NELAC V1M2 Management 2012-0717

• Audit Title

• Document No.

• Client / Site

• Conducted on

  Date

• Prepared by

• Location
  Address

• Personnel

• Audit Type

  internal audit

  external audit

21) V1M2 4.1: Organization (ISO/IEC 17025:2005(E), Clause 4.1)

• 22) V1M2 4.1.1: The laboratory or the organization of which it is part shall be an entity that can be held legally responsible.

  Drawing

• 23) V1M2 4.1.2: It is the responsibility of the laboratory to carry out its testing and calibration activities in such a way as

• 24) V1M2 4.1.2: to meet the requirements of this International Standard

  Yes

  No

  N/A

• 25) V1M2 4.1.2: and to satisfy the needs of the customer, the regulatory authorities or organizations providing recognition.

  Yes

  No

  N/A

• 26) V1M2 4.1.3: The management system shall cover work carried out in the laboratory's permanent facilities, at sites away from its permanent facilities, or in associated temporary or mobile facilities.

  Yes

  No

  N/A

• 27) V1M2 4.1.4: If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

  Yes

  No

  N/A

• 28) V1M2 4.1.4 N1: NOTE 1: Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory's compliance with the requirements of this International Standard.

• 29) V1M2 4.1.4 N2: NOTE 2: If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgment. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgment and integrity in relation to its testing or calibration activities.

• 30) V1M2 4.1.5: The laboratory shall:

• 31) 4.1.5 a): have managerial and technical personnel who, irrespective of other responsibilities, have the authority and resources needed to carry out their duties, including

  Yes

  No

  N/A

• 32) V1M2 4.1.5 a): have managerial and technical personnel who have the authority and resources needed to carry out the implementation, maintenance and improvement of the management system,

  Yes

  No

  N/A

• 33) V1M2 4.1.5 a): have managerial and technical personnel who have the authority and resources needed to identify the occurrence of departures from the management system or from the procedures for performing tests and/or calibrations

  Yes

  No

  N/A

• 34) V1M2 4.1.5 a): have managerial and technical personnel who have the authority and resources needed to initiate actions to prevent or minimize such departures (see also 5.2);

  Yes

  No

  N/A

• 35) V1M2 4.1.5 b): have arrangements to ensure that its management and personnel are free from any undue internal and external commercial, financial and other pressures and influences that may adversely affect the quality of their work;

  Yes

  No

  N/A

• 36) V1M2 4.1.5 c): have policies and procedures to ensure the protection of its customers' confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results;

  Yes

  No

  N/A

• 37) V1M2 4.1.5 d): have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational integrity;

  Yes

  No

  N/A

• 38) V1M2 4.1.5 e): define the organization and management structure of the laboratory, its place in any parent organization, and the relationships between quality management, technical operations and support services; (V1M2 4.2.8.4 e)

• 39) V1M2 4.1.5 f): specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work affecting the quality of the tests and/or calibrations;
  (V1M2 4.2.8.4 e and 5.2.5)

• 40) V1M2 4.1.5 g): provide adequate supervision of testing and calibration staff, including trainees, by persons familiar with methods and procedures, purpose of each test and/or calibration, and with the assessment of the test or calibration results; (see V1M2 4.2.8.4 e and 5.2.1)

• 41) V1M2 4.1.5 h): have technical management which has overall responsibility for the technical operations and the provision of the resources needed to ensure the required quality of laboratory operations;

  Yes

  No

  N/A

• 42) V1M2 4.1.5 i): Note: This is different from the actual qualifications of a Quality Manager. Can be determined from the organizational chart, the description of duties, and any documents relating to the selection qualifications and criteria for the position.

  Yes

  No

  N/A

• 43) V1M2 4.1.5 i): appoint a member of staff as quality manager (however named) who, irrespective of other duties and responsibilities, shall have defined responsibility and authority for ensuring that the management system related to quality is implemented and followed at all ; the quality manager shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources;

  Yes

  No

  N/A

• 44) V1M2 4.1.5 j): appoint deputies for key managerial personnel (see Note);

  Yes

  No

  N/A

• 45) V1M2 4.1.5 k): ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the objectives of the management system.

  Yes

  No

  N/A

• 46) V1M2 4.1.5 k) N: NOTE: Individuals may have more than one function and it may be impractical to appoint deputies for every function.

• 47) V1M2 4.1.6: Top management shall ensure that appropriate communication processes are established within the laboratory and that communication takes place regarding the effectiveness of the management system.

  Yes

  No

  N/A

48) V1M2 4.1.7: Additional Requirements for Laboratories

• 49) V1M2 4.1.7.1: The laboratory's quality manager and/or his/her designee(s) shall:

• 51) V1M2 4.1.7.1 a): serve as the focal point for QA/QC and be responsible for the oversight and/or review of quality control data;

  Yes

  No

  N/A

• 52) V1M2 4.1.7.1 b): have functions independent from laboratory operations for which they have quality assurance oversight;

  Yes

  No

  N/A

• 53) V1M2 4.1.7.1 c): be able to evaluate data objectively and perform assessments without outside (e.g., managerial) influence;

  Yes

  No

  N/A

• 54) V1M2 4.1.7.1 d): have documented training and/or experience in QA/QC procedures and the laboratory’s quality system;

  Yes

  No

  N/A

• 55) V1M2 4.1.7.1 e): have a general knowledge of the analytical methods for which data review is performed;

  Yes

  No

  N/A

• 56) V1M2 4.1.7.1 f): arrange for or conduct internal audits as per Section 4.14 annually;

  Yes

  No

  N/A

• 57) V1M2 4.1.7.1 g): notify laboratory management of deficiencies in the quality system; and

  Yes

  No

  N/A

• 58) V1M2 4.1.7.1 h): monitor corrective actions.

  Yes

  No

  N/A

• 59) V1M2 4.1.7.1 h) N: NOTE: Where staffing is limited, the quality manager may also be the technical manager.

• 60) V1M2 4.1.7.2: The laboratory's technical manager(s), however named, and/or his/her designee(s) shall:

• 61) V1M2 4.1.7.2 a): be a member of the staff of an environmental laboratory who exercises actual day-to-day supervision of laboratory operations for the appropriate fields of accreditation and reporting of results;

  Yes

  No

  N/A

• 62) V1M2 4.1.7.2 b): be experienced in the fields of accreditation for which the laboratory is seeking accreditation;

  Yes

  No

  N/A

• 63) V1M2 4.1.7.2 c): The laboratory's technical manager(s), however named, and/or his/her designee(s) shall have duties that include:

• 64) V1M2 4.1.7.2 c) i: • monitoring standards of performance in quality control and quality assurance, and

  Yes

  No

  N/A

• 65) V1M2 4.1.7.2 c) ii: • monitoring the validity of the analyses performed and data generated in the laboratory to assure reliable data.

