Quality Manual [PDF]

Zitiervorschau

The quality manual has the following table of contents.

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

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

REVISION HISTORY Rev 0 1 2 3 4 5

Description of Change Initial release

Author

Effective Date

-

04/02/12

QM 0.0

GENERAL

Version 1

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

03/06/2012

D 80201, 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.

0.2. This quality manual documents our quality system and demonstrates our inspection body's ability to perform inspection and to meet regulatory requirements.

This manual establishes compliance with ISO 17020.

QM 1.0

BACKGROUD OF THE INSPECTION BODY

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03/06/2012

1.1. Describe the background, sector, activities, personnel and scope of your inspection body.

The inspections performed by our inspection body include:

-- list out the inspections performed by 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 inspections which are not. --

1.2. Describe the history of your inspection body.

QM 2.0

NORMATIVE REFERENCES

Version 1

03/06/2012

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.

QM 3.0

TERMS AND DEFINITIONS

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03/06/2012

2.1. The quality manager is responsible for establishing and maintaining a list of definitions and conventions (D 0001).

Definitions from ISO/IEC 17000 are relevant. For other definitions those given in ISO 9000 are applicable.

The list is added to this quality manual.

2.2. The quality manager is responsible for establishing and maintaining a list of abbreviations used in the quality manual.

This list is added to the manual (D 0002).

QM 4.1

Independence and impartiality

Version 1

03/06/2012

4.1. The personnel of the inspection body is free from any commercial, financial and other 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 the inspections carried out (see procedure P401).

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 conditions under which it performs its services.

A. If your inspection body provides "third party" services:

Our inspection body provides "third party" services and meets the following criteria:

- Our inspection body is independent of the parties involved.

The inspection body and its staff responsible for carrying out the inspection is not the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of 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 their independence of judgement and integrity in relation to their inspection activities. In particular they are not directly involved in the design, manufacture, supply, installation, use or maintenance of the items inspected or similar competitive items.

- 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 administered in non-discrimatory manner.

B. If your inspection body forms a separate and identifiable part of an organization involved in the design, manufacture, supply, installation, use or maintenance of the items it inspects and has been established to supply inspection services to its parent organization:

Our inspection body meets the following criteria:

- A clear separation of the responsibilities of the inspection personnel from those of the personnel employed in the other functions is established by organizational 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 their independence of judgement and integrity in relation to their inspection activities. 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.

C. If your inspection body is involved in the design, manufacture, supply, installation, 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 meets the following criterion:

- Our inspection body provides safeguards within the organization to ensure adequate segregation of responsibilities and accountabilities in the provision of inspection services by organization and/or documented procedures.

Following procedures are included in ISO 17020

Procedures - Supervision of the inspections - Document control - Identification and control of non-conformities - Corrective actions - Preventive actions - Internal audits - Management review - Training - Preventive maintenance

- Calibration - Supplier review - Purchasing - Verification of purchased products - Contract review - Sample preparation and identification - Storage - Control of quality and technical records - Reporting of the results - Subcontracting - Customer complaints and feedback

P 806

Internal quality audits

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03/06/2012

1. Purpose and scope

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 training of employees is adequate to allow them to do their tasks

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

80601

Audit planning

80602

Audit preparation

80603

Auditing

80604

Writing of the audit report

80605

Follow-up actions

80606

Quality records concerning audits

3. Documents 3.1. System documents D 80601 Internal auditors D 80602 Audit planning D 80603 Audit questionnaire D 80604 Audit report 3.2. Specific documents 3.3. External documents

Written by

Checked by

Approved by

4. Method

80601

Audit planning

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03/06/2012

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:

- anticipated problem areas - actual problems - requests from Management - unforeseen changes in circumstances.

The schedule should define for each audit:

- 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

The auditor will prepare for each audit as follows:

- 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 - by preparing an audit checklist or similar aide-memoir.

80603

Auditing

version 1

03/06/2012

During the audit, the auditor will:

Written by

Checked by

Approved by

- --

- make use of standard auditing techniques to collect objective information concerning the subject being audited - not respond to rumour and hearsay - avoid confrontational situations and arguments - makes notes to aid the writing of the audit report - collect documentary evidence of conformity or nonconformity

- note where current procedures could be improved - keep the auditee informed as to the progress of the audit and any findings.

80604

Writing the audit report

version 1

03/06/2012

As soon as practical after the audit, the auditor will prepare an audit report which

- classifies the findings of the audit as follows: * acceptable: satisfies the requirements of ISO 17020 and the inspection body's own standards, procedures, manual, etc. * major: fails to satisfy the requirements of ISO 17020 * minor: satisfies the requirements of ISO 17020 but fails to satisfy the inspection body's own internal standards, procedures, manual, etc. * observation: an area of weakness that could be improved.

