5.2 Personnel Use competent staff Supervise as necessary

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Presentation transcript:

5.2 Personnel Use competent staff Supervise as necessary Document qualifications and training Maintain documented training program Define responsibilities and authorities Applies also to contracted workers

5.3 Accommodation, Environment Accommodation & environment to suit testing equipment Monitor environment as needed, records Control access to laboratories Good housekeeping

5.4 Test Methods, Validation Use appropriate methods Methods to meet client needs Prefer standard methods Validate any non-standard procedure Various ways to validate Retain validation data 5.4 Test Methods, Validation ISO/IEC 17025 is not totally prescriptive about how non-standard methods, or changes to methods, are validated. However, note 2 of clause 5.4.5.2 provides guidelines. Validation data are QMS records subject to audit, and must be retained.

5.5 Equipment Use appropriate equipment Authorised personnel operate Instructions available Unique identification, inventory Equipment calibration (also 5.6) Applies to outside equipment Equipment If critical equipment is used outside the control of the laboratory, it must be calibrated and maintained to the standard required for the laboratory’s own pieces of critical equipment.

ISO/IEC 17025 - Technical 5.6 Measurement traceability 5.7 Sampling 5.8 Handling test items 5.9 Quality assurance 5.10 Reporting

5.6 Measurement Traceability Calibrate equipment Ensure measurement traceability Use interlaboratory comparisons where possible Calibrate reference materials Protect reference materials The calibration of equipment will be discussed in detail later in the QMS section.

5.7 Sampling Ensure statistical validity

5.8 Handling Test Items Documented handling procedures Secure identification of samples Ensure sample condition acceptable Protect samples

5.9 Quality Assurance Use quality control Participate in proficiency testing Use statistics if practicable

5.10 Reporting Minimum requirements for reports Keep interpretation distinct Identify testing by subcontractors Apply also to electronic transmission Amendments - supplementary documents Reporting ISO/IEC 17025 has specific rules for the form and contents of reports. If a report has been issued and is to be changed, a new (supplementary) report must be issued.

ISO/IEC 17025 - Management 4.1 Organisation 4.2 Quality system 4.3 Document control 4.4 Contract review 4.5 Subcontracting 4.6 Purchasing 4.7 Service to the client The Quality System and Document Control will be discussed in detail later in the QMS section.

4.1 Organisation Quality Manager (title irrelevant) may have other duties direct access to top management “defined responsibility and authority for ensuring that the quality system is implemented and followed at all times”

4.4 Contract Review Requirements for any testing documented understood Appropriate methods used Adequately resourced Changes documented & agreed

4.5 Subcontracting Testing subcontracted to another lab subcontractor competent also accredited to standard? client advised in writing register of subcontractors used evidence of suitability

4.6 Purchasing Procedures for selection and purchasing where it affects test quality Inspected to confirm compliance Lists of suppliers records of evaluation

4.7 Service to the client Communication and co-operation

ISO/IEC 17025 - Management 4.8 Complaints 4.9 Control of nonconforming testing 4.10 Corrective action 4.11 Preventive action 4.12 Control of records 4.13 Internal Audits 4.14 Management Reviews Corrective and Preventive Action, Control of Records, Internal Audits and Management Review will be discussed in detail later in the QMS section.

4.9 Control of Nonconforming Testing When testing or results do not: conform with procedures meet client requirements Remedial actions what is done - by whom Client notified if necessary

A Documented Quality System

Outline What is a quality system? Why documentation is necessary Requirements for documentation Documentation structures Quality manuals, procedures, work instructions Guidance on documentation

What is a Quality System ? ISO/IEC Guide 25 (from ISO 8402) “The organisational structure, responsibilities, procedures, processes and resources for implementing quality management” What is a Quality System The terms “quality system” and “quality management system” (sometimes abbreviated to QMS) are synonymous. An integrated system of documents is needed to describe all the essential functions of the organisation. These are often called quality management system (QMS) documents.

Why Document the System? For system to function Define responsibilities and authorities who does what Ensure compliance with standard(s) Why Document the System The standards require a system of QMS documentation. The QMS documentation needs to show in some manner who is responsible for the various functions of the organisation. Such documentation of responsibilities and authorities need not be unnecessarily detailed, but is should be sufficient to ensure that there is no ambiguity about major areas of responsibility.

