ISO9001 Gap Assessment Tool QMS-FORM-00-4
Implementation Guidance This Excel sheet must be removed from the final version of the document.
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Purpose of this document This document should be used to assess the level of conformity of an organization against the ISO14001 standard. It may be used by a consultant on behalf of a client or by an organization directly.
Areas of the standard addressed All areas of the ISO9001 standard are covered.
General guidance This tool allows you to perform a gap assessment against the ISO9001 standard. The questions asked are based on the contents of the relevant standard and are designed to give a reasonable assessment of the degree to which the relevant requirements are met. In all cases a "Yes" answer is taken as a positive indication. The results are summarised in a series of tables and in a selection of charts. If you would prefer to assess your conformity directly against the requirements of the standard, CertiKit also offers as a separate chargeable product, the CertiKit ISO9001 Enhanced Gap Assessment Tool which lists the exact requirements from the standard, line by line. Because this second option contains the full text from the standard, it is subject to a licensing agreement that CertiKit maintains with the ISO via BSI. The Enhanced Gap Assessment Tool is available for purchase from our website.
Review frequency It is a good idea to revisit this assessment on a regular basis throughout your project to obtain an indication of progress and as a final check prior to an external audit.
Version number ISO9001 Toolkit Version 4
Copyright notice Except for any specifically identified third-party works included, this document has been authored by CertiKit, and is ©CertiKit except as stated below. CertiKit is a company registered in England and Wales with company number 6432088.
Licence terms This document is licensed on and subject to the standard licence terms of CertiKit, available on request, or by download from our website. All other rights are reserved. Unless you have purchased this product you only have an evaluation licence. If this product was purchased, a full licence is granted to the person identified as the licensee in the relevant purchase order. The standard licence terms include special terms relating to any third party copyright included in this document.
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ISO9001 Gap Assessment Tool QMS-FORM-00-4
Assessment Details Standard assessed: Date(s) of assessment: Location of assessment: Assessor: Assessment participants: Purpose of assessment: Scope of assessment:
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ISO9001 Gap Assessment Tool QMS-FORM-00-4
Terms used:
Quality management systems: Requirements REF
QMS: Quality management system
ISO9001 REQUIREMENTS
REQS MET?
4 Context of the organization 4.1 Understanding the organization and its context 1 2
Yes Yes
Have the external and internal issues relevant to the QMS been determined? Are these issues monitored on a regular basis? Total:
2
4.2 Understanding the needs and expectations of interested parties 1 2
Yes Yes
Have the interested parties and their requirements been identified? Is information about these interested parties and their requirements monitored and reviewed regularly? Total:
2
4.3 Determining the scope of the quality management system 1 2 3
Yes Yes Yes
Has the scope of the QMS been determined and documented? Are the boundaries and applicability of the QMS clearly defined and justified? Have the external and internal issues, requirements of interested parties and products and services been considered in determining the scope? Total:
3
4.4 Quality management system 1 2 3 4
Yes Yes Yes Yes
Is a QMS in place and being continually improved? Are the processes needed for the QMS determined? Is each process fully defined in terms of aspects such as inputs, outputs, resources, ownership, risks and improvement? Is adequate documented information maintained about the processes and their operation? Total:
4
5 Leadership 5.1 Leadership and commitment 1 2 3 4 5
Yes Yes
Does top management demonstrate leadership and commitment with respect to the QMS? Are clear leadership actions taken by top management such as taking accountability, providing resources, communicating, engaging and supporting others? Is there a focus on enhancing customer satisfaction? Are customer and other relevant requirements determined, understood and met? Are risks and opportunities affecting customer satisfaction addressed?
Yes Yes Yes
Total:
5
5.2 Quality policy 1
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Has an appropriate quality policy been established, implemented and maintained?
Yes
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ACTION NEEDED TO MEET REQUIREMENTS
ACTION OWNER
REF
ISO9001 REQUIREMENTS
2
Does it include the required framework for setting objectives and commitments to satisfying requirements and continual improvement? Is the quality policy documented? Is it communicated internally and where appropriate, externally?