- record the good points as well as the bad - makes constructive suggestions where possible - records only factual evidence (not hearsay) - clearly identifies the areas where corrective actions are required, and who is responsible for carrying them out - contains * the names of the auditor, auditees, observers * location of the audit * date of the audit - 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. Written by

80606

Checked by

Quality records concerning audits

Approved by

version 1

03/06/2012

Completed audit records are stored as quality records and have the following important functions:

- demonstrating that the audit system exists, is functioning and effective - allowing analysis of types of problems and identifying the most common problems so that preventive actions can be taken - analysing response and correction times - 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 Rev 0

Description of Change Initial Release

Following quality records are included in ISO 17020

Quality records

Definitions and terminology - Quality policy and quality objectives - Organization scheme - Personal cards - Function descriptions - Responsibilities - Training - Maintenance cards - Maintenance schedule - Maintenance survey - Tests and specifications - Client complaints - Supplier cards - Supplier problems - Supplier review - Approved suppliers - Measuring equipment - Calibration schedule - Calibration survey - Audit schedule

Author

Effective Date

10/11/12

- Audit reports - Internal problems - Projects

D 80601

Version 1

Date 02/09/2012

INTERNAL AUDITORS

Name of auditor

Qualified by

Date

D 80602

Version 1

Date 02/09/2012

AUDIT SCHEDULE

Number Audit

Auditor

Auditee

Planned date

Audit date

D 80604

AUDIT REPORT

Audit number Auditor

Version 1

Date 02/09/2012

Auditee Audit date Discuss the implementation of the procedures and work instructions

Discuss the implementation of the quality records

Discuss the implementation of the action plans

Written by

Checked by

Approved by

SO 17020, entitled “General Criteria for the Operation of Various Types of Bodies Performing Inspection”, is an internationally recognized standard for the competence of inspection bodies. ISO 17020 should not be confused with ISO 9001, which is specific to quality management systems. ISO 9001 does not require evaluation of the technical competence of an inspection body and it should not be regarded as an ‘acceptable’ alternative to ISO 17020. 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 Benefits of ISO 17020 accreditation: • Uniformity in execution and reporting method for the people carrying out the activity. • Reduced penalty in case of disputes • Meeting the accreditation requirements • Reduced customer complaints • Proof of conforms to specified requirements How to achieve ISO 17020? risGiso offers a well-defined and globally proven implementation methodology for ISO 17020 certification. • Gap Analysis • Awareness Training • Documentation Design and finalization • Implementation • Internal Auditor Training and conduct of internal audit • Management Review Meeting • Review of Implementation • Pre-assessment audit • Stage 1 – certification audit • Stage 2 – certification audit • Award of ISO / IEC 17020 Accreditation • Continual improvement of the system through value added consulting and training services

What are the requirements of ISO 17020 accreditation standard? The requirements of ISO 17020 are contained in 14 major sections including: • Administrative requirements • Requirements for independence, impartiality, and integrity • Confidentiality • Organization and management • Quality system • Personnel • Facilities and equipment • Inspection methods and procedures • Handling of inspection samples and items • Control of records • Inspection reports and inspection certificates • Subcontracting • Complaints and appeals • Cooperation with other 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 In addition risGiso recommends the following additional procedures as a minimum supplement to the required procedures: • Control of non-conforming work • Preventive action • Internal auditing • Management review • Training • Calibration of equipment • Contract review • Document control • Records control • Reporting the results of an inspection Integrate ISO 17020 with other MSS: ISO/IEC 17020 is designed to be compatible with other management systems standards and specifications, such as ISO 9001, ISO 22000, OHSAS 18001, ISO 27001, ISO 14001 and other ISO management standards. They can be integrated seamlessly through Integrated Management system approach. They share many principles so choosing an integrated management system can offer excellent value for money and an easier approach to implement, manage and improve multiple standards simultaneously. What we offer in the field of ISO 17020 standard and accreditation? As one of the largest ISO/IEC 17020 management system certification consulting companies across the world with clients in more than 50 countries, our knowledge and experience of the standards is unsurpassed. We understand how to fully exploit the benefits of your quality management system to ensure you unlock the true potential in your organization. We provide unmatched expertise and technical competence to ensure that your ISO / IEC 17020 inspection body quality management system certification project adds value to your organization.

We provide consulting, training, internal audits, pre assessment audits and facilitation during ISO / IEC 17020 certification audit. We offer our global knowledge molded locally to bring in the best results for our clients and partner their journey of standardization, compliance, growth, success and continual improvements. • Conduct an initial gap analysis • Help you establish policies and objectives • Identify documentation requirements • Make assignments and prepare schedules • Prepare documentation • Coordinate document preparation, reviews, approvals, and production • Prepare the following key documents: Quality Policy, Quality Manual, Procedures, Master List of Documents: • Manage implementation schedules, training, follow-up actions • Help you select a Registrar that has experience in your industry • Prepare status reports and monitor progress • Conduct training • Conduct internal audits • Request registration • Conduct vendor and supplier audits • Conduct customer satisfaction surveys • Develop quality system intranets to help you manage your documents To get your organization ISO / IEC 17020 certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized ISO / IEC 17020 implementation methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective.