CD Rom ISO 9001:2000 Implementation Quality Management ... · CD Rom ISO 9001:2000 Implementation Quality Management System Templates Content 8.0 Records 1. Calibration - Test Record

CD Rom ISO 9001:2000 Implementation

Quality Management System Templates

Content 1.0 Quality Manual

1. QM - Quality Manual 2.0 Quality Procedures

1. QP 01 - Control of Non Conformance 2. QP 02 - Control of Quality Records 3. QP 03 - Corrective and Preventive Action 4. QP 04 - Document Change Control 5. QP 05 - Internal Auditing

3.0 Operational Processes

1. OP 01 - Calibration of Measuring Equipment 2. OP 02 - Internal Communication 3. OP 03 - Computer Back - Up 4. OP 04 - Control of External Documents 5. OP 05 - Customer Focus 6. OP 06 - Design Control 7. OP 07 - Stock Control 8. OP 08 - Stock Inspections 9. OP 09 - Inspection of Incoming Material 10. OP 10 - Training 11. OP 11 - Inspection of Product 12. OP 12 - Job Descriptions 13. OP 13 - Maintenance of Plant and Equipment 14. OP 14 - Order Review 15. OP 15 - Preservation of Product 16. OP 16 - Performance Reporting 17. OP 17 - Plant Infrastructure & Work Environment 18. OP 18 - Supplier Assessment and Approval 19. OP 19 - Planning Product Realisation 20. OP 20 - Purchase Order Processing 21. OP 21 - Quality Management Review 22. OP 22 - Review of Quality Objectives 23. OP 23 - Quality Planning 24. OP 24 - Application of Statistical Techniques



Content 4.0 Flowcharts

1. Administration 2. Document Control 3. Design Process 4. Goods Receiving Process 5. Order Review 6. Quality Planning

5.0 Useful Guides

1. Cost of Quality and Case Studies 2. Infrastructure and Environment 3. Internal Communications 4. ISO 9001 Structures 5. Lost Profit & Case Studies 6. Performance Reporting 7. Quality Objectives 8. Quality Policy 9. Requirements for procedures & records 10. Statistical Techniques

6.0 Plans

1. Calibration Schedule 2. ISO 9001:2000 Project Plan 3. ISO 9001: Documentation 4. Product Realisation Plan 5. Internal Audits Plan 6. Equipment Maintenance Schedule 7. Management Review Agenda 8. Production Meeting Agenda 9. Sales Review Meeting Agenda 10. Staff Training Plan and Matrix 11. Quality Plan

7.0 Questionnaires

1. Customer Satisfaction Questionnaire 2. ISO 9001 Assessment Questionnaire 3. Supplier Assessment Questionnaire



Content 8.0 Records

1. Calibration - Test Record 2. Training - Staff Record 3. Suppliers - Approved List 4. Quality Records - Register 5. Stock Control - Inspection Form 6. Audits - Internal Audit Report 7. Audits - Internal Audit Checklist 8. Corrective Action - Register 9. Corrective Action - Form 10. Purchasing - Order Form 11. Document Control - Master Register for Controlled Documents 12. Document Control - Master Register for External Documents 13. Document Control - Change Note Register for Controlled Documents 14. Document Control - Change Note Form for Controlled Documents 15. Management Review - Meeting Minutes

9.0 General

1. FAQs - Frequently Asked Questions 2. ISO 9001 Structure

© Solutions Generation Limited Revision 01 Page 1 of 27

Organisation Limited

Quality Manual

Manual Number 01

© Solutions Generation Limited Revision 01 Page 2 o f 8

Contents and ISO Cross Reference

Section Title Ref to ISO 9001 Page 1 Authority and Scope 1.0 04 1.1 Authority 4.2.3 1.2 Issue of the Quality Manual 4.2.3 1.3 Amendment to the Quality Manual 4.2.3 1.4 Organisation Description 1.5 Application of Quality management system 1.2 1.6 Purpose of the Quality Manual 1.2 2 Quality Management System 4.1 05 2.1 General Requirements Purpose, Continual Improvement 3 Documentation requirements 4.2 06 3.1 Document Structure and Contents Purpose, Quality Manual, Quality Procedures System Documents, Quality Records 3.2 Control of Documents Purpose, Document Issue and Change Approval 3.3 Control of Quality Records Purpose, Control 4 Management Responsibility 5.0 07 4.1 Purpose 5.1 4.2 Management Commitment 5.1 4.3 Customer focus 5.2 Purpose, Addressing Customer Needs 4.4 Quality Policy 5.3 08 Purpose, Implementation of Policy 4.5 Planning 5.4 Purpose of Quality Objectives, Quality Objectives, Quality management system planning 4.6 Responsibility, authority and communication 5.5 09 Responsibility and authority, Management Representative, Internal communication Management Review 10


Contents and ISO Cross Reference Section Title Ref to ISO 9001 Page 5 Resource management 6.0 11 5.1 Provision of resources 6.1 5.2 Human resources Purpose, Competence, awareness and training Infrastructure, Work environment 12