  Yes

  No

  N/A

• 66) V1M2 4.1.7.2 d): not be the technical manager(s) of more than one accredited environmental laboratory without authorization from the primary Accreditation Body. Circumstances to be considered in the decision to grant such authorization shall include:

  Yes

  No

  N/A

• 67) V1M2 4.1.7.2 d) i: • the extent to which operating hours of the laboratories to be directed overlap,

• 68) V1M2 4.1.7.2 d) ii: • adequacy of supervision in each laboratory, and

• 69) V1M2 4.1.7.2 d) iii: • the availability of environmental laboratory services in the area served.

• 70) V1M2 4.1.7.2 e): if absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time staff member meeting the qualifications of the technical manager(s) to temporarily perform this function. If this absence exceeds thirty-five (35) consecutive calendar days, the primary accreditation body shall be notified in writing; and

  Yes

  No

  N/A

• 71) V1M2 4.1.7.2 f): meet qualification requirements as specified in Section 5.2.6.1.

  Yes

  No

  N/A

72) V1M2 4.2: Management (ISO/IEC 17025:2005(E), Clause 4.2)

• 74) V1M2 4.2.1: The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.

  Yes

  No

  N/A

• 75) V1M2 4.2.1: The system's documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel. (see also V1M2 4.1.6)

  Yes

  No

  N/A

• 76) V1M2 4.2.2: (Quality Policy Elements to be included in the Quality Manual - see V1M24.2.8.3 h)

  Yes

  No

  N/A

• 77) V1M2 4.2.2:
  The laboratory's management system policies related to quality, including a quality policy statement, shall be defined in a quality manual (however named). The overall objectives shall be established, and

• 78) V1M2 4.2.2: shall be reviewed during management review. The quality policy statement shall be issued under the authority of top management. It shall include at least the following:

• 79) V1M2 4.2.2 a): the laboratory management's commitment to good professional practice and to the quality of its testing and calibration in servicing its customers;

• 80) V1M2 4.2.2 b): the management's statement of the laboratory's standard of service;

• 81) V1M2 4.2.2 c): the purpose of the management system related to quality;

• 82) V1M2 4.2.2 d): The quality policy statement shall include a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work;

  Yes

  No

  N/A

• 83) V1M2 4.2.2 e): The quality policy statement shall include the laboratory management's commitment to comply with this International Standard and to continually improve the effectiveness of the management system.

  Yes

  No

  N/A

• 84) V1M2 4.2.2 e) N: NOTE: The quality policy statement should be concise and may include the requirement that tests and/or calibrations shall always be carried out in accordance with stated methods and customers' requirements. When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents.

• 85) V1M2 4.2.3: Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness.

  Yes

  No

  N/A

• 86) V1M2 4.2.4: Top management shall communicate to the organization the importance of meeting customer requirements as well as statutory and regulatory requirements.

  Yes

  No

  N/A

• 87) V1M2 4.2.5: The quality manual shall include or make reference to the supporting procedures including technical procedures. It shall outline the structure of the documentation used in the management system.

  Yes

  No

  N/A

• 88) V1M2 4.2.6: The roles and responsibilities of technical management and the quality manager, including their responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.

  Yes

  No

  N/A

• 89) V1M2 4.2.7: Top management shall ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.

  Yes

  No

  N/A

90) V1M2 4.2.8: Additional Management System Requirements

• 91) V1M2 4.2.8.1: The laboratory shall establish and maintain a documented data integrity system. There are four required elements within a data integrity system.

  Yes

  No

  N/A

• 92) V1M2 4.2.8.1: These are,

• 93) V1M2 4.2.8.1: • Data Integrity training.(see 5.2.7)

• 94) V1M2 4.2.8.1: • signed data integrity documentation for all laboratory employees,(see 5.2.7)

• 95) V1M2 4.2.8.1: The laboratory shall have within its data integrity system in-depth, periodic monitoring of data integrity,

  Yes

  No

  N/A

• 96) V1M2 4.2.8.1: • data integrity procedure documentation (see remainder of 4.2.8.1)

• 97) V1M2 4.2.8.1: The data integrity procedures shall be signed and dated by top management

  Yes

  No

  N/A

• 98) V1M2 4.2.8.1: The requirements for data integrity investigation are listed in Section 4.16. The requirements for data integrity training and documentation are listed in Section 5.2.7.

• 99) V1M2 4.2.8.1: Management shall annually review data integrity procedures and update as needed.

  Yes

  No

  N/A

• 100) V1M2 4.2.8.1 a): Laboratory management shall provide a procedure for confidential reporting of data integrity issues in their laboratory. A primary element of the procedure is to assure confidentiality and a receptive environment in which all employees may privately discuss ethical issues or report items of ethical concern.

  Yes

  No

  N/A

• 101) V1M2 4.2.8.1 b): In instances of ethical concern, the procedure shall include a process whereby laboratory management is to be informed of the need for any further detailed investigation.

  Yes

  No

  N/A

• 102) V1M2 4.2.8.2: The quality manager shall be responsible for maintaining the currency of the quality manual.

  Yes

  No

  N/A

• 103) V1M2 4.2.8.3: The quality manual shall contain:

• 104) V1M2 4.2.8.3 a): document title;

  Yes

  No

  N/A

• 105) V1M2 4.2.8.3 b): laboratory's full name and address;

  Yes

  No

  N/A

• 106) V1M2 4.2.8.3 c): name, address (if different from above), and telephone number of individual(s) responsible for the laboratory;

  Yes

  No

  N/A

• 107) V1M2 4.2.8.3 d): identification of all major organizational units which are to be covered by this quality manual and the effective date of the version;

  Yes

  No

  N/A

• 108) V1M2 4.2.8.3 e): identification of the laboratory's approved signatories;

  Yes

  No

  N/A

• 109) V1M2 4.2.8.3 f): the signed and dated concurrence (with appropriate names and titles), of all responsible parties including the quality manager(s), technical manager(s), and the agent who is in charge of all laboratory activities, such as the laboratory director or laboratory manager;

  Yes

  No

  N/A

• 110) V1M2 4.2.8.3 g): the objectives of the quality system and contain or reference the laboratory’s policies and procedures;

  Yes

  No

  N/A

• 111) V1M2 4.2.8.3 h): See V1M2 4.2.2, 4.2.2 a), b) and c) for specifics to be included in quality policy

  Yes

  No

  N/A

• 112) V1M2 4.2.8.3 h): the laboratory’s official quality policy statement, which shall include quality system objectives and management’s commitment to ethical laboratory practices and to upholding the requirements of this Standard; and

  Yes

  No

  N/A

• 113) V1M2 4.2.8.3 i): a table of contents, and applicable lists of references, glossaries and appendices.

