ISO 9001-2008 Project Gap Analysis ANTIFRAGILITY

JAG – LPGC

ISO 9001:2008

MEGA PROJECTS ANTI-FRAGILITY ASSESMENT

E.P&C PROJECT ORGANISATION

QUALITY MANAGEMENT SYSTEM (QMS)

&

TECHNICAL FRAMEWORK

PREPARED BY

Jose Agustin Gonzalez

Thursday, 09 July 2015

JAG Organization Internal & External Audits Framework

QMS AND TECHNICAL LPGC

ISO 9001:2008 REQUIREMENTS of 78

Table of Contents

ISO 9001:2008 Mandatory Procedures ................................................................................................................ 5

ISO 9001:20018 Mandatory Records ................................................................................................................... 5

ISO 9001:2008 Operating Procedures.................................................................................................................. 7

ANTI-FRAGILITY .................................................................................................................................................. 9

1 Scope ............................................................................................................................................................... 10

1.1 General ................................................................................................................................................................... 10

1.2 Application .............................................................................................................................................................. 11

2 Normative References ..................................................................................................................................... 12

3 Terms and References .................................................................................................................................... 13

4 Quality Management System ........................................................................................................................... 14

4.1 General Requirements ......................................................................................................................................... 14

4.2 Documentation Requirements ............................................................................................................................. 16

4.2.1 General ....................................................................................................................................................... 16

4.2.2 Organization Quality Plan ......................................................................................................................... 17

4.2.3 Control of Documents ............................................................................................................................... 18

4.2.4 Control of Records..................................................................................................................................... 19

5 Management Responsibility ............................................................................................................................. 20

5.2 Customer Focus .................................................................................................................................................... 21

5.3 Quality Policy ......................................................................................................................................................... 22

5.4 Planning .................................................................................................................................................................. 23

5.4.1 Quality Objectives ...................................................................................................................................... 23

5.4.2 Quality Management System Planning .................................................................................................. 24

5.5 Responsibility, Authority and Communication ................................................................................................... 25

5.5.1 Responsibility and Authority ..................................................................................................................... 25

5.5.2 Management Representative ................................................................................................................... 26

5.5.3 Internal Communication ............................................................................................................................ 27

5.6 Management Review ............................................................................................................................................ 28

5.6.1 General ....................................................................................................................................................... 28

5.6.2 Review Input ............................................................................................................................................... 29

5.6.3 Review Output ............................................................................................................................................ 30

6 Resource Management .................................................................................................................................... 31

6.1 Provision of Resources ......................................................................................................................................... 31

JAG

Organization Internal & External Audits Framework



6.2 Human Resources................................................................................................................................................. 32

6.2.1 General ....................................................................................................................................................... 32

6.2.2 Competence, Training and Awareness .................................................................................................. 33

6.3 Infrastructure .......................................................................................................................................................... 34

6.4 Work Environment ................................................................................................................................................. 36

7. Product Realization ......................................................................................................................................... 37

7.1 Planning of Product Realization .......................................................................................................................... 37

7.2 Customer-Related Processes.............................................................................................................................. 39

7.2.1 Determination of Requirements Related to the Product ...................................................................... 39

7.2.2 Review of Requirements Related to the Product .................................................................................. 40

7.2.3 Customer Communication ........................................................................................................................ 41

7.3 Design and Development ..................................................................................................................................... 42

7.3.1 Design and Development Planning ........................................................................................................ 42

7.3.2 Design and Development Inputs ............................................................................................................. 44

7.3.3 Design and Development Outputs .......................................................................................................... 45

7.3.4 Design and Development Review ........................................................................................................... 47

7.3.5 Design and Development Verification .................................................................................................... 48

7.3.6 Design and Development Validation....................................................................................................... 49

7.3.7 Control of Design and Development Changes ...................................................................................... 50

7.4 Purchasing.............................................................................................................................................................. 51

7.4.1 Purchasing Process .................................................................................................................................. 51

7.4.2 Purchasing Information ............................................................................................................................. 52

7.4.3 Verification of Purchased Product ........................................................................................................... 53

7.5 Production and Service Provision ....................................................................................................................... 54

7.5.1 Control of Production and Service Provision ......................................................................................... 54

7.5.2 Validation of Processes for Production and Service Provision ........................................................... 56

7.5.3 Identification and Traceability .................................................................................................................. 57

7.5.4 Customer Property .................................................................................................................................... 58

7.5.5 Preservation of Product ............................................................................................................................ 59

7.6 Control of Monitoring and Measuring Equipment ............................................................................................. 60

8. Measurement, Analysis and Improvement ..................................................................................................... 63

8.1 General ................................................................................................................................................................... 63

8.2 Monitoring and Measurement .............................................................................................................................. 65

8.2.1 Customer Satisfaction ............................................................................................................................... 65

8.2.2 Internal Audit .............................................................................................................................................. 66

8.2.3 Monitoring and Measurement of Processes .......................................................................................... 68

8.2.4 Monitoring and Measurement of Product ............................................................................................... 70

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8.3 Control of Nonconforming Product ..................................................................................................................... 71

8.4 Analysis of Data ..................................................................................................................................................... 74

8.5 Improvement .......................................................................................................................................................... 76

8.5.1 Continual Improvement............................................................................................................................. 76

8.5.2 Corrective Action ....................................................................................................................................... 77

8.5.3 Preventive Action ....................................................................................................................................... 78

JAG Organization Internal & External Audits Framework



ISO 9001:2008 Mandatory Procedures

No ISO CLAUSE ISO 9001:2008 REQUIREMENTS

1. 4.2.3 Document Control Procedure

2. 4.2.4 Control of Records Procedure

3. 8.2.2 Internal Audit Procedure

4. 8.3 Control of Non-Conformance Procedure

5. 8.5.2 Corrective Action Procedure

6. 8.5.3 Preventive Action Procedure

ISO 9001:20018 Mandatory Records

NO ISO

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DESCRIPTION EXAMPLE

1 5.6.1 Management reviews Management review minutes

2 6.2.2e Education, training, skills and experience Training plan, training matrix, training records and CVs

3 7.1d Evidence that the realisation processes and resulting product fulfil requirements

Project quality plan

4 7.2.2 Results of the review of requirements related to the product and actions arising from the review

Change review

5 7.3.2 Design and development inputs relating to product requirements

Customer specifications, design approval logs

6 7.3.4 Results of design and development reviews and any necessary actions

Design development minutes

7 7.3.5 Results of design and development verification and any necessary actions

Design plan, test plan document outputs

8 7.3.6 Results of design and development validation and any necessary actions

Test plans, test reports and acceptance records

9 7.3.7 Results of the review of design and development changes and any necessary actions

Design review minutes

10 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

Supplier evaluations, subcontractor assessments, approved supplier list

11 7.5.2d As required by the organisation to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

Schedules of achieved results

12 7.5.3 The unique identification of the product, where traceability is a requirement