3 4
REQS MET? Yes Yes Yes
Total:
4
5.3 Roles, responsibilities and authorities 1 2
Yes Yes
Are relevant roles, responsibilities and authorities assigned, communicated and understood? Have the required specific responsibilities and authorities been assigned (e.g. QMS, processes, reporting, customer focus, change management) Total:
2
6 Planning 6.1 Actions to address risks and opportunities 1 2
Yes Yes
Are all of the relevant risks and opportunities determined with respect to the QMS? Are actions planned to address the identified risks and opportunities? Total:
2
6.2 Quality objectives and planning to achieve them 1 2 3
Yes Yes Yes
Have measurable quality objectives been established, documented and communicated? Is there a plan to achieve the defined quality objectives? Is success against the objectives reviewed and updated regularly? Total:
3
6.3 Planning of changes 1 2
Yes Yes
Are changes to the QMS planned and managed appropriately? Is evidence available that changes have been through this process? Total:
2
Are appropriate resources provided for the QMS, both internally and where necessary, externally? Are the necessary human resources allocated to the QMS? Is the necessary infrastructure provided (e.g. buildings, equipment, technology) for the processes to operate? Is the necessary environment provided (e.g. social, psychological, physical) for the operation of the processes? If appropriate, are the resources provided to ensure valid and reliable results when monitoring or measuring the conformity of products and services? Is evidence of the fitness for purpose of monitoring and measuring resources recorded? If appropriate, is measuring equipment calibrated, idenitified and protected? Is the knowledge necessary for the operation of the processes determined? Is a process in place to maintain required knowledge and obtain new knowledge where required?
Yes Yes Yes Yes Yes
Total:
9
7 Support 7.1 Resources 1 2 3 4 5 6 7 8 9
Yes Yes Yes Yes
7.2 Competence 1 2 3
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Have the necessary competence levels been determined for the roles within the QMS? Are all of the relevant people sufficiently competent to perform their roles? Where necessary, is action taken to improve competence and are records kept?
Yes Yes Yes
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ACTION NEEDED TO MEET REQUIREMENTS
ACTION OWNER
REF
ISO9001 REQUIREMENTS
REQS MET? Total:
3
7.3 Awareness 1
Yes
Are all relevant people aware of the quality policy and their role in fulfilling quality objectives? Total:
1
7.4 Communication 1 2
Yes Yes
Is effective internal and external communication in place? Are communications about the QMS responded to? Total:
2
7.5 Documented information 1 2 3 4
Yes Yes Yes Yes
Is all of the documented information required by the standard in place? Are standards used for documentation such as titles, references, format, review and approval? Is the lifecycle of documented information controlled, including that from outside the organization? Is documented information adequately protected? Total:
4
8 Operation 8.1 Operational planning and control 1 2 3
Yes Yes Yes
Are all of the processes needed to meet requirements planned, implemented and controlled? Are planned changes controlled and the consequences of unplanned changes mitigated? Are outsourced processes identified and controlled? Total:
3
8.2 Requirements for products and services 1 2 3 4 5 6
Yes
Are the required methods of communication with customers in place e.g. product and service information, enquiries, feedback and complaints? Are the requirements for the products and services defined? Can the organization's claims for the products and services offered be met? Are reviews carried out before committing to supply products and services to a customer? Are review results, including any new requirements, documented? Are documents amended and people told when requirements change?
Yes Yes Yes Yes Yes Total:
6
8.3 Design and development of products and services 1 2 3 4 5 6
Yes Yes Yes Yes
Is a design and development process in place? Are the stages and controls defined in the process appropriate to the organization's products and services? Are design and development inputs adequate, complete, unambiguous and documented? Are the controls applied to the design and development process adequate to ensure that requirements are met and the results are verified and validated? Are the outputs of the process adequate, complete, accurate and documented? Is a change process in place to assess and manage changes made during or after design and development?
Yes Yes
Total:
6
8.4 Control of externally provided processes, products and services 1
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Is there a policy and process in place to manage the selection and management of externally provided processes and their providers?
Yes
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ACTION NEEDED TO MEET REQUIREMENTS
ACTION OWNER
REF
ISO9001 REQUIREMENTS
2
Are appropriate controls in place to ensure that externally provided processes deliver outputs that meet requirements?
REQS MET? Yes
3
Is adequate information supplied to external providers regarding the organization's requirements and controls that will be applied?
