ISO 9001:2008

Audit Information

Address
Audit Number
Audit Title
Function
Region
Audit Date & Time
Auditor Team
- Ashish Batra
- Craig Smith
- Claire Price
- Ajay Mistry
- Kasihf Mahmood
- Jeremy Halden
- Iram Nawaz
- Sal Dickinson
- Sarah Ashton-Stevens
- Linda Murray
- Jonathan Hill
- Sam Cook
- Hayley Coiler
- Lisa Dearden
Auditee

Opening Meeting

Opening Meeting Notes

Review of previous findings

Previous Findings
Review Details
Review Outcome

Section 4 -QMS

Section applicable to the function being audited
Applicable Clauses
- 4.1
- 4.2.1
- 4.2.2
- 4.2.3
- 4.2.4

4.1 General Requirements

Check for following:
1. Has Organisation established, documented, implemented and maintained a QMS and continually improved its effectiveness in accordance with ISO 9001:2008? (Questions in section 4.1 are verified throughout the audit)
2. Where has Organisation identified the processes needed for the QMS and their application throughout the organisation? (see 4.2.2)
3. Where has organisation determined the sequence and interaction of QMS processes? (see 4.2.2)
4. What are the criteria and methods organisation uses to ensure that the operation and control of QMS processes are effective?
5. Has organisation provided resources and information needed to support the operation and monitoring of QMS processes? (see section 6)
6. How does organisation monitor, measure and analyse QMS processes?
7. How has organisation implemented actions necessary to achieve planned results and continual improvement of processes needed for the QMS?
8. Are processes needed for the QMS managed by the organisation in accordance with the requirements of ISO 9001:2008?
9. When organisation outsources any process that affects product conformity with requirements, how is control ensured over such processes?
10. Where is the control of outsourced processes that affect product conformity with requirements identified within the QMS?
Has the above requirements been met for 4.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

4.2.1 Documentation Requirements

Check for following:
1. Does organisation have documented statements of a quality policy and quality objectives?
2. Does organisation have a quality manual?
3. Does organisation have the documented procedures required by ISO 9001:2008?
4. Are adequate documents in place to ensure the effective planning, operation and control of organisation’s processes?
5. Does organisation’s documentation include the records required by ISO 9001:2008?
Has the above requirements been met for 4.2.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

4.2.2 Quality Manual

Check for following:
1. Where in the organisations quality manual is the scope of the QMS identified, including details of and justification for exclusions?
2. Where does the organisations quality manual contain or reference the documented procedures established for the QMS?
3. Where does the organisations quality manual include a description of the interaction between the processes of the QMS?
Has the above requirements been met for 4.2.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

4.2.3 Control of Documents

Check for following:
1. How are the documents required by the QMS controlled? (Documents should be reviewed throughout the audit)

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

3. Check the implementation of procedure.
Has the above requirements been met for 4.2.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

4.2.4 Control of Records

Check for following:
1. What records exist that provide evidence of conformity to requirements and of the effective operation of the QMS? (Should be reviewed throughout the audit)
2. Does organization have a documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records?
3. Are records legible, readily identifiable and retrievable? (Should be reviewed throughout the audit)
Has the above requirements been met for 4.2.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN
Total Number of Findings in Section 4

Section 5 - Management Responsibility

Section applicable to the function being audited
Applicable Clauses
- 5.1
- 5.2
- 5.3
- 5.4.1
- 5.4.2
- 5.5.1
- 5.5.2
- 5.5.3
- 5.6

5.1 Management Commitment

Check the following:
1. How does top management communicate the importance of meeting customer and legal requirements to the organisation?
 2.Has a company quality policy bee established? (see 5.3 – must be in the quality manual)
3. What are the quality objectives established by top management?
4. Does top management conduct management reviews? (see 5.6)
5. How does top management ensure the availability of resources to support and continually improve the QMS?
Has the above requirements been met for 5.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.2 Customer Focus

Check the following:

How does top management ensure that customer requirements are determined and met to enhance customer satisfaction?
Has the above requirements been met for 5.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.3 Quality Policy

Check the following:

1. How does top management ensure that the quality policy is appropriate to the purpose of the organisation? 
2. Does the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the QMS?
3. Are the contents of the quality policy relevant to organisation, and measurable?
4. Is the quality policy communicated and understood within the organisation?(verify throughout the audit)
5. Is there an established process to review the quality policy for continuing suitability? (see 5.6)
Has the above requirements been met for 5.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.4.1 Quality Objectives

Check the following:

1. Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organisation?