Serial number logs

13 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use

Delivery notes, incoming material schedules, defective material reports or NCRs

14 7.6a Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist

Customer specifications, corporate standards

15 7.6 Validity of the previous measuring results when Test plan document outputs

http://www.iso-9001-checklist.co.uk/tutorial/5.6-management-review.htm

http://www.iso-9001-checklist.co.uk/tutorial/5.6-management-review.htm

http://www.iso-9001-checklist.co.uk/tutorial/6.2-human-resources.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.1-process-planning.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.2-customer-processes.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.3-design-and-development.htm











http://www.iso-9001-checklist.co.uk/tutorial/7.4.1-supplier-evaluation.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.4.1-supplier-evaluation.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.5.2-special-processes.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.5.3-identification-and-traceability.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.5.3-identification-and-traceability.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.5.4-customer-property.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.5.4-customer-property.htm

http://www.iso-9001-checklist.co.uk/tutorial/7.6-calibration.htm



JAG




NO ISO

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DESCRIPTION EXAMPLE

the measuring equipment is found not to conform to requirements

16 7.6 Results of calibration and verification of measuring equipment

Calibration certificates. records and calibration logs

17 8.2.2 Internal audit results and follow-up action Internal audit report

18 8.2.4 Indication of the person(s) authorising release of product.

Release acceptance record

19 8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

Non-conformance report, concession report

20 8.5.2 Results of corrective action Corrective action reports and logs

21 8.5.3 Results of preventive action Preventive action reports and logs


http://www.iso-9001-checklist.co.uk/tutorial/8.2.2-internal-audit.htm


http://www.iso-9001-checklist.co.uk/tutorial/8.2.4-monitor-and-measure-the-product.htm

http://www.iso-9001-checklist.co.uk/tutorial/8.3-control-of-non-conformance.htm


http://www.iso-9001-checklist.co.uk/tutorial/8.5.2-corrective-action.htm


http://www.iso-9001-checklist.co.uk/tutorial/8.5.3-preventive-action.htm


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ISO 9001:2008 Operating Procedures

Mandatory Procedures Consultants/Management

Creative/Marketing

Education

Finance/Investment

Printing/Publishing/Media

Retail

Recruitment

Airports

Call Centres

Catering

Distribution/Supplier

Health Care

IT/Communication

Security

Aerospace/Defence

Construction

Design and Build

Electrical Engineering

Energy and Power

Manufacturing

Mechanical Engineering

4.2.3 Document control

4.2.4 Control of Records

8.2.2 Internal audit

8.3 Control of non-conformance

8.5.2 Corrective action

8.5.3 Preventive action

Operating Procedures Consultants/Management

Creative/Marketing

Education

Finance/Investment


Retail

Recruitment

Airports

Call Centres

Catering


Health Care

IT/Communication

Security

Aerospace/Defence

Construction

Design & Build


Energy & Power

Manufacturing


5.5.3 Internal Communication

5.6 Management Review

6.2.2 Training and Awareness

6.3 Facilities Management

7.1 Product Realisation and Planning

http://www.iso-9001-checklist.co.uk/tutorial/4.2.3-document-control-procedure.htm

http://www.iso-9001-checklist.co.uk/tutorial/4.2.4-control-of-records.htm





http://www.iso-9001-checklist.co.uk/tutorial/6.2-human-resources.htm

JAG




Operating Procedures Consultants/Management

Creative/Marketing

Education

Finance/Investment


Retail

Recruitment

Airports

Call Centres

Catering


Health Care

IT/Communication

Security

Aerospace/Defence

Construction

Design & Build


Energy & Power

Manufacturing


7.2.2 Contract Review

7.3 Design and Development Control

7.4 Purchasing

7.5.1 Control of Production and Service Provision

7.5.2 Validation of processes

7.5.3 Identification and Traceability

7.5.4 Control of Customer Property

7.5.5 Preservation of product

7.6 Control of Monitoring and Measuring Equipment

8.2.1 Customer Satisfaction

8.2.4 Monitoring and measurement of product

8.4 Analysis of Data

8.5.1 Continual Improvement

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ANTI-FRAGILITY

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ANTI-FRAGILITY ASSESMENT

LPGC SECTION 1 SCOPE AUDIT GAP ANALYSIS

A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question of 78

1 Scope

1.1 General

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ISO 9001:2008 REQUIREMENTS

FINDINGS GAP ANALYSIS

NO YES N.B. Provide references to documentation where necessary

SQ A B C ACTUAL QMS ACTIONS REQUIRED

1. 1.1

ISO International Standard specifies requirements

for a Quality Management System where an

Organization needs to demonstrate its ability to

consistently Provide Product that meets Customer

Requirements.

2. 1.1




consistently Provide Product that meets applicable

Statutory Requirement.

3. 1.1




consistently Provide Product that meets

Regulatory Requirements.

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LPGC SECTION 1 SCOPE AUDIT GAP ANALYSIS


1 Scope

1.2 Application

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1. 1.2

All requirements of ISO 9001:2008 International

Standard Are Generic and are intended to be

applicable to All Organizations, Regardless Of

Type, Size And Product Provided.

2. 1.2

Where any requirement(s) of ISO 9001:2008 cannot

be applied due to the nature of an Organization and

its product, This Can Be Considered For Exclusion.

3. 1.2

Where exclusions are made, claims of conformity to

ISO 9001:2008 are not a Contractor unless these

exclusions are limited to requirements within

Clause 7, and such Exclusions do not affect the

Organization’s Ability, or Responsibility, to

Provide Product that meets Customer and

applicable Statutory and Regulatory Requirements.

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LPGC SECTION 2 NORMATIVE REFERENCES AUDIT GAP ANALYSIS


2 Normative References

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1. 2

The following referenced documents are

indispensable for the application of ISO 9001:2008.

For dated references, only the edition cited applies.

For undated references, the latest edition of the

referenced document (including any amendments)

applies

2. 2 ISO 9000:2005, Quality Management Systems –

Fundamentals and vocabulary.

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LPGC SECTION 3 TERMS AND DEFINITIONS AUDIT GAP ANALYSIS


3 Terms and References

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1. 3 For the purpose of this document, the terms and

definitions given in ISO 9000 apply.

2. 3 Throughout the text of ISO 9001:2008, wherever the

term “Product” occurs, it can also mean “Service”

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LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS


4 Quality Management System

4.1 General Requirements

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1. 4.1

Has the Organization Established a Quality

Management System, and Continually Improved its

Effectiveness?

2. 4.1

Has the Organization Documented a Quality


Effectiveness?

3. 4.1

Has the Organization Implemented a Quality


Effectiveness?

4. 4.1

Has the Organization Maintained a Quality


Effectiveness?

5. 4.1

Is the Organization Quality Management System, and

Continually Improving the Effectiveness of its

Quality Management System?

6. 4.1a

Has the Organization Identified The Processes

Needed for the Quality Management System and their

application throughout the Organization?

7. 4.1b Has the Organization Determined The Sequences

of the Quality Management System Processes?

8. 4.1b Has the Organization Determined The Interaction

of the Quality Management System Processes?

