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 Page 2 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
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 3 of 78
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
JAG
Organization Internal & External Audits Framework
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 4 of 78
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
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 5 of 78
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
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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
JAG
Organization Internal & External Audits Framework
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 6 of 78
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
JAG
Organization Internal & External Audits Framework
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 7 of 78
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
Printing/Publishing/Media
Retail
Recruitment
Airports
Call Centres
Catering
Distribution/Supplier
Health Care
IT/Communication
Security
Aerospace/Defence
Construction
Design & Build
Electrical Engineering
Energy & Power
Manufacturing
Mechanical Engineering
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
JAG
Organization Internal & External Audits Framework
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 8 of 78
Operating 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 & Build
Electrical Engineering
Energy & Power
Manufacturing
Mechanical Engineering
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
JAG
Organization Internal & External Audits Framework
QMS AND TECHNICAL LPGC
ISO 9001:2008 REQUIREMENTS Page 9 of 78
ANTI-FRAGILITY
JAG
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 Page 10 of 78
1 Scope
1.1 General
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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
ISO International Standard specifies requirements
for a Quality Management System where an
Organization needs to demonstrate its ability to
consistently Provide Product that meets applicable
Statutory Requirement.
3. 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
Regulatory Requirements.
JAG
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 Page 11 of 78
1 Scope
1.2 Application
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SQ A B C ACTUAL QMS ACTIONS REQUIRED
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.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 2 NORMATIVE REFERENCES AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 12 of 78
2 Normative References
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FINDINGS GAP ANALYSIS
NO YES N.B. Provide references to documentation where necessary
SQ A B C ACTUAL QMS ACTIONS REQUIRED
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.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 3 TERMS AND DEFINITIONS AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 13 of 78
3 Terms and References
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NO YES N.B. Provide references to documentation where necessary
SQ A B C ACTUAL QMS ACTIONS REQUIRED
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”
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 14 of 78
4 Quality Management System
4.1 General Requirements
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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. 4.1
Has the Organization Established a Quality
Management System, and Continually Improved its
Effectiveness?
2. 4.1
Has the Organization Documented a Quality
Management System, and Continually Improved its
Effectiveness?
3. 4.1
Has the Organization Implemented a Quality
Management System, and Continually Improved its
Effectiveness?
4. 4.1
Has the Organization Maintained a Quality
Management System, and Continually Improved its
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 15 of 78
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NO YES N.B. Provide references to documentation where necessary
SQ A B C ACTUAL QMS ACTIONS REQUIRED
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 16 of 78
4.2 Documentation Requirements
4.2.1 General
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NO YES N.B. Provide references to documentation where necessary
SQ A B C ACTUAL QMS ACTIONS REQUIRED
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 17 of 78
4.2 Documentation Requirements
4.2.2 Organization Quality Plan
No
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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. 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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 18 of 78
4.2 Documentation Requirements
4.2.3 Control of Documents
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SQ A B C ACTUAL QMS ACTIONS REQUIRED
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
Does the Document Control Procedure Define the
controls needed to Review and Update as necessary
and Re-Approve Documents?
4. 4.2.3c
Does the Document Control Procedure Define the
controls needed to ensure that Changes and the
Current Revision Status of documents are
Identified?
5. 4.2.3d
Does the Document Control Procedure Define the
controls needed to ensure that Relevant Versions of
Applicable Documents are Available at Points of
Use?
6. 4.2.3e
Does the Document Control Procedure Define the
controls needed to ensure that documents Remain
Legible and Readily Identifiable?
7. 4.2.3f
Does the Document Control Procedure Define the
controls needed to ensure that Documents of
External Origin are Identified and their Distribution
Controlled?
8. 4.2.3g
Does the Document Control Procedure Define the
controls needed to Prevent The Unintended Use Of
Obsolete Documents, and to apply Suitable
Identification to them if they are Retained for any
purpose?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 4 QUALITY MANAGEMENT SYSTEM AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 19 of 78
4.2 Documentation Requirements
4.2.4 Control of Records
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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. 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
Has the Organization Established a Documented
Procedure for the Storage of Organization
Records?
5. 4.2.4
Has the Organization Established a Documented
Procedure for the Protection of Organization
Records?
