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ISO 9001:2008 Implementation Workbook

ISO 9001 Quality Management System Implementation Workbook Contents

Section 1: Section 2: Section 3: Section 4: Section 5: Section 6: Section 7:

Section 8: Section 9:

Introduction Introduction to the ISO 9001 QMS Booklet Project Plan Introduction to ISO 9001 Implementing ISO 9001 Starter Guide Quality Management System Template Part 1 ISO 9001 Gap Analysis Part 2 Internal Auditing Part 3 Management Review Part 1 Corrective Action Part 2 Preventative Action ISO 9001 Quality Management System Certification

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ISO 9001:2008 Implementation Workbook

Section 2: Quality Management System Workbook This ISO 9001 Quality Management System workbook is an implementation tool and is intended to make your project as easy as possible when implementing an ISO 9001 compliant Quality Management System. The first steps in the process of implementing your quality management system is for the Management Representative to become familiar with the: ISO 9001:2008 Standard Quality Management System Procedures and Record Templates Implementation and training presentations Guidebook There are eight stages to the implementation process which include relevant checklists and implementation tools at each stage. This workbook can be used and completed as part of your implementation process. The following training guides are included to be used in conjunction with this guidebook: Guide to the Process of Implementing an ISO 9001 Compliant QMS Introduction to ISO 9001 Presentation With You All the Way ISO 9001 Quality Manual 84 Slide Presentation Internal Auditor Training Guide Clause 4 Quality Management System

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ISO 9001:2008 Implementation Workbook

Section 3: The Project Plan Responsibility: Senior Management Quality Management System Steering Team Management Representative Senior Management should identify a steering team for the project. It should be made up of managers from the different areas of the organisation. The purpose of this team will be to assign resources and responsibilities for the project as well as providing leadership for the project.

Complete Form 1

Senior Management Team Job Title Managing Director Site Director Operations Manager Quality Manager Planning Manager Distribution Manager Maintenance Manager Finance Manager Human Resources Manager Name Role in Team Chairman Deputy Chair Operations Reporting Quality Reporting Management Representative Planning and Capacity Reporting Distribution Reporting Services and Engineering Financial Reporting Provision Resource reporting

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ISO 9001:2008 Implementation Workbook

Complete Form 2

ISO 9001 Implementation Steering Team Steering Team Member Management Representative Name Position

The Steering Team should now meet to become familiar with this "ISO 9001 Quality Management System Implementation Workbook" and to discuss and commit to the "ISO 9001 Implementation Plan"

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ISO 9001:2008 Implementation Workbook

You will find the excel file "ISO 9001 Implementation Plan" in the implementation tools folder

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ISO 9001:2008 Implementation Workbook

Section 4: Introduction to ISO 9001:2008 Quality management System Requirements ISO 9001 is the only ISO 9000 standard for which certification can be gained. It is intended for use in any organization regardless of size, type or product including service. It provides a number of Quality Management System requirements which an organization needs to fulfil to achieve customer satisfaction. It includes a requirement for the continual improvement. For organisations with an established management system you can choose to use our Quality Management System Template and then follow our guide from Section 6 Quality Management System Template. Our PowerPoint training guide "Introduction to ISO 9001 Presentation" should be used to introduce ISO 9001 to your employees.

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ISO 9001:2008 Implementation Workbook

Section 5: Implementing ISO 9001 Starter Guide For businesses without an established Quality Management System we suggest following our eight stage Implementing ISO 9001 Process otherwise go to Section 6: Quality Management System Template and use our tailor made system then follow Section 7: ISO 9001 Gap Analysis to assess the compliance of your system. Process of Implementing a Quality Management System Section 5: Stage 1 - Define your purpose of your company Section 5: Stage 2 - Define your Policies and Objectives Section 5: Stage 3 - Determine the processes in the your company Section 5: Stage 4 - Determine the sequence of the processes Section 5: Stage 5 - Define process ownership Section 5: Stage 6 - Define Process Documentation Section 5: Stage 7 - Define the Activities Within Each Process Section 5: Stage 8 - Define Monitoring and Measurement Requirements Section 5: Stage 9 - Define the resources needed

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ISO 9001:2008 Implementation Workbook

