Quality Management Systems
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QMS Quality Management Systems
?
Qua lity Pr inc ipl es Fit for purpose Quality Management Quality Assurance Quality Control Quality Requirements
Users and Stakeholders satisfaction
Output
Input
Resources
ORGANIZATION WITH LOUSY MANAGEMENT
Q
4
Up gra din g : Ser vice Q ualit y Prod uct Q ualit y Pers on nel Qualit y
By... 5
A Proven Successful Quality Assurance System
ISO 9000
What is ISO 9000?
ISO 9000 family “The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organisation can time and time again deliver the product or services that meet the client's quality requirements. These good practices have been distilled into a set of standardised requirements for a quality management system, regardless of what your organisation does, its size, or whether it's in the private, or public sector.” (http://www.tc176.org)
Different Quality Management Systems Good Manufacturing Practice for manufacturers of medical goods
Standard for Laboratory Quality Systems
Quality Management System for all organisations ISO 9001:2000 GMP
AS 9000 ISO/TS 16949
ISO/IEC 17025 TL 9000
QMS in the telecommunication sector
QMS for aerospace industry
QMS for automotive industry
ISO 13485:2003 CMM
Capability Maturity Model for software development
QMS for medical devices and related services
What is a Quality Management System
ISO 9000 defines a QMS as:
“ Management system to direct and control an organization with regard to quality”
Why do we need a quality management system?
Quality Management System 1.
2.
A management system to direct and control an organization with regard to quality QMS refers to the activities an organisation carries out in order to satisfy the quality related expectations of customers
Two ways of standard implementation Organisations may: standardize the practice
describing the practice in the language of the standard little or no change of the practice
practise the standard
looking for the best practice to fulfil the requirements adapting the practice to comply with the standard
Core principles of QMS
St anda rd is ed a nd doc ument ed pr oc ess es
Conf orma nce
An audit trail, so that it is possible to see the system working as described in the documents
Moni tor in g an d me asur ement
Documents that describe what is done in the organisation to identify and achieve the customers’ requirements
Records to prove that it has been working according to plan
Im pr ove men t!
Quality Management Principles
Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships
Standardisation exercise
Do NOT turn over the sheet until instructed! MUST finish when time is up! Cross out the numbers in sequence from 1-49 with a diagonal line as illustrated: end
13 = OK start
13 = Reject 13 = Reject
Quality Management System Documentation Standard ISO 9000 Quality Manual LEVEL 1
Policy Statement, Commitment, Organisation, Responsibilities
Quality System Procedures
Company Practices, Interfaces
LEVEL 2
Work Instructions
Written Instructions to Control Tasks
LEVEL 3
Forms
Quality Records
LEVEL 4
Sales
Desig n
Purchasi ng
Manufactur ing
Accounts
Personn el
After Sales
Need for Quality Policy
All organizations have in mind some principles, beliefs which are their broad guides to managerial conduct These guides rest on a philosophical and ethical base They concern important issues and are intended to have a long life, i.e. to act as a stabilizer Such principles and beliefs are referred to as a Qu ali ty Pol ic y
POLICY STATEMENT:
PURPOSE:
This policy provides the direction for the processes and procedures to….
RESPONSIBILITY (use those that apply)
Program Leader/Discipline Leader/Section Head is responsible for Lab Manager is responsible for Technical Specialist/Coordinator is responsible for Staff members are responsible for Other:
SECTION
SUPPORTING STATEMENTS
• NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline • QMP-LS- Ontario Laboratory Accreditation Requirements • Others:
Supporting Documents
List the processes that support this policy:
References:
Advantages of Policies
It provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial action It forces the organization to think about quality problems to a depth never before achieved. “before you write it down, you must think it out” It establishes legitimacy and can be communicated in an authoritative, uniform manner It permits practices to be audited against that policy
Quality Objectives
An objective is an aimed-at-target– an achievement toward which effort is extended. Quality objective is an aimed-at-quality target Quality objectives should be quantifiable in nature (measurable) SMART
Objectives vs. Policies
Process Mapping
Address the path of workflow Describe how things happen here Flow Charts or Tables
What Happens (List the steps)
Who’s responsible
Procedure (or another Process)
Results
1)
2)
3)
Procedure Development
Identified from process mapping Templates developed based on certain guidelines Used for analytical and non analytical procedures
PURPOSE
This procedure gives instructions……
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS APPENDICES
Measurement, Analysis and Improvement
Concerned with the establishment of a measurement program to measure QMS performance and to identify problems Sub-clauses:
Measurement of customer satisfaction Internal audits Measurement and monitoring of processes Measurement and monitoring of product Control of nonconformity Analysis of data Continual improvement Corrective action Preventive action
8 steps to ISO 9001:2000 certification 1. Identification of the processes necessary for 2. 3. 4. 5. 6. 7. 8.