  Yes

  No

  N/A

• 114) V1M2 4.2.8.4: The quality manual shall contain or reference:

• 115) V1M2 4.2.8.4 a): all maintenance, calibration and verification procedures used by the laboratory in conducting tests;

  Yes

  No

  N/A

• 116) V1M2 4.2.8.4 b): major equipment and reference measurement standards used as well as the facilities and services used by the laboratory in conducting tests;

  Yes

  No

  N/A

• 117) V1M2 4.2.8.4 c): verification practices, which may include inter-laboratory comparisons, proficiency testing programs, use of reference materials and internal quality control schemes;

  Yes

  No

  N/A

• 118) V1M2 4.2.8.4 d): procedures for reporting analytical results;

  Yes

  No

  N/A

• 119) V1M2 4.2.8.4 e): See V1M2 4.1.5 e) , f) and g) for specific requirements to be discussed.

  Yes

  No

  N/A

• 120) V1M2 4.2.8.4 e): the organization and management structure of the laboratory, its place in any parent organization, and relevant organizational charts;

  Yes

  No

  N/A

• 121) V1M2 4.2.8.4 f): See ViM2 4.13 for specifics information to be discussed

  Yes

  No

  N/A

• 122) V1M2 4.2.8.4 f): procedures to ensure that all records required under this Standard are retained,

  Yes

  No

  N/A

• 123) V1M2 4.2.8.4 f): procedures for control and maintenance of documentation through a document control system that ensures that all standard operating procedures (SOPs), manuals, or documents clearly indicate the time period during which the procedure or document was in force;

  Yes

  No

  N/A

• 124) V1M2 4.2.8.4 g): See V1M2 4.1.5 e) for additional information

  Yes

  No

  N/A

• 125) V1M2 4.2.8.4 g): job descriptions of key staff and reference to the job descriptions of other laboratory staff;

  Yes

  No

  N/A

• 126) V1M2 4.2.8.4 h): procedures for achieving traceability of measurements;

  Yes

  No

  N/A

• 127) V1M2 4.2.8.4 i): a list of all methods under which the laboratory performs its accredited testing;

  Yes

  No

  N/A

• 128) V1M2 4.2.8.4 j): procedures for ensuring that the laboratory reviews all new work to ensure that it has the appropriate facilities and resources before commencing such work;

  Yes

  No

  N/A

• 129) V1M2 4.2.8.4 k): procedures for handling samples;

  Yes

  No

  N/A

• 130) V1M2 4.2.8.4 l): procedures to be followed for feedback and corrective action whenever testing discrepancies are detected, or departures from documented policies and procedures occur;

  Yes

  No

  N/A

• 131) V1M2 4.2.8.4 m): policy for permitting departures from documented policies and procedures or from standard specifications;

  Yes

  No

  N/A

• 132) V1M2 4.2.8.4 n): procedures for dealing with complaints;

  Yes

  No

  N/A

• 133) V1M2 4.2.8.4 o): procedures for protecting confidentiality (including national security concerns), and proprietary rights;

  Yes

  No

  N/A

• 134) V1M2 4.2.8.4 p): procedures for audits and data review;

  Yes

  No

  N/A

• 135) V1M2 4.2.8.4 q): procedures for establishing that personnel are adequately experienced in the duties they are expected to carry out and are receiving any needed training; and

  Yes

  No

  N/A

• 136) V1M2 4.2.8.4 r): policy addressing the use of unique electronic signatures, where applicable.

  Yes

  No

  N/A

• 137) V1M2 4.2.8.5: Laboratories shall maintain SOPs that accurately reflect all phases of current laboratory activities, such as assessing data integrity, corrective actions, handling customer complaints, and all methods.

  Yes

  No

  N/A

• 138) V1M2 4.2.8.5 a): These documents, for example, may be equipment manuals provided by the manufacturer, or

  Yes

  No

  N/A

• 139) V1M2 4.2.8.5 a): These documents may be internally written documents with adequate detail to allow someone similarly qualified, other than the analyst, to reproduce the procedures used to generate the test result.

  Yes

  No

  N/A

• 140) V1M2 4.2.8.5 b): The relevant SOPs shall be readily accessible to all personnel.

  Yes

  No

  N/A

• 141) V1M2 4.2.8.5 c): Each SOP shall clearly indicate the effective date of the document, the revision number, and the signature(s) of the approving authority.

  Yes

  No

  N/A

• 142) V1M2 4.2.8.5 d): Documents that contain sufficient information to perform the tests, do not need to be supplemented or rewritten as internal procedures if the documents are written in a way that they can be used as written. Any changes, including the use of a selected option, shall be documented and included in the laboratory’s method records.

  Yes

  No

  N/A

• 143) V1M2 4.2.8.5 e): The laboratory shall have and maintain an SOP for each accredited analyte or method.

  Yes

  No

  N/A

• 144) V1M2 4.2.8.5 f): The SOP may be a copy of a published or referenced method or may be written by the laboratory. In cases where modifications to the published method have been made by the laboratory or where the referenced method is ambiguous or provides insufficient detail, these changes or clarifications shall be clearly described. (4.2.8.5 d))

• 145) V1M2 4.2.8.5 f): Each method shall include or reference the following topics where applicable:

• 145.1) V1M2 4.2.8.5 f) i): identification of the method

  Yes

  No

  N/A

• 146) V1M2 4.2.8.5 f) ii): applicable matrix or matrices;

  Yes

  No

  N/A

• 147) V1M2 4.2.8.5 f) iii): limits of detection and quantitation ;

  Yes

  No

  N/A

• 148) V1M2 4.2.8.5 f) iv): scope and application, including parameters to be analyzed;

  Yes

  No

  N/A

• 149) V1M2 4.2.8.5 f) v): summary of the method;

