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

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A brief introduction of internal auditing of quality management systems.

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  • A Power Point package designed to allow organisations to run internal lean and continuous improvement training. The package is comprehensive containing 140 slides detailing continuous improvement strategy and tools. Topics include; introduction, change management, team development, facilitation, voice of the customer, the seven wastes, strategy deployment, data collection, metrics, flow, levelling, cell layout, quick changeover, just in time, root cause analysis, 5s, autonomation, error proofing, visual management, standard work, value stream mapping, A3 thinking, PDCA, kaizen, office TPM, and sustainment. Unlike other lean introductory courses, this is not solely aimed at the factory floor.Terms are defined in English and if Japanese, Romaji and Kanji
  •  品質管理 HinshitsuKanri
  • All these standards use PDCA.
  •  Kano 2 dimensions investment and satisfaction. Kano diagram plots Kano's three types of quality must-be quality one-dimensional quality attractive quality
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  •  Kano 2 dimensions investment and satisfaction. Kano diagram plots Kano's three types of quality must-be quality one-dimensional quality attractive quality
  • When quality auditing, Only 9001 is audited.Look at the whole process,
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  •  Kano 2 dimensions investment and satisfaction. Kano diagram plots Kano's three types of quality must-be quality one-dimensional quality attractive quality
  •  Kano 2 dimensions investment and satisfaction. Kano diagram plots Kano's three types of quality must-be quality one-dimensional quality attractive quality
  • ISO 9001:2008 Internal Auditing of Quality Management Systems - Introduction

    1. 1. ABN 95 844 017 962 kanriconsulting@adam.com.au
    2. 2.     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 (c) Ewan Pettigrew 2
    3. 3. Customer Focus   9000 - Fundamentals & Vocabulary Leadership 9001 - Requirements for a QMS 9000:2000 Fundamentals and Involvement of People Vocabulary 9004 - Guidelines for Performance Improvement ◦    9100 - Aerospace To support we use 10012 - Measurement 10013 - Guidelines for documentation 19011 - Audits Process Approach (Input Output Resources Controls) Process Approach Systems Approach Continuous Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 3
    4. 4. Customer Focus  Demonstrates that we can provide product of consistent quality to the Leadership customer whilst meeting the customer’s specifications. Involvement of People Process Approach Systems Approach Continuous Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 4
    5. 5.   ISO 9001:2008 Clause 1 ◦  Clause 2 ◦  Product Realisation Clause 8 ◦ Leadership Involvement of People Process Approach Systems Approach Continuous Improvement Resource Management Clause 7 ◦  Management Responsibility Clause 6 ◦  QMS Clause 5 ◦  Terms and Definitions Clause 4 ◦  Normative Reference Clause 3 ◦  Scope Customer Focus Measurement, Analysis, and Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 5
    6. 6.   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 Involvement of People Process Approach Systems Approach Continuous Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 6
    7. 7.    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 Involvement of People Process Approach Systems Approach Continuous Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 7
    8. 8.      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. Customer Focus Leadership Involvement of People Process Approach Systems Approach Continuous Improvement Factual Decision Making Mutually Beneficial Relationships (c) Ewan Pettigrew 8
    9. 9.        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 Ethical Conduct Evidence Based Approach Auditing Fair Presentation Principles Independence Due Professional Care Outputs Non conformances -> Corrective Actions 内部監査 (c) Ewan Pettigrew 9
    10. 10.  Flow for audits.  Initiate the Audit ◦ ◦ ◦ ◦  Conduct Document Review ◦ ◦  Appoint the audit team leader Define objectives, scope and criteria Determine the feasibility of the audit Select the audit team 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 (c) Ewan Pettigrew 内部監査 10
    11. 11.  Conduct On-Site Audit Activities ◦ ◦ ◦ ◦ ◦ ◦  Prepare, Approve, and Distribute the Audit Report ◦ ◦  Prepare the Audit Report Approve and Distribute the Audit Report Conduct Document Review Prepare for the On Site Audit Activities Conduct On Site Audit Activities Complete the Audit ◦  Conduct Opening Meeting Communicate During the Audit Collect and Verify information Generate Audit Findings Prepare Audit Conclusions Conduct Closing Meeting Initiate the Audit Do not distribute information to any other parties. Conduct Audit Follow-Up ◦ Follow up corrective, preventative, or improvement actions. Prepare, Approve, and Distribute the Audit Report Complete the Audit Conduct the Audit Follow Up 内部監査 (c) Ewan Pettigrew 11
    12. 12.  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; 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 (c) Ewan Pettigrew 12
    13. 13. ◦ 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, onsite facilities, etc.); ◦ Matters related to confidentiality; ◦ Any audit follow-up actions. 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 (c) Ewan Pettigrew 13
    14. 14.       Records management Audit plans Audit reports Non conformity reports Corrective and preventative action reports Audit follow up reports Audit Plans Audit Follow Up Reports Audit Reports Records Management Corrective and Preventative Action Reports Non Conformity Reports 内部監査 (c) Ewan Pettigrew 14

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