6. 4.2.4
Has the Organization Established a Documented
Procedure for the Retrieval of Organization
Records?
7. 4.2.4
Has the Organization Established a Documented
Procedure for the retention and Disposition of
Organization Records?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 20 of 78
5 Management Responsibility
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FINDINGS GAP ANALYSIS
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SQ A B C ACTUAL QMS ACTIONS REQUIRED
1. 5.
Can the Organization Provide Evidence of its
Commitment to the Development of the Quality
Management System?
2. 5.
Can the Organization Provide Evidence of its
Commitment to the Implementation of the Quality
Management System?
3. 5.
Can the Organization Provide Evidence of its
Commitment for Improving the Effectiveness of the
Quality Management System?
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 21 of 78
5.2 Customer Focus
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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. 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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 22 of 78
5.3 Quality Policy
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ISO 9001:2008 REQUIREMENTS
FINDINGS GAP ANALYSIS
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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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 23 of 78
5.4 Planning
5.4.1 Quality Objectives
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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. 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
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 24 of 78
5.4 Planning
5.4.2 Quality Management System Planning
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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. 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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 25 of 78
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
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FINDINGS GAP ANALYSIS
NO YES N.B. Provide references to documentation where necessary
SQ A B C ACTUAL QMS ACTIONS REQUIRED
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 26 of 78
5.5 Responsibility, Authority and Communication
5.5.2 Management Representative
No ISO
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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. 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
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
Implemented?
3. 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 Maintained?
4. 5.5.2b
Has the Organization Appointed a member of the
Organization who, irrespective of other responsibilities
has Responsibility and Authority for Reporting to
Organization on the Performance Of The Quality
Management System?
5. 5.5.2b
Has the Organization Appointed a member of the
Organization who, irrespective of other responsibilities
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?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 27 of 78
5.5 Responsibility, Authority and Communication
5.5.3 Internal Communication
No ISO
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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. 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
Quality Management System?
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 28 of 78
5.6 Management Review
5.6.1 General
No ISO
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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. 5.6.1
The Organization shall Review the Quality
Management System, at Planned Intervals, to
ensure its Continuing Suitability.
2. 5.6.1
The Organization shall Review the Quality
Management System, at Planned Intervals, to
ensure its Continuing Adequacy.
3. 5.6.1
The Organization shall Review the Quality
Management System, at Planned Intervals, to
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)
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 29 of 78
5.6 Management Review
5.6.2 Review Input
No ISO
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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. 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
The Input To Management Review shall include
information on Changes that could affect the Quality
Management System.
9. 5.6.2g
The Input To Management Review shall include
information on Recommendations for
Improvement.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 5 MANAGEMENT RESPONSIBILITY AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 30 of 78
5.6 Management Review
5.6.3 Review Output
No ISO
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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. 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 Output From Management Review shall include
any decisions and actions related to Improvement of
the Effectiveness of the Quality Management
Processes.
3. 5.6.3b
The Output From Management Review shall include
any decisions and actions related to Improvement of
Product related to Customer Requirements.
4. 5.6.3c
The Output From Management Review shall include
any decisions and actions related to Improvement of
the Resources Needs.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 31 of 78
6 Resource Management
6.1 Provision of Resources
No ISO
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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. 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
The Organization shall Determine the resources
needed to Maintain the Quality Management System
and continually Maintain its Effectiveness.
4. 6.1a
The Organization shall Provide the resources needed
to Maintain the Quality Management System and
continually Maintain its Effectiveness.
5. 6.1b
The Organization shall Determine the resources
needed to enhance Customer Satisfaction by
meeting Customer Requirements.
6. 6.1b
The Organization shall Provide the resources needed
to enhance Customer Satisfaction by meeting
Customer Requirements.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 32 of 78
6.2 Human Resources
6.2.1 General
No ISO
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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. 6.2.1
Personnel performing work affecting Conformity to
Product requirements shall be Competent on the
basis of Appropriate Education.
2. 6.2.1
Personnel performing work affecting Conformity to
Product requirements shall be Competent on the
basis of Appropriate Training.
3. 6.2.1
Personnel performing work affecting Conformity to
Product requirements shall be Competent on the
basis of Appropriate Skills.
