ISO 9001:2000 Gap Analysis CHECKLIST

QCB Inc., Edmonton, Alberta, Canada

Checklist Instructions
Auditor: Identify any areas not in compliance to ISO 9001:2000 during the audit in this checklist plus any additional
comments. Checklist is to be left with client upon completion of the audit. QCB does not require a copy.
Client: This checklist identifies areas to be addressed in order to also be compliant with ISO 9001:2000.
Comply
4.1 Management Responsibility N/A
Y N
4.1.1 Quality Policy
5.1 Top management is committed to the development and implementation of the quality management
system and continually improves its effectiveness.
Top management communicates to the organization the importance of meeting customer as well as statutory
and regulatory requirements.
5.3 Top management ensures that the quality policy
-includes a commitment to comply with the requirements and continually improve the effectiveness of the
quality management system
-provides a framework for establishing and reviewing quality objectives.
5.4.1 Top management ensures that quality objectives, including those needed to meet the requirements for
product, are established and documented at relevant functions and levels within the organization.
The quality objectives are measurable and consistent with the quality policy.
4.1.2 Organization
4.1.2.1 Responsibility & Authority
5.5.1 Top management ensures that the responsibilities and authorities are communicated within the
organization.
4.1.2.2 Resources
6.1 The organization determines and provides the resources needed to:
- continually improve its effectiveness, and
- enhance customer satisfaction by meeting customer requirements.
4.1.2.3 Management Representative
5.5.2 The management representative has:
-reported to top management on any need for
improvement in the quality system, and
-ensured the promotion of awareness of
customer requirements throughout the organization.
4.1.3 Management Review
5.6.1 Top management’s review includes assessing opportunities for improvement and the need for changes
to the quality management system, including the quality policy and objectives.
5.6.2 The input to the management review includes information on
-results of audits
-customer feedback
-process performance and product conformity
-status of preventive and corrective actions
-follow-up a ctions from previous management reviews
-planned changes that could affect the quality management system, and
-recommendations for improvement.
5.6.3 The output from the management review includes any decisions and actions related to
-improvement of the effectiveness of the quality management system and its processes
-improvement of product related to customer
requirements, and
-resource needs.
8.5.1 The effectiveness of the quality management system is continually improved through the use of the
quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and
management review.
5.5.3 Top management ensures that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality management
system.

Page 1 of 5 Form 106 Rev. C Complete _______

 ISO 9001:2000 Gap Analysis CHECKLIST
QCB Inc., Edmonton, Alberta, Canada

Comply
4.2 Quality System N/A
Y N
4.2.1 General
The organization has:
-identified the processes needed for the quality management system and their application throughout the
organization
-determined the sequence and interaction of these processes
-determined criteria and methods needed to ensure that both operation and control of these processes
are effective
-ensured the availability of resources and information necessary to support the operation and monitoring
of these processes
-monitored, measured and analyzed these processes, and
-implemented actions necessary to achieve planned results and continual improvement of these
processes.
4.2.2 The Quality Manual includes
-the scope of the quality management system, including details of and justification for any exclusions,
and
-a description of the interaction between the processes of the quality management system.
4.2.2 Quality System Procedures
4.2.1 The quality management system documentation includes:
-documents needed by the organization to ensure the effective planning, operation and control of its
processes.
4.2.3 Quality Planning

5.4.2 Top management ensures that:

-the integrity of the quality management system is maintained when changes to the quality
management system are planned and implemented.

7.1 The organization has determined:

-the need to establish processes, documents and provide resources specific to the product
-the required verification, validation, inspection and test activities specific to the product and the criteria for
product acceptance, and
-records needed to provide evidence that the realization processes and resulting product meet
requirements.
The output of this planning is in a form suitable for the organization’s method of operations.

Comply
4.3 Contract Review N/A
Y N
4.3.2 Review
5.2 Top management ensures that the customer requirements are determined and fulfilled with the aim of
enhancing customer satisfaction.
7.2.1 The organization has determined
-the requirements not stated by the customer but necessary for specified or intended use, where known
-statutory and regulatory requirements related to the product, and
-any additional requirements determined by the organization.
7.2.3 Customer communication:
Effective arrangements for communicating with customers have been implemented in relation to:
-product information
-enquiries, contracts or order handling, including amendments, and
-customer feedback, including customer complaints.
4.3.4 Records
Records of actions arising from the review have been maintained.

