The following includes portions of our Gap Analysis Tool. Gap Analysis is done to help find weak areas of the quality system before a major ISO 9001 implementation project is started. A concise version of this Gap Analysis tool is also included in our ISO 9001 Starter Kit.

 

 

 

 

 

 

 

 

 

 

Do all product have the following documented (including Delivery & Post-Delivery Requirements) 

  • Specification Requirements
  • Quantity Requirements
  • Packaging Requirements
  • Identification, Labeling, Traceability Requirements
  • Statutory/Regulatory Requirements
  • Availability Requirements
  • Delivery/Timing Requirements
  • Warranties/Guarantees
  • Operating Instructions
  • Technical Support Requirements
  • Specification Information/Description Requirements
  • General Information/Description Requirements
  • Other Requirements?

 

 

 

4.0 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS

Does the organization establish, document, implement, and maintain a quality management system, and continually improve its effectiveness, in accordance with the requirements of the ISO 9001 International Standard?

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4.0 QUALITY MANAGEMENT SYSTEM

4.1 GENERAL REQUIREMENTS – cont’d

Does the organization manage these processes in accordance with the requirements of the ISO 9001 International Standard?


Does the organization identify, within the quality management system, the control of such outsourced processes?

 

4.0 QUALITY MANAGEMENT SYSTEM

4.2 DOCUMENTATION REQUIREMENTS

4.2.1 GENERAL

Does the quality management system documentation include:

  • documented statements of a quality policy and quality objectives?
  • a quality manual?
  • documented procedures required by the ISO 9001 International Standard?

 

 

4.2 DOCUMENTATION REQUIREMENTS

4.2.2 QUALITY MANUAL

Has a quality manual been established and maintained that includes:

  • the scope of the quality management system, including details of, and justification for, any exclusions (see 1.2)?
  • the documented procedures established for the quality management system, or reference to them?
  • a description of the interaction between the processes of the quality management system?

 

4.2.3 CONTROL OF DOCUMENTS

Are documents required by the quality management system controlled? 

Is a documented procedure established to define controls needed:

  • to approve documents for adequacy prior to issue?
  • review, and update as necessary and re-approve documents?
  • to ensure that changes and the current revision status of documents are identified?
  • to ensure that relevant versions of applicable documents are available at points of use?
  • to ensure that documents remain legible and readily identifiable?
  • to ensure that documents of external origin are identified and their distribution controlled?
  • to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?

 

4.2.4 CONTROL OF RECORDS

Are records established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?  

Is a documented procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?

 

5.0 MANAGEMENT RESPONSIBILITY

5.1 MANAGEMENT COMMITMENT

Does top management provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:

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5.2 CUSTOMER FOCUS

Does top management ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction?

 

5.3 QUALITY POLICY

Does top management ensure that the quality policy:

  • is appropriate to the purpose of the organization?
  • includes a commitment to comply with requirements and to continually improve the effectiveness of the quality management system?
  • provides a framework for establishing and reviewing quality objectives?
  •  
  • is reviewed for continuing suitability?

 

5.4 PLANNING

5.4.1 QUALITY OBJECTIVES

Does top management ensure that quality objectives,
including those needed to meet requirements for product (see 7.1a),
are established at relevant functions and levels within the organization? 

Are the quality objectives measurable and consistent with the quality policy?

 

5.4 PLANNING

5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

Does top management ensure that:

  • the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?
  • the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?

 

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY

Does top management ensure that the responsibilities and authorities are defined and communicated within the organization?

 

 5.5.2 MANAGEMENT REPRESENTATIVE

Does top management appoint a member of management who, irrespective of other responsibilities, have responsibility and authority that includes ensuring that processes needed for the quality management system are established, implemented and maintained?

 

 

5.5.3 INTERNAL COMMUNICATION
Does top management ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system?

 

5.6 MANAGEMENT REVIEW

5.6.1 GENERAL
Does top management review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness? 

Does this review include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives?

Are records from management reviews maintained (see 4.2.4)?

 

5.6 MANAGEMENT REVIEW

5.6.2 REVIEW INPUT

Do inputs to management review include information on:

  • results of audits?
  •  
  • process performance and product conformity?
  • status of preventive and corrective actions?
  • follow-up actions from previous management reviews?
  •  
  • recommendations for improvement?

 

5.6 MANAGEMENT REVIEW

5.6.3 REVIEW OUTPUT
Do the outputs from the management review include 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?
  • resource needs?

 

6.0 RESOURCE MANAGEMENT

6.1 PROVISION OF RESOURCES
Does the organization determine and provide the resources needed:

  • to implement and maintain the quality management system and continually improve its effectiveness?
  • to enhance customer satisfaction by meeting customer requirements?