effective implementation Evaluation of existing quality procedures against the requirements of the ISO 9001 standard Identification of corrective action Definition, documentation and implementation of new procedures Preparation of a quality manual Pre-assessment meeting with certification body to analyse quality manual Actual assessment visit Certification
Step 2: Evaluation of existing quality procedures against the requirements
Where the practise can be simply standardised? Where the standard need to be practised?
Implementation strategy vs. maturity of quality management Mat uri ty of qu ali ty man ageme nt Low level High level Implementation strategy
Standardising Business as usual practice
Practising standard
Radical change
Business as usual
Development
Step 3: Identification of corrective action: Gap Analysis Compl y Yes 7.2 .1 Det ermi na tion of Req ui rem ent s Rel at ed t o t he Pro duct The requirements specified by the customer, including the requirements for delivery and postdelivery activities are determined. The requirements not stated by the customer but necessary for specified or intended use, where known, are determined. The statutory and regulatory requirements related to the product are determined. Additional requirements determined by the organisation are determined.
No
N/A
Comments
Step4: Definition, documentation and implementation of new procedures
Documentation itself cannot change employees’ behaviour! Changing employees behaviour requires carefully prepared actions
Information, training Participation Top management commitment
Step 5: Quality manual
Quality Management System Handbook Documented procedures established for the QMS with references to more detailed instructions
Audits
1. Self-Assessment – Internal audits 2. Customer audit 3. Assessment by an external organisation- Certification audit
Certification audit adequacy audit
evaluation whether the documented procedures comply with the standard’s requirements
compliance audit
evaluation whether the documented procedures are followed by the employees
Results doesn’t depend on the standard, but on…
?
Qua lity Pr inc ipl es Fit for purpose Quality Management Quality Assurance Quality Control Quality Requirements
Users and Stakeholders satisfaction
Output
Input
Resources
ORGANIZATION WITH LOUSY MANAGEMENT
Q
4
Up gra din g : Ser vice Q ualit y Prod uct Q ualit y Pers on nel Qualit y
By... 5
A Proven Successful Quality Assurance System
ISO 9000
What is ISO 9000?
ISO 9000 family “The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organisation can time and time again deliver the product or services that meet the client's quality requirements. These good practices have been distilled into a set of standardised requirements for a quality management system, regardless of what your organisation does, its size, or whether it's in the private, or public sector.” (http://www.tc176.org)
Different Quality Management Systems Good Manufacturing Practice for manufacturers of medical goods
Standard for Laboratory Quality Systems
Quality Management System for all organisations ISO 9001:2000 GMP
AS 9000 ISO/TS 16949
ISO/IEC 17025 TL 9000
QMS in the telecommunication sector
QMS for aerospace industry
QMS for automotive industry
ISO 13485:2003 CMM
Capability Maturity Model for software development
QMS for medical devices and related services
What is a Quality Management System
ISO 9000 defines a QMS as:
“ Management system to direct and control an organization with regard to quality”
Why do we need a quality management system?
Quality Management System 1.
2.
A management system to direct and control an organization with regard to quality QMS refers to the activities an organisation carries out in order to satisfy the quality related expectations of customers
Two ways of standard implementation Organisations may: standardize the practice
describing the practice in the language of the standard little or no change of the practice
practise the standard
looking for the best practice to fulfil the requirements adapting the practice to comply with the standard
Core principles of QMS
St anda rd is ed a nd doc ument ed pr oc ess es
Conf orma nce
An audit trail, so that it is possible to see the system working as described in the documents
Moni tor in g an d me asur ement
Documents that describe what is done in the organisation to identify and achieve the customers’ requirements
Records to prove that it has been working according to plan
Im pr ove men t!