6 Product Realisation 7.0 13 6.1 Planning of product realization 7.1 Purpose, Quality Plan 6.2 Customer-related processes 7.2 14 Determination and review of requirements related to the product. 6.3 Design and development 7.3 15 Purpose, Planning, Inputs, Outputs, Review Verification, Validation, Changes, Records 6.4 Purchasing 7.4 16 Purpose, Purchasing process, Purchasing information Verification of purchased products 6.5 Production and service provision 7.5 17 Purpose, Control of production and service provision, Validation of processes, Identification and Traceability, 18 Customer Property, Preservation of product 19-20 6.6 Control of measuring and monitoring devices 7.6 21 Purpose, General, Traceability to Standards Calibration Frequency, Calibration Records 7 Measurement, analysis and improvement 8.0 22 7.1 Purpose 8.1 7.2 Monitoring and Measurement 8.2 23 Customer Satisfaction, Internal audit Monitoring and measurement of processes Monitoring and measurement of product 7.3 Control of nonconforming product 8.3 24 Purpose, Materials, Products, Records 7.4 Analysis of data 8.4 Purpose, Analyses, Reports 7.5 Improvement 8.5 25 Continual Improvement, Corrective Action Preventative Action 8 List of Quality Procedures and Process Documents 4.2.2 26 9 Organisation Flow Chart 4.2.2 27


1 Authority and Scope 1.1 Authority

As Managing Director, I fully support the need for a comprehensive and effective quality management system to ensure that …etc…

1.2 Issue of the Quality Manual

Controlled copies of the quality manual are numbered, registered and issued to ..etc 1.3 Amendment to the Quality Manual

Amendments to this quality manual are published in accordance with …etc.. 1.4 Organisation Description

The organisation, as a family owned business, was established in 1956. It manufactures XXX products (provides XXX services) mainly for the XXX industries throughout Europe.

1.5 Application of Quality management system

The quality management system is designed to operate within the requirements of ISO 9001:2000. In applying the requirements of this standard, any clauses that …etc…

1.6 Purpose of the quality manual

The purpose of this quality manual is to document the policies of a quality management system that enable the organisation to …etc…

2 Quality Management System 2.1 General Requirements

2.1.1 Purpose

To continually improve the organisation's performance and its ability to satisfy customer's needs ….etc….

2.1.2 Continual Improvement

a. Identifying your processes The processes necessary for the effective and efficient operation of the organisation are defined within this quality management system and are subject to …etc…

b. Mapping out key organisation processes …etc…. c. Operating and controlling your processes. , …etc.. d. Allocating required resources …etc… e. Assessing process performance r …etc f. Planning Improvements …etc


3 Documentation Requirements 3.1 Document Structure and Contents 3.1.1 Purpose To define the structure and contents of quality management system documents operated ..etc

3.1.2 Quality Manual. This defines the scope of the quality management system ..etc

3.1.3 Quality Procedures. These implement quality policies and document …etc….

3.1.4 System Documents. These describe how work is carried out and include …etc..

3.1.5 Quality Records. These include quality and operational records required for …etc.. 3.2 Control of Documents 3.2.1 Purpose To define methods for the approval, issue and maintenance of …etc…

3.2.2 Document Issue and Change Approval New or revised controlled documents are reviewed and approved, for …etc.. 3.3 Control of Quality Records 3.3.1 Purpose To demonstrate conformance and effectiveness of the quality management system using

quality records. …etc…

3.3.2 Control A procedure defines how quality records are identified, filed and maintained, ..etc.. 4 Management Responsibility

etc…

5 Resource Management etc

6 Product Realization

etc

6.1 Planning of product realization 6.1.1 Purpose To plan and develop processes necessary for the realisation of products…etc… 6.1.2 Quality Plan

Management accepts that staff can only function effectively if supplied with suitable controlled processes and resources to perform their tasks. ..etc..


6.2 Customer-related processes 6.2.1 Determination and review of requirements related to the product

Purpose

To define the process for receipt, review and acceptance of customer order …etc..

Order Review

The organisation recognises that all of its activities must be built on the foundation of an accurate knowledge of the specific needs and requirements of the customer. During the order review process, the customer’s requirements are reviewed …etc… Amendments ..etc.. Communication …etc… Records

Relevant Contract Review activities are recorded to …etc… 6.3 Design and development

etc… 6.4 Purchasing

etc… 6.5 Production and service provision etc.. 6.6 Control of measuring and monitoring devices

etc.. 7 Measurement, Analysis and Improvement 7.1 Purpose

To establish methods for the monitoring, measurement and analysis of performance data that demonstrate conformance of products as well as the conformance and improvement of the quality management system. …etc

7.2 Monitoring and Measurement 7.2.1 Customer Satisfaction Management actively seeks the valued opinions of its customers and has defined ..etc

7.2.2 Internal audit


Purpose To define how planned internal audits are carried out to determine how the conformance

and effectiveness of the quality management system are in achieving its objectives and meeting requirements….etc

Plans

…etc.