9. 4.1c

What are the Criteria And Methods the Organization

uses to Ensure that the Operation And Control of

Quality Management System Processes Are

Effective?

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10. 4.1d

Has the Organization Provided Resources And

Information Needed To Support The Operation and

Monitoring of Quality Management System

Processes?

11. 4.1e Does the Organization Monitor Quality Management

System Processes?

12. 4.1e Does the Organization Measure the Quality

Management System Processes?

13. 4.1e Does the Organization Analyse Quality Management

System Processes?

14. 4.1f

Has the Organization Implemented Actions

Necessary to achieve Planned Results and

Continual Improvement of Processes needed for

the Quality Management System?

15. 4.1

Are Processes needed for the Quality Management

System Managed by the Organization in accordance

with the requirements of ISO 9001:2008?

16. 4.1 How does the Organization Maintain Control Over

Outsourced Processes?

17. 4.1

Are the Necessary Controls for Outsourced

Processes that affect Product Conformity with

Requirements Identified within the Quality

Management System?

18. 4.1

Does the Organization have Adequate Control over

Outsourced Processes to ensure Conformity to All

Customer Requirements?

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4.2 Documentation Requirements

4.2.1 General

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1. 4.2.1a Does the Organization have a Documented Quality

Policy?

2. 4.2.1a Does the Organization have a set of Documented

Quality Objectives?

3. 4.2.1b Does the Organization have a Quality Manual?

4. 4.2.12c Does the Organization operate a set of Documented

Procedures?

5. 4.2.1d

Are Adequate Documents in place to Ensure the

Effective Planning, Operation and Control of the

Organization’s processes?

6. 4.2.1d Does documentation include the Records Required

by ISO 9001:2008?

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4.2.2 Organization Quality Plan

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1. 4.2.2a

Where in the Organization’s quality manual is the

scope of the Quality Management System identified,

including details of and justification for exclusions?

2. 4.2.2b

Where does the Quality Management System contain

or reference the documented procedures established

for the QMS?

3. 4.2.2c

Where does the Quality Management System include

a description of the interaction between the processes

of the QMS?

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4.2.3 Control of Documents

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1. 4.2.3 Does the Organization operate an Established

Document Control Procedure?

2. 4.2.3a

Does the Document Control Procedure Define the

controls needed to Approve Documents For

Adequacy prior to issue?

3. 4.2.3b


controls needed to Review and Update as necessary

and Re-Approve Documents?

4. 4.2.3c


controls needed to ensure that Changes and the

Current Revision Status of documents are

Identified?

5. 4.2.3d


controls needed to ensure that Relevant Versions of

Applicable Documents are Available at Points of

Use?

6. 4.2.3e


controls needed to ensure that documents Remain

Legible and Readily Identifiable?

7. 4.2.3f


controls needed to ensure that Documents of

External Origin are Identified and their Distribution

Controlled?

8. 4.2.3g


controls needed to Prevent The Unintended Use Of

Obsolete Documents, and to apply Suitable

Identification to them if they are Retained for any

purpose?

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4.2.4 Control of Records

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1. 4.2.4 Has the Organization established Records to provide

Evidence Of Conformity to client’s requirements?

2. 4.2.4

Has the Organization Established Means to control

the Effective Operation of the Quality Management

System?

3. 4.2.4

Has the Organization Established a Documented

Procedure to Define the Controls needed for the

Organization Records?

4. 4.2.4


Procedure for the Storage of Organization

Records?

5. 4.2.4


Procedure for the Protection of Organization

Records?

6. 4.2.4


Procedure for the Retrieval of Organization

Records?

7. 4.2.4


Procedure for the retention and Disposition of

Organization Records?

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LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS


5 Management Responsibility

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1. 5.

Can the Organization Provide Evidence of its

Commitment to the Development of the Quality

Management System?

2. 5.


Commitment to the Implementation of the Quality

Management System?

3. 5.


Commitment for Improving the Effectiveness of the


4. 5a

Has the Organization Communicated to the

Organization Members the Importance of Meeting

Customer Requirements?

5. 5a Has the Organization Communicated the importance

of Meeting Statutory Requirements?

6. 5a Has the Organization Communicated the importance

of Meeting Regulatory Requirements?

7. 5b Has the Organization established and communicated

the Quality Policy?

8. 5c Has the Organization established Quality Objectives?

9. 5d Has the Organization Planned Management

Reviews to review the Quality Management System?

10. 5d Has the Organization Conducted Management

Reviews to revise the Quality Management System?

11. 5e Has the Organization Ensured the Availability of

Resources to meet the Quality Objectives?

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5.2 Customer Focus

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1. 5.2 Has the Organization ensured that Customer

Requirements are Determined?

2. 5.2 Has the Organization ensured that Customer

Requirements are Met?

3. 5.2 Is the Organization focused on Enhancing Customer

Satisfaction?

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5.3 Quality Policy

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A B C ACTUAL QMS ACTIONS REQUIRED

1. 5.3a Has the Organization ensured that the Quality Policy

is appropriate to the Purpose of the Organization?

2. 5.3b

Has the Organization ensured that the Quality Policy

includes the commitment to comply with Organization

requirements?

3. 5.3b

Has the Organization ensured that the Quality Policy

includes the commitment to continually improve the

effectiveness of the Organization Quality

Management System?

4. 5.3c Has the Organization provided a framework for

establishing the Quality Objectives?

5. 5.3c Has the Organization provided a framework for

reviewing Quality Objectives?

6. 5.3d Has the Organization communicated the Quality

Policy within the Organization?

7. 5.3d Has the Organization made sure that the Organization

Quality Policy is understood?

8. 5.3e Has the Organization ensured that the Quality Policy

is reviewed for continuing suitability?

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5.4 Planning

5.4.1 Quality Objectives

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1. 5.4.1

Has the Organization ensured that Quality

Objectives, including those needed to Meet

Requirements for Product (see 7.1a), are

Established at Relevant Functions within the

Organization?

2. 5.4.1

Has the Organization ensured that Quality

Objectives, including those needed to Meet

Requirements for Product (see 7.1a), are

Established at Relevant Levels within the

Organization?

3. 5.4.1 The Quality Objectives shall be Measurable with the

quality policy

4. 5.4.1 The Quality Objectives shall be Consistent with the

quality policy

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5.4 Planning

5.4.2 Quality Management System Planning

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1. 5.4.2a

Has the Organization Ensured that the Planning of

the quality management system is carried out in order

to Meet the Requirements in 4.1?

2. 5.4.2a

Has the Organization Ensured that the Planning of

the quality management system is carried out in order

to Meet the Quality Objectives?

3. 5.4.2b

Has the Organization Ensured that the Integrity of

the quality management system is Maintained when

Changes to the quality management are Planned

and Implemented?

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5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

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1. 5.5.1

Has the Organization ensured that Responsibilities

are defined and Communicated within the

Organization?

2. 5.5.1 Has the Organization ensured that Authorities are

defined and Communicated within the Organization?

