Document Control

General questions during all audits

Do you know your Quality Policy? What does it mean?

Do you know the organizations quality objectives?

How do you contribute to meeting organizations quality objectives?

Who is the ISO Management Representative?

Do you think you have received adequate training?

4.2.1 General and 4.2.2 Quality --addressed during documentation review

Does the organization have a documented Quality Manual?

Does the organization have a stated Quality Policy & Objectives?

Does the organization have the required 6 procedures stated by the standard?

Does the quality manual describe the scope of the QMS?

Does the quality Manual describe the interaction between processes?

Does the quality Manual identify exclusions, if any?

4.2.3. Control of Documents

Check that the current revision of the procedure is available.

Revision:

How are documents approved before they are issued?

Have documents been reviewed, revised, and re-approved since the last audit? List examples.

How are changes and revision status identified?

Are documents available to those who need them at the necessary locations?

Are all documents legible and easy to identify?

What are documents which originated outside of the organization which should be controlled? Have they been identified and appropriately controlled?

How are obsolete documents identified so that they are not used unintentionally?

Control of Records

4.2.4 Control of Records

Check that the current revision of the procedure is available.

Check each type of record for correct location, retention time, storage method, etc.

Management review records

Training records

Review of customer requirements /contracts

Evaluation of suppliers

Internal audit results

Nonconformances

Corrective and preventive actions

Add any comments or results relating to these records.

Management Commitment, Customer Focus, and the Quality Policy

5.1Management Commitment

For each item, locate evidence that top management has shown commitment. Enter notes here as needed.

Communicating the importance of customer and regulatory requirements

Establishing the quality policy and objectives

Conducting management reviews

Making resources available

5.2 Customer focus

Does top management ensure that customer requirements are determined and fulfilled in order to enhance customer satisfaction? (Also covered in 7.2 and 8.2)

5.3 Quality Policy

Is the quality policy appropriate for the purpose for which the organization exists?

Does the quality policy include a commitment to meeting requirements and to continual improvement?

Does the quality policy provide a framework for establishing or reviewing objectives?

What evidence shows communication of the quality policy?

What evidence shows that personnel understand the quality policy?

Planning / Responsiblity, Authority, and Communication

5.4 Planning

What are the quality objectives? Are they measurable? Are they consistent with the quality policy (including continual improvement)?

Do the objectives include those needed to meet requirements for the organization's products?

Is planning performed to meet the objectives?

Does quality planning include QMS processes, resources, and continual improvement?

How are changes planned, controlled, and QMS integrity maintained during changes? (Methods? Records?)

5.5 Responsibility, authority, and communication

How are responsibilities and authorities defined and communicated?

Has a management representative been appointed who is a member of the organization's management and has authority and responsibility to ensure that QMS requirements are established, implemented, and maintained?

Does that management representative have authority to report performance to management for review and improvement of the QMS?

Does the management representative have authority to ensure awareness of customer requirements throughout the organization?

How is QMS effectiveness communicated to various functions and levels in the organization?

Management Review

5.6. Management review

Are management reviews conducted at planned intervals? (Check date for last management review, next scheduled management review, and possibly previous dates as well.)

Does top management review the QMS to ensure that it continues to be suitable, adequate, and effective?

Are opportunities for improvement and changes needed for the QMS, quality policy, and objectives evaluated?

What record is kept?

Review the record for evidence that each of these topics has been addressed:

Results of audits, internal and external

Customer feedback

Process performance and service conformance

Status of corrective and preventive actions

Follow-up from prior reviews

Changes that could effect the QMS

Recommendations for improvement

Decisions and actions related to improving the QMS and it's processes

Decisions and actions related to improving products/services

Resource Management

6.1 Provision of Resources

Does the organization determine and provide resources needed to implement, maintain, and continually improve the QMS?

Does the organization determine and provide resources needed to enhance customer satisfaction?

6.2 Human resources

Are personnel performing work affecting conformity to requirements for product competent? Is this based on education, training, skills, and/or experience?

How does the organization determine competency needs for personnel who affect quality of services?

When needs are found, is training provided or is other action taken to address the need?

When the need has been addressed, how is the effectiveness of this action evaluated?

Does the organization ensure that employees are aware of the importance of their work and how they each contribute to achieving quality objectives?

Are training records kept, containing information about education, training, skills, and experience?

6.3 Infrastructure and 6.4 Work Environment

Has the organization determined, provided, and maintained infrastructure to meet requirements for its services? (Could include buildings, workspace, equipment, and support services)

Has the organization determined and managed the work environment needed to meet requirements for its services? (Could include health and safety, work methods, ethics, conditions, ergonomics, etc.)

Planning of Realization and Customer-related Processes

7.1 Planning of realization processes

Are the processes needed for providing services planned and developed? (Could be a diagram or procedure and may be individual or overall planning)

Have the following items been determined?

Objectives for the service, project, or contract

The need for processes, documentation, and/or resources

Verification, validation, monitoring, inspection, test, and other acceptability criteria

Records needed to show that requirements have been met

7.2 Customer Related Processes

Have requirements for products/services been determined? Consider those specified by the customer, necessary but not stated by the customer, statutory and regulatory, and others specified by the organization.

Are requirements (proposals, contracts, etc.) reviewed before a commitment to deliver products/services has been made?

Are records of these reviews and follow-up actions maintained?

Are requirements for products/services clearly defined?

Are contract requirements that differ from those expressed earlier in proposals, etc. resolved?

Are customer requirements reviewed to ensure that the organization can meet them?

When requirements are not written, are they confirmed before they are accepted?

