Allocate resourceso The QMS should not inhibit consideration of innovative product

and process developments o In certain customer or regulatory situations, the changes related to

innovation may not be permitted, but the process should capture future opportunities for later action


Sticky Clause #6: Understanding Documented Information Requirements (Clause 7.5).

1. Most significant change in 2015 is in the nomenclature2. The previous terms of “documents” and ‘records” have been

replaced with “documented information”3. The essence of the requirements is that the QMS shall include:

‐ all documented information required by ISO 9001:2015‐ documented information that the organization determines to be necessary for effective operations

‐ as applicable, the availability of applicable documented information to establish control of production and service provision (See clause 8.5.1

4. All other requirements similar to the past editions of ISO 9001

1. Most significant change in 2015 is in the nomenclature2. The previous terms of “documents” and ‘records” have been

replaced with “documented information”3. The essence of the requirements is that the QMS shall include:

‐ all documented information required by ISO 9001:2015‐ documented information that the organization determines to be necessary for effective operations

‐ as applicable, the availability of applicable documented information to establish control of production and service provision (See clause 8.5.1

4. All other requirements similar to the past editions of ISO 9001


Why Address Documented Information Requirements

o To Ensure:o Consistent performance of all activities affecting quality o Controls are in place to issue and approve documents o Changes in requirements are communicated to those who

must implement them o To prevent the use of obsolete information o To make certain that people have up-to-date instructions

and requirements


Examples of How to Address Documented Information Requirements

o Define the types of documents in your system o Determine if any change in nomenclature is required or desiredo Define the types of documentation that come from other

organizationso Maintain a clear differentiation between documents and recordso Where the term “maintain documented information” is used, the

intent is the documented information be kept up to dateo Where the term “retain documented information” is used, the

intent is similar to the ISO 9001:2008 requirements for a record


Examples of How to Address Documented Information Requirements (Continued)

o Define the control process appropriate for each type of documento The requirements for computer-based documentation may be

different from those for paper drawingso Records are a special type of document and require different

controlso See Annex A.6 Documented Information in ISO 9001:2015 o No requirement to do anything different without a good reason


Old Term New Term Purpose of Documented Information Changes & Corrections

Documented procedure Maintain documented informationProvide up to date

information for process operations

Keep up to date with changes

Record Retain documented information Provide objective evidence of activities conducted

No changes but corrections may be

permitted

This Table May Help to Understand Documented Information Requirements terminology


Sticky Clause #7: Measuring Customer Satisfaction (Clause 9.1.2)

1. Monitor information relating to customer perception as to whether the organization has met customer needs and expectations.

2. The methods to be used to get this information is not specified in the standard, butmethods must be established.

1. Monitor information relating to customer perception as to whether the organization has met customer needs and expectations.

2. The methods to be used to get this information is not specified in the standard, butmethods must be established.


Why Address Measuring Customer Satisfaction

o To understand customers’ perceptions related to your products so that you can take action to improve the QMS of the organization to improve that perception

o To understand actions needed to retain customers o To understand actions needed to expand businesso To understand actions needed to grow marketso Typically customer satisfaction is a stated objective of many

organizations, but not supported by processes to ensure it is achieved


Examples of How to Address Measuring Customer Satisfaction o Decide what information you will monitor o Determine how to get that informationo Determine how to analyze information (see examples of sources of

customer satisfaction information in next slide)o Consider that to demonstrate conformity in regulated markets, it

may be sufficient to monitor customer reports of product deficiencies

o Consider using focus groups and surveys of product userso Go beyond the requirements in Clause 9.1.2 to deploy aggressive

processes to gather and USE customer satisfaction information to enhance sustainability

o Consider ALL sources of customer satisfaction data


Examples of How to Address Measuring Customer Satisfaction o If you manufacture products for other companies, consider face-

to-face interviews with the individuals who make key buying decisions in customer organizations

o Consider that the products you produce may have associated services that are important to the customers

o Keep the process dynamic and flexible; the results of monitoring may indicate a need to gather more information through measuring

o Include methods to understand what is important to the customers, including price and delivery performance, when deciding what to monitor and measure

o Consider using QFD and voice of the customer techniques


Methods of Gathering

Active

Receptive

Indirect

SurveysFocus groupsSite visitsInterviewsComplaintsWarranty costsAllowancesLettersArticlesTrade ShowsRepeat business

Sources of Customer Satisfaction Data


Customer Ratings

R&D

Surveys

Complaints

Key Measures

Trade Shows

Sales Calls Articles

Often our customer data is like an incomplete puzzle

Credits & Returns


Customer Ratings

R&D

Surveys

Credits & Returns

Complaints

Key Measures Trade

Shows

Sales Calls

Articles

Get the pieces to fit together


Possible Sources of Data


Sticky Clause #8: Alignment of Objectives (Clauses 6.2, 7.3 and 7.4)

1. Establish quality objectives at relevant functions, levels and processes needed for the quality management system

2. 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.

3. Plan achievement of objectives. 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.

1. Establish quality objectives at relevant functions, levels and processes needed for the quality management system

2. 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.

3. Plan achievement of objectives. 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.


Why Align Objectives

o To Ensure:• Achievement of operational and financial objectives• Commonality of understanding of vision and mission and how they will

be realized• Requirements are met • Resources are allocated• Staff works with commonality of purpose • Communication of objectives and feedback of performance status


Managing to Achieve Results

Provide Resources






ensure that the resources needed are available


Any final comments or questions


Books by Cianfrani and West

Jack and Charlie are Co-authors of several books published by the American Society for Quality (ASQ) Quality Press including:

ISO 9001:2015 Explained (Fourth Edition) Cracking the case of ISO 9001:2015 for Manufacturing (Second Edition) Cracking the case of ISO 9001:2015 for Service(Second Edition) ISO 9001:2008 Explained & Expanded Unlocking the Power of your Quality Management System - Keys to

Performance Excellence How to Audit the Process-Based QMS (Second Edition) Also see our many articles in Quality Progress on all aspects of ISO 9001


Quality Management SystemImprovement

Leadership, Planning, Support, & Resource Management

Performance evaluation

SATISFACTION

CUSTOMER

REQUIREmENTS

CUSTOMER

Operational planning and control(Product and/or service realization)

Contextof the

Organization


Get Real About What Leaders Need To Do

Leadership (Clause 5)

QualityQualityManagementManagement

SystemSystem

QualityObjective

QualityObjective

QualityObjective


QualityObjective

QualityObjective

QualityObjective


AnalyzingAnalyzingMonitoringMonitoring

MeasuringMeasuring

ImprovingImproving

CustomerCustomersatisfactionsatisfaction

datadata

Improvement

Processes

Communicate!

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