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5.5.2 Management Representative

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1. 5.5.2a

Has the Organization Appointed a member of the

Organization who, irrespective of other responsibilities

has Responsibility and Authority over Processes

Needed for the Quality System Are Established?

2. 5.5.2a


Organization, who, irrespective of other

responsibilities has Responsibility and Authority

over Processes Needed for the Quality System Are

Implemented?

3. 5.5.2a



has Responsibility and Authority over Processes

Needed for the Quality System Are Maintained?

4. 5.5.2b



has Responsibility and Authority for Reporting to

Organization on the Performance Of The Quality

Management System?

5. 5.5.2b



has Responsibility and Authority for Reporting to

the Organization on Any Need For Improvement?

6. 5.5.2c

Has the Organization Ensured that the Quality

Manager Promotes the Awareness of Customer

Requirements throughout the Organization?

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5.5.3 Internal Communication

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1. 5.5.3

Has the Organization ensured that Appropriate

Communication Processes are established in the

Organization?

2. 5.5.3

Has the Organization ensured that Communication

takes place regarding the Effectiveness Of The


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5.6.1 General

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1. 5.6.1

The Organization shall Review the Quality

Management System, at Planned Intervals, to

ensure its Continuing Suitability.

2. 5.6.1



ensure its Continuing Adequacy.

3. 5.6.1



ensure its Continuing Effectiveness.

4. 5.6.1 Management Review shall assess opportunities for

Improvement.

5. 5.6.1

Management review shall assess the need for

changes to improve the Quality Management

System.

6. 5.6.1 Management shall assess the need for changes to

improve the Quality Policy.

7. 5.6.1 Management shall assess the need for changes to

improve the Quality Objectives.

8. NOTE Records from Management Reviews shall be

maintained (see 4.2.4)

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5.6.2 Review Input

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1. 5.6.2a The Input To Management Review shall include

information on Results of Audits

2. 5.6.2b The Input To Management Review shall include

information on Customer Feedback.

3. 5.6.2c The Input To Management Review shall include

information on Process Performance.

4. 5.6.2c The Input To Management Review shall include

information on Product Conformity.

5. 5.6.2d The Input To Management Review shall include

information on Preventive Actions.

6. 5.6.2d The Input To Management Review shall include

information on Corrective Actions.

7. 5.6.2e

The Input To Management Review shall include

information on Follow up actions on Previous

Management Reviews.

8. 5.6.2f


information on Changes that could affect the Quality

Management System.

9. 5.6.2g


information on Recommendations for

Improvement.

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5.6.3 Review Output

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1. 5.6.3a

The Output From Management Review shall include

any decisions and actions related to Improvement of

the Effectiveness of the Quality Management

System.

2. 5.6.3a



the Effectiveness of the Quality Management

Processes.

3. 5.6.3b



Product related to Customer Requirements.

4. 5.6.3c



the Resources Needs.

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LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS


6 Resource Management

6.1 Provision of Resources

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1. 6.1a

The Organization shall Determine the resources

needed to Implement the Quality Management

System and continually Improve its Effectiveness.

2. 6.1a

The Organization shall Provide the resources needed

to Implement the Quality Management System and

continually Improve its Effectiveness.

3. 6.1a


needed to Maintain the Quality Management System

and continually Maintain its Effectiveness.

4. 6.1a


to Maintain the Quality Management System and

continually Maintain its Effectiveness.

5. 6.1b


needed to enhance Customer Satisfaction by

meeting Customer Requirements.

6. 6.1b


to enhance Customer Satisfaction by meeting

Customer Requirements.

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6.2 Human Resources

6.2.1 General

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1. 6.2.1

Personnel performing work affecting Conformity to

Product requirements shall be Competent on the

basis of Appropriate Education.

2. 6.2.1



basis of Appropriate Training.

3. 6.2.1



basis of Appropriate Skills.

4. 6.2.1



basis of Appropriate Experience.

5. NOTE

Conformity To Product Requirements can be

affected directly or indirectly by Personnel

Performing any task within the Quality Management

System.

JAG




6.2 Human Resources

6.2.2 Competence, Training and Awareness

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1. 6.2.2a

The Organization shall Determine The Necessary

Competence for personnel performing work affecting

conformity to Product Requirements.

2. 6.2.2b

The Organization shall where applicable, Provide

Training or take other actions to Achieve The

Necessary Competence.

3. 6.2.2c The Organization shall evaluate the Effectiveness Of

The Actions Taken

4. 6.2.2d

The Organization shall ensure that its Personnel Are

Aware of the relevance and importance of their

activities and how they contribute to the

Achievement Of The Quality Objectives.

5. 6.2.2e The Organization shall maintain records of education,

training, skills and experience (see 4.2.4)

JAG




6 Resource Management

6.3 Infrastructure

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1. 6.3a

The Organization shall Determine, Provide and

Maintain the infrastructure needed to achieve

conformity to product requirements, as applicable,

Buildings.

2. 6.3a




Workspace.

3. 6.3a




Utilities.

4. 6.3b




process equipment: Hardware.

5. 6.3b




process equipment: Software.

6. 6.3b




supporting services: Transport.

7. 6.3b




supporting services: Communication.

JAG




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8. 6.3b




supporting services: Information System.

JAG




6. Resource Management

6.4 Work Environment

No ISO

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1. 6.4

The Organization shall determine and manage the

work environment: Physical, needed to achieve

conformity to product requirements

2. 6.4


work environment: Environmental, needed to

achieve conformity to product requirements

3. 6.4


work environment: Noise Level, needed to achieve


4. 6.4


work environment: Temperature Level, needed to


5. 6.4


work environment: Humidity Level, needed to


6. 6.4


work environment: Lighting Level, needed to


7. 6.4


work environment: Weather, needed to achieve


JAG


LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS


7. Product Realization

7.1 Planning of Product Realization

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1. 7.1 The Organization shall Plan And Develop The

Processes needed for Product Realization.

2. 7.1

The Organization when Planning Of Product

Realization shall be Consistent With The

Requirements of the other processes of the Quality

Management System (see 4.1)

3. 7.1a

In Planning Product Realization, the Organization

shall Determine the following, as appropriate: Quality

Objectives and Requirements For The Product.

4. 7.1b


shall Determine the following, as appropriate: the

need to establish processes and documents

specific to the product.

5. 7.1b In Planning Product Realization, the Organization

shall Provide Resources Specific To The Product.

6. 7.1c


shall Determine the Required Verification Specific

To The Product.

7. 7.1c


shall Determine the Required Validation Specific

To The Product.

8. 7.1c


shall Determine the Required Monitoring Specific

To The Product.

9. 7.1c


shall Determine the required measurement specific

to the product.

JAG




No ISO

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10. 7.1c


shall Determine the Required Inspection Specific

To The Product.

11. 7.1c


shall Determine the Required Test Activities

Specific To The Product.

12. 7.1c


shall Determine the Criteria For Product

Acceptance.

13. NOTE1

A document specifying the processes of the Quality

Management System (Including The Product

Realization Processes) and resources to be applied

to a specific product, Organization or Contract can

be referred to as Quality Plan.