Results …etc.

Corrective and Preventive Action …etc.

Staff …etc. 7.2.3 Monitoring and measurement of processes

Wherever appropriate, quantitative measurements are used for the monitoring the performance of process operations. …etc…

7.2.4 Monitoring and measurement of product

Purpose To ensure that the organisation monitors and measures the characteristics of products and

verifies that they fulfil planned product requirements. …etc.. 7.3 Control of nonconforming product 7.3.1 Purpose To document how non-conforming material is identified and segregated, to prevent its

unintended use….etc 7.4 Analysis of data 7.4.1 Purpose

To define how management investigates collated performance data from throughout the organisation and reports on the …etc…

7.5 Improvement 7.5.1 Continual Improvement

Management seeks continual improvement of the organisation's processes and of its overall performance. …etc..

7.5.2 Corrective Action When any non-conformance within the quality management system, including customer

complaints, is identified, the cause is determined and etc….


7.5.3 Preventive Action Documented procedures are established which determine and implement appropriate

preventative action to …etc..

8 List of Quality Procedures and Process Documents 8.1 Purpose

To provide a reference to quality management system and operational procedures as well as process documents which implement the stated policies of this quality manual.

Document Number and Description Quality Manual References Quality management system procedures: QP 04 Document Change Control 1.2 1.3 3.2 4.5.3 …etc… Operating process documents: OP 21 Quality Management Review 2.1.2 4.5.3 4.6.4 …etc… Process Documents: OP 05 Customer Focus 4.3 7.2 …etc…

9 Organisation Flow Chart 9.1 Purpose

To define the interactions between the processes of the quality management system operated within the organisation….etc

Organisation Limited Procedure No: QP 03 Issue: 01 Title: Corrective and Preventive Action Page: 1 of 2

© Solutions Generation Limited

ManageConsult

1.0 Purpose 1.1 To define the method for raising and implementing corrective and preventive

actions to deal with identified non-conformances. 2.0 Scope 2.1 This procedure applies to all corrective actions raised to resolve identified

non-conformances…etc 3.0 Associated Documents 3.1 ISO 9001:2000 Clause 8.5.2 and 8.5.3 3.2 Corrective Action Form QF 01 3.3 Corrective Action Register QF 03 4.0 Responsibilities 4.1 Any member of staff can initiate a corrective action form (CAF). 4.2 The Quality Manager is responsible for ensuring that all corrective and

preventive actions are appropriately implemented and closed. etc 5.0 Concept of the corrective action procedure 5.1 This procedure allows non-conformances to be dealt with in a manner which

identifies the cause(s) and assigns and records a path forward (with timescale and responsibility) to correct …etc

6.0 Raising Corrective Actions 6.1 The CAF form is raised by the initiator and contains details of the non-

conformance and is presented to the Quality Manager for review. etc

Organisation Limited Procedure No: OP 01 Issue: 01 Title: Calibration of Measuring Instruments Page: 1 of 2


ManageConsult

1.0 Purpose 1.1 To define the methods used for the calibration and maintenance of all

equipment used for the measuring, testing and inspection of ..etc 2.0 Scope 2.1 This procedure applies to all measuring equipment affecting the quality ..etc 3.0 Associated Documents 3.1 ISO 9001:2000 Clause 7.6 3.2 Calibration Form QF 10 3.3 Calibration Plan QF 11 3.4 Control of Non Conformance QP 03 4.0 Responsibilities 4.1 The Quality Manager has overall responsibility for all management, control

and calibration of inspection and test equipment. 4.2 Managers/staff are responsible for ensuring that …………..etc. 5.0 Marking of Equipment 5.1 All calibrated equipment is marked with a …etc 6.0 Issue and Return of Equipment 6.1 Details of equipment calibrations and equipment issue and returns are

recorded using …etc 7.0 Calibration 7.1 The procedure for calibrating equipment is based on ….etc. 8.0 Use of Equipment 8.1 Calibrated equipment and test standards/gauges are used in …….etc… 8.2 All sub contractor’s equipment is also subject to ……etc……. 9.0 Out of Calibration 9.1 If measuring equipment is used and subsequently found to be out of

calibration during tests ……… etc…….

