Quality Manual

Quality Manual

Feras Mfarrej – ASU 2014

Quality Manual – Why?

ISO/IEC 17025 states the necessity for an accredited laboratory to have a quality system with certain requirements as well as procedures to keep documents under control

The quality manual is the keystone of the documentation of a quality system.

Quality Manual

Contents

Document Control

Quality Manual – Contents

ISO/IEC 17025 – 4.2.1 The laboratory shall establish, implement and

maintain a quality system appropriate to the scope of its activities.

The laboratory shall document its policies, systems, programmes, procedures and instructions to the extent necessary to assure the quality of the test and/or calibration results.

The system’s documentation shall be communicated to, understood by, available to, and implemented by the appropriate personnel.

Quality Manual – Contents

ISO/IEC 17025 – 4.2.2 The laboratory’s quality system

policies and objectives shall be defined in a quality manual (however named).

The overall objectives shall be documented in quality policy statement.

The quality policy statement shall be issued under the authority of the chief executive.

Quality Manual – Contents

ISO/IEC 17025 – 4.2.2

(followed)

It shall include at least the following:◦ the laboratory management’s commitment

to good professional practice and to the quality of its testing and calibration in servicing its clients;

◦ the management’s statement of the laboratory‘s standard of service;

◦ the objectives of the quality system;

Quality Manual – Contents

ISO/IEC 17025 – 4.2.2

(followed)◦ a requirement that all personnel

concerned with testing and calibration activities within the laboratory familiarizethemselves with the quality documentation and implement the policies and procedures in their work; and

◦ the laboratory management’s commitmentto compliance with this International Standard.

Quality Manual – Contents

ISO/IEC 17025 – 4.2.3

The quality manual shall include or make reference to the supporting procedures including technical procedures.

It shall outline the structure of the documentation used in the quality system.

Quality Manual – Contents

ISO/IEC 17025 – 4.2.4

The roles and responsibilities of technical management and the quality manager, including the responsibility for ensuring compliance with this International Standard, shall be defined in the quality manual.

Quality Policy

The quality policy is one of the essentialthings in a quality system.

◦ the whole system should only reflect the quality

policy in the daily work and put the policy into

concrete terms

the policy shall be issued under the authority of the chief executive

◦ It is very important to have a clear statement,

how crucial quality is in the work of his/her

laboratory

Quality Policy

Quality policy is very specific for each laboratory in the framework of its tasks, its role in a larger organization and its relationship to its customers.

There is no recipe for the formulation

Presentation of the

Laboratory

◦ Address

◦ Phone, Fax, e-mail

◦ Internet-Website

◦ Ownership

◦ Year of foundation

◦ History

◦ Bank account

◦ Memberships in associations and organisations

Statement of independence from influences that may adversely affect the quality of the work

Cooperation with other laboratories and organizations

…

This chapter should contain:

Organization and

Management Names of persons responsible for

commercial management Names of persons responsible for

technical management◦ including a short description of the

qualification of the technical manager and his deputy

Organization chart

Organization Chart

D. Ocument

Quality Manager

A.L.Cohole

P. Henole

P. Esticide

B. Enzene

Dr. T. Oluol

Manager Organic Analysis

Deputy Technical Manager

B. Ismut

C. Opper

I. Ron

M. Anganese

Dr. T. Itan

Manager Anorganic Analysis

C. Lostridium

E. Coli

Dr. B. Acter

Manager Microbiology

Dr. T. Analyst

Technical Manager

Dr. J. Bigboss

Director

Quality Manager

The laboratory must have a quality manager (and if possible a deputy)

The name and responsibilities/dutieshave to be stated here

The quality manager must have directaccess to the highest level of management at which decisions are made on laboratory policy or resources

Staff

number of employees

names of persons responsible for subdivisions

reference, where information for all technical staff is documented concerning

◦ relevant authorizations

◦ competence

◦ educational and professional qualifications

◦ training (in the past and plans for the future)

◦ skills

◦ experience

Allocation of Responsibilities

For signing contracts For signing test reports For acquisition For procurement

List of Signatures

For all relevant staff

Administration, Access and

Review of the Quality Manual All staff must have access to the

quality manual.

This access must be managed

All copies must be current versions

The quality manual must be regularly reviewed

All these things are the duties of the quality manager

Standard Operation

Procedures

There have to be standard operation procedures for all relevant procedures

It is useful to have the SOPs in separate documents

The quality manual should contain a list of available SOPs

Standard Operation Procedure

–

Content - I general description of the method

underlying standard

sampling and conservation

range of application

interferences

necessary equipment

chemicals (purity, where to buy)

measurement

Standard Operation Procedure

–

Content - II calibration

evaluation

control charts

other quality assurance measures

use of reference materials

presentation of results

limit of detection, limit of determination

responsibilities

Standard Operation Procedure –

Standardised Methods A standard can not cover the laboratory

specific details◦ equipment

◦ supplier

◦ trained staff

◦ responsibilities

◦ QA measures

◦ limit of detection, ...

These details have to be documented

The extent of the SOP depends on the qualification of the staff

Other Guidelines

If the laboratory has other guidelines, they should be included or referenced in the quality manual◦ for calibration

◦ for calculation of detection limits

◦ for calculation and construction of control charts

◦ for ...