14. NOTE2

The Organization may also apply the requirements

given in 7.3 to the development of Product

Realization Processes.

JAG




7.2 Customer-Related Processes

7.2.1 Determination of Requirements Related to the Product

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1. 7.2.1a

The Organization shall Determine the Requirements

Specific To The Customer, including the

requirements for delivery and post-delivery activities.

2. 7.2.1b

The Organization shall Determine the Requirements

Not Stated By The Customer but necessary for

specified or intended use, where known.

3. 7.2.1c The Organization shall Determine the Statutory

Requirements applicable to the product.

4. 7.2.1c The Organization shall Determine the Regulatory

Requirements applicable to the product.

5. 7.2.1d

The Organization shall Determine any Additional

Requirements considered necessary by the

organisation.

6. NOTE

Post-Delivery Activities include, for example,

actions under warranty provisions, contractual

obligations such as maintenance services, and

supplementary services such as Recycling Of Final

Disposition.

JAG





7.2.2 Review of Requirements Related to the Product

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1. 7.2.2 The Organization shall Review The Requirements

related to the product.

2. 7.2.2

This Review Shall Be Conducted Prior to the

Organization’s commitment to supply a product to the

Customer (e.g. submission of tenders, Contractor of

contracts or orders, A Contractor Of Changes to

contracts or orders) and shall ensure that

3. 7.2.2a Product Requirements Are Defined.

4. 7.2.2b Contract or order requirements differing from those

previously expressed are resolved.

5. 7.2.2c The Organization has the Ability To Meet The

Defined Requirements.

6. 7.2.2

Where the Customer provides no documented

statement of requirement, the Customer shall be

confirmed by the Organization before acceptance.

7. 7.2.2

Where product requirements are changed, the

Organization shall ensure that Relevant Documents

are amended and that Relevant Personnel are made

aware the changed requirements.

8. NOTE

In some situations, such as internet sales, a Formal

Review is impractical for each order. Instead the

review can cover Relevant Product information such

as catalogues or advertising material.

JAG





7.2.3 Customer Communication

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1. 7.2.3a

The Organization shall Determine and Implement

effective arrangements for communicating with

Customers in relation to: Product Information.

2. 7.2.3b



Customers in relation to: Enquiries.

3. 7.2.3b



Customers in relation to: Contracts.

4. 7.2.3b



Customers in relation to: Contracts or Order

Handling.

5. 7.2.3b

The Organization shall determine and implement


Customers in relation to: Amendments.

6. 7.2.3c



Customers in relation to: Customer Feedback.

7. 7.2.3c



Customers in relation to: Customer Complaints.

JAG




7.3 Design and Development

7.3.1 Design and Development Planning

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1. 7.3.1 The Organization shall plan and develop the Design

And Development Of Product.

2. 7.3.1a

During the design and development planning, the

Organization shall Determine the Design And

Development Stages.

3. 7.3.1b


Organization shall Determine the Reviews that are

appropriate to each design and development stage.

4. 7.3.1b


Organization shall Determine the Verifications that

are appropriate to each design and development

stage.

5. 7.3.1b


Organization shall determine the validations that are

appropriate to each design and development stage.

6. 7.3.1c


Organization shall Determine the Responsibilities

for design and development.

7. 7.3.1c


Organization shall Determine the Authorities for

design and development.

8. 7.3.1

The Organization shall manage the Interfaces

between different groups involved in Design And

Development to ensure Effective Communication.

JAG




No ISO

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9. 7.3.1

The Organization shall manage the Interfaces

between different groups involved in design and

development to ensure Clear Assignment Of

Responsibilities.

10. 7.3.1 Planning Output Shall Be Updated, as appropriate,

as the design and development progresses.

11. NOTE

Design and development Review, Verification and

Validation have distinct purposes. They can be

conducted and recorded separately or in any

combination, as suitable for the product and the

Organization.

JAG





7.3.2 Design and Development Inputs

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1. 7.3.2a

Inputs Relating To Product Requirements shall be

Determined and records maintained (see 4.2.4).

These inputs shall include: Functional

Requirements.

2. 7.3.2a



These inputs shall include: Performance

Requirements.

3. 7.3.2b



These inputs shall include: Applicable Statutory

Requirements.

4. 7.3.2b



These inputs shall include: Applicable Regulatory

Requirements.

5. 7.3.2c



These inputs shall include: where applicable,

Information Derived From Previous Similar

Designs.

6. 7.3.2c



These inputs shall include: Other Requirements

Essential For Design And Development.

7. 7.3.2

The Inputs Shall Be Reviewed For Adequacy.

Requirements shall be complete, unambiguous and

not in conflict with each other.

JAG





7.3.3 Design and Development Outputs

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1. 7.3.3a

The Outputs Of Design And Development shall be

in a form Suitable For Verification against the

Design And Development Input and shall be

Approved Prior To Release. Design and

development outputs shall meet the input

requirements for design and development.

2. 7.3.3b





development outputs shall Provide Appropriate

Information For Purchasing.

3. 7.3.3b






Information For Production.

4. 7.3.3b






Information For Service Provision.

JAG




No ISO

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5. 7.3.3c



design and development input and shall be Approved

Prior To Release. Design and development outputs

shall contain or Reference Product Acceptance

Criteria.

6. 7.3.3d



design and development input and shall be Approved

Prior To Release. Design and development outputs

shall specify the characteristics of the Product that

are essential for its safe and Proper Use.

7. NOTE Information for Production and Service Provision

can include details for the Preservation Of Product.

JAG





7.3.4 Design and Development Review

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1. 7.3.4a

At suitable stages, systematic reviews of Design And

Development shall be performed in accordance with

planned arrangements (see 7.3.1) to evaluate the

ability of the results of design and development to

meet requirements.

2. 7.3.4b

At suitable stages, systematic reviews of Design And

Development shall be performed in accordance with

planned arrangements (see 7.3.1) to identify any

problems and Propose Necessary Actions.

3. 7.3.4

Participants in such reviews shall include

representatives of functions concerned with the

design and development stage(s) being reviewed.

4. 7.3.4 Records of the results of the reviews and any

necessary actions shall be maintained (see 4.2.4)

JAG





7.3.5 Design and Development Verification

No ISO

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1. 7.3.5

Verification shall be performed in accordance with

planned arrangements (see 7.3.1) to ensure that the

design and development outputs have met the

Design And Development Input Requirements.

2. 7.3.5 Records of the results of the verification and any

necessary actions shall be maintained (see 4.2.4)

JAG





7.3.6 Design and Development Validation

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1. 7.3.6

Design And Development Validation shall be

performed in accordance with planned arrangements

(see 7.3.1) to ensure the resulting product is capable

of meeting the requirements for the Specified

Application Or Intended Use, where known.

2. 7.3.6

Wherever practicable, Validation shall be completed

Prior To The Delivery of implementation of the

product.

3. 7.3.6 Records of the results of Validation and any

necessary actions shall be maintained (see 4.2.4).