Organisation Limited Procedure No: OP 09 Issue: 01 Title: Inspection of Incoming Materials Page: 1 of 4


ManageConsult

1.0 Purpose

1.1 To describe how incoming materials are checked for …etc.. 2.0 Scope

2.1 This procedure applies to all received materials/products used to …etc 3.0 Associate Documents

3.1 ISO 9001:2000 Clause 7.4.3 3.2 Stock Control OP 07…etc.. 4.0 Responsibilities

4.1 The manager/staff is responsible for the checking and handling of …etc.. 5.0 Flow Chart

5.1 The flow of material from delivery to storage/use is given in Appendix 01. 6.0 Delivery - Initial Checks

6.1 All deliveries of materials are routed via the …. etc ….. 7.0 Checking Materials Against a Purchase Order

7.1 The staff member accesses the corresponding Purchase Order and ..etc 8.0 Stock Identification

8.1 Materials/equipment are properly identified by their description ..etc.. 9.0 For Meticulous Checking of Materials

9.1 Once off-loaded, these materials are transferred to …etc.. 10.0 Stock Movement

10.1 The staff member records the movement of materials to and from store ..etc.. 11.0 Reject or On-Hold Materials

11.1 Rejected or on-hold materials remain in the …etc 12.0 Filing of the Paperwork

12.1 The Delivery Note and other consignment related documents are sent to Purchasing for processing …etc..

Organisation Limited Procedure No: OP 09 Issue: 01 Title: Inspection of Incoming Materials Page: 2 of 4


ManageConsult

Goods Receiving Flow Diagram

“Received unexamined” is written on delivery note and signed

Do materials require meticulous checking?

Yes

Yes

Yes

No

No

No

Received in good condition written on delivery note

Delivery note is updated and materials are returned to Supplier

All discrepancies are dealt with by procedure QP 01 Control of Non Conformance

Materials are checked - details noted on delivery note

File consignment related documents into Delivery Note Folder

Update Purchase Order

Transfer materials to stores as per procedure OP 07 Stock Control

Check delivery details with Purchase Order

Were materials properly inspected?

Goods receiving register updated

Details noted on delivery note and signed

Are there any material quality discrepancies?

Materials are checked for damage, description and quantity

Staff check delivery note details against delivered materials

Organisation Limited Procedure No: OP 10 Issue: 01 Title: Training Page: 1 of 3


ManageConsult

1.0 Purpose 1.1.1 To define the methods used for the identification, provision and …etc.. 2.0 Scope 2.1 This procedure applies to all aspects of formal education, training and ..etc 3.0 Associated Documents 2.1 ISO 9001:2000 Clause 6.2.2 2.2 Training Record 4.0 Responsibilities 4.1 The operations manager has overall responsibility for all training matters.

This includes ensuring appropriate funds, literature, equipment and advice is available …etc

5.0 General 5.1 All staff are provided with the necessary instruction and training to:

• maintain safe and effective working practices ..etc 6.0 Training Needs and plans 6.1 The operations manager identifies the appropriate training needs of ..etc.. 7.0 Provision of Training 7.1 In preparation of the training programme, the trainer determines the following:

• elements and levels of competence or objectives to be achieved, ..etc..

8.0 Evaluation and Approval of Training 8.1 On completion of the training session, the trainer evaluates the trainees' ..etc.. 9.0 Training Records 9.1 The manager retains a centrally held file of all staff training….etc..

Organisation Limited Procedure No: OP 11 Issue: 01 Title: Inspection of Product Page: 1 of 2


ManageConsult

1.0 Purpose 1.1 To define how in process and final product inspections are performed. 2.0 Scope 2.1 This applies to products manufactured, tested and delivered by the company. 3.0 Associated Documents 3.1 ISO 9001:2000 Clause 8.2.4 3.2 Control of Non Conformance QP 02

..etc… 4.0 Responsibilities 4.1 The production manager is responsible for ensuring etc… 4.2 The production supervisor is responsible for random in-process ..etc.. 5.0 Daily Process Inspections 5.1 The production supervisor randomly checks, ..etc 6.0 Staff Inspections 6.1 On completion of the job, such as assembly and clean, staff inspect ..etc.. 7.0 Supervisor Inspection 7.1.1 When the work in the department is completed, the supervisor ..etc.. 8.0 Final Inspection 8.1 When the fully assembled product is received into the inspection area, ..etc.. 9.0 Inspection Guide 9.1 During the inspections refer to the in-house inspection instructions …etc.. 10.0 Observations/Concerns 10.1 During all in-process and final inspections any relevant observations …etc.. 11.0 Reports 11.1 At the start of each week the production supervisor prepares and etc….

Organisation Limited Procedure No: OP 12 Issue: 01 Title: Job Descriptions Page: 1 of 1


ManageConsult

1.0 Purpose

1.1 To write job descriptions for managers and staff that contribute to the quality of the company's products and services.

2.0 Scope

2.1 These job specifications apply to all staff functions within the Company. 3.0 Associated Documents

3.1 ISO 9001:2000 Clause 5.5.1 4.0 Managing Director: The responsibilities of the managing director are to:

• Develop and approve the quality policy. etc….

5.0 Human Resource Manager: The responsibilities of the human resource manager are to: • Determine the necessary competence of staff performing work..etc

6.0 Sales Manager: The responsibilities of the sales manager are to: • Conduct quality related market research, analysis and reports..etc

7.0 Purchasing Manager: The responsibilities of the purchasing manager are to: • Approve purchase orders..etc

8.0 Operations Manager: The responsibilities of the operations manager are to: • Chair operational reviews etc./…

9.0 Design Manager: The responsibilities of the design manager are to: • Determine quality characteristics of products in terms of functionality and performance etc

10.0 Engineering Manager: The responsibilities of the engineering manager are to: • Calibrate measurement equipment etc..