What is Required? Communicated Available Understood Implemented Easily updated What is Required ? Having a set of QMS documents is not sufficient to meet the requirements of ISO 9000 or ISO/IEC 17025. Staff in the organisation must know about the documentation, and understand how it works. Documents must be available to staff (in paper or electronic form) whenever they are needed. Staff must then follow the instructions that the documentation provides. The functions of a laboratory or any other organisation are constantly changing. It must, therefore, be possible to update documentation quickly and easily as such change occurs.

Verbal Instructions Often: Not heard Misunderstood Quickly forgotten Ignored Verbal Instructions Verbal instructions are very unreliable as a means of communicating information, particularly if it is technical in nature, or is in any way complex.

What is Required? A quality manual A quality policy Document key areas of activity What is Required ? The standards allow a great deal of flexibility in the nature and structure of QMS documentation. A quality manual is essential, to provide an overview of all functions, and a link to all other documentation. For a very small laboratory with few functions, a quality manual may be the only QMS document required; usually, however, there are many others. The quality manual must contain a quality policy, which is understood by all staff. The QMS documentation must document all key areas of activity of the organisation.

A Typical Documentation Structure Quality Manual  Procedures Work Instructions Forms Records A Typical Documentation Structure This is a structure of QMS documentation that works well for many laboratories and other organisations. Records are not themselves QMS documents, but are generated in the course of the organisation’s activities.

Document Design Definition of System Increasing (Company Policy & Quality System Outline) Manual Increasing Description of the Processes Detail Procedure Manual(s) (Defines how the Policy is carried out in individual work Processes) Instructions for Individual Job Functions Work Instructions (Defines how specific tasks Document Design The NRL, Australia’s document structure consists of 3 levels: Quality Manual - provides a brief description of the quality system structure and describes WHAT we do in addressing the standard. Living, breathing document, “encapsulates spirit of organisation” a good QM should rewrite the standard into the organisation’s own language Procedures - provides a description of the process and assigns responsibility Work Instructions (sub-procedure) - are the most detailed and describe HOW specific tasks referenced in procedures are carried out. Reference Documentation - includes forms, standards, references etc. required to perform the tasks referenced in a Procedure or Work Instruction. Document Numbering Once the document structure is organised, need to develop an indexing system for this documentation Each document has a unique number assigned by the Document Controller in accordance with the indexing system outlined in the Quality Manual. that are referenced in procedures are carried out) Work Functions

What is a Quality Manual? ISO/IEC Guide 25 “A document stating the quality policy, quality system and quality practices of an organisation” What is a Quality Manual It represents an account of the individual way your particular laboratory or group chooses to interpret the standard. There are many ways in which a quality manual can be designed.

Required in Quality Manual Quality policy Structure of documentation Cross reference supporting documents Include or refer to: systems, instructions responsibilities and authorities Required in a Quality Manual These are minimum requirements. The quality manual is a guide to the rest of the QMS documentation.

Quality Policy Concise Overall objectives Authorised by chief executive Commitment to good practice Commitment to Standard(s) Staff must familiarise and use Quality Policy If those things are included, the more concise and understandable the quality policy can be, the better. It is important to make clear to all staff that senior management is committed to the quality policy.

Must Document: Scope of activities Document control and review Customer complaints Corrective, preventive action Internal audits Must Document The items on this page and page 63 all need to be documented. Typically, the scope of activities will be included in the quality manual. Typically again, the other items listed will me mentioned in general terms in the quality manual, which will also make reference to a procedure describing the activity.

Must Document: Management review Approved signatories Equipment inventory Equipment calibration & maintenance Training records

Quality Manager Typically: Creates documentation structure Creates numbering system Decides formats and styles Writes Quality Manual Writes some other documents e.g. document control how to write a document Duties of the Quality Manager The quality manager provides a framework for document control, but normally only writes (and reviews) the quality manual, and other QMS documents within his/her own area of responsibility. The latter would for example include procedures relating to document control, internal audits, and corrective and preventive action.

Quality Manager Keeps overview of documentation Makes system work document review document control Duties of the Quality Manager All staff are responsible for following documented procedures for document control and review. It is the responsibility of the quality manager to maintain an overview of the system, and ensure that it is working properly.