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Table of contents
0.0 General
1.0. Background of the inspection body
2.0. Normative references
3.0. Terms and definitions
4.1. Impartiality and independence
4.2. Confidentiality
5.1. Administrative requirements
5.2. Organization and management
6.1. Personnel
6.2. Facilities and equipment
6.3. Subcontracting
7.1. Inspection methods and procedures
7.2. Handling inspection items and samples
7.3. Inspection records
7.4. Inspection reports and inspection certificates
7.5. Complaints and appeals
8.1. Management system requirements
8.2. Management system documentation
8.3. Corrective actions
8.4. Preventive actions
8.5. Management review
8.6. Internal audits
Quality Manual: Table of contents
Number Section
0.0. General
4.2 Confidentiality
6.1. Personnel
6.3. Subcontracting
5
QM 0.0 GENERAL Version 1 03/06/2012
0.1. The numbering of this quality manual directly corresponds to the numbering of ISO
17020.
This quality manual is only valid if all pages are at the same issue level as shown in
D 80201, index quality manual.
Updates to this manual will be made by re-issuing the relevant section of this manual and
0.2. This quality manual documents our quality system and demonstrates our inspection
1.1. Describe the background, sector, activities, personnel and scope of your inspection
body.
-- describe the functions and the technical scope of activity for which the inspection body
is competent. --
-- Distinguish between the inspections which are part of the quality system and those
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
2.1. The quality manager is responsible for establishing and maintaining a list of definitions
2.2. The quality manager is responsible for establishing and maintaining a list of
pressures which might affect their judgement. Procedures are implemented to ensure that
persons or organizations external to the inspection body, cannot influence the results of
4.2. Our inspection body identifies risks to its impartiality on an ongoing basis
(procedure P401).
4.3. The quality policy shows that our inspection body has got top management
commitment to impartiality.
4.4. The inspection body is independent to the extent that is required with regard to the
Our inspection body provides "third party" services and meets the following criteria:
The inspection body and its staff responsible for carrying out the inspection is not the
items which they inspect, nor the authorized representative of any of these parties.
- The inspection body and its staff don't engage in any activities that may conflict with
In particular they are not directly involved in the design, manufacture, supply,
- All interested parties have access to the services of the inspection body. There is no
undue financial or other conditions. The procedures under which the body operates are
items it inspects and has been established to supply inspection services to its parent
organization:
- A clear separation of the responsibilities of the inspection personnel from those of the
identification and the reporting methods of the inspection body within the parent
organization.
- The inspection body and its staff don't engage in any activities that may conflict with
In particular they are not directly involved in the design, manufacture, supply,
installation, use or maintenance of the items inspected or similar competitive items.
- Inspection services are only supplied to the organization of which the inspection body
forms a part.
use or maintenance of the items it inspects or of similar competitive items and may
supply inspection services to other parties not being its parent organization:
- Our inspection body provides safeguards within the organization to ensure adequate
Procedures
The purpose of internal auditing is to ensure that the Quality Management is being operated correctly
and effectively, by performing planned and documented checks, designed to ensure that:
- the quality system documentation adequately defines the needs of the business
- the documented procedures and instructions are practical, understood and implemented
The purpose of internal audits is not to search for the guilty, or to find fault with individuals'
performance. The system is being audited - not the individuals.
The auditors must be suitably qualified, and must approach this important task with the seriousness it
deserves. Auditors may be inspection body employees or external consultants.
Internal audits are the most effective way of continually assessing the effectiveness of the Quality
System.
This procedure defines the way in which our inspection body will perform internal auditing of the quality
management system.
It applies to all internal quality audits, which will generally be performed against the requirements of ISO
17020, the inspection body's quality manual, procedures, process plans and work instructions.
2. Procedure-Sections
80603 Auditing
3. Documents
The quality manager is responsible for ensuring that the internal audit programme takes place, for
allocation and training of internal auditors, and for preparing the internal audit schedule.
Audit planning consists of preparing the internal audit schedule, which is a controlled document,
authorised by the Managing Director.
The schedule should cover all aspects of the Quality Management System at least once a year, although
particular activities may be audited more frequently depending on their importance.
The schedule should leave room (time) for unscheduled audits in response to:
- actual problems
- the auditor
- the auditee
- the date (at the planning stage the month for the audit will be sufficient: as the time approaches the
auditor will set a firm date with the auditee).
80602 Audit preparation version 1 03/06/2012
- by reading through previous audit reports covering the same area (in order that previous problem
areas can be examined in more detail, or that areas previously unexamined can be looked at more
closely)
- by familiarising himself with the requirements of ISO 17020 and the local standards (quality manual,
procedures, process plans, work instructions)
- by contacting the auditee and confirming the date/time for the audit
- make use of standard auditing techniques to collect objective information concerning the subject being
audited
- keep the auditee informed as to the progress of the audit and any findings.
As soon as practical after the audit, the auditor will prepare an audit report which
* acceptable: satisfies the requirements of ISO 17020 and the inspection body's own standards,
procedures, manual, etc.
* minor: satisfies the requirements of ISO 17020 but fails to satisfy the inspection body's own internal
standards, procedures, manual, etc.
- clearly identifies the areas where corrective actions are required, and who is responsible for carrying
them out
- contains
- is signed off by all parties as being a true and accurate representation of the facts.
80605 Following-up version 1 03/06/2012
The auditor is responsible for checking that follow-up actions take place. The actions are structured in
action plans.
If an auditee persistently fails to carry out the assigned follow-up actions, the auditor must inform the
managing director, who will take steps to ensure that the follow-up action take place.
As the follow-up actions are completed the auditor will record them by up-issuing the original audit
report. Once all follow-up actions have been completed, the auditor will sign off the audit report as
complete.
Completed audit records are stored as quality records and have the following important functions:
- allowing analysis of types of problems and identifying the most common problems so that preventive
actions can be taken
- allowing the auditor to prepare for audits by reviewing the past reports for that area or function
- providing valuable summary for use in Management Reviews of the Quality System.
5. Revision history
REVISION HISTORY
Quality records
INTERNAL AUDITORS
AUDIT REPORT
Audit number
Auditor
Auditee
Audit date
This International Standard specifies general criteria for the competence of impartial bodies
performing inspection irrespective of the sector involved. It also specifies independence criteria. This
standard is intended for the use of inspection bodies and their accreditation bodies as well as other
bodies concerned with recognizing the competence of inspection bodies
ISO 9001 and ISO 17025, ISO 17020 requires procedures in several important areas, including:
Procedure to ensure that persons or organizations external to the inspection body cannot influence
the results of inspections by the ISO 17020-accredited organization
• Procedure for feedback
• Procedure for corrective action
• Procedure for the care and maintenance of equipment
• Procedure for selecting qualified suppliers
• Procedure for purchasing
• Procedure for inspection of materials received by the organization
• Procedure for appropriate storage facilities
• Procedure for protecting the integrity of data produced by the organization
• Procedure for ensuring the security of data produced by the organization
• Procedure for dealing with defective equipment
• Procedure(s) for performing inspections
• Procedure(s) for performing non-standard inspections
• Procedure(s) for avoiding deterioration or damage to inspection items
• Procedure for dealing with complaints
• Procedure for dealing with appeals against the results of inspections
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