2. Are the quality objectives consistent with the quality policy? What are the measurements?
Has the above requirements been met for 5.4.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.4.2 Quality Management System Planning

Check the following:

1. How do you ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO 9001:2008 section 4.1, as well as the quality objectives?

2. How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?
Has the above requirements been met for 5.4.2?
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.5.1 Responsibility and Authority

Check the following:

1. How are responsibilities and authorities defined and communicated within the organisation?
Has the above requirements been met for 5.5.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.5.2 Management Representative

Check the following:

1. Who is your ISO 9001:2000 management representative?

2. Does the management representative have responsibility and authority to
a) ensure that processes needed for the QMS are established, implemented and maintained?
b) report to top management on the performance of the QMS and any need for improvement?
c) ensure the promotion of awareness of customer requirements throughout the organisation?
(Check the roles & responsibilities defined for Management representative)
Has the above requirements been met for 5.5.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.5.3 Internal Communication

Check the following:

How is information regarding the effectiveness of the QMS communicated within the organisation?
Has the above requirements been met for 5.5.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

5.6 Management Representative

Check the following:

5.6.1 General
1. What is the frequency that top management reviews the organisation's QMS?
2. What kinds of information are reviewed in management reviews? (must include suitability, adequacy and effectiveness of QMS; improvement; & changes to the QMS, quality policy and objectives)
3. Check records from recent management reviews?

5.6.2 Review Input
Check the below points are covered in the management review records
a) results of audits,
b) customer feedback,
c) process performance and product conformity,
d) status of preventive and corrective actions,
e) follow-up actions from previous management reviews,
f) changes that could affect the quality management system, and
g) recommendations for improvement

5.6.3 Review Output
What decisions or actions have resulted from management reviews for each of the following?
a) improvement of the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.
Check the above points are covered in the management review records.
Has the above requirements been met for 5.6
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN
Total Number of Findings in Section 5

Section 6 - Resource Management

Section applicable to the function being audited
Applicable Clauses
- 6.1
- 6.2
- 6.3
- 6.4

6.1 Provision of Resource

Check for the following:

1. What resources has organisation provided to implement and maintain the QMS and continually improve its effectiveness?
2. What resources has organisation provided to ensure that customer requirements are met?
Has the above requirements been met for 6.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

6.2 Human Resource

Check for the following:

6.2.1 General
(While auditing, select some personnel performing work affecting product quality) What are the education, training, skills and experience required by this position? How does this person meet those qualifications?

6.2.2 Competence, training & awareness
1. How do you determine the necessary education, training, skills and experience for people performing work affecting product quality?
2. What training or other actions do you provide to satisfy the education, training, skills and experience needs of personnel? (records)
3. When you provide training or other actions to satisfy the education, training, skills and experience needs, how do you evaluate the effectiveness of those actions? (records) (Sample throughout organisation)
4. How do your activities contribute to the achievement of quality objectives?
5. Where do you maintain records of education, training, skills and experience?
Has the above requirements been met for 6.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

6.3 Infrastructure

Check for the following:

1. Are the buildings, workspace, and utilities provided appropriate to achieve conformity to product requirements? How are they maintained?
2. What kind of process equipment (both hardware and software) is necessary to conform to product requirements? How is the equipment maintained?
3. What supporting services (such as transport or communication) are needed to ensure that service meets requirements? How are they maintained?
Has the above requirements been met for 6.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

6.4 Work Environment

Check for the following:

1. What kind of work environment is required to achieve conformity to service & contractual requirements?
2. How is this environment managed and maintained?
Has the above requirements been met for 6.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN
Total Number of Findings in Section 6

Section 7 - Product Realisation

Section applicable to the function being audited
Applicable Clauses
- 7.1
- 7.2.1
- 7.2.2
- 7.2.3
- 7.3.1
- 7.3.2
- 7.3.3
- 7.3.4
- 7.3.5
- 7.3.6
- 7.4.1
- 7.4.2
- 7.4.3
- 7.5.1
- 7.5.3
- 7.5.4
- 7.5.5
- 7.6

