|
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.
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
|