Yes
Total:
3
8.5 Production and service provision 1 2 3 4 5 6
Yes Yes Yes Yes Yes Yes
Are production and service provision implemented under appropriately controlled conditions? Are outputs identified, together with their status and uniquely if required? Are a process and controls in place to protect property belonging to customers or external providers? Are outputs preserved appropriately according to requirements? Are post-delivery activities defined and delivered according to requirements? Is a change process in place to assess and manage changes made during production or service provision? Total:
6
8.6 Release of products and services 1 2
Yes Yes
Are appropriate checks made before release to confirm that products or services meet requirements? Is documented information created and retained regarding the release of products and services to the customer? Total:
2
8.7 Control of nonconforming outputs 1 2
Yes Yes
Are outputs that do not conform to requirements identified prior to delivery? Is there a process in place to deal with nonconforming outputs appropriately? Total:
2
9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation 1 2 3 4
Yes Yes Yes Yes
Is it clearly defined what needs to be monitored and measured to determine the effectiveness of the QMS? Are the methods for monitoring, measurement, analysis and evaluation clearly defined and the results documented? Are regular evaluations of customer satisfaction carried out, using a variety of appropriate methods? Are results of monitoring and measurement analysed to evaluate key factors such as levels of conformity, customer satisfaction and need for improvement? Total:
4
9.2 Internal audit 1 2
Yes Yes
Are appropriate internal audits being carried out by suitably qualified and impartial people? Are the audit results being documented and communicated to management so that action can be taken? Total:
2
9.3 Management review 1 2 3
Yes Yes
Are documented management reviews being held regularly? Are all of the required topics (such as changes, trends, resources, risks and improvements) covered in each management review? Do the outputs from the management review cover the required areas e.g. improvements, changes and resources?
Yes
Total:
3
10 Improvement
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ACTION NEEDED TO MEET REQUIREMENTS
ACTION OWNER
REF
ISO9001 REQUIREMENTS
REQS MET?
10.1 Continual improvement 1 2
Yes Yes
Are opportunities for improvement identified, assessed and implemented on a regular basis? Is the suitability, adequacy and effectiveness of the EMS being continually improved? Total:
2
10.2 Nonconformity and corrective action 1 2
Yes Yes
Are nonconformities being identified, documented, evaluated and addressed? Is the effectiveness of corrective actions reviewed and the QMS changed if necessary? Total:
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ACTION NEEDED TO MEET REQUIREMENTS
ACTION OWNER
ISO9001 Gap Assessment dashboard (summary) To refresh chart data, click on “Refresh All” on the Data ribbon.
AREA OF STANDARD
REQS IN SECTION
4 Context of the organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance evaluation 10 Improvement Total
NO OF REQS MET
11 11 7 19 9 9 4 70
PERCENTAGE CONFORMITY
11 11 7 19 9 9 4 70
Percentage conformity to the ISO9001 standard summary level radar chart
100% 100% 100% 100% 100% 100% 100% 100%
4 Context of the organization 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%
10 Improvement
Level of conformity to the ISO9001 standard summary level
5 Leadership
9 Performance evaluation
NO OF REQS MET
6 Planning
REQS IN SECTION
11 4 Context of the organization 11
8 Operation
7 Support
11
5 Leadership 11
Percentage level of conformity to the ISO9001 standard summary level
7 6 Planning
100%
100%
100%
100%
100%
100%
100%
0% 4 Context of the organization
5 Leadership
6 Planning
7 Support
8 Operation
9 Performance evaluation
10 Improvement
100% 7
90% 19
80%
7 Support 19
70% 28
60%
28
50%
8 Operation
40% 9 9 Performance evaluation
30%
9
20% 4
10%
10 Improvement 4 0
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5
10
15
20
25
30
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ISO9001 Gap Assessment dashboard (detailed) To refresh chart data, click on “Refresh All” on the Data ribbon.
