QTP - TS16949:2009 System Audit

• Document No.

• Audit Title

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

4.2.2 Quality Documentation

• Is the quality documentation up to date?<br>

  Yes

  No

  N/A

• Have changes to the organisation structure and responsibilities been reflected in the QMS?

  Yes

  No

  N/A

• Are justification for any exclusions (see 1.2) accurate?

  Yes

  No

  N/A

4.2.3 Control of Documents

• Does a document control procedure exist?<br>

  Yes

  No

  N/A

• Are all documents required by the quality management system controlled?<br>

  Yes

  No

  N/A

• Are changes and revision status of documents identified?<br>

  Yes

  No

  N/A

• Are relevant versions of applicable documents available at points of use?<br>

  Yes

  No

  N/A

• Are controlled documents legible and readily identifiable?<br>

  Yes

  No

  N/A

4.2.3.1 Engineering Specifications

• Does the organisation have a process for timely review and implementation of customer engineering specifications?

  Yes

  No

  N/A

4.2.4 Control of Records

• Does a documented record control procedure established?

  Yes

  No

  N/A

• Are computer files adequately backed up and protected?

  Yes

  No

  N/A

• Are retention time of records defined?<br>

  Yes

  No

  N/A

• Are records legible, identifiable and readily retrievable? <br>

  Yes

  No

  N/A

5.3 Quality Policy

• Is the quality policy appropriate to the purpose of the organisation?<br>

  Yes

  No

  N/A

• Is the quality policy communicated and understood within the organisation?<br>

  Yes

  No

  N/A

• Is the policy reviewed for continuing suitability?<br>

  Yes

  No

  N/A

5.4.1 Quality Objectives

• Has top management defined and documented its quality objectives?<br>

  Yes

  No

  N/A

• Are the quality objectives measurable?<br>

  Yes

  No

  N/A

• Are the quality objectives consistent with the quality policy?<br>

  Yes

  No

  N/A

5.5.1 Responsibility and Authority

• Are responsibilities and authorities defined and communicated within the organisation?<br>

  Yes

  No

  N/A

5.5.2 Management Representative

• Has top management appointed a management representative?

  Yes

  No

  N/A

• Are responsibilities for the management representative in line with ISO9001?<br>

  Yes

  No

  N/A

5.5.3 Internal Communication

• Does management ensured communication processes are established within the organisation?<br>

  Yes

  No

  N/A

• Does communication takes place regarding the effectiveness of the quality management system?<br>

  Yes

  No

  N/A

5.6.1 Management Review - General

• Does top management review the quality management system, at planned intervals?<br>

  Yes

  No

  N/A

• Are records of management reviews maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

5.6.2 Review Input

• Do inputs to the management reviews satisfy ISO9001 requirements?<br>

  Yes

  No

  N/A

5.6.3 Review Output

• Do the output of the management review include actions to improvement of the effectiveness of the QMS?<br>

  Yes

  No

  N/A

6.1 and 6.2.2 Competence, Awareness & Training

• Are personnel performing work affecting quality competent on the basis of appropriate education, training, skills and experience?<br>

  Yes

  No

  N/A

• Are personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?<br>

  Yes

  No

  N/A

• Are records of education, training, skills and experience maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

6.3 Infrastructure

• Is the. infrastructure needed to achieve conformity to product adequate?<br>

  Yes

  No

  N/A

6.4 Work Environment

• Is the work environment needed to achieve conformity to product effectively controlled?<br>

  Yes

  No

  N/A

7.2.1 Sales Enquiry and Order Process

• Are enquiries and quotations defined and documented?<br>

  Yes

  No

  N/A

• Are enquiries logged and followed up?

  Yes

  No

  N/A

• Are statutory and regulatory requirements related to the product determined?<br>

  Yes

  No

  N/A

7.2.2 Review of Requirements Related to the Product

• Is a formal contract review conducted prior to the organisation's commitment to supply a product?<br>

  Yes

  No

  N/A

• Have records and actions arising from the review maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Are verbal orders confirmed by the organisation before acceptance?<br>

  Yes

  No

  N/A

• Are relevant documents updated and personnel are made aware of changed requirements?<br>

  Yes

  No

  N/A

7.2.3 Customer Communication

• Is pertinent information determine communicated to customers?<br>

  Yes

  No

  N/A

7.3.1 Design and Development Process?

• Does the organisation plan and control product design and development?<br>

  Yes

  No

  N/A

• Are the responsibilities and authorities for design and development documented?<br>

  Yes

  No

  N/A

• Wherever practicable, is validation completed prior to the delivery or implementation of the product?<br>

  Yes

  No

  N/A

• Are records of design and development maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Are design and development changes identified and records maintained?<br>

  Yes

  No

  N/A

7.4.2 Purchasing and Receipt Verification Process

• Do purchasing documents describe the product or service to be purchased?<br>

  Yes

  No

  N/A

• Does the organisation ensure specified purchase requirements are verified prior to the PO being issued?<br><br><br><br>

  Yes

  No

  N/A

7.4.1 Supplier Evaluation and Approval

• Are records of supplier evaluation and approval maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Is the extent of supplier evaluation commensurate with the type of product/service being purchased?<br>

  Yes

  No

  N/A

• Has the criteria for selection, evaluation and re-evaluation been established?<br>

  Yes

  No

  N/A

7.4.3 Verification of Purchased Product

• Does the organisation inspect or otherwise verify purchased product to ensure it meets specified purchase requirements?<br>

  Yes

  No

  N/A

• Are records of receiving verification recorded and maintained?<br>

  Yes

  No

  N/A

• Does the organisation record non conforming products received from suppliers?