IS0 9001 Manual First Stage of Implementation Process Stage 1 Form 1 Define the Purpose of your Organisation Senior Management to Complete

Formulate a checklist of Customers and Potential Customers that meet your defined purpose Customer/Potential Customer Record Details of your action and findings

Action (i)

Interview Customers and Potential Customers Sales and Marketing Managers - Feedback to the Senior Management Team Customer/Potential Customer Record Details of your action and findings

Action (ii)

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ISO 9001:2008 Implementation Workbook

Action (iii)

Check with Customers to ensure your understanding of their requirements Customer/Potential Customer Record Details of your action and findings

Senior Management Team determine the requirements for the quality management system Requirement Record Details of your action and findings

Action (iv)

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ISO 9001:2008 Implementation Workbook

Section 5: Stage 3 Process of Implementing a Quality Management System

Determine the processes needed for achieving the intended outputs. These processes include : Determine all the processes needed to produce the desired outputs. These processes include Management, Resources, Realization and Measurement, Analysis and Improvement Management

Resources

Realization Measurement Analysis

Determine the processes in the your company

Improvement

Identify all process inputs and outputs, including your suppliers and customers

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ISO 9001:2008 Implementation Workbook

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ISO 9001:2008 Implementation Workbook

Section 5: Form 3 Part 1 Stage 3 Determining the Processes

The Senior Management Team Determine all the processes needed to produce the desired outputs Determine the processes needed for Record Details of your action achieving the intended outputs. and findings These processes include : Management Team Resources ­ Training and Competence Product Realization Measurement Action (i) Analysis Design and Development Sales Planning Improvement Supplier Assurance Auditing Management Systems Identify all process inputs and outputs, including your suppliers and customers : Process :Product Realisation Action (ii) Inputs: Planning Training and Competence Record Details of your action and findings

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ISO 9001:2008 Implementation Workbook

Section 5: Form 4 Stage 4 Determine the Sequence of the Processes Checklist

Determine the sequence of the processes Determine how the processes flow in sequence and interaction. Consider the customer and inputs and outputs of each process, effectiveness of the sequence and how the processes flow in sequence and interaction. Define and describe the processes Confirm each has been and their interaction. considered Consider the following: Supplier and Customer of each process Inputs and outputs of each process Which processes are interacting Interaction, timing and sequence of the processes Effectiveness and efficiency of the sequence Use flowcharts to support the development of process sequences and their interactions

Action (iv)

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ISO 9001:2008 Implementation Workbook

Using Stage 3 & Stage 4 Forms you should now be able to draw a flow diagram of the processes within your organisation:

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ISO 9001:2008 Implementation Workbook

Process Owner

Example Planning Process Owner Planning Manager

Responsibe for: implementation of the planning process maintenance of the planning process improvement of planning process Interacting effectively with Sales and Production Processes and Owners Objectives from Company Objectives are: 100% Accurate Production Plan 100% Order Completion < 1% Wastage

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ISO 9001:2008 Implementation Workbook

Section 5: Stage 5 Define Process Ownership Form 5 Part 1

Define Process Ownership Establish a Process Management team that has an overview across all the processes, and which includes representatives (Process Owners) from each of the interacting processes. Eg. Planning Manager - Planning Process Owner Process Owner Job Title Name

Action (v)

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ISO 9001:2008 Implementation Workbook

Section 5: Stage 5 Assign Responsibility and Authority Form 5 Part 2 Example

Assign Responsibility and authority for Individual Roles for Each Process Role/Job Title Responsibility Planning Department implementation of the planning process maintenance of the planning process improvement of planning process Interacting effectively with Sales and Production Processes and Owners Objectives from Company Objectives are: 100% Accurate Production Plan 100% Order Completion < 1% Wastage Authority

Action (v) Planning Manager

Management of Planning/Senior Manager

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ISO 9001:2008 Implementation Workbook

Section 5: Stage 8 Define the Monitoring and Measurement Requirements Form 8

Measure or monitor to determine the effectiveness and efficiency of the process, taking into account such factors as : Conformity with requirements Customer satisfaction Supplier performance On time delivery Waste Process costs Incident frequency Action Determine the need for recording results (viii) Measurement Required for .......Process: Confirm

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ISO 9001:2008 Implementation Workbook

Stage 9 Process of Implementing a Quality Management System

Define the resources needed

Determine the resources including Human resources, Infrastructure, Work environment, Information, Natural resources, Materials and Financial resources that are needed for the effective operation of each process.

