AuditChecklist-020211.xls

Quality Management System Audit Checklist (a cumulative audit report/summary and management summary)

LEAD AUDITOR

Intelex Audit Report #

DEPARTMENT CONTACT INFORMATION/AUDIT PLANNING Name:

AUDIT DATE (RANGE)

Department:

(Contact)

AUDITORS

Email:

Locations Sampled:

Phone:

Audit Scope/Criteria: (e.g., area(s) being audited, applicable clauses from ISO 9001, applicable Administrative Directive requirements, state or federal regulations, etc.) SUMMARY OF AUDIT RESULTS

Fax:

FINDINGS Audit Summary:

MAJOR

System Strength:

Minor

System Weakness:

4.2.1 Documentation Requirements 4.2.2 Quality Manual

4.2.3 Control of Documents

4.2.4 Control of Records

a a a

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Do you know your Quality Policy? What does it mean? What are the organization 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? Does the Organization have a documented Quality Manual? Does the organization have stated Quality Policy & Objectives? Does the organization have the 6 required procedures stated by the standard? What other additional Documents does the organization provide to show effective planning, operation & control of its processes? 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? Does the organizations Document Control procedure address the following: - Approval of documents - Review of documents - Revision control of documents - proper identification controls of documents - reapproval of documents, as necessary - control of external documents - control of obsolete documents to prevent unintended use. If so, how? Does the organization have a Master Document list? If so how is it controlled & managed? Does the Master Document List identify all the organizations documents with accurate information? Does the Master Document List include external documents?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

EXPECTATION DEFINED

Minor

Recorded

Proven

Documented

Relationship with ISO 9001:2008 General questions during all audit

TYPE OF EXPECTATION

Comment

Comment

CLAUSE

TO

Intelex NC # & CA #

NC#

CA#

Does the organization have a documented Records control procedure that addresses the following? - identification controls for records - strorage requirements for records - protection requirements for records - retreival/access controls for records - retention policy for records - define disposition of records after their intended use Are the records legible & identifiable? Do the records have proper revision controls? Does the organization has a records control list? If so, does it address all the required controls for records?

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5.3 Quality Policy

5.4 Planning

Did the organization establish documented quality objectives, including product-related ones, at all relevant functions and levels? Are the quality objectives measurable & consistant with the quality policy? What QMS planning activities are used to establish the following: - identify processes needed - determine sequence & interaction of processes - methods and criteria needed to show effective operation & control - availability of resources & information ncecessary for support operations - monitor, measure & analyze processes - implement actions necessary to achieve planned results and continual improvement - establish controls for outsourced processes How does the organization plan to maintain the integrity of the QMS when changes occur?

5.5 Responsibility, authority and communication

How are responsibilities & authorities estblished within the organization? Does it have an ORG chart? Did the organization appoint an Management Representative? What kind of responsibilities & authority does the Management Representative has in achieving the following: - establish, implement & maintain processes needed for effective QMS - report to management on the performance of the QMS & any improvements necessary - promote awareness of customer requirements throughout the organization What kind of communication channels are established regarding the effectiveness of the QMS?

5.6 Management Review

Are Management Reviews conducted at planned intervals to ensure the continued suitability, adequecy & effectiveness of its QMS? Are records of Management Review minutes maintained? Does the Management reviews take into account of the following? - results of previous audits - customer feedback/complaints - process performance (Objectives) & product conformity (NCR's) - status of corrective & preventive actions (CA/PA's) - follow-up actions from previous management reviews - changes that could affect the QMS - recommendations/opportunities for improvement Does the result of Management Reviews provide the following: - improvement of the effectiveness of the QMS & its processes - improvement of product/service in relation to its customers - address resource needs Are the resources needed to implement, maintain & continually improve the effectiveness of the QMS & its processes determined & being provided? Are resources needed to enhance customer satisfaction determined & being provided?

6.0 Resource Management 6.1 Provision of Resources

6.2 Human Resources

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Does the organization have an established Quality Policy? Does the organization have a established Quality Objectives? How does the organization provide effective communication of customer, statutory & regulatory requirements? Does the management conduct Management review meetings? Does the organization provide resources for effective operation of its processes? Is the documented quality policy appropriate for the purpose of the organization? Does the quality policy include a commitment to comply with requirements? Does the quality policy include a commitment to continual improvement?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 5.1 Management Commitment

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

Is the competence of the personnel affecting quality of the product/service determined in relation to their education, training, skills and experience? Are the personnel affecting quality are being provided with training? Is the training effective? How is it evaluated? Does staff understand the importance of their training and how their activities contribute to the quality objectives of the organization? Are records of education, training, skills & experience properly maintained and readily available?