  Yes

  No

  N/A

7.5.1 Warehouse and Despatch Process

• Are products identified and protected while in storage?<br>

  Yes

  No

  N/A

• Are specific packaging requirements defined where appropriate?<br>

  Yes

  No

  N/A

• Is the warehouse equipment maintained effective?<br>

  Yes

  No

  N/A

• Are Proof of delivery records maintained?

  Yes

  No

  N/A

• Are picking errors recorded and analysed?

  Yes

  No

  N/A

• Do records indicate the person(s) authorising the release of product for delivery to the customer (see 4.2.4)?<br>

  Yes

  No

  N/A

• Are non conforming products clearly identified?

  Yes

  No

  N/A

7.5.4 Customer property

• Does the organisation identify, verify, protect and safeguard customer property?<br>

  Yes

  No

  N/A

• If any customer property is lost, damaged or otherwise found to be unsuitable, is this reported to the customer?<br>

  Yes

  No

  N/A

7.5.2 (8.2.4) Manufacturing Process

• Does the organization apply suitable methods to plan production?<br>

  Yes

  No

  N/A

• Are controls implemented over processes where the resulting output cannot be verified by subsequent monitoring or measurement?<br>

  Yes

  No

  N/A

• Does the organisation monitor and measure the characteristics of the product?<br>

  Yes

  No

  N/A

• Has evidence of conformity with the acceptance criteria been maintained?<br>

  Yes

  No

  N/A

• approval of equipment and qualification of personnel?<br>

  Yes

  No

  N/A

• Are work instructions and specific methods and procedures used?<br>

  Yes

  No

  N/A

• requirements for records (see 4.2.4)?<br>

  Yes

  No

  N/A

7.6 Control of monitoring and measuring equipment

• Is measuring equipment calibrated or verified at specified intervals?<br>

  Yes

  No

  N/A

• Is calibration traceable to national measurement standards?<br>

  Yes

  No

  N/A

• Is equipment safeguarded from adjustments that would invalidate the measurement result?<br>

  Yes

  No

  N/A

• Have records of the results of calibration and verification been maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Does the organisation assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements?<br>

  Yes

  No

  N/A

8.2.1 Customer satisfaction

• Are methods for obtaining customer feedback determined and recorded?<br>

  Yes

  No

  N/A

8.2.2 Internal Audit

• Does the organisation conduct internal audits at planned intervals<br>

  Yes

  No

  N/A

• Does the audit programme ensure that auditors do not audit their own work?<br>

  Yes

  No

  N/A

• Are records of the audits and their results maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Are audit corrective actions taken without undue delay and do they eliminate potential causes?

  Yes

  No

  N/A

• Are audit actions verified as effective (see 8.5.2)?<br>

  Yes

  No

  N/A

8.3 Control of nonconforming product

• Does the organisation ensure that product which does not conform to product requirements is identified and controlled?

  Yes

  No

  N/A

• Have the controls and related responsibilities and authorities been defined in a documented procedure?<br>

  Yes

  No

  N/A

• by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started?

  Yes

  No

  N/A

• When nonconforming product is corrected is it subject to re-verification to demonstrate conformity to the requirements?<br>

  Yes

  No

  N/A

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

  Yes

  No

  N/A

8.4 Analysis of data

• Does the organisation determine, collect and analyse appropriate data?<br>

  Yes

  No

  N/A

• Is action taken following analysis (see 8.2.3 and 8.2.4)?<br>

  Yes

  No

  N/A

8.5.2 Corrective action

• Has a documented procedure been established (including customer complaints)?<br>

  Yes

  No

  N/A

• Is corrective action taken to eliminate the causes of nonconformities?<br>

  Yes

  No

  N/A

• determining the causes of nonconformities?<br>

  Yes

  No

  N/A

• Are records of the results of action taken maintained (see 4.2.4)?<br>

  Yes

  No

  N/A

• Is the effectiveness of the corrective action taken maintained?<br><br><br><br><br><br>

  Yes

  No

  N/A

8.5.3 Preventive action

• Has a documented procedure been established for determining potential nonconformities?<br>

  Yes

  No

  N/A

• Has the organization determined action to eliminate the causes of potential nonconformities?<br>

  Yes

  No

  N/A

• Are preventive actions appropriate to the effects of the potential problems?<br>

  Yes

  No

  N/A

• records of results of action taken (see 4.2.4)?<br>

  Yes

  No

  N/A

• reviewing the effectiveness of the preventive action taken?<br>

  Yes

  No

  N/A