11.0 Store Supervisor: The responsibilities of the store supervisor are to: • Receive and check supplied materials effectively and report all discrepancies etc/…

12.0 Quality Manager: The responsibilities of the quality manager are to: • Maintain, improve and report the effectiveness of the quality management system etc..

13.0 Administrator : The responsibilities of the administrator are to: • Maintain the formal document change control system etc…

14.0 Operations Supervisor: The responsibilities of the operations supervisor are to: • Work with staff to resolve daily work problems and to ensure the quality of work .. tc…

15.0 All Staff: The responsibilities of staff are to: • Assist with implementation of quality policies and achievement of quality objectives etc

Organisation Limited Procedure No: OP 21 Issue: 01 Title: Quality Management Review Page: 1 of 2


ManageConsult

1.0 Purpose 1.1 To define the methods for conducting quality management reviews …etc 2.0 Scope 2.1 This procedure applies to all quality management reviews …etc 3.0 Associated Documents 3.1 ISO 9001:2000 Clause 5.6 3.2 Quality Management Review minutes 4.0 Responsibilities 4.1 The Managing Director is responsible for convening and etc 4.2 Managers to present required reports for the review process etc.. 5.0 Quality Management Review 5.1 The Managing Director convenes a quality management review meeting at

least once every 12 months with appropriate managers attending ..etc 6.0 Objectives of Quality Management Review 6.1 The review team objectives are to:

a) ensure quality management objectives are being achieved;…etc 7.0 Areas Reviewed 7.1 The quality management review meeting considers items including:

a) setting and achievement of quality objectives..etc 8.0 Records 8.1 Minutes are maintained of all quality management review meetings ..etc


ManageConsult

Goods Receiving Flow Diagram

“Received unexamined” is written on delivery note and signed

Do materials require meticulous checking?

Yes

Yes

Yes

No

No

No

Received in good condition written on delivery note

Delivery note is updated and materials are returned to Supplier

All discrepancies are dealt with by procedure QP 01 Control of Non Conformance

Materials are checked - details noted on delivery note

File consignment related documents into Delivery Note Folder

Update Purchase Order

Transfer materials to stores as per procedure OP 07 Stock Control

Check delivery details with Purchase Order

Were materials properly inspected?

Goods receiving register updated

Details noted on delivery note and signed

Are there any material quality discrepancies?

Materials are checked for damage, description and quantity

Staff check delivery note details against delivered materials

ISO 9001 Structure

ISO 9001:2000 and ISO 9001:1994

1

Contents This document provides information that enables you to compare the structures and clause titles between the ISO 9001:2000 and ISO 9001:1994 standards. This is presented as:-

Corresponding clauses between ISO 9001:1994 and ISO 9001:2000 Corresponding clauses between ISO 9001:2000 and ISO 9001:1994

Corresponding clauses between ISO 9001:1994 and ISO 9001:2000

ISO 9001:1994 Clauses Corresponding ISO 9001:2000 Clauses 1 Scope 1 Scope 2 Normative reference 2 Normative reference 3 Definitions 3 Terms and definitions 4 Quality management system Requirements -title. 4.1 Management responsibility - (title only)

5.1 Management commitment 5.3 Quality policy

4.1.1 Quality policy

5.4.1 Quality objectives 4.1.2 Organisation - (title only) 4.1.2.1 Responsibility and authority 5.5.1 Responsibility and authority

5.1 Management commitment 6.1 Provision of resources 6.2.1 General - Resource management

4.1.2.2 Resources

6.3 Infrastructure 4.1.2.3 Management representative 5.5.2 Management representative

5.6.1 General - management review 5.6.2 Review input 5.6.3 Review output

4.1.3 Management review

8.5.1 Continual improvement 4.2 Quality management system - (title only)

………………. Etc ……………

Corresponding clauses between ISO 9001:2000 and ISO 9001:1994 Table provide in document …. Etc ….

Organisation's Quality Policy We aim to become and remain a quality supplier of "Super Quality Products and Services" by:

♦ identifying Customer's needs and expectations and satisfying them on time every time,

♦ developing and implementing controlled processes, ♦ continual improvements in our operational

responsiveness, ♦ etc

We are committed to providing quality, choice and value for money in the products and services we deliver to our customers.

Managing Director: B. Boss

© Solutions Generation Limited Reg. No. in Scotland 146030

M a n ag em entC on su lta nt s

Quality Assurance Department Audit Schedule

Activity to be Audited

Year 19.... 19....

Mth Nov. Dec. Jan Feb Mar Apr.

W/E 6 13 20 27 4 11 18 25 1 8 15 22 29 5 12 19 26 4 11 18 25 1 8 15 22 29

Wk No

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Contract Review

Document Control

Procurement Control

Material Control

Identification Control

Inspection Control

Control of Measuring / Inspection Equip

Control of Non-Conforming Items

Control of Quality Records

Control of Special Processes

Client Audits

Audit Schedule approved: ............................ Date Schedule reviewed: ............................