For example for product realisation resources required may be: Human resources Production Staff , Training & Competence Infrastructure - buildings, workspace layout, process equipment, tools, supporting services and information systems Work environment - layout of facilities, plant equipment, pest control, waste control, work wear, noise, temperature, humidity, lighting and weather

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ISO 9001:2008 Implementation Workbook

Section 5: Stage 9 Define the Resources Needed Form 9 Example

Determine the resources that are needed for the effective operation of each process including: Human resources Infrastructure Work environment Information Natural resources Materials Financial resources Resources product realisation: Human resources - Production Staff Training & Competence Action (ix) Infrastructure ­ buildings Workspace layout Process equipment supporting services and information systems Work environment - layout of facilities, plant equipment, pest control, waste control, work wear, noise, temperature, humidity, lighting and weather Confirm

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ISO 9001:2008 Implementation Workbook

Section 6: Quality Management System Template As an established business you can use our Quality Management System Template documents to fill any gaps in your system. The Quality Management System Template contains the following:

Quality Management System Section 4.1 Introduction to the Quality Management System Document Hierarchy Documentation Requirements Customer, Statutory and Regulatory Requirements Document Control Procedure Record Control Procedure Management Responsibility Section 5.1 Section 5.2 Section 5.3 Section 5.4 Senior Management Commitment Customer Focus Quality Policy Quality Management System Planning Quality Objectives Responsibility, Authority and Communication Responsibility & Authority Management Representative Internal Communication Section 5.6 Management Review Resource Management Section 6.1 www.9001manual.com Provision of Resources

Section 4.2

Section 5.5

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ISO 9001:2008 Implementation Workbook

The controlled records of the Quality Management System are pre-fixed QMR and are as follows: QMR 001 Management Review Minutes QMR 002 Training Record QMR 003 Product Release Record QMR 004 Design and Development Records QMR 005 Supplier Assessment Record QMR 006 Validation Record QMR 007 Identification and Traceability Record QMR 008 Register of Customer Property QMR 009 Calibration Record QMR 010 Internal Audit Record QMR 011 Records of Non-conforming Product QMR 012 Corrective Action Request Form QMR 013 Preventative Action Request Form QMR 014 Supplier Self Assessment and Approval Form There are also optional supplementary records supplied with our Quality Management System. Section 6: Quality Management System Template Checklist Use Section 6: Form 1 Quality Management System Procedure Template Checklist to check the implementation of your procedures.

Quality Management System Section 4.1 Introduction to the Quality Management System Document Hierarchy Documentation Requirements Customer, Statutory and Regulatory Requirements Document Control Procedure Implemented Date

Section 4.2

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ISO 9001:2008 Implementation Workbook

Use Section 6: Form 2 Quality Management System Record Template Checklist to check the implementation of your records.

Quality Management System Records QMR 001 Management Review Minutes QMR 002 Training Record QMR 003 Product Release Record QMR 004 Design and Development Records QMR 005 Supplier Assessment Record QMR 006 Validation Record QMR 007 Identification and Traceability Record QMR 008 Register of Customer Property QMR 009 Calibration Record QMR 010 Internal Audit Record QMR 011 Records of Non-conforming Product QMR 012 Corrective Action Request Form QMR 013 Preventative Action Request Form QMR 014 Supplier Self Assessment and Approval Form Implemented Date

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ISO 9001:2008 Implementation Workbook

Section 7: Verifying Quality Management System

Verify the process against its planned objectives

Confirm that the characteristics of the processes are consistent with the purpose of your company

Verify that all the requirements identified in the first stage are satisfied. If not, consider what additional process activities are required in the first stage

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ISO 9001:2008 Implementation Workbook

Section 7: Verifying the Quality Management System There are several methods that you can use to verify your quality management system meets both the requirements of the ISO 9001:2008 Standard and the Policies and Objectives established by Senior Management for the organisation Section 7 Form 1 Confirm that the characteristics of the processes are consistent with the purpose of your company.

