Quality Manual

ISO/IEC17025
Version 1
December 2003

(Incomplete sample)

NDT Company

Quality Manual: Table of contents Version 1

Number Section

REVISION HISTORY Author

Page

1.0. Ver. General Description of Change 1.1. Index and revision status 1.2. Purpose of the manual

Effective Date

Initial release

2.0. 1 2.1. 2.2.

Background of the laboratory Correction scope accreditation Activities and of Organogram History and backgroud Definitions and conventions Definitions and terminology Abbreviations Management requirements Organization / Organograms Quality system Document control Review of requests, tenders and contracts Subcontracting Purchasing Service to the client Complaints Control of non-conforming work Corrective actions Preventive actions Control of quality records Internal audits Management review Technical requirements General Personnel Accomodation Test methods and validation Equipment Measurement traceability Sampling Test items receipt, transportation, protection, delivery Quality control Reports / certificates

3.0. 3 3.1. 3.2. 4 4.0. 5 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.8. 4.9. 4.10. 4.11. 4.12. 4.13. 4.14. 5.0. 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7. 5.8. 5.9. 5.10.

ISO / IEC Quality Manual

1.0
1.1

GENERAL
INDEX AND REVISION STATUS

Version 1

The numbering of this quality manual directly corresponds to the numbering of ISO 17025. This quality manual is only valid if all pages are at the same issue level as shown in the index quality manual. Updates to this manual will be made by re-issuing the relevant section of this manual and adapting the issue level in the index.
1.2 PURPOSE

This quality manual documents our quality system and demonstrates the laboratory's ability to execute the indicated tests and to meet regulatory requirements.

This manual establishes compliance with ISO / IEC 17025. 2.0

2.1

LABORATORY BACKGROUND
ACTIVITIES

Version 1

Describe the background, activities, personnel and tests of your laboratory. Our laboratory's tests include: -- list out the tests provided by your laboratory --- Distinguish between the tests which are part of the quality system and those tests which are not. Described clearly the Scope of the Accreditation
2.2 HISTORY

Describe the history of your laboratory. Describe Installations. 3.0

3.1

DEFINITIONS AND CONVENTIONS

DEFINITIONS AND TERMINOLOGY

Version 1

The quality manager is responsible for setting up and maintaining a list of definitions and conventions bellow described the list is added to the Manual. Definitions from ISO/IEC Guide 2, edition 1986, "General terms and their definitions concerning standardization and related activities" are relevant above the list is added to the manual.
3.2 ABBREVIATIONS

The quality manager is responsible for setting up and maintaining a list of abbreviations used in the quality manual bellow described. The list is added to the manual. QMA Quality Manual TM Technical Manager PM Program Manager QM Quality Manager PR - Procedure IT - Instruction GD General Director SI International Measurement System ---

4.0
4.1

MANAGEMENT REQUIREMENTS
ORGANIZATION

Version 1

4.1.1 Legal identity 4.1.1.1 The laboratory is authorized under NDT company statute Indicate the legal identity of the laboratory. If the laboratory hasn't its own legal identity because it is part of a larger company, indicate the legal identity of this larger company.

4.1.2

Organization 4.1.2.1 Authority, interrelation, and responsibilities of all laboratory personnel are on file in the form of job descriptions (F 50204). The responsibilities of Quality Manager and Technical Manager are assigned to designated staff as shown in the organizational chart bellow.
General Director

Program Manager

Quality Manager

Technical Manager

Adm-Finance Manager

PRO

LOG

QC

QA

TS1

TS2

PUR

4.1.3

Responsibility

NOTE: The following is an example of laboratory personnel responsibilities. Indicate the responsibilities of key personnel of the large organisation that influence testing activities (QM, Tech M, Support M) too. - Put general function descriptions in this manual - Put detailed function descriptions and organisation chart 4.1.3.1 General Director The General Director is responsible for the overall compliance of the laboratory to this Quality Manual and is the direct supervisor of the NDT Company. 4.1.3.2. Management (Program Manager, however named ) The management of the laboratory: A. implements and enforces the applicable good laboratory practices described in reference documents; B. provides resources, adjusts workloads, and provides training