Page 2 of 5 Form 106 Rev. C Complete _______

 ISO 9001:2000 Gap Analysis CHECKLIST
QCB Inc., Edmonton, Alberta, Canada

Comply
4.4 Design Control N/A
Y N
4.4.4 Design Input
7.3.2 Design and development inputs:
Inputs relating to product requirements include:
-functional and performance requirements
-where applicable, information derived from previous similar designs, and
-other requirements essential for design and development.
4.4.5 Design Output
7.3.3 Design and development outputs have provided appropriate information for purchasing, production and
service provision.4.4.6 Design Review
7.3.4 Design reviews have:
-evaluated the ability of the results of design and development to meet requirements, and
-identified any problems and proposed necessary actions.
Design records include any necessary actions.
4.4.7 Design Verification
7.3.5 Design records include any necessary actions.
4.4.8 Design Validation
7.3.6 Design records include the validation results and any necessary actions.
4.4.9 Design Changes
7.3.7 Design records include the results of the review of changes and any necessary actions.

4.5 Document & Data Control Comply N/A

Y N
4.5.1 General
4.2.3 A documented procedure has been established to define the controls needed to:
- ensure that documents remain legible and identifiable, and
-ensure that documents of external origin are identified and their distribution controlled.

Comply
4.6 Purchasing N/A
Y N
4.6.2 Evaluation of Subcontractors
7.4.1 Criteria for the selection, evaluation and re-evaluation of suppliers has been established.
Records include the results of evaluations and any necessary actions arising from the evaluation.
Where the organization has chosen to outsource any process that affects product conformity with requirements,
control over such processes have been assured.
Control over such outsourced processes has been identified within the quality management system.
Comply
4.9 Process Control N/A
Y N
Controlled conditions i nclude the following:
6.3 The organization determines, provides and maintains the infrastructure needed to achieve conformity to
product requirements, including:
-buildings workspace and associated utilities
-supporting services such as transport and communication.
7.5.1 Controlled conditions include the following:
- the availability of information that describes the characteristics of the product
7.5.2 Processes for production or service provision have been validated, where the resulting output cannot be
verified by subsequent monitoring or measurement. This includes any processes where the
deficiencies become apparent only after the product is in use or the service has been delivered.
Validation demonstrates the ability of these processes to achieve planned results.
Arrangements for these processes includes as applicable
-defined criteria for review and approval of the process
-use of specific methods and procedures
-requirements for records, and
-revalidation.

Page 3 of 5 Form 106 Rev. C Complete _______

 ISO 9001:2000 Gap Analysis CHECKLIST
QCB Inc., Edmonton, Alberta, Canada

Comply
4.10 Inspection & Test N/A
Y N
4.10.4 Final Inspection & Testing
8.2.4 Product release and service delivery shall not proceed until all the planned arrangements have been
satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by
the custom er.
Comply
4.11 Control of Inspection, Measuring and Test Equipment N/A
Y N
4.11.1 General
7.5.1 Controlled conditions include the following:
- the availability and use of monitoring and measurement devices
4.11.2 Control Procedure
The supplier has:
e) maintained calibration records;
7.6 Records maintained include the results of calibration and verification.
Comply
4.13 Control of Nonconforming Product N/A
Y N
4.13.2 Review and Disposition of Nonconforming Product
8.3 The controls and related responsibilities and authorities for dealing with nonconforming product have
been defined and documented.
8.3 Records maintained include the nature of the nonconformities and any subsequent actions taken,
including concessions obtained.
When nonconforming product is detected after delivery or use has started, action has been taken appropriate
to the effects, or potential effects of the nonconformity.
Comply
4.14 Corrective and Preventative Action N/A
Y N
4.14.2 Corrective Action
8.5.2 Records of corrective actions include the results of actions taken.
4.14.3 Preventive Action
8.2.1 Customer Satisfaction
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.
8.5.3 Records of preventive actions include the results of actions taken.

4.15 Handling, Storage, Packaging, Preservation & Delivery Comply N/A

Y N
4.15.5 Preservation
7.5.5 Preservation shall also apply to the constituent parts of a product.

Comply
4.17 Internal Quality Audits N/A
Y N
8.2.2 The audit criteria, scope, frequency and methods, have been defined.

Comply
4.18 Training N/A
Y N
6.2.2 The organization has:
-determined the necessary competence for personnel performing work affecting product quality
-provided training or takes other actions to satisfy these needs
-evaluated the effectiveness of the actions taken
-ensured that its personnel are aware of the relevance and importance of their activities and how they
contribute to the achievement of the quality objectives, and
- maintained records, which include education, training, skills and experience.

Page 4 of 5 Form 106 Rev. C Complete _______

 ISO 9001:2000 Gap Analysis CHECKLIST
QCB Inc., Edmonton, Alberta, Canada

Comply
4.20 Statistical Techniques N/A
Y N
8.4 Analysis of Data
The organization shall determine, collect and analyse appropriate data to demonstrate the suitability and
effectiveness of the quality management system and to evaluate where continual improvement of the
effectiveness of the quality management system can be made. This shall include data generated as a result of
monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to:
a) Customer satisfaction
b) Conformity to product requirements
c) Characteristics and trends of processes and products including opportunities for preventive action, and
d) Suppliers.

Comments:

Page 5 of 5 Form 106 Rev. C Complete _______