4. 6.2.1
Personnel performing work affecting Conformity to
Product requirements shall be Competent on the
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 33 of 78
6.2 Human Resources
6.2.2 Competence, Training and Awareness
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 34 of 78
6 Resource Management
6.3 Infrastructure
No ISO
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F.
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. 6.3a
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
Buildings.
2. 6.3a
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
Workspace.
3. 6.3a
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
Utilities.
4. 6.3b
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
process equipment: Hardware.
5. 6.3b
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
process equipment: Software.
6. 6.3b
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
supporting services: Transport.
7. 6.3b
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
supporting services: Communication.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 35 of 78
No ISO
CL
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F.
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
8. 6.3b
The Organization shall Determine, Provide and
Maintain the infrastructure needed to achieve
conformity to product requirements, as applicable,
supporting services: Information System.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 6 RESOURCE MANAGEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 36 of 78
6. Resource Management
6.4 Work Environment
No ISO
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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. 6.4
The Organization shall determine and manage the
work environment: Physical, needed to achieve
conformity to product requirements
2. 6.4
The Organization shall determine and manage the
work environment: Environmental, needed to
achieve conformity to product requirements
3. 6.4
The Organization shall determine and manage the
work environment: Noise Level, needed to achieve
conformity to product requirements
4. 6.4
The Organization shall determine and manage the
work environment: Temperature Level, needed to
achieve conformity to product requirements
5. 6.4
The Organization shall determine and manage the
work environment: Humidity Level, needed to
achieve conformity to product requirements
6. 6.4
The Organization shall determine and manage the
work environment: Lighting Level, needed to
achieve conformity to product requirements
7. 6.4
The Organization shall determine and manage the
work environment: Weather, needed to achieve
conformity to product requirements
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 37 of 78
7. Product Realization
7.1 Planning of Product Realization
No ISO
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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. 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
In Planning Product Realization, the Organization
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
In Planning Product Realization, the Organization
shall Determine the Required Verification Specific
To The Product.
7. 7.1c
In Planning Product Realization, the Organization
shall Determine the Required Validation Specific
To The Product.
8. 7.1c
In Planning Product Realization, the Organization
shall Determine the Required Monitoring Specific
To The Product.
9. 7.1c
In Planning Product Realization, the Organization
shall Determine the required measurement specific
to the product.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 38 of 78
No ISO
CL
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F.
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
10. 7.1c
In Planning Product Realization, the Organization
shall Determine the Required Inspection Specific
To The Product.
11. 7.1c
In Planning Product Realization, the Organization
shall Determine the Required Test Activities
Specific To The Product.
12. 7.1c
In Planning Product Realization, the Organization
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 39 of 78
7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 40 of 78
7.2 Customer-Related Processes
7.2.2 Review of Requirements Related to the Product
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 41 of 78
7.2 Customer-Related Processes
7.2.3 Customer Communication
No ISO
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F.
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. 7.2.3a
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Product Information.
2. 7.2.3b
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Enquiries.
3. 7.2.3b
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Contracts.
4. 7.2.3b
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Contracts or Order
Handling.
5. 7.2.3b
The Organization shall determine and implement
effective arrangements for communicating with
Customers in relation to: Amendments.
6. 7.2.3c
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Customer Feedback.
7. 7.2.3c
The Organization shall Determine and Implement
effective arrangements for communicating with
Customers in relation to: Customer Complaints.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 42 of 78
7.3 Design and Development
7.3.1 Design and Development Planning
No ISO
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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. 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
During the design and development planning, the
Organization shall Determine the Reviews that are
appropriate to each design and development stage.
4. 7.3.1b
During the design and development planning, the
Organization shall Determine the Verifications that
are appropriate to each design and development
stage.
5. 7.3.1b
During the design and development planning, the
Organization shall determine the validations that are
appropriate to each design and development stage.
6. 7.3.1c
During the design and development planning, the
Organization shall Determine the Responsibilities
for design and development.
7. 7.3.1c
During the design and development planning, the
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 43 of 78
No ISO
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F.