ManageConsult

Sample Plant and Equipment Maintenance Plan Maintenance Record for Plant, Equipment and Tools

12 Weekly Checks ( Use CAF - Corrective Action Form No to record actions)_

Ref Description / Instruction Qty Person CAF Person CAF Person CAF

1 Heating and Ventilation Systems: - Check functionality with supplier's specification

1

2 Gas and Water Supplies: - Check pipes, pressure and leaks.

1

3 Transport Vans: - Check Oil, water, screen wash, types.

2

4 15 Ton Hydraulic Bender:- Check operation and leaks

1

5 2 Ton and 5 Ton Chain Blocks Check safety latch and chain condition

1

6 2.25 Ton Trolley Jack Check operation and leaks

1

7 Angle and Bench Grinders Check operation and electrical checks

4

8 Floodlight, lighting Halogen, Spotlight 240 volts:- Check safety & electrical condition.

1

9 Cable Reels 110 Volt and 240 volt:- Check operation and electrical checks

4

10 Fire-hoses and extinguishers: - Check operation.

1

11 Direct Drive Compressors 75 & 150 Litre Check oil and electrical safety

2

12 Floor Pillar Drill :- Electrical safety and mechanical condition

1

13 Hand Power Pack Jack:- Check operation and leaks

2

14 Jig Saw: - Check electrical and safety condition.

1

15 Mig Welder: - Check electrical safety, gas line condition.

1

16 Oil Pump and Pressure Test Rig: - Check oil, electrical and safety condition.

1

17 Turbo Cleaning Tank: - Electrical safety, degrease condition

1

Planned Maintenance Date 09/01/01 02/04/01 25/06/01

Actual Maintenance Date

Maintenance checks performed & approved:

Manage

Consult

Quality Management Review Meeting Agenda Attendees:

• Managing Director, Quality Manager, Sales Manager, • Operations Manager, Administration Manager

Agenda: 1. Review of Previous minutes

• Review and follow-up of previous management review actions 2. Key performance Indicators - Quality and Operational Objectives

• Customer Complaints and Feedback, Contractor Complaints, etc 3. Review of ISO 9001:2000 Project Plan

• Resource Planning & Availability, Projected Time-scales, Additional Items etc 4. External Assessments

• Preparation for Assessments, Date for Certification, Selection of Certification Body

5. Review of Q.M.S. documentation and Proposed Changes • Suitability of quality management system policy, objectives and documents, including

quality manual, procedures and process guides. Etc/… 6. Status of Non Conformance

• etc

Purpose

-

-

-

- Clause 4: Quality Management System- Clause 6: Resource Management- Clause 8: Measurement, Analysis and Improvement

Exclusions from the Quality Management System

Use of this Document

Helpline and Feedback

Please provided us with your details:

Address:

Clause 5: Management ResponsibilityClause 7: Product Realisation

--

Solution Generation 01

Contact Name

Position

Post / Zip Code

Nature of Business: Web Site Addresss:

Company Name:

Telephone Number: Fax No: E-Mail:

ISO 9001:2000 Self Assessment QuestionnaireProduced by Solutions Generation

Using this document enables you to quickly confirm if your organisation has addressed all the requirements of the new 2000 standard. Changes between ISO 9001:2000 and ISO 9001:1994 are highlighted in blue bold text. The

degree of change is indicated as either (N) for new, or (E) for an enhancement when compared to ISO 9001:1994. Corresponding clauses of ISO 9001:1994 are also provided. You may list your organisations' documents that relate to or support each specific clause in the "QMS Reference" column.

If you wish our consultant specialists to comment on your self assessment results, or any other concerns you may have, please E-Mail or fax your completed questionnaire and comments to us and we will gladly assist you.

Due to the nature of different organisations' products or services, it is possible that some of the clauses in the standard may not be appropriate and can therefore be excluded from the scope of the quality management system. Such exclusions are only permissible within Clause 7 - Product Realisation, For example, if the organisation has no design function, then clause 7.3 Design and Development may be excluded.

ISO 9000: Quality management systems - Fundamentals and vocabularyISO 9001: Quality management systems - Requirements ISO 9004: Quality management systems - Guidance for performance improvement

The new standard is broken into 4 Main Clauses namely:-

New Sections of ISO 9001:2000

The structure and contents of the 1994 standards were revised while maintaining the essential requirements of those current standards. Essentially, the proliferation of the ISO 9000:1994 family containing some 20 standards and documents was stopped with the introduction of the ISO 9000 2000 quality management standards.

The three primary standards are: -

ISO 9001 and ISO 9004 were produced together, with the same numbering, sequence and structure, in order to form a "consistent pair" of standards. Also ISO 9000 was developed in parallel with ISO 9001 and ISO 9004 to achieve a coherent terminology in the ISO 9000 Family, ISO 14000 Family and other management standards.