Confirm that the characteristics of the processes are consistent with the purpose of your company. Verify that all the requirements identified in the first stage are satisfied. If not, consider what additional process activities are required in the first stage. Verification Activity: ISO 9001 QMS Gap Analysis Tool Internal Audit Management Review Confirm

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ISO 9001:2008 Implementation Workbook

Section 7: QMS Verification Part 1 Quality Management System Gap Analysis Section 7: Form 2 Quality Management System Gap Analysis The following gap analysis checklist should now be used to check that your Quality Management System complies with the requirements of the ISO 9001:2008 Standard.

Read each clause in the standard carefully and complete this form to assess if your system meets the requirements of the standard, firstly identifying your relevant processes and process owners, current activities and existing documentation (including the templates provided). Decide what future actions are required to ensure compliance. Allocate Responsibility and formulate an action plan. Process ISO 9001 ISO 9001: 2008 and Current Existing Action Required Completion Responsibility Clause Requirement Process Activities Documents to Comply Date Owner ISO 9001:2008 Section 4 Quality Management Establish quality System 4.1 management Template system provided by ISO 9001 Manual

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ISO 9001:2008 Implementation Workbook

Process and Process Owner

ISO 9001 Clause

ISO 9001: 2008 Requirement

Current Activities

Existing Documents

Action Required to Comply

Responsibility

Completion Date

5.1

Include customer, statutory and regulatory requirements in your Quality Policy and Manual Circulate and Brief your Quality Policy Define and Brief your quality objectives Implement management reviews and use the record enclosed with Manual Pack

ISO 9001:2008 Section 5 Customer, Statutory and Regulatory Conformance Quality Policy Quality Policy

5.1

Quality Policy

5.1

5.1

Management Review QMR 001 Management Review Minutes

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ISO 9001:2008 Implementation Workbook

Process and Process Owner

ISO 9001 Clause

ISO 9001: 2008 Requirement

Current Activities

Existing Documents

Action Required to Comply

Responsibility

Completion Date

8.1

8.1

Provide evidence that you have planned and implemented processes to monitor and measure to ensure conformity of the product to requirements. Ensure you have agreed specifications. Document a Product control Plan if necessary.

ISO 9001:2008 Section 4 Measurement and Monitoring

Measurement and Monitoring

Completed By: Management Representative

Date:

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ISO 9001:2008 Implementation Workbook

Section 7: QMS Verification Part 2 - Internal Auditing Once you have established your Quality Management System it needs to be audited to verify that it is effective. The Management Representative should manage internal auditing by ensuring there are an adequate number of trained internal auditors to audit the entire Quality Management System on a schedule determined by the importance and issues related to each area to be audited. Use our training presentation "Internal Auditor Training Guide Clause 4 Quality Management System" to train your Internal Auditors Use our checklist "Insider Tips on an ISO 9001 audit from an Auditor Perspective" as a full audit template The scope of the Internal Audit System should include all products manufactured on site and activities conducted on site including the quality management system. The Internal Audit Schedule should be planned annually and designed to comprehensively cover all areas of the Quality Management system including procedures, policies and activities as outlined below. Internal Audit List Scope of the Quality Management System Document Control Customer, Statutory and Regulatory Conformance Record Control Management Commitment Quality Policy Responsibility and Authority Management Review Resources and Training

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ISO 9001:2008 Implementation Workbook

The following form: QMR 010 Quality System Audit Form should be completed when conducting Internal Audits:

Quality System Audit Form Date Of Audit Procedure Document Or Area Audited Manual Document Number Title Issue Number Time Of Audit

Non-Conformances Found (To Be Completed By Auditor)

Action To Be Taken (To Be Agreed Between Auditor And Auditee With Timescales)

Log Corrective Action Request Numbers Raised In Box Below:

Name (Auditor) Name (Auditee)

Signature (Auditor) Signature (Auditee)

Date Date

Actions Complete And Corrective Actions Signed Off Audit Form Closed Name Signature Date

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ISO 9001:2008 Implementation Workbook