  Yes

  No

  N/A

• 150) V1M2 4.2.8.5 f) vi): definitions;

  Yes

  No

  N/A

• 151) V1M2 4.2.8.5 f) vii): interferences;

  Yes

  No

  N/A

• 152) V1M2 4.2.8.5 f) viii): safety;

  Yes

  No

  N/A

• 153) V1M2 4.2.8.5 f) ix): equipment and supplies;

  Yes

  No

  N/A

• 154) V1M2 4.2.8.5 f) x): reagents and standards;

  Yes

  No

  N/A

• 155) V1M2 4.2.8.5 f) xi): sample collection, preservation, shipment and storage;

  Yes

  No

  N/A

• 156) V1M2 4.2.8.5 f) xii): quality control;

  Yes

  No

  N/A

• 157) V1M2 4.2.8.5 f) xiii): calibration and standardization;

  Yes

  No

  N/A

• 158) V1M2 4.2.8.5 f) xiv): procedure;

  Yes

  No

  N/A

• 159) V1M2 4.2.8.5 f) xv): data analysis and calculations;

  Yes

  No

  N/A

• 160) V1M2 4.2.8.5 f) xvi): method performance;

  Yes

  No

  N/A

• 161) V1M2 4.2.8.5 f) xvii): pollution prevention;

  Yes

  No

  N/A

• 162) V1M2 4.2.8.5 f) xviii): data assessment and acceptance criteria for quality control measures;

  Yes

  No

  N/A

• 163) V1M2 4.2.8.5 f) xix): corrective actions for out-of-control data;

  Yes

  No

  N/A

• 164) V1M2 4.2.8.5 f) xx): contingencies for handling out-of-control or unacceptable data;

  Yes

  No

  N/A

• 165) V1M2 4.2.8.5 f) xxi): waste management;

  Yes

  No

  N/A

• 166) V1M2 4.2.8.5 f) xxii): references; and

  Yes

  No

  N/A

• 167) V1M2 4.2.8.5 f) xxiii): any tables, diagrams, flowcharts and validation data.

  Yes

  No

  N/A

168) V1M2 4.3: Document Control (ISO/IEC 17025:2005(E), Clause 4.3)

169) V1M2 4.3.1: General

• 170) V1M2 4.3.1: The laboratory shall establish and maintain procedures to control all documents that form part of its management system (internally generated or from external sources), such as regulations, standards, other normative documents, test and/or calibration methods, as well as drawings, software, specifications, instructions and manuals.

  Yes

  No

  N/A

• 171) V1M2 4.3.1 N1: NOTE 1: In this context "document" could be policy statements, procedures, specifications, calibration tables, charts, text books, posters, notices, memoranda, software, drawings, plans, etc. These may be on various media, whether hard copy or electronic, and they may be digital, analog, photographic or written.

• 172) V1M2 4.3.1 N2: NOTE 2: The control of data related to testing and calibration is covered in 5.4.7. The control of records is covered in 4.13.

173) V1M2 4.3.2: Document Approval and Issue

• 174) V1M2 4.3.2.1: All documents issued to personnel in the laboratory as part of the management system shall be reviewed and approved for use by authorized personnel prior to issue.

  Yes

  No

  N/A

• 175) V1M2 4.3.2.1: A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system shall be established and shall be readily available to preclude the use of invalid and/or obsolete documents.

  Yes

  No

  N/A

• 176) V1M2 4.3.2.2: The document procedure(s) adopted shall ensure that:

• 177) V1M2 4.3.2.2 a): authorized editions of appropriate documents are available at all locations where operations essential to the effective functioning of the laboratory are performed;

  Yes

  No

  N/A

• 178) V1M2 4.3.2.2 b): documents are periodically reviewed and, where necessary, revised to ensure continuing suitability and compliance with applicable requirements;

  Yes

  No

  N/A

• 179) V1M2 4.3.2.2 c): invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

  Yes

  No

  N/A

• 180) V1M2 4.3.2.2 d): obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

  Yes

  No

  N/A

• 181) V1M2 4.3.2.3: Management system documents generated by the laboratory shall be uniquely identified.

  Yes

  No

  N/A

• 182) V1M2 4.3.2.3: Management system document identification shall include the date of issue and/or revision identification, page numbering, the total number of pages or a mark to signify the end of the document, and the issuing authority(ies).

  Yes

  No

  N/A

183) V1M2 4.3.3: Document Changes

• 184) V1M2 4.3.3.1: Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.

  Yes

  No

  N/A

• 185) V1M2 4.3.3.1: The designated personnel shall have access to pertinent background information upon which to base their review and approval.

  Yes

  No

  N/A

• 186) V1M2 4.3.3.2: Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.

  Yes

  No

  N/A

• 187) V1M2 4.3.3.3: If the laboratory's document control system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.

  Yes

  No

  N/A

• 188) V1M2 4.3.3.3: Amendments shall be clearly marked, initialled and dated.

  Yes

  No

  N/A

• 189) V1M2 4.3.3.3: A revised document shall be formally re-issued as soon as practicable.

  Yes

  No

  N/A

• 190) V1M2 4.3.3.4: Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled.

  Yes

  No

  N/A

191) V1M2 4.4: Review of Requests, Tenders and Contracts (ISO/IEC 17025:2005(E), Clause 4.4)

• 192) V1M2 4.4.1: The laboratory shall establish and maintain procedures for the review of requests, tenders and contracts. (4.4.1 a) through c)

• 193) V1M2 4.4.1 a): The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the requirements, including the methods to be used, are adequately defined, documented and understood (see 5.4.2);

  Yes

  No

  N/A

• 194) V1M2 4.4.1 b): The policies and procedures for the review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the laboratory has the capability and resources to meet the requirements;

  Yes

  No

  N/A

• 195) V1M2 4.4.1 c): The policies and procedures for he review of requests, tenders and contracts leading to a contract for testing and/or calibration shall ensure that: the appropriate test and/or calibration method is selected and is capable of meeting the customers' requirements (see 5.4.2).

  Yes

  No

  N/A

• 196) V1M2 4.4.1 c): Any differences between the request or tender and the contract shall be resolved before any work commences. Each contract shall be acceptable both to the laboratory and the customer.

  Yes

  No

  N/A

• 197) V1M2 4.4.1 c) N1: NOTE 1: The request, tender and contract review should be conducted in a practical and efficient manner, and the effect of financial, legal and time schedule aspects should be taken into account. For internal customers, reviews of requests, tenders and contracts can be performed in a simplified way.