Reference Materials

The laboratory should keep a list of reference materials used

This list has to be in the quality manual

or a note where the RM‘s are listed

Accommodation and

Environmental Conditions

ISO/IEC 17025 contains requirements for accommodation and environmental conditions

Their fulfilment must be described in the quality manual

Description of the rooms Floor plan

Equipment

There must be records on each item of equipment and its software significant to tests and/or calibration performed

Usually on separate documents List of all records (Guideline, what has to be recorded)

Defect and Incorrect Working

Test Equipment

Equipment that has been shown to be defective or outside specified limits must be taken out of service

There must be regulations in the quality manual◦ how the equipment has to be labeled

◦ what must be arranged

Internal Audits

Internal Audits can show that the operation of the laboratory is in compliance with its quality system and with ISO/IEC 17025

Schedule

Prescribed procedure

Schedule and procedure must be documented in the quality manual

Management Review

A management review can show the continuing suitability and effectiveness of the quality system and of the testing activities

Schedule

Prescribed procedure

Schedule and procedure must be documented in the quality manual

Interlaboratory Tests

Participation in interlaboratory test should be a matter of course for each laboratory in its testing field

Planning Results Corrective actions

Complaints

Policy and procedure for the handling of complaints◦ from clients

◦ from other parties

Document Control - General

ISO/IEC 17025 – 4.3.1 The laboratory shall establish and maintain

procedures to control all documents that form part of its quality system (internally generated or from external sources), such as ◦ regulations,

◦ standards,

◦ other normative documents,

◦ test and/or calibration methods, as well as

◦ drawings,

◦ software,

◦ specifications,

◦ instructions and

◦ manuals.

Document Control System Every document must be clearly

identified in the control system together with its revision status this can be done e.g. by a numbering

system that includes the revision (e.g. SOP-SA-132-3.1)

standard operation procedure

soil analysis

No 132 rev. 3.1

Document Approval and Issue

ISO/IEC 17025 – 4.3.2.1All documents issued to personnel in the

laboratory as part of the quality system shall be reviewed and approved for use by

authorized personnel prior to issue.

A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the quality system shall be established and be readily available to preclude the use of invalid and/or obsolete documents.

Master List

There can be e.g. a master list of all valid documents together with their revision status in the quality manual (or in a separate document)

Document Approval and Issue

ISO/IEC 17025 – 4.3.2.2 The procedure(s) adopted shall ensure that:

◦ authorized editions of appropriate documents are available at all locations where operations essential to effective functioning of the laboratory are performed;

◦ documents are periodically reviewed and, where necessary, revised to ensure that continuing suitability and compliance with applicable requirements;

◦ invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use;

◦ obsolete documents retained for either legal or knowledge preservation purposes are suitably marked.

Availability

Authorized copies of the quality manual should be available◦ in the quality manager‘s office

◦ in the laboratory manager‘s office

◦ in the laboratory for all staff

Obsolete Documents

have to be removed immediately it must be assured, that they are

removed in all authorized copies obsolete documents must be marked but they have to be retained for◦ legal purposes

◦ knowledge preservation

Document Approval and Issue

ISO/IEC 17025 – 4.3.2.3

Quality system documents generated by the laboratory shall be uniquely identified.

Such identification shall include

◦ the date of issue and/or

◦ revision identification,

◦ page numbering,

◦ the total number of pages or a mark to signify the

end of the document, and

◦ the issuing authority(ies).

Document Changes

ISO/IEC 17025 – 4.3.3.1

Changes to documents shall be reviewed and approved by the same function that performed the original review unless specifically designated otherwise.

The designated personnel shall have access to pertinent background information upon which to base their review and approval.

Document Changes

ISO/IEC 17025 – 4.3.3.2

Where practicable, the altered or new text shall be identified in the document or the appropriate attachments.

Document Changes

ISO/IEC 17025 – 4.3.3.3 If the laboratory’s documentation control

system allows for the amendment of documents by hand pending the re-issue of the documents, the procedures and authorities for such amendments shall be defined.

Amendments shall be clearly marked, initialled and dated.

A revised document shall be formally re-issued as soon as practicable.

Document Changes

ISO/IEC 17025 – 4.3.3.4

Procedures shall be established to describe how changes in documents maintained in computerized systems are made and controlled

Header of the Quality Manual

At least on the first page of each chapter:◦ identification of the laboratory

◦ a statement that this is a part of the quality manual

◦ number of the chapter

◦ title of the chapter

Header of the Quality Manual

On each page of each chapter:

◦ Date of issue

◦ Revision number

◦ Name of author

◦ Eventually name of person, who checked the

content

◦ Approval notice

◦ Page number

◦ Total number of pages of the chapter

Example – Top and Bottom of a

Quality Manual Page

Quality Manual

Quality Policy

chapter: 1

revision: 1

page 1 of 3

author: checked: approved: date of issue:

Structure of the Quality

Manual It is up to the author of the quality

manual to decide about the detailed structure of “his” quality manual.

But it is extremely useful to separate it in chapters, which can be revised separately without revising and renumbering the whole manual.

THANKS

Feras Mfarrej – ASU 2014