 

 

6.2 HUMAN RESOURCES

6.2.1 GENERAL
Are personnel competent on the basis of appropriate education, training, skills and experience?

 

 

6.2.2 COMPETENCE, AWARENESS AND TRAINING

Does the organization:

  • determine the necessary competence for personnel performing work affecting product quality?
  •  
  • evaluate the effectiveness of the actions taken?
  • ensure that its personnel are aware of the importance of their activities?
  • maintain appropriate records of education, training, skills and experience ?

 

6.0 RESOURCE MANAGEMENT

6.3 INFRASTRUCTURE
Does the organization determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?

Does it include, as applicable:

  • buildings, workspace and associated utilities?
  •  
  • supporting services (such as transport or communication)?

 

 6.4 WORK ENVIRONMENT
Does the organization determine and manage the work environment needed to achieve conformity to product requirements?

 

7.0 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION
Does the organization plan and develop the processes needed for product realization?

Is planning of product realization processes consistent with the  requirements of the other processes of the quality management system (see 4.1)?

 

In planning product realization, does the organization determine the following, as appropriate:

  • quality objectives and requirements for the product?

Is the output of this planning in a form suitable for the organization’s method of operations?

 

7.2 CUSTOMER-RELATED PROCESSES

7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT
Does the organization determine:

  • requirements specified by the customer, including the requirements for delivery and post-delivery activities?

 

7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
Does the organization review the requirements related to the product?

Is this review conducted prior to the organization’s commitment to supply a product to the customer (eg. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders )?

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7.2 CUSTOMER-RELATED PROCESSES

7.2.3 CUSTOMER COMMUNICATION
Does the organization determine and implement effective arrangements for communicating with customers in relation to:

  • product information?
  • inquiries, contracts or order handling, including amendments?
  •  

 

7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING
Does the organization plan and control design and development of  product?

During the design and development planning does the organization determine:

  • the design and development stages?
  • the review, verification and validation that are appropriate to each design and development stage?
  • the responsibilities and authorities for design and development?

Are interfaces between different groups involved in design and development managed to ensure effective communication and clear assignment of responsibility?

Is the planning output updated, as appropriate, as the design and/or development progresses?

 

7.3.2 DESIGN AND DEVELOPMENT INPUTS
Are inputs relating to product requirements determined and records maintained (see 4.2.4)? 
Do these inputs include:

  • functional and performance requirements?
  • applicable statutory and regulatory requirements?
  • where applicable, information derived from previous similar designs?
  • other requirements essential for design and development?

 

Are requirements complete, unambiguous and not in conflict with each other?

 

7.3.3 DESIGN AND DEVELOPMENT OUTPUTS
Are the outputs of design and development process provided in a form that enables verification against the design and development input?

Does design and development output:

  • meet the input requirements for design and development?
  • provide appropriate information for purchasing, production and service provision (see 7.5)?
  • contain or reference product acceptance criteria?
  • specify the characteristics of the product that are essential for its safe and proper use?

 

7.3.4 DESIGN AND DEVELOPMENT REVIEW
At suitable stages, are systematic reviews of design and development performed in accordance with planned arrangements (see 7.3.1):

  • to evaluate the ability of the results of design and development to meet requirements?
  • to identify any problems and propose necessary actions?

Do participants in such reviews include representatives of functions concerned with the design and development stage(s) being reviewed? 

Are records of the results of the reviews and any necessary actions maintained (see 4.2.4)?

 

7.3.5 DESIGN AND DEVELOPMENT VERIFICATION
Is verification performed in accordance with planned arrangements (see 7.3.1) to ensure the design and development outputs have met the design and development input requirements? 

Are records of the results of the verification and any necessary actions maintained (see 4.2.4)?

 

7.3.6 DESIGN AND DEVELOPMENT VALIDATION
Is design and development validation performed in accordance with planned arrangements  to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known?

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7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Are design and development changes identified and records maintained? 

Are the changes reviewed, verified and validated, as appropriate, and approved before implementation?

Does this review include evaluation of the effect of the changes on constituent parts and product already delivered?

 

7.4 PURCHASING

7.4.1 PURCHASING PROCESS
Does the organization ensure that purchased product conforms to specified purchase requirements? 

Are the type and extent of control applied to the supplier and the purchased product dependent upon the effect of the purchased product on subsequent product realization  or final product?

 

7.4.2 PURCHASING INFORMATION
Does purchasing information describe the product to be purchased, including where appropriate:

  • requirements for approval of:
  • product
  •  
  • processes?
  •  
  • requirements for qualification of personnel?
  • quality management system requirements?

