Transcript Neoteric Enterprises Inc. ISO 9001 - Quality Management Systems

Neoteric Enterprises Inc.
ISO 9001 - Quality Management
Systems
ISO 9001 - An Introduction
• ISO stands for International Organization for
Standardization.
• ISO 9001:2008 is an international standard for the
implementation and management of a quality
assurance system.
• ISO is the only series of standards of this nature
that are accepted for accreditation by a
government body (the Standards Council of
Canada).
ISO 9001 - General Overview
• The ISO Quality Management Standards have
been around since 1987 and have quickly become
a major element of supplier management strategy
for business along with becoming the central
regulatory approach for many jurisdictions.
ISO 9001 - General Overview
• An example of the impact created by the initiation
of ISO Standards is that most government,
military, European, and multi-national company
contracts make it mandatory to possess
registration to one (or more) of the standards.
ISO 9001 - General Overview
• As well, in the late 1990’s, the three major North
American automotive companies (GM, Ford, and
Chrysler) made it mandatory for all of their first
tier suppliers (23,000) to acquire ISO/TS 16949
(formerly known as QS 9000) registration (a
customized version of the ISO 9001 standard).
ISO 9001 - General Overview
• In the years since the introduction of ISO 9001,
several issues have arisen, including the
application of the standards to cover services,
software development, pharmaceutical, processing
industries, the concept of an expanded stakeholder
accountability beyond customers, the needs of the
smaller organizations, and the needs of other
specialized industry sectors, such as Medical
Devices (ISO 13485) and Aerospace (AS 9100).
ISO 9001 - The Quality Loop
Marketing and
Market Research
Disposal after
Use
Sales and
Distribution
Technical
Assistance
and
Maintenance
Design/Specification
Engineering and
Product Development
Customer/
Consumer
Producer/
Supplier
Procurement
Installation
and
Operation
Process Planning
And Development
Packing and
Storage
Inspection, Testing,
And Examination
Production
ISO 9001 - Objectives
• The objectives of any good quality
management system are the following:
• Assure that the customer receives the service or product
that is expected and remains satisfied
• Prevent errors in all operations
• Prevent delivery delays
• Reduce costs of operation
• Increase productivity
• Increase the reliability of service or product
• Meet all the quality requirements specified by the customer
ISO 9001 - Prerequisites of a
Quality Management System
• Whatever the definition of quality, one must first
focus on three fundamental elements: Quality
Policy, Quality Management, and Quality System.
ISO 9001 - Prerequisites of a
Quality Management System
• Quality Policy: Overall quality objectives and
direction of an organization pertaining to key
elements of quality such as fitness for use,
performance, safety and reliability, as formally
expressed by top management.
ISO 9001 - Prerequisites of a
Quality Management System
• Quality Management: That aspect of the overall
management function that establishes and
implements the quality policy.
ISO 9001 - Prerequisites of a
Quality Management System
• Quality System: The organizational structure,
responsibilities, procedures, processes, and
resources used for implementing quality
management.
ISO 9001 - The Philosophy
• Basically, there are two mindset approaches to
ISO 9001 registration. First, to view the ISO 9001
standard as an entity that needs to be addressed
sooner or later. This first approach is invariably
and primarily motivated by a commercial /
marketing / business set of convictions.
ISO 9001 - The Philosophy
• The other approach sees the ISO 9001 standard as
something more than just a model for quality
assurance. This philosophy will more often than
not see in ISO 9001 an opportunity to improve
managerial style. Most experts speak of ways in
which the ISO 9001 model can help a company
reduce internal cost and/or increase efficiency
thereby boosting profits.
ISO 9001 - Documentation
• Policies, Procedures, and the Manual: Basically,
the quality documentation consists of varying
stages or tiers. There are typically 3 or 4 tiers
comprised of different levels of information.
ISO 9001 - The Documentation
Pyramid
Tier 1
States Policy and Objectives for each of
the pertinent ISO elements
Tier 2
Departmental Procedures & responsibilities
Tier 3
Forms, Work Instructions &
Equipment Instructions
Tier 4
Business supporting documents
ISO 9001 - Documentation
• Tier 1 consists of the Quality Policy, business unit
policies and objectives.
ISO 9001 - Documentation
• Tier 2 consists of the departmental procedures and
responsibilities for each of the pertinent ISO
elements.
(It is the combination of Tiers 1 & 2 which comprise
the Quality Manual)
ISO 9001 - Documentation
• Tier 3 consists of the procedures reflecting the
individuals’ day-to-day business activities (Work
Instructions, Plant Equipment Instructions, etc.).
ISO 9001 - Documentation
• Tier 4 (sometimes not applicable) consists of any
business supporting documentation (Accounting
data, scheduling, etc.).
ISO 9001 - Execution
• When people realize that a significant portion of
the executing efforts required to achieve
registration consist of documenting what you say
you do, some individuals develop an allergic
reaction to ISO (my paperwork is going to triple,
I’ll need to write a memo just to go to the
washroom, etc.).