JAG





7.3.7 Control of Design and Development Changes

No ISO

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1. 7.3.7 Design and development changes shall be identified

and records maintained (see 4.24).

2. 7.3.7

The changes shall be reviewed, verified and

validated, as appropriate, and approved before

implementation.

3. 7.3.7

The review of design and development changes shall

include evaluation of the effect of the changes on

Constituent Parts and product already delivered.

4. 7.3.7

Records of the results of the review of changes and

any necessary actions shall be maintained (see

4.2.4).

JAG




7.4 Purchasing

7.4.1 Purchasing Process

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1. 7.4.1

The Organization shall ensure that the purchased

product conforms to Specified Purchase

Requirements.

2. 7.4.1

The type and extent of control applied to the Supplier

and the purchased product shall be dependent upon

the effect of the purchased product on subsequent

product realization or the Final Product.

3. 7.4.1

The Organization shall Evaluate Suppliers based on

their Ability To Supply Product in accordance with

the Organization’s Requirements.

4. 7.4.1

The Organization shall Select Suppliers based on

their Ability To Supply Product in accordance with

the Organization’s Requirements.

5. 7.4.1 Criteria for selection, evaluation and re-evaluation

shall be established.

6. 7.4.1

Records of the results of evaluations and any

necessary actions arising from the evaluation shall be

maintained (see. 4.2.4).

JAG




7.4 Purchasing

7.4.2 Purchasing Information

No ISO

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1. 7.4.2

Purchasing information shall describe the product to

be purchased, including, where appropriate:

Requirements For Approval Of Product.

2. 7.4.2



Procedures On How The Product Will Be

Approved.

3. 7.4.2



Processes And Equipment For The Production Of

The Product.

4. 7.4.2



Requirements For The Qualification Of Personnel.

5. 7.4.2


be purchased, including, where appropriate: Quality

Management System Requirements.

6. 7.4.2

The Organization shall ensure the adequacy of

specified purchase requirements prior to their

Communication To The Supplier.

JAG




7.4 Purchasing

7.4.3 Verification of Purchased Product

No ISO

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1. 7.4.3

The Organization shall establish and Implement the

Inspection Activities necessary for ensuring that the

purchased product meets specified purchase

requirements.

2. 7.4.3

The Organization shall establish and Implement

Other Activities necessary for ensuring that the

purchased product meets specified purchase

requirements.

3. 7.4.3

Where the Organization or its Customer intends to

perform Verification At The Supplier’s Premises,

the Organization shall state the intended Verification

arrangements and Method Of Product Release in

the purchasing information.

JAG




7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision

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1. 7.5.1a

The Organization shall plan and carry out production

and service provision under controlled conditions.

Controlled conditions shall include, as applicable: The

Availability Of Information That Describes The

Characteristics Of The Product.

2. 7.5.1b




Availability Of Work Instructions, As Necessary.

3. 7.5.1c




Use Of Suitable Equipment.

4. 7.5.1d




Availability And Use Of Monitoring Equipment.

5. 7.5.1d




Availability And Use Of Measuring Equipment.

6. 7.5.1e




Implementation Of Monitoring Equipment.

JAG




No ISO

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7. 7.5.1e



Controlled conditions shall include, as applicable: the

implementation of measurement.

8. 7.5.1f




Implementation Of Product Release.

9. 7.5.1f




Implementation Of Product Delivery.

10. 7.5.1f




Implementation Of Post-Delivery Activities.

JAG





7.5.2 Validation of Processes for Production and Service Provision

No ISO

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1. 7.5.2

The Organization shall Validate any Processes For

Production and Service Production where the

resulting output cannot be verified by subsequent

monitoring or measurement and, as a consequence,

deficiencies become apparent only after the product is

in use or the service has been delivered.

2. 7.5.2 Validation shall demonstrate the ability of above

mentioned Processes to achieve planned results.

3. 7.5.2a

The Organization shall establish arrangements of

above processes including, as applicable: Defined

Criteria For Review And Approval Of The

Processes.

4. 7.5.2b


above processes including, as applicable: Approval

Of Equipment And Qualification Of Personnel.

5. 7.5.2c


above processes including, as applicable: Approval

Of Specific Methods And Procedures.

6. 7.5.2d


above processes including, as applicable:

requirements for records (see 4.2.4)

7. 7.5.2e


above processes including, as applicable:

Revalidation.

JAG





7.5.3 Identification and Traceability

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SQ A B C ACTUAL QMS ACTIOS REQUIRED

1. 7.5.3

Where appropriate, the Organization shall Identify

The Product by suitable means Throughout

Product Realization.

2. 7.5.3

The Organization shall Identify the product status

with respect to Monitoring And Measurement

Requirements throughout Product Realization.

3. 7.5.3

Where traceability is a requirement, the Organization

shall Control The Unique Identification of the

Product and Maintain Records (see 4.2.4).

4. NOTE

In some industry sectors, Configuration

Management is a means by which Identification

And Traceability are maintained.

JAG





7.5.4 Customer Property

No ISO

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1. 7.5.4

The Organization shall exercise care with Customer

Property while it is under the Organization’s control

or being used by the Organization.

2. 7.5.4 The Organization shall Identify Customer Property

provided for Use or Incorporation into the product.

3. 7.5.4 The Organization shall Verify Customer Property


4. 7.5.4 The Organization shall Protect Customer Property


5. 7.5.4

The Organization shall Safeguard Customer

Property provided for Use or Incorporation into the

product.

6. 7.5.4

If any Customer Property Is Lost, the Organization

shall report this to the Customer and maintain records

(see 4.2.4)

7. 7.5.4

If any Customer Property Is Damaged, the

Organization shall report this to the Customer and

maintain records (see 4.2.4)

8. 7.5.4

If any Customer Property is found to be Unsuitable

For Use, the Organization shall report this to the

Customer and maintain records (see 4.2.4)

9. NOTE Customer property can include Intellectual Property

and Personal Data.

JAG





7.5.5 Preservation of Product

No ISO

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1. 7.5.5

The Organization shall Preserve The Product

During Internal Processing in order to maintain

conformity to requirements.

2. 7.5.5

The Organization shall Preserve The Product

During Delivery in order to maintain conformity to

requirements.

3. 7.5.5 As applicable, preservation shall include:

Identification

4. 7.5.5 As applicable, preservation shall include: Handling

5. 7.5.5 As applicable, preservation shall include: Packaging

6. 7.5.5 As applicable, preservation shall include: Storage

7. 7.5.5 As applicable, preservation shall include: Protection

8. 7.5.5 Preservation shall also apply to the Constituent

Parts of a product.

JAG




7. Product Realization

7.6 Control of Monitoring and Measuring Equipment

No ISO

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1. 7.6

The Organization shall Determine the Monitoring to

be undertaken to provide evidence of conformity of

product to determined requirements.

2. 7.6

The Organization shall Determine the Monitoring

Equipment needed to provide evidence of conformity

of product to determined requirements.

