iso 9001.2015 transition (sample)

• ISO 9001:2015 / ISO 9001:2008 Standards Comparison

• Key Terminology Changes

• Major Differences between ISO 9001:2015 and ISO 9001:2008

• ISO 9001:2015 Changes & Additions – by Clause / Elements

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ISO 9001:2015 ISO 9001:2008 Clause 4: •Context of Organization – Internal & External • Needs & Expectations of Interested Parties • Scope of QMS & Processes – Risks & Opportunities / Documented Information

Clause 4: •QMS • Documentation Requirements; including Quality Manual, & Control of Documents / Records

Clause 5: •Leadership & Commitment – Customer Focus •Quality Policy •Organizational Roles, Responsibilities, & Authorities

Clause 5: •Management Commitment – Customer Focus •Quality Policy • Responsibility & Authority •Management Representative & Communication •Management Review

Clause 6: •Actions to Address Risks & Opportunities •Quality Objectives & Planning to Achieve

Clause 6: •Resource Management – Human Resources •Infrastructure • Work Environment

Clause 7: •Resources – People, Organizational Knowledge, Competence, Awareness, & Communication •Infrastructure •Environment for Operation of Processes •Monitoring & Measuring Resources

Clause 7: •Planning of Product Realization •Customer-Related Processes •Design & Development •Purchasing Process •Production & Service Provision •Control of Monitoring & Measuring Equipment

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ISO 9001:2015

ISO 9001:2008

Added “Risk-Based Thinking”


Strategic Planning

• Context of Organization

• Needs / Expectations of Interested Parties

• Risks & Opportunities (Risk-Based Thinking)

• Internal & external issues, relevant to purpose and strategic direction, that affects ability of organization to achieve intended results of QMS (ex: technology, market, company culture, performance)

Context of Organization

• Individuals and/or groups that have a stake in or are affected by the QMS of an organization and its products or services (ex: customers, suppliers, end-users, regulatory bodies)

Interested Parties

•RIsks - effects of uncertainty; having a negative or positive result (ex: using single source supplier)

•Opportunities - situation favorable for achieving an intended result (ex: addressing new customers)

Risks & Opportunities (Risk-Based Thinking)


Reduce / eliminate undesirable

Enhance desirable / Achieve

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Infrastructure & Environment

Buildings, Utilities,

Workspace / Environment Suitable to Operations (human & physical factors)

Monitoring & Measuring

Resources / Equipment

People & Communication

Competency Requirements

/ Needs

Communication & Awareness of

QMS

Organizational Knowledge

Company-specific information, product / trade relative, or tribal knowledge

which may result from lessons learned or previously

undocumented

Information necessary for operation of processes / achieving conformity of

products & services


Control of Production &

Service Provision

Identification, Traceability, & Preservation

Property belonging to Customers or

External Providers

Post Delivery Activities

Control of Changes

Control of Nonconforming Outputs


Control of Production & Service Provision

now includes:

•use of suitable infrastructure / environment

• appointment of competent / qualified persons

• implementation of actions to prevent human errors

Post Delivery Activities

include:

• statutory / regulatory requirements

•potential undesired consequences

•nature, use, & intended product / service lifetime

• customer requirements

• customer feedback

Control of Changes

include:

• review / control changes to extent necessary to ensure continuing conformity with requirements

• retain documented information describing results of change review, actions, & person(s) authorizing change


Management Review

Internal Audit

Monitoring, Measurement,

Analysis, & Evaluation

QMS

PERFORMANCE

EVALUATION


•React & take action to control / correct

•Evaluate need to eliminate cause / prevent recurrence

Nonconformity

• Implement any action needed

•Review effectiveness of Corrective Action taken

•Update Risks & Opportunities determined during planning

•Make changes to QMS, as necessary

Corrective Action

•Continually improve suitability, adequacy, and effectiveness of QMS

•Consider results of analysis, evaluation, and outputs from Management Review

Continual Improvement