ISO 9001 - Execution
• The real issue lost here is total quality
management. To achieve that objective, everyone
must be involved to solve a multitude of problems
which may have accumulated over several years.
• And if your amount of paperwork increases
significantly, then the implementation of the
Quality Management System was incorrect.
ISO 9001 - Execution
• Such criticisms are not well founded for several
reasons. First of all, the ISO standard is a model
for the management of a quality assurance system
designed to insure that at a minimum, a series of
steps are taken to ensure that you do indeed satisfy
your customer requirements.
ISO 9001 - Execution
• Whereas it is true that ISO 9001 will never
question your technical ability to satisfy your
customer specifications, some of its paragraphs
have specifically been written to verify that you
have an effective system in place to do so.
ISO 9001 - Execution
• Role of Employees: In its simplest form, by
saying what they do and doing what they say, the
employees effectively ensure the continued
success of any quality system. This holds true for
ISO 9001 as well. In fact, it is the foundation upon
which registration lies.
ISO 9001 - Execution
• Role of the Internal Quality Assurance
Individual(s): The requirement for internal audits is
clearly specified by ISO 9001. To ensure compliance, most
companies enroll their designated quality assurance
individual(s) into one of the many Quality Auditor courses
currently offered by the few “officially approved” agencies
or Registrars. The individual(s) shall also be responsible
for the upkeep and maintenance of all the documentation
included in the company’s quality manual and quality
records, ensure that the system continues to function
effectively over time, and act as the main liaison with the
Registrar.
ISO 9001 - Execution
• Role of the Registrar: Once the quality assurance
system has been documented, implemented and
checked, an accredited Registrar must be
consulted to conduct a review of the quality
manual and to perform a third party audit.
Accreditation in Canada is granted by the SCC
(Standards Council of Canada). At present there
are around 16 accredited registrars in Canada
alone.
ISO 9001 - Execution
• As most businesses begin to implement a quality
assurance system, they quickly notice that a vast
network of internal customer/supplier
relationships begin to develop. When done
properly and in a spirit of cooperation, the settingup of an ISO 9001 quality assurance system can
lead to a sharing and exchange of information
across previously impermeable departmental
barriers.
ISO 9001:2008 - The Standard
• The ISO 9001:2008 Standard consists of 5 main
sections addressing some 23 different ‘main’
elements of compliance.
ISO 9001:2008 - The Standard
The Main Sections:
• Section 4 - Quality Management System
• Section 5 - Management Responsibility
• Section 6 - Resource Management
• Section 7 - Product Realization
• Section 8 - Measurement, Analysis and Improvement
Section 1 identifies the ‘Scope’ of the standard, Section
2 deals with the ‘Normative Reference’ of the
standard, and Section 3 addresses the ‘Terms and
Definitions’ of the standard.
ISO 9001:2008 - The Standard
Section 4 - Quality Management System:
• This Section deals with the establishment, implementation, and
maintenance of the QMS with regards to the control of
documentation and records
Section 5 - Management Responsibility:
• This Section serves to provide evidence of management’s
commitment to the development and implementation of the QMS
and to continually improve its effectiveness
Section 6 – Resource Management:
• This Section covers the organization’s provision of requirements
such as Human Resources, Infrastructure, and Work
Environment
ISO 9001:2008 - The Standard
Section 7 - Product Realization:
• This Section serves to confirm how the organization plans and
develops the processes needed for product realization
Section 8 - Measurement, Analysis and Improvement:
• This Section deals with the planning and implementation of the
monitoring, measurement, analysis and improvement processes
needed to (a) demonstrate conformity of the product, (b) ensure
conformity of the QMS, and (c) continually improve the
effectiveness of the QMS
ISO 9001 - The Strategy
• Basically there are 6 working phases to
successfully map out any worthwhile Quality
Management System:
ISO 9001 - The Strategy
* Phases *
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System Investigation – existing processes
System Analysis – gap analysis
System Design – format and content
System Development – new processes
System Implementation – launch and audit
System Maintenance – document control,
calibration, preventive maintenance, corrective &
preventive action, data analysis, internal auditing
and management review
ISO 9001 - Summary
• study current documentation
• conduct interviews and/or
perform surveys
• observe individuals actually
performing the activities
• create new documentation
• meet with executive
management of responsibility
to critique & approve the new
documentation
• finalize and control new
documentation
• train all staff
• perform internal audits of the
ISO 9001:2000 Standards’
elements
• identify all major and/or
minor non-conformances
• recommend corrective actions
• perform ‘follow-up’ internal
audits to confirm the
effectiveness of the corrective
actions
• have the Quality Manual
reviewed and approved by an
accredited ISO Registrar
• have the QMS audited by the
Registrar
ISO 9001 - Summary
Basically, for a company to achieve
Registration to an ISO Standard, it’s quite
simple:
“Comply to the Standard, say what you do,
and do what you say…”