ISO 9001:2008 Internal Auditing of Quality Management Systems - Introduction

ISO 9001 Quality Management

ABN 95 844 017 962

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(c) Ewan Pettigrew 2

Quality Management Systems

ISO 9001

System which is implemented to ensure customer requirements are met.

Roots are MIL-Q-9858 Quality Program Requirements in 1959.

Elements◦ Management◦ Resources◦ Services and Products◦ Monitoring

PDCA.

Customer Focus

Leadership

Involvement of People

Process Approach

Systems Approach

Continuous Improvement

Factual Decision Making

Mutually Beneficial Relationships



9000 - Fundamentals & Vocabulary9001 - Requirements for a QMS

9000:2000 Fundamentals and Vocabulary9004 - Guidelines for Performance Improvement◦ 9100 - Aerospace

To support we use 10012 - Measurement

10013 - Guidelines for documentation19011 - Audits

Process Approach (Input Output Resources Controls)

Customer Focus

Leadership


Process Approach

Systems Approach





Quality Management System

Demonstrates that we can provide product of consistent quality to the customer whilst meeting the customer’s specifications.

Customer Focus

Leadership


Process Approach

Systems Approach






ISO 9001:2008 Clause 1

◦ Scope

Clause 2◦ Normative Reference

Clause 3◦ Terms and Definitions

Clause 4◦ QMS

Clause 5◦ Management Responsibility

Clause 6◦ Resource Management

Clause 7◦ Product Realisation

Clause 8◦ Measurement, Analysis, and Improvement

Customer Focus

Leadership


Process Approach

Systems Approach






4. Quality Management System - Control of Documents, Control of Records (this means we need a quality manual amongst other things).

5. Management Responsibility - management commitment, management Representative (Quality Manager), Customer Focus Management Review, quality policy, planning

Customer Focus

Leadership


Process Approach

Systems Approach






6. Resource Management - provision of resources, human resources, infrastructure, work environment,

7.Product Realisation - planning of product, customer related processes, design and development, purchasing

8. Measurement Analysis and Improvement - monitoring and measurement (internal audit), control of non conforming product, improvement (CI, corrective action, preventative action), we also need to measure instructions for all processes.

Customer Focus

Leadership


Process Approach

Systems Approach






Must be registered by external organisation.

Once registered, requires external audits.

Internal audits, or first party audits conducted by organisation.

2nd party audits - customers (external).

3rd party audits - registration or certification external.

Require an audit program - organisation wide - yearly

Customer Focus

Leadership


Process Approach

Systems Approach





Internal Auditing (Naibu kansa)

Purpose to improve performance of the organisation for the customer.

We use ISO 19011 as guidance. Work to enterprise audit schedule

Auditors to come from all parts of the organisation

Only shows that what was audited was free from non conformities.

Auditing processes

Outputs Non conformances -> Corrective Actions

AuditingPrinciples

Ethical Conduct

Fair Presentati

on

Due Profession

al Care

Independence

Evidence Based

Approach

内部監査



Flow for audits.

Initiate the Audit◦ Appoint the audit team leader◦ Define objectives, scope and criteria◦ Determine the feasibility of the audit◦ Select the audit team

Conduct Document Review◦ Review relevant management system

documents, reports and records◦ Determine adequacy in respect to audit

criteria

Prepare for the On-Site Audit Activities◦ Prepare the Audit Plan◦ Assign Work to the Audit Team◦ Prepare Work Documents◦ Prepare Audit Checklists

Initiate the Audit

Conduct Document Review

Prepare for the On Site Audit Activities

Conduct On Site Audit Activities

Prepare, Approve, and Distribute the Audit Report

Complete the Audit

Conduct the Audit Follow Up内部監査



Conduct On-Site Audit Activities◦ Conduct Opening Meeting◦ Communicate During the Audit◦ Collect and Verify information◦ Generate Audit Findings◦ Prepare Audit Conclusions◦ Conduct Closing Meeting

Prepare, Approve, and Distribute the Audit Report◦ Prepare the Audit Report◦ Approve and Distribute the Audit Report

Complete the Audit◦ Do not distribute information to any other

parties.

Conduct Audit Follow-Up◦ Follow up corrective, preventative, or

improvement actions.

Initiate the Audit





Complete the Audit

Conduct the Audit Follow Up内部監査



Contents of the Audit Plan◦ The audit objectives;◦ The audit criteria and any

reference documents;◦ The audit scope, including

identification of the organizational and functional units and processes to be audited;

◦ The dates and places where the on-site audit activities are to be conducted;

◦ The expected time and duration of on-site audit activities, including meetings with the auditee’s management and audit team meetings;

◦ The roles and responsibilities of the audit team members and accompanying persons;

内部監査

Initiate the Audit





Complete the Audit

Conduct the Audit Follow Up



◦ The allocation of appropriate resources to critical areas of the audit.

◦ The audit plan should also cover the following, as appropriate:

◦ Identification of the auditee’s representative for the audit;

◦ The working and reporting language of the audit where this is different from the language of the auditor and/or the auditee;

◦ The audit report topics;◦ Logistic arrangements (travel, on-

site facilities, etc.);◦ Matters related to confidentiality;◦ Any audit follow-up actions.

内部監査

Initiate the Audit





Complete the Audit

Conduct the Audit Follow Up



Records management Audit plans Audit reports Non conformity reports Corrective and

preventative action reports Audit follow up reports

Records Managem

ent

Audit Plans

Audit Reports

Non Conformity Reports

Corrective and Preventative

Action Reports

Audit Follow Up Reports

内部監査

ISO 9001:2008 Internal Auditing of Quality Management Systems - Introduction

Business

Transcript of ISO 9001:2008 Internal Auditing of Quality Management Systems - Introduction