ISO 9001 Quality Management

ABN 95 844 017 962

kanriconsulting@adam.com.au
Quality Management Systems
Customer Focus

 ISO 9001 Leadership

 System which is implemented to

ensure customer requirements are Involvement of People
met.

Process Approach
 Roots are MIL-Q-9858 Quality
Program Requirements in 1959.
Systems Approach
 Elements
◦ Management
◦ Resources
◦ Services and Products
Continuous Improvement
◦ Monitoring

 PDCA
Factual Decision Making
.
Mutually Beneficial Relationships
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Quality Management Systems
Customer Focus

 9000  - Fundamentals & Vocabulary Leadership

9001  - Requirements for a QMS
 9000:2000 Fundamentals and
Vocabulary Involvement of People
9004  - Guidelines for Performance
Improvement
◦ 9100 - Aerospace Process Approach
 To support we use
 10012  - Measurement Systems Approach
10013 - Guidelines for
documentation
19011  - Audits Continuous Improvement
 Process Approach (Input Output
Resources Controls) Factual Decision Making

Mutually Beneficial Relationships

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Quality Management System
Customer Focus

 Demonstrates that we can provide Leadership

product of consistent quality to the
customer whilst meeting the
customer’s specifications. Involvement of People

Process Approach

Systems Approach

Continuous Improvement

Factual Decision Making

Mutually Beneficial Relationships

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Quality Management Systems
Customer Focus

 ISO 9001:2008 Leadership

 Clause 1
◦ Scope
 Clause 2 Involvement of People
◦ Normative Reference
 Clause 3
◦ Terms and Definitions Process Approach
 Clause 4
◦ QMS
 Clause 5 Systems Approach
◦ Management Responsibility
 Clause 6
◦ Resource Management Continuous Improvement
 Clause 7
◦ Product Realisation
 Clause 8 Factual Decision Making
◦ Measurement, Analysis, and Improvement

Mutually Beneficial Relationships

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Quality Management Systems
Customer Focus

 4. Quality Management System - Leadership

Control of Documents, Control of
Records (this means we need a quality
manual amongst other things). Involvement of People
 5. Management Responsibility -
management commitment, Process Approach
management Representative (Quality
Manager), Customer Focus 
Management Review, quality policy,
planning Systems Approach

Continuous Improvement

Factual Decision Making

Mutually Beneficial Relationships

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Quality Management Systems
Customer Focus

 6. Resource Management - provision Leadership

of resources, human resources,
infrastructure, work environment,
Involvement of People
 7.Product Realisation - planning of
product, customer related processes,
design and development, purchasing Process Approach
 8. Measurement Analysis and
Improvement - monitoring and Systems Approach
measurement (internal audit), control
of non conforming product,
improvement (CI, corrective action,
preventative action), we also need to Continuous Improvement
measure instructions for all
processes.
Factual Decision Making

Mutually Beneficial Relationships

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Quality Management Systems
Customer Focus

 Must be registered by external Leadership

organisation.

 Once registered, requires external Involvement of People

audits.

 Internal audits, or first party audits Process Approach

conducted by organisation.

 2nd party audits - customers Systems Approach

(external).

 3rd party audits - registration or Continuous Improvement

certification external.

Factual Decision Making

Mutually Beneficial Relationships

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Internal Auditing (Naibu kansa)

Auditing
 Purpose to improve performance of Principles
the organisation for the customer.

Evidence
Ethical
 We use ISO 19011 as guidance. Based
Approach Conduct
 Work to enterprise audit schedule

 Auditors to come from all parts of the

organisation

Fair
 Only shows that what was audited Indepe Presentatio
ndence n
was free from non conformities.

Due
 Auditing processes Profession
al Care

 Outputs Non conformances ->

Corrective Actions

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Internal Auditing (Naibu kansa)

 Flow for audits. Initiate the Audit

 Initiate the Audit

◦ Appoint the audit team leader Conduct Document Review
◦ Define objectives, scope and criteria
◦ Determine the feasibility of the audit
◦ Select the audit team Prepare for the On Site Audit
 Conduct Document Review Activities
◦ Review relevant management system
documents, reports and records
◦ Determine adequacy in respect to audit criteria Conduct On Site Audit Activities
 Prepare for the On-Site Audit
Activities
◦ Prepare the Audit Plan Prepare, Approve, and Distribute
◦ Assign Work to the Audit Team the Audit Report
◦ Prepare Work Documents
◦ Prepare Audit Checklists
Complete the Audit

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Internal Auditing (Naibu kansa)

 Conduct On-Site Audit Activities Initiate the Audit

◦ Conduct Opening Meeting
◦ Communicate During the Audit
◦ Collect and Verify information Conduct Document Review
◦ Generate Audit Findings
◦ Prepare Audit Conclusions
◦ Conduct Closing Meeting Prepare for the On Site Audit
 Prepare, Approve, and Distribute the Activities
Audit Report
◦ Prepare the Audit Report
◦ Approve and Distribute the Audit Report Conduct On Site Audit Activities
 Complete the Audit
◦ Do not distribute information to any other
parties. Prepare, Approve, and Distribute
 Conduct Audit Follow-Up the Audit Report
◦ Follow up corrective, preventative, or
improvement actions.
Complete the Audit

Conduct the Audit Follow Up

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Internal Auditing (Naibu kansa)

 Contents of the Audit Plan Initiate the Audit

◦ The audit objectives;
◦ The audit criteria and any reference
documents; Conduct Document Review
◦ The audit scope, including
identification of the organizational Prepare for the On Site Audit
and functional units and processes Activities
to be audited;
◦ The dates and places where the
on-site audit activities are to be Conduct On Site Audit Activities
conducted;
◦ The expected time and duration of Prepare, Approve, and Distribute
on-site audit activities, including
meetings with the auditee’s
the Audit Report
management and audit team
meetings; Complete the Audit
◦ The roles and responsibilities of
the audit team members and
accompanying persons;
Conduct the Audit Follow Up
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Internal Auditing (Naibu kansa)

◦ The allocation of appropriate Initiate the Audit

resources to critical areas of the
audit.
◦ The audit plan should also cover Conduct Document Review
the following, as appropriate:
◦ Identification of the auditee’s Prepare for the On Site Audit
representative for the audit;
Activities
◦ The working and reporting
language of the audit where this is
different from the language of the Conduct On Site Audit Activities
auditor and/or the auditee;
◦ The audit report topics;
Prepare, Approve, and Distribute
◦ Logistic arrangements (travel, on-
site facilities, etc.);
the Audit Report
◦ Matters related to confidentiality;
◦ Any audit follow-up actions. Complete the Audit

Conduct the Audit Follow Up

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Internal Auditing (Naibu kansa)

Records
Manageme
 Records management nt
 Audit plans
 Audit reports Audit
Audit
Follow Up
 Non conformity reports Reports Plans
 Corrective and preventative
action reports
 Audit follow up reports

Corrective and
Preventative
Audit
Action Reports
Reports

Non
Conformit
y Reports

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