Section 7: Part 3 QMS Verification ­ Management Review Senior management now need to review the company management system and continue to do so at a minimum annually to ensure their continuing suitability, adequacy and effectiveness. The review includes assessing opportunity for improvements and the need for amendments to the systems. The proceedings of all reviews should be documented. The review meeting should chaired by the Managing Director and include Senior Management from Operations, Engineering, Planning, Distribution and Quality departments. Review inputs should include: - Review of the Quality Policy - Review of Management Changes - Minutes and Follow-up actions from previous review meetings - Outstanding Non-conformances as a result of internal and external audits - Trends analysis of the results of internal and external audits - Results of internal, second and third-party audits - Trend analysis of Customer and Supplier complaints - Quality Key Performance Indicators Review and trend analysis - Quality incidents, recalls, withdrawals - Process performance and product conformity - Corrective and preventive action status - Review of changes which could affect the Control Plans - Changes to policies and objectives - Review of Resources - Recommended improvements

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ISO 9001:2008 Implementation Workbook

Management Review Meeting - Date xx month YEAR

Meeting Objective To review and assess the effectiveness of the Quality Management System and to continually improve site effectiveness at meeting international standard ISO 9001:2008 and exceeding customer expectations. Attendees Managing Director - Chairman Operations Manager Engineering Manager Planning Manager Distribution Manager Quality Manager

Review Inputs Performance, Review Comments & Details Review of the Quality Policy Review of Management Changes Minutes and Follow-up actions from previous review meetings Outstanding Nonconformances as a result of internal and external audits Trends analysis of the results of internal and external audits Results of internal, second and third-party audits Corrective or Preventative Action Required -

-

-

-

-

-

-

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ISO 9001:2008 Implementation Workbook

Section 8: Taking Corrective and Preventative Actions Section 8: Part 1 Corrective Action Corrective Action Corrective Action is the action taken to eliminate the cause of an existing non-conformance in order to prevent a recurrence. The Corrective Action procedure defines that when NonConformances are raised a corresponding agreed corrective action is raised to eliminate the non-conformance and the cause of the non-conformance and that action is taken to reduce the risk of or prevent a recurrence. When implementing a corrective action, the time and resource required takes into consideration the significance of the nonconformance. Corrective Actions are recorded using QMR 012 Corrective Action Request Form:

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ISO 9001:2008 Implementation Workbook

Corrective Action Request COMPLETED CORRECTIVE ACTION REVIEW Corrective Action Report Number: Issued to: Date: The following Non-compliance has been noted:

Reference Audit Report or Quality System Area Risk Assessment : High / Medium / Low Corrective action required:

Person Responsible for corrective Action: Target Date to be completed by: Details of Action taken:

Sign to confirm action completed: Date Completed:

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ISO 9001:2008 Implementation Workbook

Section 8: Part 2 Preventative Action Preventative Action Preventative Action is the action taken to eliminate the cause of a potential non-conformance. The procedure for Preventative action is normally managed by the Quality Manager. The procedure for Preventative Action is used when corrective actions to alleviate quality issues may often require more permanent solutions by identifying and eliminating the underlying and/or contributory causes. Preventative actions are usually raised as a result of management review. Sources of potential non-conformances requiring preventative action include the following; Customer Complaints trends Management Review Customer Surveys Internal audits review External audits review Laboratory Analysis review Quality Control checks review Trend Analysis Non-conformance record review

Preventative Actions are recorded using QMR 013 Preventative Action Request:

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ISO 9001:2008 Implementation Workbook

Section 9: ISO 9001 Certification Process The process of gaining certification follows three simple steps: 1. Application for certification is made by applying to your chosen certification body. 2. An initial assessment by an auditor from the certification body to confirm that you are ready for full assessment. The assessor will: - confirm that the quality manual conforms to the requirements of ISO 9001:2008 - confirm its implementation status - confirm the scope of certification - check legislative compliance - produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required - produce an assessment plan and confirm a date for the Stage 3 audit and assessment 3. A full audit and assessment to confirm that your quality management system fully conforms to the requirements of ISO 9001:2008 in practice. The auditor will: - undertake sample audits of the processes and activities defined in the scope of assessment - document how the system complies with the standard - report any non-compliances or potential for noncompliance - produce a surveillance plan and confirm a date for the first surveillance visit

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