• 198) V1M2 4.4.1 c) N2: NOTE 2: The review of capability should establish that the laboratory possesses the necessary physical, personnel and information resources, and that the laboratory's personnel have the skills and expertise necessary for the performance of the tests and/or calibrations in question. The review may also encompass results of earlier participation in interlaboratory comparisons or proficiency testing and/or the running of trial test or calibration programmes using samples or items of known value in order to determine uncertainties of measurement, limits of detection, confidence limits, etc.

• 199) V1M2 4.4.1 c) N3: NOTE 3: A contract may be any written or oral agreement to provide a customer with testing and/or calibration services.

• 200) V1M2 4.4.2: Records of the review of requests, tenders and contracts, including any significant changes, shall be maintained.

  Yes

  No

  N/A

• 201) V1M2 4.4.2: Records shall also be maintained of pertinent discussions with a customer relating to the customer's requirements or the results of the work during the period of execution of the contract.

  Yes

  No

  N/A

• 202) V1M2 4.4.2 N: NOTE: For review of routine and other simple tasks, the date and the identification (e.g. the initials) of the person in the laboratory responsible for carrying out the contracted work are considered adequate. For repetitive routine tasks, the review need be made only at the initial enquiry stage or on granting of the contract for on-going routine work performed under a general agreement with the customer, provided that the customer's requirements remain unchanged. For new, complex or advanced testing and/or calibration tasks, a more comprehensive record should be maintained.

• 203) V1M2 4.4.3: The review of requests, tenders and contracts shall also cover any work that is subcontracted by the laboratory.

  Yes

  No

  N/A

• 204) V1M2 4.4.4: The customer shall be informed of any deviation from the contract.

  Yes

  No

  N/A

• 205) V1M2 4.4.5: If a contract needs to be amended after work has commenced, the same contract review process shall be repeated and any amendments shall be communicated to all affected personnel.

  Yes

  No

  N/A

206) V1M2 4.5: Subcontracting of Environmental Tests (ISO/IEC 17025:2005(E), Clause 4.5)

• 207) V1M2 4.5.1: When a laboratory subcontracts work, whether because of unforeseen reasons (e.g. workload, need for further expertise or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this work shall be placed with a competent subcontractor. A competent subcontractor is one that, for example, complies with this International Standard for the work in question.

• 208) V1M2 4.5.2: The laboratory shall advise the customer of the arrangement in writing and, when appropriate, gain the approval of the customer, preferably in writing.

  Yes

  No

  N/A

• 209) V1M2 4.5.3: The laboratory is responsible to the customer for the subcontractor's work, except in the case where the customer or a regulatory authority specifies which subcontractor is to be used.

  Yes

  No

  N/A

• 210) V1M2 4.5.4: The laboratory shall maintain a register of all subcontractors that it uses for tests and/or calibrations and a record of the evidence of compliance with this International Standard for the work in question.

  Yes

  No

  N/A

• 211) V1M2 4.5.5: When a laboratory subcontracts work, this work shall be placed with a laboratory accredited to this Standard for the tests to be performed or with a laboratory that meets applicable statutory and regulatory requirements for performing the tests and submitting the results of tests performed.

  Yes

  No

  N/A

• 212) V1M2 4.5.5: The laboratory performing the subcontracted work shall be indicated in the final report.

  Yes

  No

  N/A

• 213) V1M2 4.5.5: The laboratory shall make a copy of the subcontractor’s report available to the client when requested.

  Yes

  No

  N/A

214) V1M2 4.6: Purchasing Services and Supplies (ISO/IEC 17025:2005(E), Clause 4.6)

• 215) V1M2 4.6.1: The laboratory shall have a policy and procedure(s) for the selection and purchasing of services and supplies it uses that affect the quality of the tests and/or calibrations.

  Yes

  No

  N/A

• 216) V1M2 4.6.1: Procedures shall exist for the purchase, reception and storage of reagents and laboratory consumable materials relevant for the tests and calibrations.

  Yes

  No

  N/A

• 217) V1M2 4.6.2: The laboratory shall ensure that purchased supplies and reagents and consumable materials that affect the quality of tests and/or calibrations are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned.

  Yes

  No

  N/A

• 218) V1M2 4.6.2: These services and supplies used shall comply with specified requirements.

  Yes

  No

  N/A

• 219) V1M2 4.6.2: Records of actions taken to check compliance of services and supplies shall be maintained.

  Yes

  No

  N/A

• 220) V1M2 4.6.3: Purchasing documents for items affecting the quality of laboratory output shall contain data describing the services and supplies ordered.

  Yes

  No

  N/A

• 221) V1M2 4.6.3: These purchasing documents shall be reviewed and approved for technical content prior to release.

  Yes

  No

  N/A

• 222) V1M2 4.6.3 N: NOTE: The description may include type, class, grade, precise identification, specifications, drawings, inspection instructions, other technical data including approval of test results, the quality required and the management system standard under which they were made.

• 223) V1M2 4.6.4: The laboratory shall evaluate suppliers of critical consumables, supplies and services which affect the quality of testing and calibration,

  Yes

  No

  N/A

• 224) V1M2 4.6.4: The laboratory shall maintain records of the evaluation suppliers of critical consumables, supplies and services and list those approved.

  Yes

  No

  N/A

225) V1M2 4.7: Service to the Client (ISO/IEC 17025:2005(E), Clause 4.7)

• 226) V1M2 4.7.1: The laboratory shall be willing to cooperate with customers or their representatives in clarifying the customer's request and in monitoring the laboratory's performance in relation to the work performed, provided that the laboratory ensures confidentiality to other customers.

  Yes

  No

  N/A

• 227) V1M2 4.7.1 N1: NOTE 1: Such cooperation may include:

• 228) V1M2 4.7.1 N1 a): providing the customer or the customer's representative reasonable access to relevant areas of the laboratory for the witnessing of tests and/or calibrations performed for the customer;

• 229) V1M2 4.7.1 N1 b): preparation, packaging, and dispatch of test and/or calibration items needed by the customer for verification purposes.

• 230) V1M2 4.7.1 N2: NOTE 2: Customers value the maintenance of good communication, advice and guidance in technical matters, and opinions and interpretations based on results. Communication with the customer, especially in large assignments, should be maintained throughout the work. The laboratory should inform the customer of any delays or major deviations in the performance of the tests and/or calibrations.

