• Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

4.1 Organisation

Scope of management system 4.1.3

  • ensure management system covers activities in the laboratory’s permanent facility, sites away from its permanent facilities, temporary or mobile facilities

Conflict of interest 4.1.4

  • when part of an organisation, ensure the laboratory defines the responsibilities of key personnel to identify potential conflicts of interest

Managerial and technical personnel 4.1.5a

  • How do we ensure managerial and technical personnel have the authority and resources needed to carry out duties and to identify and initiate actions to prevent or minimise departures from the management system or testing/calibration procedures

Undue pressure 4.1.5b

  • How do we ensure arrangements are in place so that management and personnel are free from internal and external commercial, financial and other pressures that might adversely affect the quality of their work

Customer confidentiality 4.1.5c

  • How do we ensure there are policies and procedures related to customer confidentiality, including electronic storage and transmission of results. Demonstrate how we look after our customers.

Operational integrity 4.1.5d

  • ensure the laboratory has policies and procedures to avoid involvement in activities that compromise the confidence in its competence, impartiality, judgement or operational integrity

Organisation chart 4.1.5e

  • Confirm that the organisation and management structure needs to be defined, including relationships between quality management, technical operations, support services and parent organisation (if applicable)

Responsibility and authority 4.1.5f

  • specify the responsibility and authority of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations

Laboratory supervision 4.1.5g

  • Can it be confirmed that adequate supervision by appropriate personnel of all staff involved in calibration and testing activities

Technical management 4.1.5h

  • identify technical management that has overall responsibility for technical operations and resources

Quality manager 4.1.5i

  • appoint a member of staff, with direct access to senior management, as quality manager who has defined responsibility and authority for implementing and maintaining the management system

Managerial deputies 4.1.5j

  • Who are the, appointed deputies for key managerial personnel

Importance of roles 4.1.5k

  • How do you ensure personnel aware of relevance and importance of their activities and how they contribute to the objectives of the management system

Appropriate communi- cation 4.1.6

  • How do we ensure that the appropriate communication processes is established and include the effectiveness of the management system

4.2 Management System

Policies and procedures 4.2.1

  • Is a document policies and procedures as a management system to ensure quality of all work and that they are communicated, available, understood and implemented

Quality policy statement 4.2.2

  • ensure the quality policy statement is issued under the authority of top management and includes:<br>􏰀 the laboratory management’s commitment to good professional practice and quality of its service<br>􏰀 a statement of the laboratory’s standard of service<br>􏰀 the purpose of the management system<br>a requirement for all personnel to be familiar with and implement the quality documentation<br>􏰀 the laboratory management’s commitment to compliance with the Standard and to continually improve the management system<br>􏰀 these overall objectives are to be reviewed as part of management review

Quality manual 4.2.2, 4.2.5, 4.2.6

  • maintain a quality manual that:<br>􏰀 defines management system policies and objectives<br>􏰀 includes or makes reference to supporting procedures, including technical procedures and outlines structure of the documentation in the management system<br>􏰀 defines the roles and responsibilities of technical management and the quality manager

Commitment to management system 4.2.3

  • Where is it highlighted, that evidence of commitment to development, implementation and continual improvement of the management system must be available

Customer requirements 4.2.4

  • How do we communicate, importance of meeting customer, statutory and regulatory requirements.

Changes to management system 4.2.7

  • (Authorised change) integrity of the management system must be maintained when changes are made

4.3 Document Control

Procedures 4.3.1

  • How do we ensure procedures to control all documentation included in the management system are established and maintained

Approval and issue

  • How do we ensure documents are reviewed and approved by authorised personnel prior to issue, and are included on a master list which identifies the revision status and distribution


  • ensure all necessary quality documentation is available where required, reviewed and revised to maintain suitability

Obsolete documents

  • ensure documents are removed when obsolete and suitably marked if retained for either legal or knowledge preservation purposes


  • Confirm the following, that all management system documents must be uniquely identified and include date of issue and/or revision identification, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority(ies)

Document changes

  • ensure changes to documents are reviewed and approved by the same function that performed the original review, or a designate

Altered or new text

  • ensure where practical, the altered or new text is identified in the document or the appropriate attachments

Handwritten amendments

  • ensure if hand written amendments are allowed, defined procedures are available, which include authorities, clear marking, initialling, dating, and formal re-issue

Electronic documents

  • establish procedures to describe how changes in documents maintained electronically are made and controlled

4.4 Review of requests, tenders and contracts

Policies and procedures 4.4.1, 4.4.3

  • ensure policies and procedures related to review of requests, tenders and contracts are established, maintained and include:<br>􏰀 defining, documenting and understanding customer requirements before commencing work<br>􏰀 laboratory’s capability and resources<br>􏰀 appropriate method selection<br>􏰀 work that is subcontracted by the laboratory

Records of review 4.4.2

  • maintain records of reviews, including any significant discussions and/or changes throughout the contract

Notification of customer 4.4.4

  • How do we ensure customer is informed of any deviation from the contract

Changes to contracts 4.4.5

  • ensure same contract review process is repeated if a contract has to be amended after work has commenced and that all affected staff are advised of the amendment

4.5 Subcontracting of tests and calibrations

Competency 4.5.1, 4.5.4

  • NA_ensure that subcontractors are competent (eg accredited laboratory) and records are maintained of subcontractors used and their competency (eg scope of accreditation)

Customer approval 4.5.2

  • ensure customer is advised in writing and approval gained where appropriate

Responsibility 4.5.3

  • Is there a statment somewhere? unless customer or regulatory authority specifies subcontractor, laboratory is responsible for subcontractors’ work

4.6 Purchasing services and supplies

Policies and procedures 4.6.1

  • document policies and procedures for selection, purchasing, reception and storage of relevant services and supplies

Verification 4.6.2

  • ensure all purchased supplies that affect the quality are not used until verified as complying with defined specifications, and records of the actions taken to demonstrate compliance are maintained

Purchasing documents 4.6.3

  • ensure purchasing documents for items affecting the quality of work are reviewed and approved for technical content prior to release

Approved suppliers 4.6.4

  • maintain a list and records of the evaluations of all approved suppliers

4.7 Service to the customer

Cooperation 4.7.1

  • cooperate with customers to clarify requests and monitor laboratory's performance whilst ensuring confidentiality to other customers

Feedback 4.7.2

  • feedback must be sought and used to improve the laboratory’s activities

4.8 Complaints

Policy, procedure and records 4.8

  • document policy and procedure for the resolution of complaints from customers or other parties and ensure records of the complaints, investigations and corrective actions (4.11) are maintained

4.9 Control of nonconforming testing and/or calibration work

  • document policy and procedure for the resolution of complaints from customers or other parties and ensure records of the complaints, investigations and corrective actions (4.11) are maintained

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