opportunities for laboratory staff to facilitate completion of assigned tasks in a safe work environment consistent with test requirements and personnel capabilities; and C. assigns deputies for both the technical and quality managers in the case of an absence. 4.1.3.3. Technical Manager The technical manager : A. is a technician who has completed the required level III training as specified in accreditation requirements for the level at which the laboratory maintains accreditation; B. is responsible for the overall administrative and technical operations of the laboratory; C. specifies and/or approves all methodologies used; D. implements good laboratory practices by providing instruction and training as needed, develops work plans and procedures, and requires that these be followed in all day-to-day operations; E. assigns only competent personnel to complete tests; F. attests, by signature, to the validity of all laboratory tests and reports (a list of Approved Signatories is maintained in the laboratory and G. ensures continued accreditation capability of the laboratory.

4.1.3.4

Quality Manager The Quality Manager : A. is a technician who has completed the required level III training as specified in accreditation requirements for the level at which the laboratory maintains accreditation; B. coordinates internal audits of the laboratory in accordance with Section 4.13 of this quality manual; C. maintains, analyzes, and updates statistical data and/or control charts; D. participates in available and relevant proficiency tests, roundrobins, and/or interlaboratory collaborative studies; E. where necessary, identifies, develops, and implements improvement of the laboratory measurement and test capability to meet the requirements of national authority, department programs, and laboratory clients; F. maintains the quality manual; and G. has direct access to management and to the technical manager.

NOTE: Many laboratories are limited in staff. These laboratories are often operated by one person or a part-time person. In these cases, the responsibilities of both technical and quality manager fall on that person. Special care and precaution must be taken and documented to ensure that the quality system and services quality are not adversely affected by limited laboratory staff.
4.2 QUALITY SYSTEM

4.2.1. The quality system documentation consists of different levels: - documented statements of the quality policy (issued by the chief executive) and the quality objectives - this quality manual - documented procedures required by all applicable standards: they detail the implementation of requirements and guidelines for the operation. - Instructions: they detail specific quality or inspection information and specific instructions for performance or individual tasks. - documents needed by the organization to ensure the effective planning, operation and management of its processes, and - records required by all applicable standards per the records procedure. When the term documented procedure appears within this quality manual, the procedure is established, documented, implemented and maintained. Our laboratory maintains its documents on various media such as paper, electronic, magnetic, optical, etc.

4.2.2. Our laboratory has established and maintains this quality manual that: - defines the structure of the quality system. - makes reference to the quality policy, the supporting procedures (also technical) and the instructions. - defines the roles and responsibilities of technical and quality staff The quality system documentation is communicated to the personnel and is understood. It is available at the location needed and it is implemented. 4.2.3. A list of the procedures, the instructions and the quality records which are included in the quality system, is maintained (F40301, F40302, F40303, F40304, F40305 and F 40306). 4.2.4. Quality Policy 4.2.4.1 NDT Company Quality Policy: NDT Company will provide our employees with adequate procedures to satisfy standards acceptable to most industrial entities. We will strive to improve the

quality of our services at reduced cost and to constantly satisfy the expectations of our customers and relevant agencies. The Senior Management and Staff of NDT Company also undertake to ensure that all activities are conducted in strict accordance with company documented procedures and comply with the requirements of the ISO/IEC 17025 Standard.
4.3 DOCUMENT CONTROL

4.3.1. Documents required by the quality system are managed per the Documentation Management Procedure (PR-AAA) . Records are a special type of document and are managed per the records procedure (PR-BBB). 4.3.2. The documentation management procedure is established to define the means needed to: - 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 managed using the documentation master list, and - prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.

