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ISO 9001:2015Management Overview of Changes

PRESENTED BY PQA INTERNATIONALON 6/14/16 AND 6/15/16

Who is PQA?

u Certifying body for ISO 9001, ISO 13485, ISO 14001, and OSHAS 18001

u In business since 1984, accredited to ISO 17021 since 1990u Serve clients of 2-200 employees in the USA, Canada,

Mexico and the UKu Training, assessment and certification for over 30 yearsu Here to serve you!

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Overview Outline

uBackground to the revisionuNew structureuNew requirements / clarificationsu Transition planninguA brief overview, for top management, not full text

of the standard or all requirements. uNot sufficient for internal auditor transition training!uWe’ll send you a copy of the slides

Background to ISO 9001

u9001 is designed to be a generic quality management system standardu Can be used in any company (Private and public)u Over 1.1 million certifications worldwide in 186 countries.

(@33,000 in the US, 40,000 in the UK, 342,000 in China)u Not limited to manufacturing. Growing use in service and

knowledge industries

uCertification is intended to be the result of a well-implemented QMS

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Background to ISO 9001

uCAUSE & EFFECT in a QMS.uCommitted top managementuCompetent peopleuManagement review & strategyuInternal auditsuCalibrated equipmentuMonitoring & measurementuWork instructions etcuDocumented informationuEtc, etc, etc,

Consistent conforming product

Effectiveness = “Ability to achieve

planned results”

Efficiency = “Ability to achieve planned

results with minimum resources”

Background to ISO 9001

u3 core conceptsu Identify the processes needed to achieve planned resultsu Continually monitor the risks (Risk based thinking, cause & effect)u Manage the processes using PDCA (Plan-Do-Check-Adjust)

u Plan: What to do? (objectives address risks) & How to do it? (procedure)u Do: Follow the plan (work instructions, retained info/records of what

happened)u Check: Monitor & measure results (did things happen according to plan?)u Adjust: How do we improve next time? (review objectives, plans, risks, & results)

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What To Look For in the 2015 Revision

uNew StructureuNew Requirements / ClarificationsuUnchanged RequirementsuDeleted RequirementsuTransition deadline: September 2018

New Structure

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9001:2008 vs. 9001:2015 u 0 Introduction

u 1 Scopeu 2 Normative references

u 3 Terms & definitions

u 4 Quality Management Systemu 5 Management Responsibilityu 6 Resource Managementu 7 Product Realizationu 8 Measurement Analysis & Improvement

u 0 Introduction

u 1 Scopeu 2 Normative references

u 3 Terms and definitions

u 4 Context of the Organizationu 5 Leadershipu 6 Planningu 7 Supportu 8 Operationu 9 Performance Evaluationu 10 Improvement

New Structure4

Context

Understanding the organization & its

context

Needs & expectations of interested parties

Scope of the QMS

QMS and its processes

5Leadership

Leadership and commitment

Quality policy

Roles , responsibilities and authorities

6Planning

Actions to address risks and

opportunities

Quality objectives and planning

Planning of changes

7Support

Resources

Competence

Awareness

Communication

Documented information

8Operation

Operational planning & control

Determination of requirements

Des ign and development

Control of externally provided

products & services

Production & service provis ion

Release of products and services

Nonconforming processes , products

& services

9 Performance

Evaluation

Monitoring, measurement,

analys is & evaluation

Internal Audits

Management Review

10Improvement

Non-conformity & corrective actions

Continuous Improvement

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Why the New Requirements / Clarifications

uMore flexibility in documentationu Increased emphasis on achieving desired process

results, for the company and customersuExplicit requirement for risk-based thinking to support

and improve process approachuClarified requirements for leadership engagementu Increased emphasis on planninguEmphasis on supply chain management

u0.3.3 Plan and implement actions to address risks & opportunitiesu RISK BASED THINKING integrates strategy & systems. Applying risk-

based decision making at every level and in every process allows resources to be better allocated.

uRisk = ”The effect of uncertainty on an expected result”uRisk isn’t always negative – opportunities are a positive risk (new

customers/products/markets, less waste, improved productivity)u Risk Evaluation needs a structure of

qualifications for each level, and criteria for defining when action is needed. Grading can be Quantitative (where Likelihood x Severity = Risk level) or Qualitative (high, medium, low)

New Requirements/Clarifications

Low

Med/Low

Medium Med/High

Medium

Med/Low Medium

Med/High

High

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New Requirements / Clarificationsu 4.1 Understanding the organization & its context:u Define business environment: Intended results of the QMS, plus

relevant internal and external issues that affect your ability to achieve those results: Basic strategic planning.

