1. ISO 9001:1994/2000 Gap Analysis CHECKLIST
Checklist Instructions
Client: This checklist identifies areas to be addressed in order to also be compliant with ISO 9001:2000.
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.
Comply
4.1 Management Responsibility
Y N
N/A
4.1.1 Quality Policy
5.1 Top management shall provide evidence of its commitment to continually improves its effectiveness by:
− communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements;
− establishing the quality policy;
− ensuring that quality objectives are established;
− conducting management reviews; and
− ensuring the availability of resources
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 shall ensure 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 authority and responsibility to:
-report to top management on any need for
improvement in the quality system, and
-ensure 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 actions 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 shall continually improve 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 shall ensure that appropriate communication processes are established within the
organization and that communication takes place regarding the effectiveness of the quality management system.
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2. ISO 9001:1994/2000 Gap Analysis CHECKLIST
Comply
4.2 Quality System
Y N
N/A
4.2.1 General
4.1 The organization has:
-measured and analyzed processes needed for the quality management system, 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.
Comply
4.3 Contract Review
Y N
N/A
4.3.2 Review
5.2 Top management shall ensure 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
The organization shall determine and implement effective arrangements for communicating with customers
in relation to:
-product information
-enquiries, contracts or order handling, including amendments, and
-customer feedback, including customer complaints.
Comply
4.4 Design Control
Y N
N/A
4.4.4 Design Input
7.3.2 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 shall be provide 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.
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3. ISO 9001:1994/2000 Gap Analysis CHECKLIST
Comply
4.5 Document & Data Control
Y N
N/A
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
Y N
N/A
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.
4.1 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
Y N
N/A
Controlled conditions include the following:
6.3 The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to
product requirements, including:
-buildings workspace and associated utilities
-supporting services such as transport and communication.
7.5.2 Arrangements for these processes includes as applicable
--revalidation
Comply
4.13 Control of Nonconforming Product
Y N
N/A
4.13.2 Review and Disposition of Nonconforming Product
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
Y N
N/A
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.
Comply
4.15 Handling, Storage, Packaging, Preservation & Delivery
Y N
N/A
4.15.5 Preservation
7.5.5 Preservation shall also apply to the constituent parts of a product.
Comply
4.17 Internal Quality Audits
Y N
N/A
8.2.2 The audit criteria, scope, frequency and methods, have been defined.
8.2.3 Monitoring & Measurement of Processes – (also applicable to 4.20 Statistical Techniques)
The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality
management system processes. These methods shall demonstrate the ability of the processes to achieve
planned results. When planned results are not achieved, correction and corrective action shall be taken, as
appropriate, to ensure conformity of the product.
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4. ISO 9001:1994/2000 Gap Analysis CHECKLIST
Comply
4.18 Training
Y N
N/A
6.2.2 The organization shall:
-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.
Comply
4.20 Statistical Techniques
Y N
N/A
(also see 8.2.3 in 4.17)
8.4 Analysis of Data
The organization shall determine, collect and analyze 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:
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