• 231) V1M2 4.7.2: The laboratory shall seek feedback, both positive and negative, from its customers.

  Yes

  No

  N/A

• 232) V1M2 4.7.2: The feedback shall be used and analysed to improve the management system, testing and calibration activities and customer service.

  Yes

  No

  N/A

• 233) V1M2 4.7.2 N: NOTE: Examples of the types of feedback include customer satisfaction surveys and review of test or calibration reports with customers.

234) V1M2 4.8: Complaints (ISO/IEC 17025:2005(E), Clause 4.8)

• 235) V1M2 4.8: The laboratory shall have a policy and procedure for the resolution of complaints received from customers or other parties.

  Yes

  No

  N/A

• 236) V1M2 4.8: Records shall be maintained of all complaints and of the investigations and corrective actions taken by the laboratory (see also 4.11).

  Yes

  No

  N/A

237) V1M2 4.9: Control of Nonconforming Environmental Testing Work (ISO/IEC 17025:2005(E), Clause 4.9)

• 238) V1M2 4.9.1: The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. The policy and procedures shall ensure that:

  Yes

  No

  N/A

• 239) V1M2 4.9.1: The policy and procedures shall ensure that:

• 240) V1M2 4.9.1 a): the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified;

  Yes

  No

  N/A

• 241) V1M2 4.9.1 b): an evaluation of the significance of the nonconforming work is made;

  Yes

  No

  N/A

• 242) V1M2 4.9.1 c): correction is taken immediately, together with any decision about the acceptability of the nonconforming work;

  Yes

  No

  N/A

• 243) V1M2 4.9.1 d): where necessary, the customer is notified and work is recalled;

  Yes

  No

  N/A

• 244) V1M2 4.9.1 e): the responsibility for authorizing the resumption of work is defined.

  Yes

  No

  N/A

• 245) V1M2 4.9.1 e) N: NOTE: Identification of nonconforming work or problems with the management system or with testing and/or calibration activities can occur at various places within the management system and technical operations. Examples are customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and calibration certificate checking, management reviews and internal or external audits.

• 246) V1M2 4.9.2: Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory's operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly followed.

  Yes

  No

  N/A

247) V1M2 4.1: Improvement (ISO/IEC 17025:2005(E), Clause 4.10)

• 248) V1M2 4.1: The laboratory shall continually improve the effectiveness of its management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

  Yes

  No

  N/A

249) V1M2 4.11: Corrective Action (ISO/IEC 17025:2005(E), Clause 4.11)

250) V1M2 4.11.1: General

• 251) V1M2 4.11.1: The laboratory shall establish a policy and a procedure for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

  Yes

  No

  N/A

• 252) V1M2 4.11.1: The laboratory shall designate appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and procedures in the management system or technical operations have been identified.

  Yes

  No

  N/A

• 253) V1M2 4.11.1 N: NOTE: A problem with the management system or with the technical operations of the laboratory may be identified through a variety of activities, such as control of nonconforming work, internal or external audits, management reviews, feedback from customers and from staff observations.

254) V1M2 4.11.2: Cause Analysis

• 255) V1M2 4.11.2: The procedure for corrective action shall start with an investigation to determine the root cause(s) of the problem.

  Yes

  No

  N/A

• 256) V1M2 4.11.2 N: NOTE: Cause analysis is the key and sometimes the most difficult part in the corrective action procedure. Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include customer requirements, the samples, sample specifications, methods and procedures, staff skills and training, consumables, or equipment and its calibration.

257) V1M2 4.11.3: Selection and Implementation of Corrective Actions

• 258) V1M2 4.11.3: Where corrective action is needed, the laboratory shall identify potential corrective actions

  Yes

  No

  N/A

• 259) V1M2 4.11.3: It shall select and implement the action(s) most likely to eliminate the problem and to prevent recurrence.

  Yes

  No

  N/A

• 260) V1M2 4.11.3: Corrective actions shall be to a degree appropriate to the magnitude and the risk of the problem.

  Yes

  No

  N/A

• 261) V1M2 4.11.3: The laboratory shall document and implement any required changes resulting from corrective action investigations.

  Yes

  No

  N/A

262) V1M2 4.11.4: Monitoring of Corrective Actions

• 263) V1M2 4.11.4: The laboratory shall monitor the results to ensure that the corrective actions taken have been effective.

  Yes

  No

  N/A

264) V1M2 4.11.5: Additional Audits

• 265) V1M2 4.11.5: Where the identification of nonconformities or departures casts doubts on the laboratory's compliance with its own policies and procedures, or on its compliance with this International Standard, the laboratory shall ensure that the appropriate areas of activity are audited in accordance with 4.14 as soon as possible.

  Yes

  No

  N/A

• 266) V1M2 4.11.5 N: NOTE: Such additional audits often follow the implementation of the corrective actions to confirm their effectiveness. An additional audit should be necessary only when a serious issue or risk to the business is identified.

• 267) V1M2 4.11.6: The laboratory shall have documented procedure(s) to address 4.11.1 (see 4.11.1)

• 268) V1M2 4.11.6: The laboratory shall have documented procedure(s) to address 4.11.3

  Yes

  No

  N/A

• 269) V1M2 4.11.6: The laboratory shall have documented procedure(s) to address 4.11.4

  Yes

  No

  N/A

• 270) V1M2 4.11.6: The laboratory shall have documented procedure(s) to address 4.11.5

  Yes

  No

  N/A

• 271) V1M2 4.11.6 a): These procedure(s) shall also include: which individual(s) or positions are responsible for assessing each QC data type; and

  Yes

  No

  N/A

• 272) V1M2 4.11.6 b): These procedure(s) shall also include: which individual(s) or positions are responsible for initiating and/or recommending corrective actions.

  Yes

  No

  N/A

• 273) V1M2 4.11.7: Cause analysis described in 4.11.2 applies to failures that indicate a systematic error.

  Yes

  No

  N/A

274) V1M2 4.12: Preventive Action (ISO/IEC 17025:2005(E), Clause 4.12)

• 275) V1M2 4.12.1: Needed improvements and potential sources of nonconformities, either technical or concerning the management system, shall be identified.

  Yes

  No

  N/A

• 276) V1M2 4.12.1: When improvement opportunities are identified or if preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement.

  Yes

  No

  N/A

• 277) V1M2 4.12.2: Procedures for preventive actions shall include the initiation of such actions and the application of controls to ensure that they are effective.