AREA OF STANDARD
SECTION
4 Context of the organisation 4 Context of the organisation 4 Context of the organisation 4 Context of the organisation 5. Leadership 5. Leadership 5. Leadership 6. Planning 6. Planning
4.1 Understanding the organisation and its context 4.2 Understanding the needs & expectations of interested parties 4.3 Determining the scope of the quality management system 4.4 Quality management system 5.1 Leadership and commitment 5.2 Quality policy 5.3 Roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information 8.1 Operational planning and control 8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of externally provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review 10.1 Continual improvement
7. Support 7. Support 7. Support 7. Support 7. Support 8. Operation 8. Operation
9. Performance evaluation 9. Performance evaluation 9. Performance evaluation 10. Improvement
REQS IN SECTION 2 2 3 4 5 4 2 2 3 2 9 3 1 2 4 3 6 6 3 6 2 2 4 2 3 2
10.2 Nonconformity and corrective action
10. Improvement Total
NO OF REQS MET 2 2 3 4 5 4 2 2 3 2 9 3 1 2 4 3 6 6 3 6 2 2 4 2 3 2
2 89
PERCENTAGE CONFORMITY 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
2 89
Percentage conformity to the ISO9001 standard detailed level radar chart
4.1 Understanding the organisation and its context 10.2 Nonconformity and corrective action 100% 4.2 Understanding the needs & expectations of interested parties 10.1 Continual improvement 4.3 Determining the scope of the quality management system 90%
9.3 Management review
80%
4.4 Quality management system
70% 9.2 Internal audit
5.1 Leadership and commitment
60% 50%
9.1 Monitoring, measurement, analysis and evaluation
5.2 Quality policy
40%
30% 20%
8.7 Control of nonconforming outputs
5.3 Roles, responsibilities and authorities
10% 0%
8.6 Release of products and services
6.1 Actions to address risks and opportunities
8.5 Production and service provision
6.2 Quality objectives and planning to achieve them
8.4 Control of externally provided processes, products and…
6.3 Planning of changes
8.3 Design and development of products and services
7.1 Resources
8.2 Requirements for products and services
7.2 Competence
8.1 Operational planning and control 7.5 Documented information
7.3 Awareness 7.4 Communication
100% 100%
Level of conformity to the ISO9001 standard detailed Level NO OF REQS MET 10
9
REQS IN SECTION
9
9 8 7
6
6
5
5
4
4
3
3
2
2
2
6
6
6
6
6
5
4
4
4
4
3
3
2
2
2
2
2
2
3
3
4
3
2
2
2
4 3
1
3
3
4
3
3
2
2
2
2
2
2
3
2
2
2
2
2
1
1 0 4.1 Understanding4.2 Understanding 4.3 Determining the organisation the needs & the scope of the and its context expectations of quality interested parties management system
4.4 Quality management system
5.1 Leadership and commitment
4 Context of the organisation
5.3 Roles, responsibilities and authorities
5.2 Quality policy
6.1 Actions to address risks and opportunities
5. Leadership
6.3 Planning of changes
6.2 Quality objectives and planning to achieve them
7.1 Resources
7.2 Competence
6. Planning
7.3 Awareness
7.4 Communication
7.5 Documented information
8.1 Operational 8.2 Requirements 8.3 Design and planning and for products and development of control services products and services
7. Support
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
8. Operation
9.1 Monitoring, 9.2 Internal audit 9.3 Management measurement, review analysis and evaluation
10.1 Continual improvement
9. Performance evaluation
10.2 Nonconformity and corrective action
10. Improvement
Percentage level of conformity to the ISO9001 standard detailed level 100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
5.3 Roles, responsibilities and authorities
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
100%
100%
100%
100%
100%
100%
100%
100%
100%
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
9.1 Monitoring, measurement, analysis and evaluation
100%
100%
100%
10.1 Continual improvement
10.2 Nonconformity and corrective action
100%
90% 80% 70%
60% 50% 40%
30% 20% 10%
0% 4.1 Understanding4.2 Understanding 4.3 Determining the organisation the needs & the scope of the and its context expectations of quality interested parties management system 4 Context of the organisation
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4.4 Quality management system
5.1 Leadership 5.2 Quality policy and commitment
5. Leadership
6. Planning
7. Support
8.1 Operational 8.2 Requirements 8.3 Design and planning and for products and development of control services products and services
8. Operation
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9.2 Internal audit 9.3 Management review
9. Performance evaluation
10. Improvement