External Issues

Internal Issues

Intended results of QMS

• Market ( local, national, international )• Competitors, Cultural, Legal, Social,

Technology, Economic, Workforce

• Culture, Values• Knowledge, Performance

•Company strategic objectives•KPIs and metrics used to evaluate performance

New Requirements / Clarifications

u4.2: Understanding the needs and expectations of relevant interested partiesu The intent: anticipate current and

future needs/expectations; couldlead to identifying opportunities forimprovement or innovation

u “Relevant” includes customers and all others affected by the company and its products/services.

u The organization is required to monitorand review this information aboutinterested parties and their requirements

Interested Parties

Employees &

Families

Regulators/Government

Partners /Investors

Customers / End Users

Community

Suppliers

Retailers /distributors

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Revised Requirements

u4.3 Scope of the QMSuMust consider the internal and external issues (4.1)uMust consider requirements of interested parties (4.2)uScope must be available as documented informationuMust state the types of products and services covereduMust provide justification for any requirements that are Not

Applicable (only if the N/A does not affect ability or responsibility to ensure product conformity or enhancement of customer satisfaction)

New Requirements/Clarifications

u4.4 Quality Management Systems and its ProcessesuA-D - Are the same requirements as in 2008 uE – Assign responsibilities & authorities for those processes (likely

not all 1 person)uF – Must address Risks and Opportunities, (see 6.1 & 10.2)uG – Evaluate processes & implement changes needed to

ensure they achieve their intended resultsuH – Improve the processes and the QMS

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New Terms

u4.4.2 “Documented Information” instead of Manual/Procedures/Work Instructions

u4.4.2 “Retained Information” instead of Recordsu Reflects a growing trend for electronic informationu The company decides the necessity and type of documented

information. Existing documentation may be retained if useful, or may be converted to something more useful to the company.

u NOTE: there are now many more instances where the organization must “determine” – and in order to be audited, this information must be retained somewhere.

Changed Responsibilitiesu5.1 Leadership & commitment

u “Management representative” role deleted, encouraging a more proactive participatory role from all managers,

u Top management responsible for (10 bullets altogether)uEffectiveness of QMS

uEnsuring integration of QMS into the organization’s business processesuEnsuring that the QMS achieves its intended resultsuPromoting improvementuEnsuring that the quality policy and quality objectives are established,

and are compatible with the company’s context and strategic direction

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Revised Requirements

u5.1.2 Customer FocusuNew: “applicable statutory and regulatory

requirements”uClarification: Risks and opportunities determined

and addressedu“Enhancing customer satisfaction” still the aim.

New Requirements

u6.1 Actions to address RISKS and OPPORTUNTIESu“Identify risks” in 4.1, 4.2, 4.4 uHere you “plan actions” to address those risks.uThe NOTE clarifies options to address Risks & Opportunities

uAddressing Risk replaces Preventive Actions, by using risk-based thinking to integrate actions into the QMS, and monitor their effectiveness. uWhat is the risk/opportunity? How do we control it? Is the process

adequately defined?uMore guidance at www.iso.org/tc176/sc2/public

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Revised Requirementsu6.2 ‘Quality objectives’ now includes planning to

achieve them.u Objectives must be measurable, monitored, and updated as

neededu Planning how to achieve them includes determining:

uWhat will be done, uRequired resourcesuWho will be responsible, uWhen it will be completed, and uHow results will be evaluated.

New Requirements

u6.3 Planning of Changesu“undertake changes in a planned and systematic manner”

by considering:uPotential consequences of changeuIntegrity of the QMSuAvailability of resourcesuAllocation or reallocation of responsibilities and authorities

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Revised Requirements: Supportu7.1.4 Environment necessary for the operation of

process and to achieve conformity product and services

uCan be a combination of human and physical factorsu Social (non-discriminatory, calm, non-confrontational)u Psychological (stress-reducing, burnout prevention)u Physical (temperature, heat, humidity, light, airflow, noise,

hygiene)u Factors vary depending on the products and services provided.