Does the organization ensure the adequacy of specified purchase requirements prior to their communication to the supplier?

 

7.4.3 VERIFICATION OF PURCHASED PRODUCT
Does the organization establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements?

Where the organization or its customer intends to perform verification at the supplier’s premises, does the organization state the intended verification arrangements and method of product release in the purchasing information?

 

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION
Does the organization plan and carry out production and service provision under controlled conditions?

 

 7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION

Does the organization validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement?

Does the organization establish arrangements for these processes including, as applicable:

  • defined criteria for review and approval of the processes?
  •  
  •  use of specific methods and procedures?
  •  
  •  revalidation?

 

 7.5.3 IDENTIFICATION AND TRACEABILITY

Does the organization identify, where appropriate, the product by suitable means throughout product realization?

Does the organization control and record the unique identification of the product, where traceability is a requirement (see 4.2.4)?

identification and traceability are maintained.

 

7.5.4 CUSTOMER PROPERTY
Does the organization exercise care with customer property while it is under the organization’s control or being used by the organization? 

Does the organization identify, verify, protect and safeguard customer property provided for use or incorporation into the product? 

Is any customer property that is lost, damaged or otherwise found to be unsuitable for use reported to the customer and records maintained (see 4.2.4)?

NOTE     Customer property can include intellectual property.

 

7.5.5 PRESERVATION OF PRODUCT
Does the organization preserve the conformity of product during internal processing and delivery to the intended destination?

Does this preservation include identification, handling, packaging, storage and protection?

Is preservation also applied to the constituent parts of a product?

 

7.6 CONTROL OF MONITORING AND MEASURING DEVICES
Does the organization determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1)?

 

 
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8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 GENERAL
Does the organization plan and implement the monitoring, measurement, analysis and improvement processes needed:

  • to demonstrate conformity of the product?
  • to ensure conformity of the quality management system?
  • to continually improve the effectiveness of the quality management system

Does this include determination of applicable methods including statistical techniques, and the extent of their use?

 

 8.2 MONITORING AND MEASUREMENT

8.2.1 CUSTOMER SATISFACTION
Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements, as one of the measurements of performance of the quality management system? 

Are the methods for obtaining and using this information determined?

 

 8.2.2 INTERNAL AUDIT
Does the organization conduct internal audits at planned intervals to determine whether the quality management system:

  • conforms to the planned arrangements (see 7.1),

conforms to the requirements of the current revision of the ISO 9001 Standard?

conforms to the quality management system requirements established by the organization?

  • is effectively implemented and maintained?

Are the audit criteria, scope, frequency and methods defined? 

 

Does the selection of auditers and conduct of audits ensure objectivity and impartiality of the audit process?

 

Do follow-up activities include the verification of the actions taken and the reporting of verification results (see 8.5.2)?

 

8.2.3 MONITORING AND MEASUREMENT OF PROCESSES
Does the organization apply suitable methods for monitoring, and where applicable, measurement of the quality management system processes? 

Do these methods demonstrate the ability of the processes to achieve planned results?

When planned results are not achieved, is correction and corrective action taken, as appropriate, to ensure conformity of the product?

 

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
Does the organization monitor and measure the characteristics of the product to verify that product requirements have been met?

Does the organization ensure that product release and service delivery does not proceed until all the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer?

 

8.3 CONTROL OF NONCONFORMING PRODUCT
Does the organization ensure that product which does not conform to product requirements is identified and controlled to prevent unintended use or delivery? 

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 Are records maintained (see 4.2.4) of the nature of nonconformities and any subsequent actions taken, including concessions obtained? 

When nonconforming product is detected after delivery or use has started, does the organization take action appropriate to the effects, or potential effects, of the nonconformity?

 

8.4 ANALYSIS OF DATA
Does the organization 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? 

Does this include data generated as a result of monitoring and measurement and from other relevant sources?

Does the organization analyze this data to provide information relating to:

  • customer satisfaction (see 8.2.1)?
  •  
  • characteristics and trends of processes and products including opportunities for preventive action?
  •  

 

8.5 IMPROVEMENT

8.5.1 CONTINUAL IMPROVEMENT
Does the organization continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review?

8.5.2 CORRECTIVE ACTION

Does the organization take action to eliminate the cause of nonconformities in order to prevent recurrence? 

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8.5.3 PREVENTIVE ACTION
Does the organization determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence? 

Are preventive actions appropriate to the effects of the potential problems?

Does the documented procedure for preventive action define requirements for:

  • determining potential nonconformities and their causes?
  • evaluating the need for action to prevent occurrence of nonconformities?
  •  
  • records of results of action taken (see 4.2.4)?
  •