7.1 Planning of Product Realisation

Check for the following

1. Where are the processes needed for product realisation identified?
2. Is the planning of product realisation consistent with the requirements of the other processes of the QMS? (Verify there are no inconsistencies or conflicts between quality system procedures)
3. Where in the product realisation process do you determine the quality objectives and requirements for products?
4. When planning for product realisation, how do you establish processes, documents, and provide resources specific to the product
5. How do you determine verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance?
6. What records exist showing that both the realisation processes and the product meet requirements?
7. What are the outputs of product realisation planning? Are they in a form suitable for organisation?
Has the above requirements been met for 7.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.2.1 Determination of Requirements Related to the Product

Check for the following

How does organisation determine each of the following requirements?
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organisation.
Has the above requirements been met for 7.2.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.2.2 Review of Requirements Related to the Product

Check for the following

1. How does the function ensure that product requirements are defined and reviewed before committing to supply product?
2. How does the function ensure that contract or order requirements differing from those previously expressed are resolved before committing to supply product?
3. What kind of review is done to ensure that organization has the ability to meet requirements before committing to supply product?
4. Check records of the product requirement review results and actions resulting from them?
5. When customers don’t have documented requirements, how does the function confirm their requirements before accepting orders?
6. When product requirements are changed, how does the function ensure that relevant documents are changed and that relevant personnel are made aware of the changes?
Has the above requirements been met for 7.2.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.2.3 Customer Communication

Check for the following

1. What method(s) are used to communicate with customers regarding to product information?
2. How does organisation communicate with customers about enquiries, contracts, or order handling, including amendments?
3. How does the function communicate with customers regarding feedback, including customer complaints?
Has the above requirements been met for 7.2.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.1 Design & Development Planning

Ask the following questions

1. Can you explain to me the process used by organization to plan and control the design and development of product?
2. What are the stages in the design and development process?
3. How do you determine the review, verification and validation activities appropriate to each design and development stage? (see 7.3.4a)
4. How is it determined who has responsibilities and authorities for design and development?
5. How does organization ensure effective communication and clear assignment of responsibility between different groups involved in design and development?
6. As product design and development progresses, how are the planning outputs updated?
Has the above requirements been met for 7.3.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.2 Design & Development Inputs

Check for the following

1. What are the design inputs relating to each of the following product requirements?
- functional and performance requirements,
- applicable statutory and regulatory requirements,
- where applicable, information derived from previous similar designs, and
- other requirements essential for design and development. Where are they recorded?
2. How & when are the design and development inputs reviewed for adequacy?
3. How does organisation ensure that requirements are complete, unambiguous and don’t conflict with each other?
Has the above requirements been met for 7.3.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.3 Design & Development Outputs

Check for the following

1. How can design and development outputs be verified against the inputs? (see 7.3.5q1) Are these outputs approved prior to release?
2. Check some examples of design and development outputs and how they meet the input requirements?
3. How are design and development outputs translated into information for purchasing, production and service?
4. What design and development outputs contain or reference product acceptance criteria?
5. Where does the function specify the characteristics of the product that are essential for its safe and proper use?
Has the above requirements been met for 7.3.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.4 Design & Development Review

Check for the following

1. At what stages of design and development do you perform reviews to evaluate if the results meet requirements? (see 7.3.1)
2. Check some problems that have been identified and actions proposed at these reviews?
3. What functions are represented at these reviews? At each stage, are all of the functions concerned with that stage represented?
4. Check records of the results of the reviews and any necessary actions taken?
Has the above requirements been met for 7.3.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.5 Design & Development Verification

Check for the following

1. What verification activities are performed to ensure that the design and development outputs have met the input requirements? (see 7.3.3)
2. Check records of the results of the verification activities and resulting actions?
Has the above requirements been met for 7.3.5
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.3.6 Design & Development Validation

Check for the following

1. What design and development validation activities are performed to ensure that the product is capable of meeting the requirements for the intended use?
2. Is the validation done before product shipment? If not, is the justification recorded?
3. Check records of the validation activity results and any follow-up actions?
Has the above requirements been met for 7.3.6
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.4.1 Purchasing Process

