Quality Assurance Schemes/Standards (Week 2) Flashcards
Managing quality:
QA schemes Standards Standards organisations - write standards Iso core concepts Iso standards structure
What are QA schemes?
Provide guidelines or standards that facilitate the assessment of quality and suppport continous improvement Help business be: More efficient - can achieve goals Improve customer satisfaction Identify and address risks Meet regulatory requirements
What are the standards?
Can be organised heirachally to show how they are related:
1) Iso standards - Internationally
recognized standards
2) ILAC/IAF, UKAS
Standards that provide guidance
on the implementation of ISO standards
3) Professional bodies, ENFSI, EURACHEM - Standards that assess specifics for the
processes being followed by the laboratory
4) NIST Scientific Working Groups, UNODC - Organizations that provide appropriate standard methods and procedures
What is ISO
ISO is the International Organization for Standardization.
ISO is an independent, non-governmental organisation that develops international standards for products and services to
ensure quality, safety and efficiency.
over 18,000 international standards.
Types of ISO standards?
1) Standards where the level of competence or the quality is set
by the customer - ISO 9000 series of standards.
2) Standards where the levels of competence are set by an
authoritative organisation - ISO/IEC 17025 - lab standard
What is ILAC?
ILAC – International Laboratory Accreditation Collaboration.
Role includes developing and harmonising laboratory and
inspection body accreditation practices. - Write guidlines on how to implement iso standards
What is IAF?
IAF – International Accreditation Forum.
Performs a similar role to ILAC, but operates in the fields of
management systems, products, services, personnel and other
similar programmes.
Ilac focuses on lab areas
Other bodies?
BSI – British Standards Institution - wide range of products - supply cerificates
ENFSI – European Network of Forensic Science Institutes
CSFS – Chartered Society of Forensic Sciences
The Forensic Science Regulator
IUPAC – International Union of Pure and Applied Chemistry
EURACHEM; A focus of analytical chemistry in Europe
Core concepts of ISO?
- A process approach
- The Plan-Do-Check-Act cycle.
- Risk based thinking
What iso structure made of?
Clauses - like chapters in book
Requirements
Easy to implement and understand across different organisations
Iso structure clauses? For ISO 9001:2015
Structure for ISO 9001:2015 Clause 4 – Context of the organisation Clause 5 – Leadership Clause 6 – Planning Clause 7 – Support Clause 8 – Operation Clause 9 – Performance evaluation Clause 10 - Improvement
Clauses explained?
5)Leadership (from the top): Customer focus Quality policy Roles and responsibilities 6. Planning: Risk based thinking Quality objectives 7. Support: Resources People Infrastructure Environment Monitoring and measuring resources Measurement traceability Competence Awareness Communication Documentation and document control 8. Operation: Process planning and control Customer requirements Design and development Control of external activities Control of production Identification and traceability (product) Control of changes Release of products (QC) Non-conforming products 9. Performance Evaluation: Monitoring, measurement, analysis and evaluation Customer satisfaction Internal Audit Management review 10. Improvement: Non-conformance and corrective actions Continual improvement