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
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 44 of 78
7.3 Design and Development
7.3.2 Design and Development Inputs
No ISO
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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. 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
Inputs Relating To Product Requirements shall be
Determined and records maintained (see 4.2.4).
These inputs shall include: Performance
Requirements.
3. 7.3.2b
Inputs Relating To Product Requirements shall be
Determined and records maintained (see 4.2.4).
These inputs shall include: Applicable Statutory
Requirements.
4. 7.3.2b
Inputs Relating To Product Requirements shall be
Determined and records maintained (see 4.2.4).
These inputs shall include: Applicable Regulatory
Requirements.
5. 7.3.2c
Inputs Relating To Product Requirements shall be
Determined and records maintained (see 4.2.4).
These inputs shall include: where applicable,
Information Derived From Previous Similar
Designs.
6. 7.3.2c
Inputs Relating To Product Requirements shall be
Determined and records maintained (see 4.2.4).
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 45 of 78
7.3 Design and Development
7.3.3 Design and Development Outputs
No ISO
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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. 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
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 Provide Appropriate
Information For Purchasing.
3. 7.3.3b
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 Provide Appropriate
Information For Production.
4. 7.3.3b
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 Provide Appropriate
Information For Service Provision.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 46 of 78
No ISO
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F.
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
5. 7.3.3c
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 contain or Reference Product Acceptance
Criteria.
6. 7.3.3d
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 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 47 of 78
7.3 Design and Development
7.3.4 Design and Development Review
No ISO
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F.
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. 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
ANTI-FRAGILITY ASSESMENT
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A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 48 of 78
7.3 Design and Development
7.3.5 Design and Development Verification
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 49 of 78
7.3 Design and Development
7.3.6 Design and Development Validation
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 50 of 78
7.3 Design and Development
7.3.7 Control of Design and Development Changes
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 51 of 78
7.4 Purchasing
7.4.1 Purchasing Process
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 52 of 78
7.4 Purchasing
7.4.2 Purchasing Information
No ISO
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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. 7.4.2
Purchasing information shall describe the product to
be purchased, including, where appropriate:
Requirements For Approval Of Product.
2. 7.4.2
Purchasing information shall describe the product to
be purchased, including, where appropriate:
Procedures On How The Product Will Be
Approved.
3. 7.4.2
Purchasing information shall describe the product to
be purchased, including, where appropriate:
Processes And Equipment For The Production Of
The Product.
4. 7.4.2
Purchasing information shall describe the product to
be purchased, including, where appropriate:
Requirements For The Qualification Of Personnel.
5. 7.4.2
Purchasing information shall describe the product to
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 53 of 78
7.4 Purchasing
7.4.3 Verification of Purchased Product
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 54 of 78
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
No ISO
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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. 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
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Availability Of Work Instructions, As Necessary.
3. 7.5.1c
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Use Of Suitable Equipment.
4. 7.5.1d
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Availability And Use Of Monitoring Equipment.
5. 7.5.1d
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Availability And Use Of Measuring Equipment.
6. 7.5.1e
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Implementation Of Monitoring Equipment.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 55 of 78
No ISO
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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
7. 7.5.1e
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: the
implementation of measurement.
8. 7.5.1f
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Implementation Of Product Release.
9. 7.5.1f
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Implementation Of Product Delivery.
10. 7.5.1f
The Organization shall plan and carry out production
and service provision under controlled conditions.
Controlled conditions shall include, as applicable: The
Implementation Of Post-Delivery Activities.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 56 of 78
7.5 Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
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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. 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
The Organization shall establish arrangements of
above processes including, as applicable: Approval
Of Equipment And Qualification Of Personnel.
5. 7.5.2c
The Organization shall establish arrangements of
above processes including, as applicable: Approval
Of Specific Methods And Procedures.
6. 7.5.2d
The Organization shall establish arrangements of
above processes including, as applicable:
requirements for records (see 4.2.4)
7. 7.5.2e
The Organization shall establish arrangements of
above processes including, as applicable:
Revalidation.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 57 of 78
7.5 Production and Service Provision
7.5.3 Identification and Traceability
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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 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 58 of 78
7.5 Production and Service Provision
7.5.4 Customer Property
No ISO
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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. 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
provided for Use or Incorporation into the product.