Check for the following

1. How does the function ensure that purchased product conforms to specified purchase requirements?
2. How does the function determine 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 the final product)
3. How does the function evaluate and select suppliers? (based on their ability to supply product in accordance with organization’s requirements)
4. Check the criteria for selection, evaluation and re-evaluation of suppliers?
5. Check records of the results of supplier evaluations and any necessary actions? (verify that criteria have been met)
Has the above requirements been met for 7.4.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.4.2 Purchasing Information

Ask the following questions

1. Do you have any requirements for qualification of supplier personnel? If so, can you show me where the requirement is documented?
2. Do you have any QMS requirements of your suppliers? If so, can you show me where they are required?
3. How does organisation ensure the adequacy of purchasing requirements before communicating them to the supplier?
Has the above requirements been met for 7.4.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.4.3 Verification of Purchased Product

Check for the following

1. What inspection or other activities are used to ensure that purchased product meets your purchasing requirements?
2. Does the function perform product verification at the supplier's site?
3. If so, where are the verification arrangements and method of product release identified?
Has the above requirements been met for 7.4.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.5.1 Control of Production & Service Provision

Check for the following

When carrying out production (or service) are all of the following controlled conditions in place?
Is information that describes the characteristics of the product available?
Are appropriate work instructions available (if needed)?
Is suitable equipment used for carrying out production (or service)?
Are appropriate gages, etc. used in production (or service)? (See 7.6)
Are appropriate kinds of monitoring and measurement done?
Are proper release, delivery and post-delivery activities in place?
Has the above requirements been met for 7.5.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.5.3 Identification & Traceability

Check for the following

1. Identify the products in the function
2. Does the function products requiring traceability? If so, how do you identify the product throughout the process?
3. How is product inspection status identified?
4. Check for unique identification records for products requiring traceability?
Has the above requirements been met for 7.5.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.5.4 Customer Property

Check for the following

1. Does the function use any customer-owned property? (If so, ask questions below)
2. How do you ensure that customer-owned property provided for use or incorporation into the product is identified, verified, protected, and safeguarded?
3. If any customer property is lost, damaged etc., how is it reported to the customer? Can you show me records regarding this?
Has the above requirements been met for 7.5.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.5.5 Preservation of Product

Check for the following

1. How do you preserve the conformity of product during internal processing and delivery? (Verify product throughout audit)
2. How does identification, handling, packaging, storage and protection address the preservation of product?
3. Does this also apply to component parts?
Has the above requirements been met for 7.5.5
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

7.6 Control of Monitoring & Measuring Equipment

Check for the following

1. Has the organisation determined the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements (see 7.2.1)?
2. Has the organisation established processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements?
3. Where necessary to ensure valid results, has the organisation ensured that measuring equipment shall be calibrated or verified, or both, at specified intervals, or prior to use,
4. In addition, does the organisation assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements?
5. Does the organisation take appropriate action on the equipment and any product affected?
6. Have records of the results of calibration and verification been maintained (see 4.2.4)?
7. When used in the monitoring and measurement of specified requirements, is the ability of computer software to satisfy the intended application confirmed?
8. Is this undertaken prior to initial use and reconfirmed as necessary?
Has the above requirements been met for 7.6
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN
Total Number of Findings in Section 7

Section 8 - Measurement, Analysis & Improvement

Section applicable to the function being audited
Applicable Clauses
- 8.1
- 8.2.1
- 8.2.2
- 8.2.3
- 8.2.4
- 8.3
- 8.4
- 8.5.1
- 8.5.2
- 8.5.3

8.1 General

Check for following

1. How does the function plan and implement measurement, analysis and improvement processes needed to demonstrate products conform to requirements?
2. How does the function plan and implement measurement, analysis and improvement processes needed to ensure conformity of the QMS?
3. How does the function plan and implement measurement, analysis and improvement processes needed to continually improve the effectiveness of the QMS?
4. How does the function determine what methods to use, including statistical techniques? How do you determine the extent of their use?
Has the above requirements been met for 8.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.2.1 Customer Satisfaction

Check for following

1. How does the function monitor information about customer perception as to whether organization has met customer requirements?
2. How the information is obtained? How is it used?
Has the above requirements been met for 8.2.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.2.2 Internal Audit

