Transcript ISO 9000:2000 Auditor Update Training

ISO-9001 : 2000
“Lessons learned” from a Quality Registrar’s
Perspective
Presented by
Bea H. Ng - BVQi(NA) Lead Auditor
Issue: 05.1.03
ISO9001:2000 Lessons Learned
1
ISO-9001:2000 “Lessons Learned”
Major Topics:
8 Quality Management
Principles

ISO-9001:2000 Interpretations
by BVQi(NA)

Issue: 05.1.03
ISO9001:2000 Lessons Learned
2
Customer focused
Customer focused:
Organisations depend
on customers.
Determine customer
needs & expectations
Requirements
Principle 1
Customer satisfaction
Issue: 05.1.03
ISO9001:2000 Lessons Learned
3
Leadership
Leaders establish unity of purpose, direction
and internal environment in which people
become fully involved.
Principle 2
Issue: 05.1.03
ISO9001:2000 Lessons Learned
4
Involvement of people
People
are the essence of the
organisation.
Their full involvement enables using their
abilities to the benefit of the organisation.
Principle 3
Issue: 05.1.03
ISO9001:2000 Lessons Learned
5
Process approach
A desired result is more efficiently achieved
when resources and activities are managed
as a process.
Principle 4
Issue: 05.1.03
ISO9001:2000 Lessons Learned
6
Process approach
New structure
 Familiar
20 elements are gone but are identifiable
 New structure is process based and more generic
based on Plan - Do - Check - Act principle
 Major clauses:
 Clearly
 Management
responsibilities
 Resource management
 Product realisation
 Measurement, analysis & improvement
 Alignment
Issue: 05.1.03
with ISO-14000
ISO9001:2000 Lessons Learned
7
Process approach
C
U
S
T
O
M
E
R
Quality Management System
Continual Improvement
R
e
q
u
i
r
e
m
e
n
t
s
Management
responsibility
Resource
management
Input
Measurement, analysis,
improvement
Product
realisation
S
a
t
i
s
f
a
c
t
i
o
n
C
U
S
T
O
M
E
R
Product
Output
Issue: 05.1.03
ISO9001:2000 Lessons Learned
8
System approach
Identifying, understanding and managing a
system of interrelated processes for a given
objective contributes to effectiveness and
efficiency.
Principle 5
Issue: 05.1.03
ISO9001:2000 Lessons Learned
9
Continual improvement
Continual improvement is a permanent
objective of the organisation
Quality improvement:
Principle 6
“part of quality management
focusing on increasing
effectiveness and efficiency”
(ISO-9000:2000)
Issue: 05.1.03
ISO9001:2000 Lessons Learned
10
Factual approach to decision making
Effective decisions are based on the logical
and intuitive analysis of data and
information.
Principle 7
Issue: 05.1.03
ISO9001:2000 Lessons Learned
11
Mutually beneficial supplier
relationship
Mutually beneficial relationship between
organisation and its suppliers enhance the
ability of both organisations to create value.
Principle 8
Issue: 05.1.03
ISO9001:2000 Lessons Learned
12
ISO-9001:2000 “Lessons Learned”
ISO-9001:2000 INTERPRETATIONS
from a
Quality Registrar’s Perspective
Issue: 05.1.03
ISO9001:2000 Lessons Learned
13
ISO-9001:2000 “Lessons Learned”
1) Standard Requirements - Justifiable Exclusions

4.2.2 Quality Manual
a) the scope of the quality management system, including
details of and justification for any exclusions
1.2 Application
Where any requirements of this standard can not be applied
due to the nature of an organisation and its product, this can
be considered for exclusion
Where exclusions are made, claims of conformity to this
standard are not acceptable unless they are limited to
requirements in clause 7, and such exclusions do not affect
the organisations ability, or responsibility, to provide product
that meets customer and applicable regulatory requirements.
Issue: 05.1.03
ISO9001:2000 Lessons Learned
14
ISO-9001:2000 “Lessons Learned”

BVQi Interpretation - Justifiable Exclusions


Must be adequately stated in the quality manual if exclusions are
taken.
Typical exclusions:
- 7.3 Design and Development
- 7.5.2 Validation of processes for production or service
- 7.5.4 Customer property
- 7.6 Control of monitoring and measuring devices
Discussion Topics



Any others that may be applicable to your company?
What is a typical statement of exclusion?
Is it OK just to say “not applicable to our method of operation”?
Issue: 05.1.03
ISO9001:2000 Lessons Learned
15
ISO-9001:2000 “Lessons Learned”
2) Standard Requirements - Documentation


4.2 Documentation requirements
Quality management systems documentation shall include
a) documented statements of a quality policy and quality
objectives
b) a quality manual
c) documented procedures required by the standard
d) documents needed by the organisation to ensure the
effective planning, operation and control of its processes
e) records required by this standard
4.2.3 Control of documents
b) to review and update as necessary and re-approve
documents
Issue: 05.1.03
ISO9001:2000 Lessons Learned
16
ISO-9001:2000 “Lessons Learned”

BVQi Interpretations - Documentation





Manual content and design
Structure of the manual and form
Documentation structure
Document control
Discussion Topics

Acceptable form and structure of manuals - Manual reviews
Process interaction description
Flow charts - not a requirement, preferred approach
Review of existing documents, frequency and evidence

Measurable objectives



Issue: 05.1.03
ISO9001:2000 Lessons Learned
17
ISO-9001:2000 “Lessons Learned”
3) Standard Requirement - Measurable Objectives