When contract changes occur, are the relevant documents amended and are the appropriate personnel notified of changes?

Has the organization defined communication requirements for information about products/services; inquiries, contracts, and changes; and for customer feedback and complaints?

7.3 Design and development -- Excluded

Realization of Services - continued

7.4 Purchasing

Are there purchasing controls to ensure that incoming purchased product or services conform to requirements? Does the type of control and the extent depend on the effect on the organization's products/services?

Are suppliers evaluated and chosen on the basis of their ability to meet requirements?

Are there established criteria for evaluating , re-evaluating, and selecting suppliers?

Do supplier records show results of evaluations and of and follow-up actions that are necessary?

Do the organization's contracts, purchase orders, etc. describe fully the product or service that is ordered? (Could be type, class, style, grade, model, part number, etc.)

If appropriate, are requirements for approval of product, procedures, processes, and equipment described?

If appropriate, are requirements for qualification of personnel identified?

If appropriate, is any applicable QMS requirement identified in purchase orders? (For example a requirement for ISO 9001 registration)

Are purchasing documents checked for adequacy before they are communicated to the supplier?

Are activities established and implemented to ensure that incoming purchased product meets requirements? (Inspection or other activities)

When the organization or a customer perform on-site supplier verification, are arrangements and methods for verification specified in purchasing documents?

7.5 Production and Service Provision

As applicable, does service information specify characteristics that help control conditions? (For example, acceptance criteria)

Are there applicable work instructions?

As applicable, is appropriate equipment used to produce products or provide services?

As applicable, are there measuring and monitoring implemented with the appropriate devices available and used?

Are processes for release, delivery, and applicable post-delivery activities implemented?

7.5.2 Special Processes -- Excluded
7.5.3 Identification and Traceability -- Excluded
7.5.4 Customer Property -- Excluded
7.5.5 Preservation of Product -- Excluded

Control of Measuring and Monitoring Equipment

7.6 Calibration --Excluded

Measurement, Analysis, and Improvement

8.1 General Requirements

Are measurement and monitoring activities planned and implemented to demonstrate conformity of product?

Are measurement and monitoring activities planned and implemented to ensure conformity of the QMS?

Are measurement and monitoring activities planned and implemented to continually improve the effectiveness of the QMS?

Have appropriate methods, including statistical tools, been identified?

8.2.1 Customer Satisfaction

Is customer perception monitored?

Are methods and measures defined for collecting and using customer satisfaction information?

8.2.2 Internal Auditing

Are internal quality audits conducted at planned intervals?

Do audits determine conformance to ISO 9001, planned arrangements, and effective implementation of and conformance to the QMS?

Does the audit program plan consider status and importance of the activities and areas to be audited and results of previous audits?

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

Are audits and auditors objective and impartial?

Are responsibilities and requirements for planning, conducting, and reporting of audits in accordance with documented procedures?

Are timely corrections and corrective action taken by top management on any deficiencies found during the audit?

Are follow-up actions carried out to verify the implementation of the corrective action? Are the verification results reported?

Monitoring and Measurement of Processes and Product -- Nonconforming Product

8.2.3 Monitoring and Measurement of Processes

Does monitoring and measuring of the quality management system processes demonstrate achievement of the intended results?

Is corrective action taken to ensure conformity of products or services when planned results are not achieved?

8.2.4 Monitoring and Measurement of Product

Are the product characteristics measured and monitored at appropriate stages or the realization process to verify that requirements are met?

Is there evidence showing conformance to acceptance criteria? (Are there records?)

Do records indicate the person releasing product?

Is product held until all planned activities are satisfactorily completed, unless otherwise approved (waiver)?

8.3 Control of Nonconforming Product

Are nonconforming products identified and controlled to prevent unintended delivery in accordance with the documented procedure?

Are the controls, responsibilities, and authorities for dealing with nonconforming product defined in a documented procedure?

Are nonconforming products dealt with by: a) eliminating the nonconformity, b) accepted by concession of the customer or the organization's management, c) taking action to preclude its original intended use or application, or d) taking action appropriate to the effects of the nonconformity when detected after delivery has started?

Are records maintained which describe the nonconformity and subsequent actions?

When products are "corrected" is there re-verification activity to demonstrate conformity?

Is appropriate action taken regarding the consequences of nonconformities found after delivery or use?

Analysis of Data -- Improvement

8.4 Analysis of Data

Is data collected and analyzed to determine the suitability, effectiveness, and adequacy of the QMS and to identify areas for continual improvement?

Does data provide information on

Customer Satisfaction

Conformance to requirements for products/services

Characteristics and trends of the organization's processes and products

Suppliers

8.5 Improvement

Is there continual improvement of the QMS through the use of the quality policy, quality objectives, management review, audit results, corrective and preventive actions, and analysis of data?

8.5.2 Corrective Action

Has the documented procedure for corrective action been used?

Are corrective actions implemented based on importance (effect)?

Are nonconformities reviewed, including customer complaints

Are causes of nonconformities determined?

Is there an evaluation of the need for actions to ensure that nonconformities do not recur?

Are corrective actions determined and implemented?

Are the results of the investigation recorded?

Are corrective actions that were taken reviewed for effectiveness?

8.5.3 Preventive Action

Has the documented procedure for preventive action been used?

Are preventive actions implemented based on importance (effect)?

Are potential nonconformities identified, along with their causes?

Is there an evaluation of the need for actions to ensure that nonconformities do not occur?

Are preventive actions determined and implemented?

Are the results of the preventive action recorded?

Are preventive actions that were taken reviewed for effectiveness?