4. 7.5.4 The Organization shall Protect Customer Property
provided for Use or Incorporation into the product.
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 59 of 78
7.5 Production and Service Provision
7.5.5 Preservation of Product
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 60 of 78
7. Product Realization
7.6 Control of Monitoring and Measuring Equipment
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 61 of 78
No ISO
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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
9. 7.6b
Where necessary to ensure valid results, Measuring
Equipment shall be Adjusted Or Re-Adjusted as
necessary.
10. 7.6c
Where necessary to ensure valid results, Measuring
Equipment shall have Identification in order to
determine its Calibration Status.
11. 7.6d
Where necessary to ensure valid results, Measuring
Equipment shall be Safeguarded from adjustments
that would invalidate the measurement result.
12. 7.6e
Where necessary to ensure valid results, Measuring
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
maintained (see 4.2.4)
18. 7.6 Records of the results of Verification shall be
maintained (see 4.2.4)
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 7 PRODUCT REALIZATION AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 62 of 78
No ISO
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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
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 63 of 78
8. Measurement, Analysis and Improvement
8.1 General
No ISO
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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. 8.1a
The Organization shall Plan and Implement the
Monitoring Processes needed to demonstrate
Conformity to Product Requirements
2. 8.1b
The Organization shall Plan and Implement the
Monitoring Processes to ensure Conformity of the
Quality Management System.
3. 8.1c
The Organization shall Plan and Implement the
Monitoring Processes to Continually Improve the
effectiveness of the Quality Management System.
4. 8.1a
The Organization shall Plan and Implement the
Measurement Processes needed to demonstrate
Conformity to Product Requirements
5. 8.1b
The Organization shall Plan and Implement The
Measurement Processes to ensure Conformity of
the Quality Management System.
6. 8.1c
The Organization shall Plan and Implement the
Measurement Processes to Continually Improve
the effectiveness of the Quality Management
System.
7. 8.1a
The Organization shall Plan and Implement the
Analysis Processes needed to demonstrate
Conformity to Product Requirements
8. 8.1b
The Organization shall Plan and Implement the
Analysis Processes to ensure Conformity of the
Quality Management System.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 64 of 78
No ISO
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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
9. 8.1c
The Organization shall Plan and Implement the
Analysis Processes to Continually Improve the
effectiveness of the Quality Management System.
10. 8.1a
The Organization shall Plan and Implement the
Improvement Processes needed to demonstrate
Conformity to Product Requirements
11. 8.1b
The Organization shall Plan and Implement the
Improvement Processes to ensure Conformity of
the Quality Management System.
12. 8.1c
The Organization shall Plan and Implement the
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 65 of 78
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
No ISO
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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. 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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 66 of 78
8.2 Monitoring and Measurement
8.2.2 Internal Audit
No ISO
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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. 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
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 The
Quality Management System Established By The
Organization.
3. 8.2.2b
The Organization shall Conduct Internal Audits at
planned intervals to determine whether the Quality
Management System is Effectively Implemented.
4. 8.2.2b
The Organization shall Conduct Internal Audits at
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 67 of 78
No ISO
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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
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
maintained (see 4.2.4)
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 68 of 78
8.2 Monitoring and Measurement
8.2.3 Monitoring and Measurement of Processes
No ISO
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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. 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
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, Corrective Action
shall be taken as appropriate.
3. 8.2.3
The Organization shall apply suitable Methods for
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
The Organization shall apply suitable Methods for
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
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 69 of 78
No ISO
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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
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
effectiveness of the Quality Management System.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 70 of 78
8.2 Monitoring and Measurement
8.2.4 Monitoring and Measurement of Product
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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. 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.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 71 of 78
8. Measurement, Analysis and Improvement
8.3 Control of Nonconforming Product
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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. 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
The Organization shall ensure that Product which
does not conform to product requirements is
Identified to prevent its Delivery.
3. 8.3
The Organization shall ensure that Product which
does not conform to product requirements is
Controlled to prevent its Unintended Use.
4. 8.3
The Organization shall ensure that Product which
does not conform to product requirements is
Controlled to prevent its Delivery.
5. 8.3
A Documented Procedure shall be established to
Define the Controls for dealing with Nonconforming
Product.