5.4.1 Quality objectives
Top management shall ensure that the quality objectives,
including those needed to meet requirements for product
are established at relevant functions and levels within the
organisation. The quality objectives shall be measurable
and consistent with the policy.
5.4.2 Quality Management system planning
a) the planning of the QMS is carried out in order to meet
the requirements given in 4.1, as well as the objectives, and
b) the integrity of the QMS is maintained when changes to
the QMS are planned and implemented
Issue: 05.1.03
ISO9001:2000 Lessons Learned
18
ISO-9001:2000 “Lessons Learned”

BVQi Interpretations - Measurable Objectives



Established at relevant function and levels
» “relevant” functions may include; purchasing, RI, sales
marketing, customer service, design/R&D, servicing, etc.
Must be measurable and consistent with the policy
» Process and Product related
Discussion Topics



Where have you seen objectives documented and
controlled? If contained in meeting minutes, is this
acceptable?
How do we determine if objectives are linked to the policy?
How do people answer the policy questions? Do they know
their objectives (Reference 6.2.2 d)?
Planning activities related to the achievement of objectives
Issue: 05.1.03
ISO9001:2000 Lessons Learned
19
ISO-9001:2000 “Lessons Learned”
4) Standard Requirement - Continual Improvement

8.5.1 Continual Improvement
The organisation shall continually improve the effectiveness of
the quality management system through the use of the quality
policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and management review.
 ISO 9000-2000 definition
-- recurring activity to increase the ability to fulfil
requirements

Issue: 05.1.03
NOTE: THE PROCESS OF ESTABLISHING OBJECTIVES AND FINDING
OPORTUNITIES FOR IMPROVEMENT IS A CONTINUAL PROCESS
THROUGH THE USE OF AUDIT FINDINGS AND AUDIT CONCLUSIONS,
ANALYSIS OF DATA, MANAGEMENT REVIEWS OR OTHER MEANS
AND GENERALLY LEADS TO CORRECTIVE ACTION OR PREVENTIVE
ACTION.
ISO9001:2000 Lessons Learned
20
ISO-9001:2000 “Lessons Learned”

BVQi Interpretations - Continual Improvement
• Significant new requirement
• Distinction between continuous and continual
• Significant or sustained lack of improvement must be met
with corrective action, unless the undesirable condition is
expected/predicted, resulting from a conscious/deliberate
decision be management.

Discussion topics
• What if efforts do not result in improvement?
• Does the improvement activity need to be documented?
• Where and how deep into the organization do improvement
efforts need to be made (drivers)?
• If they are not showing improvement, can an organization
stay certified?
Issue: 05.1.03
ISO9001:2000 Lessons Learned
21
ISO-9001:2000 “Lessons Learned”
5) Standard Requirement - Process Approach
 4.1 The Organization shall
a) identify the processes needed for the QMS and their
application throughout the organization
b) determine their sequence and interaction of these
processes
c) determine criteria and methods needed to ensure that both
the operation and control of these processes are effective
d) ensure availability of resources and information necessary
to support the operation and monitoring of these processes
e) monitor, measure and analyse these processes, and
f) implement actions necessary necessary to achieve planned
results and continual improvement of these processes
Issue: 05.1.03
ISO9001:2000 Lessons Learned
22
ISO-9001:2000 “Lessons Learned”

BVQi Interpretations - Process Approach



Process Identification
BVQi auditors will expect to see the process model that
explains the key processes of the business and how each
relates and links to others.
Sequence and interaction
The organization is not required to produce system maps, flow
charts, lists of processes etc., as evidence to demonstrate that
the processes and their sequence and interactions were
identified. Such documents may be used by an organization
should they deem them useful, but are not mandatory.
Discussion topics
What do we expect to see and how can we determine
compliance? Minimum description requirements in the manual.
 Referencing a separate document in the manual to
describe/show sequence and interaction, is this acceptable?

Issue: 05.1.03
ISO9001:2000 Lessons Learned
23
ISO-9001:2000 “Lessons Learned”
6) Standard Requirements - Competency


6.2.1 General
Personnel performing work affecting product quality shall be
competent on the basis of appropriate education, skills, and
experience
6.2.2 Competence, awareness and training
a) determine the necessary competence for personnel
performing work affecting product quality
b) provide training or take other action to satisfy these needs
c) evaluate the effectiveness of the action taken
Issue: 05.1.03
ISO9001:2000 Lessons Learned
24
ISO-9001:2000 “Lessons Learned”

BVQi Interpretations - Competency



Determine the necessary competence
» The organization should determine knowledge and/or skills an
employee would need to be considered competent, in their
opinion, to perform a particular job.
Evaluate the effectiveness of the actions
» The new requirement is aimed at ensuring that the training or
other activity has produced a competent employee. ….
Effectiveness of other actions may be evaluated by a variety of
means & organizations should select what best suits their needs.
Discussion topics



Job descriptions for competency determination.
Training effectiveness vs... competence decisions.
Operational personnel & supervision/management expectations.
» Do internal auditors need external training?
Issue: 05.1.03
ISO9001:2000 Lessons Learned
25
ISO-9001:2000 “Lessons Learned”
7) Other Sub-Clauses:
 Customer Focus (5.2)
 Customer Communication (7.2.3)
 Customer Property (7.5.4)
 Customer Satisfaction (8.2.1)
 Analysis of Data (8.4)

Issue: 05.1.03
Any others? Questions??
ISO9001:2000 Lessons Learned
26
ISO-9001:2000 “Lessons Learned”
Thank you and Good Night !!
Happy Auditing
Drive Safely
from Bea H. Ng and Jim Rivas
Issue: 05.1.03
ISO9001:2000 Lessons Learned
27