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7.0 Product Realization 7.1 Product Planning

5.2 Customer Focus 7.2 Customer Related Processes

7.3 Design 7.3.1 Design & development planning

7.3.2 Design & development inputs

7.3.3 Design & development outputs

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Are necessary infrastructure (buildings; work space & associated utilities; equipment - both hardware & software; supporting services - transportation, communications…etc) provided & maintained to ensure product/service conformity to requirements? Does the organization determine & manage the work environment (conditions such as lighting, ventilation, clealinesses of work spaces...etc) necessary to achieve conformity of product/service requirements? Are the processes needed for product/service realization identified, planned, developed & implemented? Are product related Quality Objectives established? Are the following identified, established & implemented in relation to the product/service: - processes - resources - documents - verifications, validations, monitoring, Inspection & test activities - criteria for acceptance Are the product/service specific records identified, established & maintained (per 4.2.4)?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 6.3 Infrastructure 6.4 Work Environment

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

How does the organization determine customer requirements, including delivery & post-delivery requirements? How does the organization address unstated customer requirements? How does the organization determine statutory, regulatory & any other additional requirements determined by the organization? Are all product/service requirements identified, reviewed & confirmed prior to acceptance of order/contract? Does the organizations ability to fullfill the customer requirements established? Show that relevant documents are amended & communicated to all involved parties when product/service requirements have changed after acceptance of order/contract? Are proper records of reviews, changes & customer communication maintained? When the customer provides no documented statement of requirement, does the organization confirm the requirements before acceptance? Are proper communication channels established for handling customer feedback & customer compliants? Does the organization has established plan & controls for design & development? Does the design & development plan identify the design changes? Does the design & development plan identify reviews, verifications & validations required at each stage? Does the design & development plan identify the roles, responsibilities & authority? Does the design plan establish effective communication plan? Are the design inputs identified & records maintained? Does design inputs include the following: - functional & performance requirements - statuatory & regulatory requirements - inputs ffrom previous similar designs, where applicable - any other essectial requirements as needed Are the design inputs reviewed for adequecy (requirements are complete, unambiguous and not in conflict with each other)? Are the design outputs reviewed & verified to meet design inputs? Are the design outputs approved prior to release? Does the design outputs show appropriate information for purchasing, production and/or service, as applicable? Does the design outputs provide appropriate reference to product acceptance criteria? Does the design outputs specify the characteristics of the product that are essential for its safe & proper use?

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7.3.5 Design & development verification

7.3.6 Design & development validation

Are design validation activities planned & conducted at appropriate stages? Does the design validation ensure that the product/service met its intended purpose? Where applicable, is the design validation conducted & performed prior to its delivery or implementation? Are the records of validation & any necessary actions properly maintained?

7.3.7 Design & development changes

Are design changes reviewed, verified/validated and approved before implementation? Does the review of design changes include its effect on constituent parts and product already delivered? Are the records of the results of design changes and any necessary actions properly maintained? What type and extent of controls does the organization has over its suppliers? Does the organization has controls established for any outsourced processes or products? Is supplier evaluation criteria established? How often are suppliers evaluated? Are records maintained on supplier evaluations? Does the purchaing information describe the product/service to be purchased? Does the purchasing information describe the following: - requirements for approval of product/service, procedures, processes and equipment? - requirements for qualification of personnel? - requirements of Quality Management System? (such as a purchasing procedure or policies) How does the organization verify the adequecy of the purchasing requirements prior to communicating them to supplier? What kind of inspection or other activities are established to verify that the purchased product meets the purchasing requirements? Does the organization has the available information that describes the characteristics of the product/service? Does the organization have the necessary work instruction needed to carryout production and service provsion? Does the organization use suitable equipment for carrying out production and service provision? Does the organization use & maintain measuring & monitoring equipment where needed? How does the organization control the release, delivery and post-delivery activities?

7.4 Purchasing

7.5 Production and Service provision 7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service provision

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Are systematic design reviews being conducted at planned stages? Does the design reviews evaluate the ability of the results to meet requirements? Does the design reviews identify problems & propose necessary actions? Are appropriate personnel involved in the design reviews? (representatives of functions & stackholders) Are the records of design reviews properly maintained? Are design verificaton activities planned & conducted at appropriate stages? Does the design verification ensure that outputs met design requirements? Are the records of verificaion & any necessary actions properly maintained?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 7.3.4 Design & development review

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

Does the organization have any special processes where the output of the process cannot be verified by subsequent monitoring or measurement?If so, how does the organization address the following: - validation of such processes to achieve planned results - defined criteria for review and approval of those processes - approval of equipment or personnel related to those processes - use of methods and procedures for those processes - any requirements for records - revalidation of those processes when changes occur to those processes Are proper records maintained including records of revalidation of any such processes?

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7.5.4 Customer property

7.5.5 Preservation of product

7.6 Control of monitoring and measuring devices

8.0 Measurement, analysis & improvement 8.1 General 8.2 Monitoring and measurement 8.2.1 Customer satisfaction

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Where necessary, does the organizaton address traceability requirements? Is the product/service identified using suitable means throughout its realization process? Is the product status identified with respect to monitoring and measurement requirements? Where traceability is a requirement, are proper records maintained?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 7.5.3 Identification and traceability