At the start of your ISO 9000 program it will be necessary for you to assess the status of your quality management system and to prepare plans for its development to take your company towards ISO 9001:2000 certification.

When you have read and completed this assessment and wish our consultant specialists to comment on your self assessment results, free of charge, please e-mail or fax your details to Solutions Generation.

Help Line

Overview of the 2000 Changes

1994 ClauseQMS

ReferenceNotes and

Actions(yes or no)

4.0 Quality Management System

4.1 General Requirement 4.2.1, 4.5.1

- 4.2.1, 4.5.1

- 4.2.1, 4.5.1 N

a Have processes needed for the QMS been identified and applied throughout the organisation?

4.2.1

b Have the interaction and sequence of processes been determined?

4.2.2; 4.2.3 E

c Have the criteria and methods necessary for the effective operation and control of these processes been determined?

4.2.2 & 4.2.3, 4.5

d Are resources and information needed to support the operation and monitoring of these processes available?

4.1.3, 4.2.3

e Are the QMS processes measured, monitored and analysed to achieve planned results?

4.1.3

f Are actions implemented necessary to achieve planned results and continual improvement of these processes? E

-

-

4.2 Documentation Requirements

4.2.1 General Requirement 4.2.1, 4.51

- Does the QMS documentation include the following:

a statements of quality policy and quality objectives? Nb quality manual?

c documented quality procedures required by ISO9001:2000?

4.2.2.a

d documents needed for the effective planning, operation and control of QMS processes?

4.2.2.b E

e quality records required by ISO 9001:2000?

- 4.1.3, 4.2.3

- E

4.2.2 Quality Manual 4.2.1

Does the QMS quality manual include the following:

a scope of the QMS as well as any details of and justifications for exclusions?

4.2.1 E & N

b specified documented procedures or reference to them? 4.2.1

c a description of the interaction between the processes of the QMS?

4.2.1 N

Solutions Generation 02Assessor's Notes: ......etc...

Are the QMS processes managed in accordance with the requirements of ISO9001:2000?

Clauses & Checklist

Does the organisation continually improve the effectiveness of the QMS?

Has the organisation established, implemented and maintained a quality management system?

ISO 9001:2000 Assessment Questionnaire

Are any out-sourced processes identified for control?

Note 2: Does the format and extent of the QMS reflect the organisation, its processes and competence of personnel?

Note 1: Are all QMS documented procedures established, implemented and maintained?


ManageConsult

Supplier Selection : Flow Chart

Quality Manager receivesrequest to have supplier rated

Quality manager conductsreview of supplier

Reject

Approve

Supplier is rated 4 onSupplier Register

Suppplier is rated 1 to 3 anddetails recorded on SupplierRegister

Quality Managerrates the supplier

Sample of Approved Supplier List

Supplier Rating Register Grade Approval Status

Supplier Name

Contact Name

Before Now By Date CAFAssessment Method(s) Reason

ABC Supplier Limited

C. Hanlon, Operations Manager

1 4 WB 24-Jan 1 OK

Roll Shutters

J Edmunds, Quality Manager

N/a 1 WB 24-Jan 8 2, 3, 4 Do not use, too

costly and unreliable

Metal Fabrication Products Ltd

T Hughes, Technical Director

N/a 1 WB 24-Jan 1, 2 OK

Approved by: - W. Bienkowski Date 26/01/01 Note: CAF is a corrective action form that is raised to address identified problems.


ManageConsult

Sample of a Supplier Record Card Supplier Name

Metal Fabrication Products Limited

Postal Address

Merriton House 8 Larch Road Glasgow, G41 5DA

Contact Name

T Hughes, Technical Director Tel No. Fax No.

0141 427 1446 0141 427 5541

Product / Services provided. Mild Steel Sheet Products Supplier of the Year from DIY Household Limited

Dates 1999 to 2000 Awards Received (from clients/certification bodies)

ISO 9002, 1994 certification from Accreditation Body

Dates June 14, 1999

Period January to March 2001

Performance Review No of orders received 250

Assessment Indicator Promised / Planned Actual Poor Fair Good

% On Time Delivery (within 1 day) 95% 85% x % Rejects-deliveries Below 5% 1% x Delivery Lead Time (average) 8 days 11 days x Cost per Unit £ 16.53 £ 13.80 x Comments / Discussion notes with Supplier 13/3/00 WB

Supplier has confirmed that transport difficulties led to lead time delivery problems. These have been resolved.

