ISO 13485:2002

Forecast
ISO 9000:2000 and 9001:2000
Revisions
Pierre Landry
Medical Devices Bureau
8th Conference on the Global Harmonization Task Force
Ottawa, 2000/09/22
 Medical Devices
Quality System Requirements
EN 46001 ISO 13485 QSR
EN 13485?

ISO/TC 210
ISO 9001
ISO/TC 176


GMP ISO 13485

 Medical Devices
Quality System Requirements
EN 46002
EN 13488? ISO 13488 QSR

ISO 9002
X
Design
Sec. 4.4
Control

GMP ISO 13488

 9000 family - Before and After
Existing 2000 Revisions
 8402 - Vocabulary 9000-  9000 - Fundamentals
1 Selection/Use and vocabulary
 9001, 9002, 9003 - QMS  9001 - QMS
Requirements Requirements
 9004-1 - QMS  9004 - QMS Guidelines
Guidelines  19011 - QMS / EMS
 10011 - QMS Audit Audit Process
Process
 Timeline for Introduction
 ISO 9000:2000 family by end of 2000
Including a Product Introduction Package
 ISO 19011:2001 ???
QMS and EMS Auditing process replacing 10011
 ISO 13485:2002 and ISO 13488:2002
 Not sure to update ISO 9000-2:1997
Guideline on the application of 9001
9000-2 was the base for 14969 (for medical devices)
 ISO 14969:2003 ???
Guideline for the application of 13485
 9000:2000 family - 3 Changes
 Terminology and fundamental concepts
9000 Fundamentals clause (informative)
9000 Vocabulary clause (normative)

 Requirements (concept and layout)

9001 with clause 1.2 re. permissible exclusions rather
than tier 9001/2/3
9001 process model - continual improvement

 Auditing process i.e. tie quality QMS with

environmental EMS
 Fundamentals in 9000:2000
 Narrative “informative” not “normative” and replaces
9000-1
Rationale for QMS
8 quality management principles
Process Approach (from 20 elements in 1994 to 5 processes
in 2000)
Role of top management
Documenting the QMS
Continual Improvement
Role of statistical techniques
 Vocabulary in 9000:2000
 Normative and replaces 8402:1994
Usually adopted “as is” e.g. Clause 2 of ISO
13485:1996
Concise, precise, in 10 thematic groupings
82 definitions as opposed to 67 in 8402:94
quality, management, organization, process and
product, characteristics, conformity, documentation,
examination, audit, QA of measurement process
ISO/TC 37 Terminology methodology
 9000:2000 - Documentation
Concept Diagram
information document
meaningful data information and its
supporting media

procedure document
[not defined, see note to
procedure]

specification quality manual quality plan record

document stating document specifying the document specifying document stating
requirements quality management which procedures and results achieved or
system of an associated resources evidence of activities
organization shall be applied by performed
whom and when to a
specific project,
product, process or
contract
 9000:2000 - Documentation
Concept Diagram
information document
meaningful data information and its
supporting media

specification
“information and
its supporting
specification
media” stating
document
specification requirements
document stating stating
requirements
requirements

Rule of Substitution
 Example 9000:2000
clause 3.7.3
document (3.7.2)
 3.7.3 Specification:
stating requirements (3.1.2)

information and its supporting media

stating need or expectation that is stated,
generally implied or obligatory
 Example 9000:2000
clause 3.7.5 cont’d

 Quality Plan - Definitions

8402 document setting out the specific quality
practices, resources and sequence of activities
relevant to a particular product, project or
contract
9000:2000 document specifying which procedures
and associated resources shall be applied by
whom and when to a specific project, product,
process or contract
9001:1994 Requirements

1 Scope
2 Normative Reference
3 Terms and Definitions
4.1

to 20 elements
(product life cycle)
4.20
 9001:2000 Requirements
1 Scope
2 Normative Reference
3 Terms and Definitions
4 Quality Management System
5 Management Responsibility
6 Resource Management
7 Product Realization
8 Measurement, Analysis and Improvement
 Note: see comparison table between 9001:1994
and 9001:2000
 9001:2000 Requirements cont’d

 PIP (Product Introduction Package) Modules will assist

in understanding of 9001:2000
Permissible exclusion (for comments ISO/176 SC2N524)
Documentation (for comments ISO/176 SC2N525)
Terminology (for comments ISO/176 SC2N526)
Self Assessment (to be developed)
Process Approach (to be developed)
Transition 1994 to 2000 (to be developed)
 9001:2000 Requirements cont’d

 Quality Plan Requirement

9001:1994, clause 4.2.3 Q. Planning
the supplier shall give consideration to the following … in
meeting specified requirements for product, projects or contract: a)
preparation of quality plan…
9001:2000, clause 7.1
…organization shall plan and develop the processes needed for
product realization...
Note: A document specifying the processes of the QMS (including the
product realization processes) and the resources to be applied to a
specific product, project or contract, can be referred as a quality plan
 9001:2000 Requirements
 Clause 1.2 “Permissible Exclusions” in
replacement of the tier 9001/2/3:1994
 Applicable to all product categories
hardware, processed material, software and service
 New layout based on the process approach, fully
compatible with 9004
 Aim to enhance customer satisfaction via
processes for continual improvement of the QMS
 9001:2000 Requirements cont’d

 Permissible Exclusion
Organization may exclude parts of clause 7
dealing with product realization processes
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
 9001:2000 Requirements cont’d

 Permissible Exclusion
Condition: Exclusions do not affect ability and
responsibility to provide product that fulfils
customer and regulatory requirements
Could be “fuzzy” at time of conformity
assessment
ISO/TC 210 prefers the ISO 13485/13488
approach - 13485:2002 should not adopt this
provision of 9001:2000
Thank you for your interest and
participation

 Questions