  Yes

  No

  N/A

• 278) V1M2 4.12.2 N1: NOTE 1: Preventive action is a pro-active process to identify opportunities for improvement rather than a reaction to the identification of problems or complaints.

• 279) V1M2 4.12.2 N2: NOTE 2: Apart from the review of the operational procedures, the preventive action might involve analysis of data, including trend and risk analyses and proficiency-testing results.

280) V1M2 4.13: Control of Records (ISO/IEC 17025:2005(E), Clause 4.13)

281) V1M2 4.13.1: General

• 282) V1M2 4.13.1.1: The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records.

  Yes

  No

  N/A

• 283) V1M2 4.13.1.1: Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions.

  Yes

  No

  N/A

• 284) V1M2 4.13.1.2: All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss.

  Yes

  No

  N/A

• 285) V1M2 4.13.1.2: Retention times of records shall be established.

  Yes

  No

  N/A

• 286) V1M2 4.13.1.2 N: NOTE: Records may be in any media, such as hard copy or electronic media.

• 287) V1M2 4.13.1.3: All records shall be held secure and in confidence.

  Yes

  No

  N/A

• 288) V1M2 4.13.1.4: The laboratory shall have procedures to protect and back-up records stored electronically

  Yes

  No

  N/A

• 289) V1M2 4.13.1.4: The laboratory shall have procedures to prevent unauthorized access to or amendment of these records.

  Yes

  No

  N/A

290) V1M2 4.13.2: Technical Records

• 291) V1M2 4.13.2.1: The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period.

  Yes

  No

  N/A

• 292) V1M2 4.13.2.1: The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original.(4.13.3 f)

• 293) V1M2 4.13.2.1: The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.

  Yes

  No

  N/A

• 294) V1M2 4.13.2.1 N1: NOTE 1: In certain fields it may be impossible or impractical to retain records of all original observations.

• 295) V1M2 4.13.2.1 N2: NOTE 2: Technical records are accumulations of data (see 5.4.7) and information which result from carrying out tests and/or calibrations and which indicate whether specified quality or process parameters are achieved. They may include forms, contracts, work sheets, work books, check sheets, work notes, control graphs, external and internal test reports and calibration certificates, customers' notes, papers and feedback.

• 296) V1M2 4.13.2.2: Observations, data and calculations shall be recorded at the time they are made and shall be identifiable to the specific task.

  Yes

  No

  N/A

• 297) V1M2 4.13.2.3: When mistakes occur in records, each mistake shall be crossed out, not erased, made illegible or deleted, and the correct value entered alongside.

  Yes

  No

  N/A

• 298) V1M2 4.13.2.3: All such alterations to records shall be signed or initialled by the person making the correction.

  Yes

  No

  N/A

• 299) V1M2 4.13.2.3: In the case of records stored electronically, equivalent measures shall be taken to avoid loss or change of original data.

  Yes

  No

  N/A

300) V1M2 4.13.3: Additional Requirements

• 301) V1M2 4.13.3 a): The laboratory shall establish a record keeping system that allows the history of the sample and associated data to be readily understood through the documentation.

  Yes

  No

  N/A

• 302) V1M2 4.13.3 a): This system shall produce unequivocal, accurate records that document all laboratory activities such as laboratory facilities, equipment, analytical methods, and related laboratory activities, such as sample receipt, sample preparation, or data verification, and inter-laboratory transfers of samples and/or extracts.

  Yes

  No

  N/A

• 303) V1M2 4.13.3 b): The laboratory shall retain all records for a minimum of five years from generation of the last entry in the records.

  Yes

  No

  N/A

• 304) V1M2 4.13.3 c): Records shall be available to the accreditation body.

  Yes

  No

  N/A

• 305) V1M2 4.13.3 d): Records that are stored only on electronic media shall be supported by the hardware and software necessary for their retrieval.

  Yes

  No

  N/A

• 306) V1M2 4.13.3 e): Access to archived information shall be documented with an access log.

  Yes

  No

  N/A

• 307) V1M2 4.13.3 f): All information necessary for the historical reconstruction of data shall be maintained by the laboratory.

  Yes

  No

  N/A

• 308) V1M2 4.13.3 f): Historical reconstruction information shall include

• 309) V1M2 4.13.3 f) i: all raw data, whether hard copy or electronic, for calibrations, samples and quality control measures, including analysts’ worksheets and data output records (chromatograms, strip charts, and other instrument response readout records);

  Yes

  No

  N/A

• 310) V1M2 4.13.3 f) ii: a written description or reference to the specific test method used, which includes a description of the specific computational steps used to translate parametric observations into a reportable analytical value;

  Yes

  No

  N/A

• 311) V1M2 4.13.3 f) iii: laboratory sample ID code;

  Yes

  No

  N/A

• 312) V1M2 4.13.3 f) iv: date of analysis;

  Yes

  No

  N/A

• 313) V1M2 4.13.3 f) v: time of analysis is required if the holding time is seventy-two hours or less

  Yes

  No

  N/A

• 314) V1M2 4.13.3 f) v: time of analysis is required when time critical steps are included in the analysis (e.g., extractions and incubations);

  Yes

  No

  N/A

• 315) V1M2 4.13.3 f) vi: instrumentation identification and instrument operating conditions/parameters (or reference to such data);

  Yes

  No

  N/A

• 316) V1M2 4.13.3 f) vii: all manual calculations;

  Yes

  No

  N/A

• 317) V1M2 4.13.3 f) viii: analyst's or operator's initials/signature or electronic identification;

  Yes

  No

  N/A

• 318) V1M2 4.13.3 f) ix: sample preparation, including cleanup, separation protocols, incubation periods or subculture, ID codes, volumes, weights, instrument printouts, meter readings, calculations, reagents;

  Yes

  No

  N/A

• 319) V1M2 4.13.3 f) x: test results;

  Yes

  No

  N/A

• 320) V1M2 4.13.3 f) xi: standard and reagent origin, receipt, preparation, and use;

  Yes

  No

  N/A

• 321) V1M2 4.13.3 f) xii: calibration criteria, frequency and acceptance criteria;

  Yes

  No

  N/A

• 322) V1M2 4.13.3 f) xiii: data and statistical calculations, review, confirmation, interpretation, assessment and reporting conventions;

  Yes

  No

  N/A

• 323) V1M2 4.13.3 f) xiv: quality control protocols and assessment;

  Yes

  No

  N/A

• 324) V1M2 4.13.3 f) xv: electronic data security, software documentation and verification, software and hardware audits, backups, and records of any changes to automated data entries;

  Yes

  No

  N/A

• 325) V1M2 4.13.3 f) xvi: method performance criteria including expected quality control requirements;

  Yes

  No

  N/A

• 326) V1M2 4.13.3 f) xvii: proficiency test results;

  Yes

  No

  N/A

• 327) V1M2 4.13.3 f) xviii: records of demonstration of capability for each analyst; and

  Yes

  No

  N/A

• 328) V1M2 4.13.3 f) xix: a record of names, initials, and signatures for all individuals who are responsible for signing or initialing any laboratory record.

