1. 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

2. 5.3 Accommodation, Environment
Accommodation & environment to suit
testing
equipment
Monitor environment as needed, records
Control access to laboratories
Good housekeeping

3. 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 is not totally prescriptive about how non-standard methods, or changes to methods, are validated. However, note 2 of clause provides guidelines.
Validation data are QMS records subject to audit, and must be retained.

4. 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.

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

6. 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.

7. 5.7 Sampling
Ensure statistical validity

8. 5.8 Handling Test Items Documented handling procedures
Secure identification of samples
Ensure sample condition acceptable
Protect samples

9. 5.9 Quality Assurance Use quality control
Participate in proficiency testing
Use statistics if practicable

10. 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 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.

11. 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.

12. 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”

13. 4.4 Contract Review Requirements for any testing
documented
understood
Appropriate methods used
Adequately resourced
Changes documented & agreed

14. 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

15. 4.6 Purchasing Procedures for selection and purchasing
where it affects test quality
Inspected to confirm compliance
Lists of suppliers
records of evaluation

16. 4.7 Service to the client
Communication and co-operation

17. 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.

18. 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

19. A Documented Quality System

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

21. 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.

22. 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.

23. 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
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.

24. 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.

25. 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.

26. 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.

27. 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

28. 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.

29. 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.

30. 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.

31. 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.

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

33. 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.

34. 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.