ISO Standards & the QMS

Question 1

What is ISO

Answer 1

International Organisation for Standardisation
ISO is an independent, non-governmental organisation that develops international standards for products and services to ensure quality, safety, and efficiency.

Question 2

ISO core concepts

Answer 2

1. A process approach: Apply systematic management of processes to enable the organisation to achieve its intended results, in accordance with its quality policy. The Quality Management system (QMS) must be aligned with the strategic direction of the organisation.
2. The Plan-Do-Check-Act Cycle: This applies to individual processes and the system as a whole, ie. how the processes fit together and whether they are successful in achieving the organisations aims.
3. Risk Based thinking: Identify what the risks are, understand the risks, plan how to avoid or eliminate the risk, implement a plan, check the effectiveness, learn from experience (improve).

Question 3

ISO standards structure

Answer 3

All ISO standards follow a similar structure: Clauses, Requirements.

Question 4

ISO 9000 family of standards

Answer 4

Primarily concerned with ensuring quality management. Ensures customer’s requirements are met.

Question 5

ISO 9001:2015

Answer 5

Sets out the requirement for a Quality management system (QMS).
Helps businesses and organisations to be more effective and improve customer satisfaction
-Applicable to service and manufacturing sectors
-Widely adopted in the chemical and process industries.
It does NOT address any specific scientific activities that ensure validity
It does NOT asses the technical competence of individual analysts or of the lab as a whole.

Question 6

What is a QMS?

Answer 6

A way of defining how an organisation can meet the requirements of its customers.
Organisation- structure & management
The customer- regulations
Resources - staff & equipment
Procedures - HR, IT, Analytical
Improvement - complaint, Non-conformance
Communication - Records & Document control

Question 7

ISO/IEC 17025:2017

Answer 7

General requirements for the competence of testing and calibration laboratories.
-Assesses the competence of the organisation and personnel.
-Provides assurance of the scientific validity of the analytics methods and results being produced.
-Every test has to be validated
Accreditation: by an accrediting body (UKAS)

Question 8

ISO 15189:2012

Answer 8

Specific to medical laboratories and relates to clinical measurements.
Based on ISO/IEC 17025:2005
Incorporates systems required by ISO 9001
Additional criteria : provides advice on type of sample and testing required, responsibility to liase with clinicians, patient care, opinions on diagnosis, ethics.

Question 9

Similarities of ISO standards

Answer 9

• Management Structure & Responsibility
  -Documentation
  -Records (validation, calibration, complaints, etc.)
  -Training
  -Auditing
  -Annual review
  -Third party assessment

Question 10

Differences of ISO standards

Answer 10

• ISO 9001 is very general & does not cover technical parts
  -ISO/IEC 17025 enables laboratories to demonstrate their competency to produce valid results. Accreditation is given for specific tests.
  -ISO 15189 is specifically for medical laboratories and relates to clinical measurements.