Supplier's Current Grade : 01 Date Downgrade Retain Upgrade Quality Manager's Recommendation on Grading 13/3/00 x


ManageConsult

Sample of a Supplier Questionnaire


ManageConsult

Sample of Quality Records Register

Description Where Used

Ref Title of Quality Record QP Title of Related ProcedureMinimum Retention File Location Comment

1 Quality Records Register 20 Quality Records n/a 2 Management Review Minutes QP 01 Quality Management

Review 36 QMS Folder Quality

3 Quality Plan Form OP 03 Quality Plan 36 QMS Folder Quality 4 Enquiry Form OP 04 Enquiry and Order

Processing 36 Enquiry Folder Sales

5 Enquiry Register OP 04 Enquiry and Order Processing

36 Enquiry Folder Sales

6 Quotation Book OP 04 Enquiry and Order Processing

36 Quotation Book Sales

7 Quotations OP 04 Enquiry and Order Processing

36 Quotations From Us Folder

Sales

Etc.

© Solutions Generation Limited Reg. No. in Scotland 146030

M a n ag em entC on su lta nt s

Corrective Action Register

CAF No

Originator Name

Date Raised

Details of Non Conformance Person Responsibl

e

Action Dates

QM Sig

Plan Actual Closed 01 A Andrews 2/2/97 Material, batch 5/97 was found

in stores beyond its shelf life S Hardy 14/2 16/2 AA AA

02 C Carter 6/2/97 Metal rule found in production by S Stone was not calibrated

C Caliber 10/2 11/2 CC AA

03 J Jones 14/3/97 Client enquiry ref 35/97 was not formally reviewed

S Sales 20/2 20/2 SS AA

04 N Start 3/3/97 V Young did not receive induction training in health and safety

S Safe 15/3 156/3 SS AA

Frequently Asked Questions

© Solutions Generation Limited 1 of 12

Manageme

Consulta

Introduction

This section provides the users with numerous and frequently asked questions withanswers and is intended to develop a better understanding of the background andrequirements of the revised ISO 9001:2000 standard. If you have any questions notcovered please e-mail your question to us at [email protected].

This list of Frequently Asked Questions (FAQs) is structured in a logical sequence.Input has been obtained from consultants and practitioners of the ISO 9000 standards.

Solutions generation will regularly review and update this list with new or amendedquestions as appropriate to ensure that it remains accurate and helpful. The intentionis to provide users with a useful point of reference for additional information.

These questions have been grouped into six main categories, namely,

1. Background 2. Main features3. Benefits and Implications4. Transition5. Certification 6. Impact

Questions

1.0 What is the background to the revised ISO 9000:2000 standards?

1.1 Why revise the ISO 9000:1994 standards?

2.0 What are the main features of the revised standards?

2.1 Are the revised standards compatible with national quality award criteria?2.2 Does the scope of ISO 9001:2000 address financial issues?2.3 What new requirements and main changes are introduced to the revised

standards?2.4 Why do the standards require the monitoring of customer satisfaction and

how will they improve it?2.5 What is a process?2.6 What is meant by "continual improvement"?2.7 Do the requirements of the ISO 9001:2000 standard address the needs of

sector organisations?

3.0 What are the key benefits and implications of the revised standards?

3.1 When will my current 1994 certification be affected?3.2 Will the transition to the revised standards be costly?3.3 How will the quality management system change?3.4 Will all the quality management system documentation need to be re-

written?

Frequently Asked Questions

© Solutions Generation Limited 2 of 12

Manageme

Consulta

3.0 What are the key benefits and implications of the revised standards? -cont.

3.5 What are the main organisational benefits of the revised standards?

3.6 How can the revised standards assist an organisation improve itsefficiency?

3.7 How will certification to the revised standards be perceived?3.8 What should organisations do if they are registered to ISO 9003?3.9 Should my organisation start developing an ISO 9001, ISO 9002, or

ISO 9003:1994 compliant quality management system now?3.10 Who should benefit from organisations adopting the new ISO 9004?3.11 How does a small organisation apply the ISO 9001:2000 standard?3.12 How are the new standards applicable to service organisations?

4.0 What must be considered during the transition and changeover to therevised standards?

4.1 How long can registrations to the ISO 9001, 9002 and 9003:1994standards be held?

4.2 How do organisations already registered to ISO9002 or ISO 9003 seekISO 9001:2000 certification?

4.3 What should an organisation do now for certification?4.4 How will certificates to the 1994 standards be affected?4.5 How do auditors prepare for the 2000 standards?

5.0 What are the key certification issues?

5.1 When will certification bodies begin to conduct full reassessments to therevised standard?

5.2 Which certificates will organisations receive?5.3 What will happen to the ISO 9001, 9002 and 9003:1994 standards?5.4 If an organisation has ISO 9002:1994, which requirement clauses of the

revised standard need to be addressed for ISO 9001:2000 certification?5.5 Can organisations be registered to ISO 9004:2000?5.6 How will the scope of the quality management system be defined in

certificates issued to ISO 9001:2000?5.7 How will a certificated organisation be affect by the "consistent pair" of

standards?5.8 How does an organisation prepare for certification to ISO 9001: 2000?

6.0 What about the impact of the revised standards on other standards?

6.1 What will happen to the ISO 9000:1994 series of standards?6.2 How are the 1994 standards affected by 2000 Revisions?6.3 How does the ISO 9001:2000 standard relate to ISO 14001? ....etc.....