Quality Management Principles
Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships
Standardisation exercise
Do NOT turn over the sheet until instructed! MUST finish when time is up! Cross out the numbers in sequence from 1-49 with a diagonal line as illustrated: end
13 = OK start
13 = Reject 13 = Reject
Quality Management System Documentation Standard ISO 9000 Quality Manual LEVEL 1
Policy Statement, Commitment, Organisation, Responsibilities
Quality System Procedures
Company Practices, Interfaces
LEVEL 2
Work Instructions
Written Instructions to Control Tasks
LEVEL 3
Forms
Quality Records
LEVEL 4
Sales
Desig n
Purchasi ng
Manufactur ing
Accounts
Personn el
After Sales
Need for Quality Policy
All organizations have in mind some principles, beliefs which are their broad guides to managerial conduct These guides rest on a philosophical and ethical base They concern important issues and are intended to have a long life, i.e. to act as a stabilizer Such principles and beliefs are referred to as a Qu ali ty Pol ic y
POLICY STATEMENT:
PURPOSE:
This policy provides the direction for the processes and procedures to….
RESPONSIBILITY (use those that apply)
Program Leader/Discipline Leader/Section Head is responsible for Lab Manager is responsible for Technical Specialist/Coordinator is responsible for Staff members are responsible for Other:
SECTION
SUPPORTING STATEMENTS
• NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline • QMP-LS- Ontario Laboratory Accreditation Requirements • Others:
Supporting Documents
List the processes that support this policy:
References:
Advantages of Policies
It provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial action It forces the organization to think about quality problems to a depth never before achieved. “before you write it down, you must think it out” It establishes legitimacy and can be communicated in an authoritative, uniform manner It permits practices to be audited against that policy
Quality Objectives
An objective is an aimed-at-target– an achievement toward which effort is extended. Quality objective is an aimed-at-quality target Quality objectives should be quantifiable in nature (measurable) SMART
Objectives vs. Policies
Process Mapping
Address the path of workflow Describe how things happen here Flow Charts or Tables
What Happens (List the steps)
Who’s responsible
Procedure (or another Process)
Results
1)
2)
3)
Procedure Development
Identified from process mapping Templates developed based on certain guidelines Used for analytical and non analytical procedures
PURPOSE
This procedure gives instructions……
POLICY
EQUIPMENT
MATERIALS
SPECIMEN
SPECIAL SAFETY
QUALITY CONTROL
PROCEDURE
LIMITATIONS
INTERPRETATION
CALCULATIONS
REFERENCE RANGE
RESULTS REPORTING
REFERENCES
RELATED DOCUMENTS APPENDICES
Measurement, Analysis and Improvement
Concerned with the establishment of a measurement program to measure QMS performance and to identify problems Sub-clauses:
Measurement of customer satisfaction Internal audits Measurement and monitoring of processes Measurement and monitoring of product Control of nonconformity Analysis of data Continual improvement Corrective action Preventive action
8 steps to ISO 9001:2000 certification 1. Identification of the processes necessary for 2. 3. 4. 5. 6. 7. 8.
effective implementation Evaluation of existing quality procedures against the requirements of the ISO 9001 standard Identification of corrective action Definition, documentation and implementation of new procedures Preparation of a quality manual Pre-assessment meeting with certification body to analyse quality manual Actual assessment visit Certification
Step 2: Evaluation of existing quality procedures against the requirements
Where the practise can be simply standardised? Where the standard need to be practised?
Implementation strategy vs. maturity of quality management Mat uri ty of qu ali ty man ageme nt Low level High level Implementation strategy
Standardising Business as usual practice
Practising standard
Radical change
Business as usual
Development
Step 3: Identification of corrective action: Gap Analysis Compl y Yes 7.2 .1 Det ermi na tion of Req ui rem ent s Rel at ed t o t he Pro duct The requirements specified by the customer, including the requirements for delivery and postdelivery activities are determined. The requirements not stated by the customer but necessary for specified or intended use, where known, are determined. The statutory and regulatory requirements related to the product are determined. Additional requirements determined by the organisation are determined.
No
N/A
Comments
Step4: Definition, documentation and implementation of new procedures
Documentation itself cannot change employees’ behaviour! Changing employees behaviour requires carefully prepared actions
Information, training Participation Top management commitment
Step 5: Quality manual
Quality Management System Handbook Documented procedures established for the QMS with references to more detailed instructions
Audits
1. Self-Assessment – Internal audits 2. Customer audit 3. Assessment by an external organisation- Certification audit
Certification audit adequacy audit
evaluation whether the documented procedures comply with the standard’s requirements
compliance audit
evaluation whether the documented procedures are followed by the employees
Results doesn’t depend on the standard, but on…
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