3. 7.6

The Organization shall Establish Processes to

ensure that Monitoring can be carried out in a

manner that is Consistent with the Monitoring

Requirements

4. 7.6

The Organization shall Determine the Measurement

to be undertaken to provide evidence of conformity of

product to determined requirements.

5. 7.6

The Organization shall Determine the Measuring

Equipment needed to provide evidence of conformity

of product to determined requirements.

6. 7.6

The Organization shall Establish Processes to

ensure that Measurement can be carried out in a

manner that is Consistent with the Measurement

Requirements.

7. 7.6a

Where necessary to ensure Valid Results,

Measuring Equipment shall be Calibrated Or

Verified, or both, at specified intervals, or prior to use,

against measurement standards Traceable To

International Standards or national measurement

standards

8. 7.6a Where No Such Standards Exist, the basis used for

calibration or verification shall be recorded (See 4.2.4)

JAG




No ISO

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9. 7.6b

Where necessary to ensure valid results, Measuring

Equipment shall be Adjusted Or Re-Adjusted as

necessary.

10. 7.6c


Equipment shall have Identification in order to

determine its Calibration Status.

11. 7.6d


Equipment shall be Safeguarded from adjustments

that would invalidate the measurement result.

12. 7.6e


Equipment shall be Protected from damage and

deterioration during Handling.

13. 7.6e

Where necessary to ensure valid results, measuring

equipment shall be protected from damage and

deterioration during Maintenance.

14. 7.6e

Where necessary to ensure valid results, measuring

equipment shall be protected from damage and

deterioration during Storage.

15. 7.6

In addition, the Organization shall assess and record

(see 4.2.4) the validity of the previous measuring

results when the equipment is found not to conform to

requirements.

16. 7.6 The Organization shall take appropriate action on the

equipment and any product affected.

17. 7.6 Records of the results of Calibration shall be


18. 7.6 Records of the results of Verification shall be


JAG




No ISO

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19. 7.6

When used in the Monitoring of specified

requirements, the Ability Of Computer Software to

satisfy the intended application shall be confirmed.

This shall be undertaken prior to initial use and

reconfirmed as necessary

20. 7.6

When used in the Measurement of specified

requirements, the Ability Of Computer Software to

satisfy the intended application shall be confirmed.

This shall be undertaken prior to initial use and

reconfirmed as necessary

21. NOTE

Confirmation of the ability of Computer Software to

satisfy the intended application would typically include

its Verification and Configuration Management to

maintain its suitability for use.

JAG


LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS


8. Measurement, Analysis and Improvement

8.1 General

No ISO

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1. 8.1a

The Organization shall Plan and Implement the

Monitoring Processes needed to demonstrate

Conformity to Product Requirements

2. 8.1b


Monitoring Processes to ensure Conformity of the

Quality Management System.

3. 8.1c


Monitoring Processes to Continually Improve the

effectiveness of the Quality Management System.

4. 8.1a


Measurement Processes needed to demonstrate


5. 8.1b

The Organization shall Plan and Implement The

Measurement Processes to ensure Conformity of

the Quality Management System.

6. 8.1c


Measurement Processes to Continually Improve

the effectiveness of the Quality Management

System.

7. 8.1a


Analysis Processes needed to demonstrate


8. 8.1b


Analysis Processes to ensure Conformity of the

Quality Management System.

JAG




No ISO

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9. 8.1c


Analysis Processes to Continually Improve the


10. 8.1a


Improvement Processes needed to demonstrate


11. 8.1b


Improvement Processes to ensure Conformity of

the Quality Management System.

12. 8.1c


Improvement Processes to Continually Improve

the effectiveness of the Quality Management

System.

13. 8.1

This shall include Determination of Applicable

Methods, including statistical techniques, and the

extent of their use.

JAG




8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

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1. 8.2.1

As one of the measurements of the performance of

the quality management system, the Organization

shall Monitor Information relating to Customer

Perception as to whether the Organization has met

customer requirements. The methods for obtaining

and using this information shall be determined.

2. NOTE

Monitoring Customer Perception can include

obtaining input from sources such as Customer

Satisfaction Surveys, Customer Data on Delivered

Product Quality, User Opinion Surveys, Lost

Business Analysis, Compliments, Warranty Claims

and Dealer Reports.

JAG





8.2.2 Internal Audit

No ISO

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1. 8.2.2a

The Organization shall Conduct Internal Audits at

planned intervals to determine whether the quality

management system conforms to the planned

arrangements (see 7.1), to the Requirements Of ISO

9001:2008 International Standard.

2. 8.2.2a


planned intervals to determine whether the quality

management system conforms to the planned

arrangements (see 7.1), to the Requirements Of The

Quality Management System Established By The

Organization.

3. 8.2.2b


planned intervals to determine whether the Quality

Management System is Effectively Implemented.

4. 8.2.2b


planned intervals to determine whether the Quality

Management system is Effectively Maintained.

5. 8.2.2

An audit programme shall be planned, taking into

consideration the status and Importance Of The

Processes and Areas To Be Audited.

6. 8.2.2 An audit programme shall be planned, taking into

consideration the Results Of Previous Audits.

7. 8.2.2 The audit criteria, scope, frequency and methods

shall be defined.

8. 8.2.2

The Selection Of Auditors and conduct of audits

shall ensure Objectivity And Impartiality of the audit

process. Auditors Shall Not Audit Their Own Work.

JAG




No ISO

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9. 8.2.2

A Documented Procedure shall be established to

define the responsibilities and requirements for

Planning And Conducting Audits, establishing

records and reporting results.

10. 8.2.2 Records of the audits and their results shall be


11. 8.2.2

The Management Responsible for the area being

audited shall ensure that any Necessary Corrections

are taken without undue delay to eliminate detected

Nonconformities And Their Causes.

12. 8.2.2

The Management Responsible for the Area Being

Audited shall ensure that any Necessary Corrective

Actions are taken without undue delay to eliminate

detected Nonconformities And Their Causes.

13. 8.2.2

Follow-Up Activities shall include the Verification of

the actions taken and the Reporting Of Verification

Results (see 8.5.2).

JAG





8.2.3 Monitoring and Measurement of Processes

No ISO

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1. 8.2.3

The Organization shall apply suitable Methods for

Monitoring the Quality Management System

Processes. This method shall demonstrate the ability

of the processes to achieve planned results. When

planned results are not achieved, Correction shall be

taken as appropriate.

2. 8.2.3


Monitoring the Quality Management System

Processes. This method shall demonstrate the ability

of the processes to achieve planned results. When

planned results are not achieved, Corrective Action

shall be taken as appropriate.

3. 8.2.3


Measurement, where applicable, of the Quality

Management System Processes. This method shall

demonstrate the ability of the processes to achieve

planned results. When planned results are not

achieved, Correction shall be taken as appropriate.

4. 8.2.3


Measurement, where applicable, of the Quality

Management System Processes. This method shall

demonstrate the ability of the processes to achieve

planned results. When planned results are not

achieved, Corrective Action shall be taken as

appropriate.