New Requirements

uResource management now includes 7.1.6, Organizational Knowledgeu Maintained and available as necessaryu Determine how to acquire or access any needed additional

knowledge and required updates.u Generally, knowledge specific to an organization (or industry)u Internal sources – e.g. intellectual property, experience, lessons

learned from failures & successes, results of improvementsu External sources – e.g. standards, academia, conferences,

customers, external providers

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Revised Requirements

u7.4 Communication is more specificu“The organization shall determine the internal and

external communications relevant to the QMS,” including:uOn What it will communicateuWhen to communicateuWith Whom to communicateuHow to communicateuWho will communicate

Revised Requirements

u8.4 Control of Externally Provided processes, products and services - revision of Purchasing.uExternally provided processes remain within the control of

the QMS whether uincorporated into product, uprovided directly to customer, or uprovided to the company.

u Information to providers shall include requirements (see Standard for list)

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Revised Requirementsu8.5.1 Production control

u Definition of controlled conditions includes: uDocumented information (characteristics, activities, and results)uMonitoring & measuring equipment and activitiesuCompetence of staffuProcess validation and monitoringu Implementations to prevent human error (New)uRelease, delivery, and post-delivery activities

u8.5.6 Control of changes (within Production)u Retain documented information of review, authorization, and

actions taken as a result of the review.

Revised Requirements

u8.5.3 Property belonging to customers or external providersuSame requirements for protection of customer property,

now extended to that provided by external providersuCan include materials, components, tools & equipment,

premises, intellectual property & personal data

u8.5.4 PreservationuNow includes contamination control

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Revised Requirements

u8.6 Release of products and servicesuVerify that requirements have been met, at appropriate

stagesuNo release until completed, unless approved by relevant

authority or customer.uRetained documented information shall include:

uEvidence of conformity with acceptance criteriauTraceability to the persons authorizing release (New).

Revised Requirements

u8.7 Control of nonconforming outputsuRetain documented information that:

uDescribes the NCuDescribes the actions takenuDescribes any concessions obtainedu Identifies the authority deciding the action to be taken

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Revised Requirements

u9.1 Performance monitoring, measurement, analysis and evaluation of performance & QMS effectivenessuDetermine:

uWhat needs to be monitored & measured (KPIs)uMethods needed to ensure valid resultsuWhen the monitoring & measuring shall be performeduWhen results shall be analyzed and evaluated

uRetain documented info as evidence of results

Revised Requirements

u9.1.3 Analysis and evaluation, using data from monitoring & measurement, to determine:

uConformity of products & servicesuDegree of customer satisfactionuIf planning was implemented effectively uPerformance of external suppliersuQMS performance & effectivenessuNeed for improvements to the QMSuEffectiveness of actions to address risks/opportunities

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New Requirementsu10.1 Improvement u “Determine and select opportunities for improvement

including implementing any necessary actions to meet customer requirements and enhance customer satisfaction.” Shall include:u Improving products and services to meet requirements, future

needs and expectations.u Correcting, preventing, reducing undesired effectsu Improving the performance of the QMS

uE.g. correction, corrective action, continual improvement, breakthrough change, innovation and re-organization

Revised Requirementsu10.2 Nonconformity and corrective action

u React - control, correction, & dealing with consequences of NCu Evaluate the need for action so that it doesn’t recur or occur

elsewhereu Implement needed action (CAs appropriate to effects of the NCs)u Review effectiveness of any corrective actions takenu Update Risks & Opportunities identified during planningu Revise the QMS, if necessaryu Retain documented information as evidence of

uNature of NC’s & subsequent actionsuResults of any corrective actions

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Transition Planning: Deadline Sept 2018u Become familiar with 9000 and 9001 standardsu Identify organizational gaps to addressu Develop implementation plan, assign responsibilities,

create timeline u Provide needed training (PQA can help)u Update your QMS as neededu Full cycle of internal audits to new requirementsu Consider adding a gap audit u Transition to 2015 as soon as you’re ready – we are! u Last PQA audits to the 2008 revision = June 2017

Questions?

uAny questions during presentation --uRemember, you can call 303-800-5345 uor email us with your questions/concerns:

uOffice@pqacertification.comuMarkm@pqacertification.com