Check for following

1. Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by organization? (Review records to demonstrate conformance)
2. Do they determine whether the QMS is effectively implemented and maintained? (Review records)
3. Is there an audit plan that takes into consideration the importance of the processes and areas to be audited, and the results of previous audits?
4. Where are the audit criteria, scope, frequency and methods defined?
5. How does the function ensure that both the selection of auditors and the conduct of audits are objective and impartial?
6. Can you demonstrate that internal QMS auditors don’t audit their own work?
7. Check the internal audit procedure? (Does it include planning and conducting audits, reporting results, and maintaining records?) Check the records of internal QMS audits?
8. Who ensures that actions are taken to eliminate detected nonconformities and their causes? Are they being taken care of in a timely manner? (verify with audit/CA records)
9. What activities are done to verify the actions taken, and how are the verification results reported?
Has the above requirements been met for 8.2.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.2.3 Monitoring and measurement of process

Check for following

1. What methods are used to monitor and measure the QMS processes?
2. How does the function determine if the Quality Management System processes have produced the desired results?
3. When the desired results are not achieved, what actions are taken to ensure that the product meets requirements?
Has the above requirements been met for 8.2.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.2.4 Monitoring and measurement of product

Check for following

1. What characteristics are checked to verify that product requirements have been met?
2. At what stages of the product realisation process do monitoring and measuring activities take place?
3. How is evidence of conformity with acceptance criteria maintained?
4. Check records that indicate who has authorised release of product to the next stage of the process?
5. How does the function ensure that product is not released until the all requirements have been met? If product must be released prior to this, how is it approved?
Has the above requirements been met for 8.2.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.3 Control of non-conforming product

Check for following

1. How does the function ensure that nonconforming products are identified and controlled to prevent unintended use or delivery?
(Verify product throughout audit)
2. Is there a documented procedure defining the controls for dealing with nonconforming product?
3. Does it include related responsibilities and authorities?
4. When there us a nonconforming product, what method is used to deal with it?
5. Check for any records of nonconforming product and any actions taken?
6. Are there any records of concessions obtained?
7. When nonconforming product is corrected, how is it re-verified to ensure it conforms to requirements?
8. When nonconforming product is detected after shipment, what actions are taken, such as containment? (Verify corrective action records)
Has the above requirements been met for 8.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.4 Analysis of data

Check for following

1. What data is collected and analysed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made?
2. What information does this analysis provide relating to customer satisfaction?
3. What information does this analysis provide relating to conformity to product requirements?
4. What information does this analysis provide relating to characteristics and trends of processes and products?
5. What information does this analysis provide relating to suppliers?
Has the above requirements been met for 8.4
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.5.1 Continual Improvement

Check for following

1. Can the function demonstrate that effectiveness of their process continually improves?
2. What tools do they use?
Has the above requirements been met for 8.5.1
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.5.2 Corrective Action

Check for following

1. Check for a documented procedure defining requirements for each of the following?
a) reviewing nonconformities (including customer complaints)
b) determining the causes of nonconformities
c) evaluating the need for action to ensure that nonconformities do not recur
d) determining and implementing action needed
e) records of the results of action taken
f) reviewing effectiveness of corrective action taken
2. Check records of corrective actions taken?
3. Audit a few areas where corrective action taken and check if the comply to the requirements.
Has the above requirements been met for 8.5.2
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN

8.5.3 Preventive Action

Check for following

1. Check for a documented procedure defining requirements for each of the following?
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing effectiveness of preventive action taken.
2. Check records of preventive actions taken?
3. Audit a few areas where corrective action taken and check if the comply to the requirements.
Has the above requirements been met for 8.5.3
Auditor Notes
Compliance Level
Finding Type
- Non-Conformance RED
- Non-Conformance AMBER
- Observation RED
- Observation AMBER
- Observation GREEN
- Feedback GREEN
Total Number of Findings in Section 8

Closing Meeting

Closing Meeting Notes
Findings Raised
Non-Conformance RED
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0
Non-Conformance AMBER
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0
Observation RED
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0
Observation AMBER
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0
Observation GREEN
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0
Feedback GREEN
- 1
- 2
- 3
- 4
- 5
- 6
- 7
- 8
- 9
- 10
- 0

Audit Signoff

Sign off Audit Team
- Lead Auditor
- Support Auditor
- Auditor in Training
- Functional Owner
- Auditee
Lead Auditor
Support Auditor
Auditor in Training
Functional Owner
Auditee Team
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