successful implementation of management system certification...iso 9001: 2015? •7. support...
TRANSCRIPT
TÜV SÜD Group
Successful Implementation of Management System Certification
TÜV SÜD Management Service GmbH
ISO 9001: 2015? What will the future bring?
ISO 9001: 2015?
27.05.2015 Abteilung: 3
ISO 9001: 2015?
• 1. Scope
• 2. Normative references
• 3. Terms and definitions
• Clauses 4-10 are now distinctively different
(2 more clauses than at present)
• 4. Context of the organisation -
Scope and expectations for the management system.
• 5. Leadership management commitment,
Policy, roles, responsibilities and authorities (offices).
• 6. Planning -
Risks and opportunities, and objectives and plans.
27.05.2015 Abteilung: 5
ISO 9001: 2015?
• 7. Support resources –
Expertise, awareness, communication and documented
information.
• 8. Operation –
Operational planning and control.
• 9. Performance evaluation –
Monitoring, measurement, analysis, evaluation,
internal audits and management review
• 10. Improvement –
of nonconformities, corrective actions, and
continuous improvement.
27.05.2015 Abteilung: 6
1. The Process Approach is now embedded in requirements
Clause 4.4 specifies requirements 'considered essential to the adoption of the
process approach'. Mostly, these consist of requirements that were already in
9001, but which have now been brought together. But the explicit requirement of
the process approach
2. Risk management is in, preventive action out
Risk management is a requirement. Preventive action has been removed
27.05.2015 Abteilung: 7
3. The structure has changed
There are now 10 main clauses, 1-3 as before, with requirements now set out in
clauses 4-10
This brings it into line with ISO's new harmonised and consistent structure, to be
used for all management system standards in future.
4.'Documented information' replaces both procedures and records - nil
mandatory procedures
One of the most controversial changes, and one where further changes are likely
before publication.
27.05.2015 Abteilung: 8
5. Terminology changes
The term 'product' has been replaced with 'goods and services'. This is to make
it more generic and applicable to service fields, and remove the inherent
manufacturing bias.
27.05.2015 Abteilung: 9
What is ISO/TS 16949?
• ISO/TS 16949 is the international quality management standard
specifically intended for organizations in the automotive
industry supply community. It is for organizations that produce
and deliver parts, sub-assemblies, process materials, and
certain other products and services to OEM manufacturing
locations.
• A quality management system standard resulting from the
harmonization of European and North American Automotive
Quality Management System requirements.
• ISO/TS 16949 certification is recognized by well known
Automotive OEMs such as Chrysler, General Motors, Ford,
BMW, Volkswagen among others.
ISO/TS 16949:2009 - AUTOMOTIVE
QUALITY MANAGEMENT SYSTEM
11
• Satisfies the demands of current or prospective customers for
registration.
• Improves customer focus. We focus controls on management of the
processes that enable us to achieve and improve customer
satisfaction.
• Boost international acceptance and credibility. ISO/TS 16949 is in
fact an international quality management specification. It is known,
recognized, and accepted without question all over the world.
• Places you in an elite category of businesses. Registration to
ISO/TS 16949 puts your organization on the identical level of
excellence shared by organizations of all kinds worldwide.
EXTERNAL BENEFITS OF
ISO/TS 16949 IMPLEMENTATION
12
• Keeps you prepared for external audits and inspections – i.e. regulators,
customers, etc.
• Facilitates continual improvement. It sounds like a cliche, but it really is true. In
today's intensely competitive global market, there is no such thing as a safe,
protected market. Your competitors, out to eat your lunch, are striving to improve.
You must do so too.
• Provides competitive advantage. When you're head-to-head with a competitor for
a piece of business -- and you're certified but they're not -- who's going to get the
nod?
13
EXTERNAL BENEFITS OF
ISO/TS 16949 IMPLEMENTATION
• Transforms your operation from detection mode to prevention mode. Prevention is less
work and less expense than detection.
• Creates consistency throughout the organization built around "best practices".
• Improves business performance. A well designed, well implemented management system
can help improve satisfaction of customers and consumers; and boost internal manufacturing
and operational efficiencies.
• Lessens dependency on key individuals. Tasks or processes don't collapse just because
one person leaves or changes jobs.
14
INTERNAL BENEFITS OF
ISO/TS 16949 IMPLEMENTATION
15
INTERNAL BENEFITS OF
ISO/TS 16949 IMPLEMENTATION
• Provides blueprint for controlled, disciplined growth. ISO/TS management systems as a
way to organize the business, systematize practices, and ensure management accountability
as the organization expands.
• Ensures consistent training. Each road map provides direction from one end of a process
to the other.
• Improves management oversight. This system incorporates monitoring and measurement
of key performance indicators in quality and customer satisfaction. And then management
review, closing the loop, provides management with solid data, enabling management to
make decisions based on facts and evidences.
16
INTERNAL BENEFITS OF
ISO/TS 16949 IMPLEMENTATION
HOW TO START?
- Identify your automotive customers;
- Set-up your SMART Business plans;
- Discover your customer specific requirements;
-Appoint a Management Representative with define responsibilities,
authorities and accountabilities;
- Provide him ISO/TS 16949 training including appropriate core tools;
-Provide multi-disciplinary teams coming from different departments that
will assist Top Management in setting-up a consistent Top-Down quality
objectives, and defining the resources needed, and
- Document and implement different processes to meet the defined
quality objectives;
-Conduct internal quality audit, and
-Top management review performance and continually improve the QMS
processes.
• Contact Certification Body for initial discussion;
• Signed the certification contract;
• Inform the Certification Body if a minimum of 12 –months
performance data was achieved;
• Certification Body Stage 1 audit
• Organization’s corrective action implementation for Stage 1
audit findings;
• Certification Body Stage 2 audit
• Organization’s corrective action implementation for Stage 2
audit findings;
• Certification Body Technical Review;
• ISO/TS 16949:2009 Certificate issuance.
18
HOW TO BE
ISO/TS 16949 CERTIFIED?
19
Rules changed point from 3rd to 4th
Rules 3rd 4th
3rd- ( )
4th - ( )
Changed Content Source of changes
12(3.1) 18(3.1) ...
g) consultants to the client cannot be physically present at the client’s site during the audit or participate in the audit in any way.
SI#1
17(5.2) 25(5.2) 5.2 Audit day determination
c) The minimum audit time in manufacturing shall be a
minimum of one-third of the total audit days
e) the audited entity includes:
- the total number of employees on site (including permanent, part time, contract, average number of daily workers for the previous six (6) month period, and temporary employees),
h) if a portion of the site is dedicated to automotive, then the headcount from that portion can be used to determine audit time when the following conditions are met:
- approval from the relevant Oversight office is received prior to implementation,
- all automotive manufacturing processes are physically separated from non-automotive manufacturing (e.g. separate building, permanent barrier in between auto and non-automotive lines/machines, etc.),
- personnel working in the automotive manufacturing process areas are completely dedicated,
- all support activity personnel are included in the headcount,
Note: If automotive manufacturing processes are integrated on the manufacturing floor with non-automotive manufacturing processes, then this requirement cannot be applied.
New
18(5.2) 26(5.2 q) ...
q) when the total number of employees on site changes prior to or during the
New
QUESTIONS/CLARIFICATIONS?
20
