• Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

4.2.2 Quality Documentation

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

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

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

4.2.3 Control of Documents

  • Does a document control procedure exist?<br>

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

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

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

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

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

4.2.4 Control of Records

  • Does a documented record control procedure established?

  • Are computer files adequately backed up and protected?

  • Are retention time of records defined?<br>

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

5.3 Quality Policy

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

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

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

5.4.1 Quality Objectives

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

  • Are the quality objectives measurable?<br>

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

5.5.1 Responsibility and Authority

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

5.5.2 Management Representative

  • Has top management appointed a management representative?

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

5.5.3 Internal Communication

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

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

5.6.1 Management Review - General

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

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

5.6.2 Review Input

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

5.6.3 Review Output

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

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>

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

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

6.3 Infrastructure

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

6.4 Work Environment

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

7.2.1 Sales Enquiry and Order Process

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

  • Are enquiries logged and followed up?

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

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>

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

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

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

7.2.3 Customer Communication

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

7.3.1 Design and Development Process?

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

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

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

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

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

7.4.2 Purchasing and Receipt Verification Process

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

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

7.4.1 Supplier Evaluation and Approval

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

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

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

7.4.3 Verification of Purchased Product

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

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

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

7.5.1 Warehouse and Despatch Process

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

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

  • Is the warehouse equipment maintained effective?<br>

  • Are Proof of delivery records maintained?

  • Are picking errors recorded and analysed?

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

  • Are non conforming products clearly identified?

7.5.4 Customer property

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

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

7.5.2 (8.2.4) Manufacturing Process

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

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

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

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

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

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

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

7.6 Control of monitoring and measuring equipment

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

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

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

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

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

8.2.1 Customer satisfaction

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

8.2.2 Internal Audit

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

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

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

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

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

8.3 Control of nonconforming product

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

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

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

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

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

8.4 Analysis of data

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

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

8.5.2 Corrective action

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

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

  • determining the causes of nonconformities?<br>

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

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

8.5.3 Preventive action

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

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

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

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

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

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.