  Yes

  No

  N/A

• 329) V1M2 4.13.3 g: All generated data, except those that are generated by automated data collection systems, shall be recorded legibly in permanent ink.

  Yes

  No

  N/A

• 330) V1M2 4.13.3 g i: i. An individual making corrections to records shall date and initial the correction.

  Yes

  No

  N/A

• 331) V1M2 4.13.3 g ii: ii. Corrections due to reasons other than transcription errors shall specify the reason for the correction.

  Yes

  No

  N/A

• 332) V1M2 4.13.3 h: The laboratory shall have a plan to ensure that the records are maintained or transferred according to the clients’ instructions in the event that a laboratory transfers ownership or goes out of business.

  Yes

  No

  N/A

• 333) V1M2 4.13.3 h: In addition, appropriate regulatory and state legal requirements concerning laboratory records shall be followed.

  Yes

  No

  N/A

334) V1M2 4.14: Internal Audits (ISO/IEC 17025:2005(E), Clause 4.14)

• 335) V1M2 4.14.1: The laboratory shall periodically, and in accordance with a predetermined schedule and procedure, conduct internal audits of its activities to verify that its operations continue to comply with the requirements of the management system and this International Standard.

  Yes

  No

  N/A

• 336) V1M2 4.14.1: The internal audit programme shall address all elements of the management system, including the testing and/or calibration activities.

  Yes

  No

  N/A

• 337) V1M2 4.14.1: It is the responsibility of the quality manager to plan and organize audits as required by the schedule and requested by management.

  Yes

  No

  N/A

• 338) V1M2 4.14.1: Such audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity to be audited.

  Yes

  No

  N/A

• 339) V1M2 4.14.1 N: NOTE: The cycle for internal auditing should normally be completed in one year.

• 340) V1M2 4.14.2: When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory shall take timely corrective action

  Yes

  No

  N/A

• 341) V1M2 4.14.2: When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of the laboratory's test or calibration results, the laboratory notify customers in writing if investigations show that the laboratory results may have been affected.

  Yes

  No

  N/A

• 342) V1M2 4.14.3: The area of activity audited, the audit findings and corrective actions that arise from them shall be recorded.

  Yes

  No

  N/A

• 343) V1M2 4.14.4: Follow-up audit activities shall verify and record the implementation and effectiveness of the corrective action taken.

  Yes

  No

  N/A

344) V1M2 4.14.5: Additional Items

• 345) V1M2 4.14.5 a): The laboratory shall have a policy that specifies the time frame for notifying a client of events that cast doubt on the validity of the results.

  Yes

  No

  N/A

• 346) V1M2 4.14.5 b): The laboratory management shall ensure that these actions are discharged within the agreed time frame.

  Yes

  No

  N/A

• 347) V1M2 4.14.5 c): The Internal audit schedule shall be completed annually,

  Yes

  No

  N/A

348) V1M2 4.15: Management Reviews (ISO/IEC 17025:2005(E), Clause 4.15)

• 349) V1M2 4.15.1: In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to ensure their continuing suitability and effectiveness

  Yes

  No

  N/A

• 350) V1M2 4.15.1: In accordance with a predetermined schedule and procedure, the laboratory's top management shall periodically conduct a review of the laboratory's management system and testing and/or calibration activities to introduce necessary changes or improvements.

  Yes

  No

  N/A

• 351) V1M2 4.15.1: -The management review shall take account of: the suitability of policies and procedures;

  Yes

  No

  N/A

• 352) V1M2 4.15.1: -The management review shall take account of: reports from managerial and supervisory personnel;

  Yes

  No

  N/A

• 353) V1M2 4.15.1: -The management review shall take account of: the outcome of recent internal audits;

  Yes

  No

  N/A

• 354) V1M2 4.15.1: -The management review shall take account of: corrective and preventive actions;

  Yes

  No

  N/A

• 355) V1M2 4.15.1: -The management review shall take account of: assessments by external bodies;

  Yes

  No

  N/A

• 356) V1M2 4.15.1: -The management review shall take account of: the results of interlaboratory comparisons or proficiency tests;

  Yes

  No

  N/A

• 357) V1M2 4.15.1: -The review shall take account of: changes in the volume and type of the work;

  Yes

  No

  N/A

• 358) V1M2 4.15.1: -The management review shall take account of: customer feedback;

  Yes

  No

  N/A

• 359) V1M2 4.15.1: -The management review shall take account of: complaints;

  Yes

  No

  N/A

• 360) V1M2 4.15.1: -The management review shall take account of: recommendations for improvement;

  Yes

  No

  N/A

• 361) V1M2 4.15.1: -The management review shall take account of: other relevant factors, such as quality control activities, resources, and staff training.

  Yes

  No

  N/A

• 362) V1M2 4.15.1 N1: NOTE 1: A typical period for conducting a management review is once every 12 months.

• 363) V1M2 4.15.1 N2: NOTE 2: Results should feed into the laboratory planning system and should include the goals, objectives and action plans for the coming year.

• 364) V1M2 4.15.1 N3: NOTE 3: A management review includes consideration of related subjects at regular management meetings.

• 365) V1M2 4.15.2: Findings from management reviews and the actions that arise from them shall be recorded.

  Yes

  No

  N/A

• 366) V1M2 4.15.2: The management shall ensure that those actions are carried out within an appropriate and agreed timescale.

  Yes

  No

  N/A

• 367) V1M2 4.15.3: Management review shall be completed on an annual basis.

  Yes

  No

  N/A

• 368) V1M2 4.16: Data Integrity Investigations

• 369) V1M2 4.16: All investigations resulting from data integrity issues should be conducted in a confidential manner until they are completed.

  Yes

  No

  N/A

• 370) V1M2 4.16: These investigations shall be documented as well as any notifications made to clients receiving any affected data.

  Yes

  No

  N/A

• Assessor

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• Lab Representative

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