6. 8.3
A Documented Procedure shall be established to
Define the Responsibilities for dealing with
Nonconforming Product.
7. 8.3
A Documented Procedure shall be established to
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.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 72 of 78
No ISO
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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
9. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Use under
concession by a Relevant Authority.
10. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Use under
concession, where applicable, by the Customer.
11. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Release under
concession by a Relevant Authority.
12. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Release under
concession, where applicable, by the Customer.
13. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Acceptance
under concession by a Relevant Authority.
14. 8.3b
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by Authorizing Its Acceptance
under concession, where applicable, by the
Customer.
15. 8.3c
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by taking action to preclude its original
Intended Use.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 73 of 78
No ISO
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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
16. 8.3c
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by taking action to preclude its original
Intended Application.
17. 8.3d
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
following ways: by taking action appropriate to the
Effects Of The Nonconformity when nonconformity
is detected After Delivery.
18. 8.3d
Where applicable, the Organization shall deal with
nonconforming product by one or more of the
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)
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 74 of 78
8. Measurement, Analysis and Improvement
8.4 Analysis of Data
No
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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. 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
Effectiveness Of The Quality Management
System.
3. 8.4
The Organization shall Analyse the appropriate data
needed to demonstrate the Suitability and
Effectiveness Of The Quality Management
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
The analysis of data shall provide information relating
to: characteristics and trends of Processes, including
opportunities for preventive action (see 8.2.3 and
8.2.4)
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 75 of 78
No
ISO
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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
9. 8.4c
The analysis of data shall provide information relating
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)
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 76 of 78
8.5 Improvement
8.5.1 Continual Improvement
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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. 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
The Organization shall continually improve the
effectiveness of the quality management system
through the use of the Quality Objectives.
3. 8.5.1
The Organization shall continually improve the
effectiveness of the quality management system
through the use of Audit Results.
4. 8.5.1
The Organization shall continually improve the
effectiveness of the quality management system
through the use of the Analysis Of Data.
5. 8.5.1
The Organization shall continually improve the
effectiveness of the quality management system
through the use of Corrective Actions.
6. 8.5.1
The Organization shall continually improve the
effectiveness of the quality management system
through the use of Preventive Actions.
7. 8.5.1
The Organization shall continually improve the
effectiveness of the quality management system
through the use Management Review.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 77 of 78
8.5 Improvement
8.5.2 Corrective Action
No ISO
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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. 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
A Documented Procedure shall be established to
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
A Documented Procedure shall be established to
define requirements for: Evaluating The Need For
Action To Ensure That Nonconformities Do Not
Recur.
6. 8.5.2d
A Documented Procedure shall be established to
define requirements for: Determining Action
Needed.
7. 8.5.2d
A Documented Procedure shall be established to
define requirements for: Implementing Action
Needed.
8. 8.5.2e
A Documented Procedure shall be established to
define requirements for: Records Of The Results Of
Action Taken (see 4.2.4)
9. 8.5.2f
A Documented Procedure shall be established to
define requirements for: Reviewing The
Effectiveness Of The Corrective Action Taken.
JAG
ANTI-FRAGILITY ASSESMENT
LPGC SECTION 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT AUDIT GAP ANALYSIS
A Opportunity for Improvement B Minor Non-conformance C Major Non-conformance SQ Supplementary Question Page 78 of 78
8.5 Improvement
8.5.3 Preventive Action
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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. 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
A Documented Procedure shall be established to
define requirements for: Determining Potential
Nonconformities And Their Causes.
4. 8.5.3b
A Documented Procedure shall be established to
define requirements for: Evaluating The Need For
Action To Prevent Occurrence Of
Nonconformities.
5. 8.5.3c
A Documented Procedure shall be established to
define requirements for: Determining Action
Needed.
6. 8.5.3c
A Documented Procedure shall be established to
define requirements for: Implementing Action
Needed.
7. 8.5.3d
A Documented Procedure shall be established to
define requirements for: Records Of Results Of
Action Taken (see 4.2.4).
8. 8.5.3e
A Documented Procedure shall be established to
define requirements for: Reviewing The
Effectiveness Of The Preventive Action Taken.
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