4.4

REVIEW OF REQUESTS, TENDERS, AND CONTRACTS

4.4.1 Contract/order review is an integral part of the quality system at NDT Company. All contracts/orders are reviewed and accepted only if the requirements are clear and understood, and the company has the capability and capacity to assure full customer expectations. 4.4.2 Records of reviews, including any significant changes, are maintained. 4.4.3 Communications are maintained with the client from request/quote through commencement of work. This includes informing the client of any deviation from the contract. 4.4.4 The process for contract review is further defined in the Contract Review Procedure. (PR-XXX)
4.9 CONTROL OF NONCONFORMING WORK

4.9.1 NDT Company has established and maintains a policy and procedures that are 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 client. 4.9.2 The policy and procedures shall ensure that nonconforming work or problems that do not conform to requirements are identified and managed, to prevent unintended use or delivery. This procedure ensures that non-conforming work or problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. Where required by the contract, the proposed rectification of nonconforming work or problems is reported for concession to the customer, the end user, regulatory body, or other applicable authority. 4.9.3 Identification of nonconforming work or problems with the quality system or with testing and/or calibration activities can occur at various points within the quality system, and technical operations such as customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report and certificate checking, management reviews, and internal or external audits. 4.9.4 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of NDTCompany operations with its own policies and procedures, the corrective actions procedure shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s). 4.9.5 The process for nonconforming work is further defined in the Control of Nonconforming Testing or Calibration Work Procedure. (PR-YYY)

5.0
5.1

TECHNICAL REQUIREMENTS
TECHNICAL REQUIREMENTS - GENERAL

Version 1

5.1.1 NDT Company recognizes that many factors determine the correctness and reliability of the tests performed by a laboratory. These factors include contributions from: human factors (5.2), accommodation and environmental conditions (5.3), test methods and method validation (5.4), equipment (5.5), measurement traceability (5.6), and handling of test items (5.8). 5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests. NDT Company takes into account these factors in developing test methods, in the training and qualification of personnel, and in the selection of the equipment it uses.
5.2 PERSONNEL

5.2.1 NDT Company's management ensures the competency of all who operate specific equipment, who perform tests, evaluate results and sign test reports and certificates. When using staff that is undergoing training, adequate and appropriate supervision is

provided. Personnel performing specific tasks are qualified on the basis of appropriate education, training, experience, and/or demonstrated skills, as required by.... 5.4.5 Validation of methods 5.4.5.1 All standard and non-standard test methods and procedures are validated to ensure that such methods and procedures are fit for their intended use and are relevant to the requirements of ISO/IEC 17025 Clause 5.4.5 as well as the client. 5.4.5.2 The results of such validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use. 5.4.6 Uncertainty of Results 5.4.6.1 The uncertainty oftest and calibration results are calculated and documented in accordance with the requirements of ISO/IEC 17025 Clause 5.4.6. The Estimation of Uncertainty of Measurement Procedure (PR-ZZZ) is applied to all in house calibrations/tests OR The uncertainty of measurement is available on the certificate of tests or calibration certificate from subcontractors. 5.4.6.2 The Estimation of Estimation of Uncertainty of Measurement Procedure (PR-VVV) is applied for estimating uncertainty of measurement, except when the test methods preclude such rigorous calculations. In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory attempts to identify all the components of uncertainty and make the best possible estimation, and ensure that the form of reporting does not give an exaggerated impression of accuracy. Reasonable estimation is based on knowledge of the performance of the method and on the measurement scope, and makes use of previous experience and validation data.

The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as: Requirements of the test method Requirements of the client The existence of narrow limits on which decisions on conformance to a specification are based In cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied the estimation uncertainty of measurement by following the test method and reporting instructions (see section 5.10). 5.10 Reporting the Results

5.10.1 The results of each test, or series of tests carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively, and in accordance with any specific instructions in the test methods. The results are normally reported in a test report or certificate and include all the information requested by the client and necessary for the interpretation of the test results, and all information required by the method used. In the case of test performed for internal clients, or in the case of a written agreement with the client, the results may be reported in a simplified way and may not require the formalized certificate, but all data (data that would be on an actual test certificate if one were to be generated) is readily available and kept permanently on file