ISO 17020 Quality Manual

Order Quality Manual

Table of Contents

Introduction 
Quality Policy Statement 
1.0 Scope 
2.0 References 
3.0 Terms and Definitions 
4.0 General Requirements 
    4.1 Impartiality and Independence
    4.2 Confidentiality
5.0 Structual Requirements 
    5.1 Administrative 
Requirements 
    5.2 Organization and Management
6.0 Resource 
Requirements 
    6.1 Personnel
    6.2 Facilities and Equipment 
    6.3 Subcontracting
    6.4 Purchasing Services and Supplies

    6.5  Service to the Customer
7.0  Process Requirements
    7.1 Inspection Methods and Procedures 
    7.2 Handling Inpsection Items and Samples 
    7.3 Inspection Records 
   
7.4 Inspection Reports and Inspection Certificates 
   
7.5 Compalaints and Appeals 
   
7.6 Control of Nonconforming Product/Work 
   
7.7 Sampling
8.0 Management System Requirements
   
8.1 Options
   
8.2 Management System Documentation
   
8.3 Control of Documents 
   
8.4 Control of Records
    8.5 Management Review
 
    8.6 Internal Audits 
   
8.7 Corrective Actions  
   
8.8 Preventive Actions


INTRODUCTION

XYZ Inspection Body recognizes its responsibility as provider of quality services.  To this end, XYZ Inspection Body has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the organization.  The quality system complies with the international standards ISO/IEC 17020:2012 and ISO 9001:2008.

This manual has been prepared to define the quality system, establish responsibilities of the personnel affected by the system, and to provide general procedures for all activities comprising the quality system. In addition, this manual is utilized for the purpose of informing our customers of the quality system, and what specific controls are implemented to assure service quality.


5.0 Structual Requirements

5.2 Organization and Management

5.2.1 XYZ Inspection Body holds legal responsibility for its operation and is organized to operate in accordance with the requirements of ISO 17020, whether carrying out work in its permanent facilities or on location, at customer sites.

5.2.2 XYZ Inspection Body is not part of an organization performing activities other than inspection; therefore, there is no potential conflict of interest amongst its personnel.

The organization of XYZ Inspection Body is illustrated below in Figure 1.

7.1 Inspection Methods and Procedures

7.1.1 Validation of Methods

7.1.1.1 All standard and non-standard inspection 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 17020, as well as, the client.

7.1.1.2 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.

7.4 Inspection Reports and Inspection Certificates

7.4.1 The results of each inspection carried out by the inspection body are reported accurately, clearly, unambiguously, and objectively, and in accordance with any specific instructions in theinspection methods. The results are normally reported in an inspection report report and include all the information requested by the client and necessary for the interpretation of the inspection results, and all information required by the method used. 

7.6 Identification and Control of Nonconformities

7.6.1 XYZ Company has established and maintains a policy and procedures that are implemented when there are problems with the management system, products, or with services, and activities do not conform to its own procedures or the agreed requirements of the client.

7.6.2 The policy and procedures shall ensure that nonconforming product, work, or problems that do not conform to requirements are identified and managed, to prevent unintended use or delivery of services. This procedure ensures that non-conforming product, work, or problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. Where required by the agreement, the proposed rectification of non-conformingproduct,  work, or problems is reported for concession to the customer, the end user, regulatory body, or other applicable authority.

7.6.3 Identification of nonconforming product, work, or problems with the quality system or with inspection 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, inspection report checking, management reviews, and internal or external audits.

7.6.4 Where the evaluation indicates that the nonconforming product or work could recur, or that there is doubt about the compliance of XYZ Inspection Body 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).

7.6.5 The process for nonconforming work is further defined in the Control of Nonconforming Product/Work Procedure.

8.2 Management System Documentation

8.2.1 Documentation of the System

8.2.1.1 The Quality Manual is the principal document that defines the quality system at XYZ Inspection Body.

8.2.1.2 Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality.  Quality procedures will be readily available to personnel for reference and implementation. The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.

Note:  Paragraph numbering in the above sample is for illustration purposes only.  The numbering in the actual product may differ.

ISO 17020 Sample Procedure

Order Quality Manual


ISO 17020 Quality Manual Information