JAG




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5. NOTE

When determining Suitable Methods, it is advisable

that the Organization consider the type and extent of

Monitoring or Measurement appropriate to each of

its processes in relation to their Impact on the

Conformity to Product Requirements and on the


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8.2.4 Monitoring and Measurement of Product

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1. 8.2.4

The Organization shall Monitor the Characteristics

Of The Product to Verify that Product

Requirements have been met. This shall be carried

out at Appropriate Stages of the Product

Realization process in accordance with the planned

arrangements (see 7.1). Evidence of Conformity

with the Acceptance Criteria shall be maintained.

2. 8.2.4

The Organization shall Measure the Characteristics

Of The Product to Verify that Product

Requirements have been met. This shall be carried

out at Appropriate Stages of the Product

Realization process in accordance with the planned

arrangements (see 7.1). Evidence of Conformity

with the Acceptance Criteria shall be maintained.

3. 8.2.4

Records shall indicate the person(s) Authorizing

Release Of Product for delivery to the customer (see

4.2.4)

4. 8.2.4

The Release Of Product to the customer shall not

proceed until the planned arrangements (see 7.1)

have been satisfactorily completed, unless otherwise

Approved by a Relevant Authority and, where

applicable by the customer.

5. 8.2.4

The Delivery Of Product to the customer shall not

proceed until the planned arrangements (see 7.1)

have been satisfactorily completed, unless otherwise

Approved by a Relevant Authority and, where

applicable by the customer.

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8.3 Control of Nonconforming Product

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1. 8.3

The Organization shall ensure that Product which

does not conform to product requirements is

Identified to prevent its Unintended Use.

2. 8.3



Identified to prevent its Delivery.

3. 8.3



Controlled to prevent its Unintended Use.

4. 8.3



Controlled to prevent its Delivery.

5. 8.3


Define the Controls for dealing with Nonconforming

Product.

6. 8.3


Define the Responsibilities for dealing with

Nonconforming Product.

7. 8.3


Define the Authority for dealing with

Nonconforming Product.

8. 8.3a

Where applicable, the Organization shall deal with

Nonconforming Product by one or more of the

following ways: By Taking Action To Eliminate The

Detected Nonconformity.

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9. 8.3b


nonconforming product by one or more of the

following ways: by Authorizing Its Use under

concession by a Relevant Authority.

10. 8.3b



following ways: by Authorizing Its Use under

concession, where applicable, by the Customer.

11. 8.3b



following ways: by Authorizing Its Release under

concession by a Relevant Authority.

12. 8.3b



following ways: by Authorizing Its Release under

concession, where applicable, by the Customer.

13. 8.3b



following ways: by Authorizing Its Acceptance

under concession by a Relevant Authority.

14. 8.3b



following ways: by Authorizing Its Acceptance

under concession, where applicable, by the

Customer.

15. 8.3c



following ways: by taking action to preclude its original

Intended Use.

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16. 8.3c



following ways: by taking action to preclude its original

Intended Application.

17. 8.3d



following ways: by taking action appropriate to the

Effects Of The Nonconformity when nonconformity

is detected After Delivery.

18. 8.3d



following ways: by taking action appropriate to the

Potential Effects Of The Nonconformity when

nonconformity is detected After Use Has Started.

19. 8.3

When nonconforming product is corrected it shall be

subject to re-verification to demonstrate conformity to

the requirements.

20. 8.3

Records of the nature of nonconformities and any

subsequent actions taken, including concessions

obtained, shall be maintained (see 4.2.4)

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8.4 Analysis of Data

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1. 8.4

The Organization shall Determine the appropriate

data needed to demonstrate the Suitability and

Effectiveness Of The Quality Management

System.

2. 8.4

The Organization shall Collect appropriate data

needed to demonstrate the Suitability and


System.

3. 8.4

The Organization shall Analyse the appropriate data

needed to demonstrate the Suitability and


System.

4. 8.4

The Organization shall Evaluate where Continual

Improvement of the quality management system can

be made.

5. 8.4

The Organization shall include data generated as a

result of monitoring and measurement and from other

relevant sources.

6. 8.4a The analysis of data shall provide information relating

to: Customer Satisfaction (see 8.2.1)

7. 8.4b

The analysis of data shall provide information relating

to: Conformity To Product Requirements (see

8.2.4)

8. 8.4c


to: characteristics and trends of Processes, including

opportunities for preventive action (see 8.2.3 and

8.2.4)

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9. 8.4c


to: characteristics and trends of Products, including

opportunities for preventive action (see 8.2.3 and

8.2.4)

10. 8.4d The analysis of data shall provide information relating

to: Suppliers (see 7.4)

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8.5 Improvement

8.5.1 Continual Improvement

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1. 8.5.1

The Organization shall continually improve the

effectiveness of the quality management system

through the use of the Quality Policy.

2. 8.5.1



through the use of the Quality Objectives.

3. 8.5.1



through the use of Audit Results.

4. 8.5.1



through the use of the Analysis Of Data.

5. 8.5.1



through the use of Corrective Actions.

6. 8.5.1



through the use of Preventive Actions.

7. 8.5.1



through the use Management Review.

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8.5 Improvement

8.5.2 Corrective Action

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1. 8.5.2

The Organization shall take action to eliminate the

causes of nonconformities in order to Prevent

Recurrence.

2. 8.5.2 Corrective actions shall be appropriate to the effects

of the nonconformities encountered.

3. 8.5.2a


define requirements for: Reviewing

Nonconformities (including customer complaints).

4. 8.5.2b

A documented procedure shall be established to

define requirements for: Determining The Causes Of

Nonconformities.

5. 8.5.2c


define requirements for: Evaluating The Need For

Action To Ensure That Nonconformities Do Not

Recur.

6. 8.5.2d


define requirements for: Determining Action

Needed.

7. 8.5.2d


define requirements for: Implementing Action

Needed.

8. 8.5.2e


define requirements for: Records Of The Results Of

Action Taken (see 4.2.4)

9. 8.5.2f


define requirements for: Reviewing The

Effectiveness Of The Corrective Action Taken.

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8.5 Improvement

8.5.3 Preventive Action

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1. 8.5.3

The Organization shall Determine action to eliminate

the causes of potential nonconformities in order to

Prevent Their Occurrence.

2. 8.5.3 Preventive actions shall be appropriate to the effects

of the Potential Problems.

3. 8.5.3a


define requirements for: Determining Potential

Nonconformities And Their Causes.

4. 8.5.3b


define requirements for: Evaluating The Need For

Action To Prevent Occurrence Of

Nonconformities.

5. 8.5.3c


define requirements for: Determining Action

Needed.

6. 8.5.3c


define requirements for: Implementing Action

Needed.

7. 8.5.3d


define requirements for: Records Of Results Of

Action Taken (see 4.2.4).

8. 8.5.3e


define requirements for: Reviewing The

Effectiveness Of The Preventive Action Taken.

ISO 9001-2008 Project Gap Analysis ANTIFRAGILITY

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Transcript of ISO 9001-2008 Project Gap Analysis ANTIFRAGILITY