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

Does the organization identify customer property while it is under the organization's control or use? How is the customer property safegaurded & protected while it is under the organization's control or use? If any customer property is lost, damaged or otherwise found to be unsuitable for use, how is this reported to the customer? How are records maintained in relation to handling of customer property? How does the organization handle the preservation requirments of the product/service (or its constituent parts) during its internal processing & delivery? Does the preservation process address the following: - identification methods of the product/service - handling methods of the product/service - packaging requirements for the product/service - storage requirements for the product/service - protection requirments for the product/service Does the organization use monitoring & measuring devices to prove evidence of conformity? Does the organization establish processes to enable performance of monitoring & measuring activities that are consistent with the monitoring & measuring requirments? Does the organization identify the calibration needs for these measuring & monitoring devices? Does the organization establish the criteria & frequency of calibration for these measuring & monitoring devices? Are the calibration requirements/methods traceable to a known International or national standard? If there is no known standard, how does the organization perform calibration of such devices? Are the measuring or monitoring equipment adjusted or re-adjusted as necessary? What kind of controls are in place to safegaurd adjustments that would invalidate the measurement result? How can the calibration status of these devices be identified? (Is there a calibration log or a calibration sticker on these devices?) How are these calibrated devices protected from damage and deterioration during handling, maintenance and storage? When a device is found to be out-of calibration, how does the organization assess & record the validity of the previous measuring results? How type of actions does the organization take on any equipment or product when a out-of-calibration situation occurs with the measuring device that is used? When using computer software as part of the measuring & monitoring activities, is the ability of this application confirmed prior to initial use and reconfirmed as necessary? How does the organizaton demonstrate the following: - conformity of product/service - conformity to Quality Management System - continually improve the effectiveness of the Quality Management System What methods does the organization use to collect customer perception? How does it use that information?

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8.2.3 Monitoring and measurement of processes

8.2.4 Monitoring and measurement of products

8.3 Control of Nonconforming product

8.4 Analysis of Data

8.5 Improvement 8.5.1 Continual Improvement

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Does the organization has an internal audit procedure? Does the Internal audit procedure define roles, responsibilities & authority for planning, conducting audits, & reporting audit results? Are internal audits conducted at planned intervals to determine the effectiveness of the QMS? Does the internal audit criteria include status, importance & results of previous audits of the audit area? Does the audits define the following: Audit criteria, scope, audit frequency & audit methods? Are the audits conducted in a manner that ensures impartiality and objectivity? Are the audit records properly maintained? Does the audit area take appropriate actions in a timely manner when nonconformities are identified? Does follow-up activities of the audit include verification of actions? Are the results of these verification recorded? What methods does the organization have in place to measure & monitor their processes? Does the organization take necessary corrective actions when its processes are found not to achieve planned results? How does the organization measure & monitor product/service characteristics? Does the organization identify the appropriate stages for monitoring & measuring of product/service? Does the organization maintain proper records to show evidence of conformity of the product/service? Does the organization ensure that all monitoring & measuring activities are completed before the product is released? How does the organization identify & segregate nonconforming material? What measures/controls does the organization have to prevent unintended use or delivery of onconforming product? Does the organization define the responsibilities and authorities in relation to dealing with nonconforming product? Does the organization perform the following: - take action when nonconformace is detected - authorize its use, release or acceptance under concession by relevant authority - take action to preclude its original intended use or application Are proper records for nonconformances maintained including for any subsequent actions taken? Does the organization reverify product/service once the nonconformance is corrected? How does the organization deal if nonconformance is detected after the product/service is delivered? Does the organization collect & analyze appropriate data to demonstrate the suitability & effectiveness of the QMS? How does the organization utilize this data to evaluate continual improvement in the effectiveness of the QMS? Does the organization collect and analyze data in relation to the follwoing: - Customer satisfaction - conformity of product/service requirements - characteristics and trends of processes & products - suppliers

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 8.2.2 Internal audits

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

Does the organization use Quality policy, objectives, audit results, analysis of data, management reviews, corrective and preventive actions to continually improve the effectiveness of the QMS?

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8.5.3 Preventive action

AUDITOR COMMENTS

Evidence reviewed and/or issues identified. (black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])

FINDING

MAJOR

This is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.) Does the organization have a corrective action procedure? Does the procedure address how to handle the following: - review nonconformities including customer complaints - determine the cause of nonconformities (root cause analysis) - evaluate the need for action to prevent reoccurance - determine and implement necessary actions - maintain records of results of the action taken - review corrective action taken Does the procedure describe the responsibilities & authorities in relation to the corrective action process? Are the corrective actions performed in a timely manner? Are the results of the corrective actions verified & approved by proper authority before they are closed?

SYSTEM TRAIL This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC , this is a required record for the records control procedure addressed in 4.2.4.

Minor

EXPECTATION DEFINED

Comment

Recorded

Proven

Relationship with ISO 9001:2008 8.5.2 Corrective action

TYPE OF EXPECTATION

Documented

CLAUSE

Intelex NC # & CA #

NC#

CA#

Does the organization have a preventive action procedure? Does the procedure address how to handle the following: - determine potential nonconformities and their causes - evaluate the need for action to prevent occurance - determine and implement necessary actions - maintain records of results of the action taken - review preventive action taken Does the procedure describe the responsibilities & authorities in relation to the preventive action process? Are the preventive actions performed in a timely manner? Are the results of the preventive actions verified & approved by proper authority before they are closed?

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