Wednesday, January 20, 2016

Re-certification audit ISO 9001: 2015 standard

ISO 9001:2015 key focus is undoubtedly had some differences in some areas. As for me main changes would be there will be no more Quality Manual needed for you to certify under this new standard ISO 9001:2015 version. That's a huge u turn since previous version, it is a very important element needed as requirement to be audited. Previously ISO 9001:2008, there even company or organization was denied to be visited by auditor for re certification if the quality manual is not readily available or incomplete.

 More focus on risk analysis that is expected to be implemented in the new ISO 9001 version. As for bigger and established organization already adopt risk analysis into their planning and continuous improvement and development, it is sure aligned to the new version of ISO 9001:2015. But it might get difficult for small and medium organization especially a traditional one to implement this is not a piece of cake. Some even hired a consultants to do so or additional recruitment or at least sent somebody for a short course to understand how to do it right.

The best way to get a Re certification audit ISO 9001: 2015 standard successfully, is to be early bidder. Yes, indeed it is still new, but this goes same to the re-certification body auditor as well. So first time audit using a brand new standard would be less strict and more grey area to look into and discuss. After a year or so, the new standards adapt and the requirement might get stringent as well. So go for the Re-certification audit ISO 9001: 2015 standard earlier to certified without hassle.

Monday, November 30, 2015

ISO 9001:2008 Standard Quality Management System (QMS)

1 Scope
1.1 General
This standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to constantly provide products that meets customer and applicable
statutory requirements and
b) intends to increase customer satisfaction by applying the scheme effectively. This includes
the organization has processes to continuously improve the system and ensures that the requirements of
customer and applicable regulatory requirements.
NOTE. 1 This Standard uses the term "product" only
a) product intended for, or requested by a customer and
b) Such outcomes are intentionally result of product realization processes.
NOTE. 2 Constitutional requirements include requirements in laws, regulations and official regulations.
1.2 Application
All requirements of this standard are generic and intended to be applicable to all organizations, regardless of
industry, size and product provided.
Where any requirement of this standard can not be applied due to the nature of the organization and its product,
may the exclusion of such requirements should be considered.
When the exclusions made can not be argued that the requirements of this standard are met, unless these exclusions are
limited to the requirements in section 7 and they do not affect the organization's ability or responsibility to provide
a product that meets customer and applicable regulatory requirements.
2 Normative reference
This document refers to the following documents which are absolutely necessary when this document will be applied.
For dated references apply only to the edition stated. For undated references are recent
edition of the document (including all supplements).
ISO 9000: 2005 Quality management systems - Fundamentals and vocabulary
Swedish Ministry. ISO 9000 is translated and established as Swedish standard SS-EN ISO 9000: 2005 Management System
quality - principles and terminology (ISO 9000: 2005)
3 Terms and Definitions
This document applies to the terms and definitions given in EN ISO 9000th
This standard applies consistently to the term "product" occurs, it can also mean "service".

Monday, October 26, 2015

ISO 9001:2015 Revision-Part 2

The Revised Quality principles
revised quality principles iso 9001 2015
Quality Management Principle 1.Customer Focus
The primary focus of Quality management is to meet customer requirements and to strive to exceed customer expectation.

Quality Management Principle 2.Leadership
Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization.

Quality Management Principle 3.Engagement of People It is essential for the organization that all people are competent,empowered and engaged in delivering value.

Quality Management Principle 4.Process Approach
Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as coherent system.

Quality Management Principle 5.Improvement
Successful organizations have an ongoing focus on improvement.

Quality Management Principle 6 Evidence based Decision Making Decision based on the analysis and evaluation of data and information are more likely to produce desired result

Quality Management Principle 7.Relationship Management
For sustained success,organizations manage their relationships with interested parties,such as suppliers.

Sunday, October 25, 2015

ISO 9001:2015 Revision-Part 1

Objective of revision
Maintain relevance
•Enhance an organization’s ability to satisfy customers.
•Provide integrated approach to organizational management,and integrate with other management systems.
•Reflect needs of all user groups and increasingly complex operating environments
•Set a consistent foundation for next 10 years

What's new?
Explicit requirement for “risk-based thinking” to support and improve the understanding and application of the process approach,
•Fewer prescribed requirements; more performance based,
•Less emphasis on documents,
•Improved applicability for services,
•Standardized core text, structure, definition enable organizations with multiple management systems to achieve improved integration and implementation.

Wednesday, August 12, 2015

More ISO 9001:2015 latest revision free training and seminars

A lot of training sessions , briefing and workshop carried out starting last month on wards in Malaysia to introduce quality personnel around the world on the latest ISO 9001:2015 revision. Among the sessions, there were in depth explanation and also a few which just like a briefing session discussing the main changes on the latest revision of ISO 9001:2015 standard which have been drafted quite some time by the committee. Transition from 5 years to revise the standard now become more than that.

Anyway the most important thing is not just the main big changes contain in the lastest ISO 9001:2015 revision but also the impact that going to happen.There were so many questions to address. Does it impact our factory operations/plant? does it impact our cost? Does it impact our resources?Does it impact any legal/regulations? Does it involved new additional training to my company to fulfill the requirement? All these questions pop out.

To get all the information there were many ways. You can go for free training by SIRIM from link here:  Free ISO training for ISO 9001:2015

Or in the other hand you could just go for paid one. Example from BSI which i found it below. Its quite cheap and reasonable. BSI, im promoting this, i think i should get paid a little money here. ;)

Enjoy our special offer 2-for-1 admission.
Seats are limited.
Do not wait any longer and book your seat now!
Date: 18th September 2015 Time: 0830 - 1230
Venue: Armada Hotel, Petaling Jaya Price: RM60 and
Receive a second free registration

Wednesday, August 5, 2015

ISO 9001: 2015 draft is now finalized

Final draft of ISO 9001:2015 is out. Last year SIRIM had similar seminar on final draft of the ISO 9001:2015 changes. Now the standards is finalized and it is no more called final draf 2015 but it is a new revised ISO 9001 standards. The main changes in ISO 9001:2015 are the adoption of the HLS as set out in Annex SL of ISO Directives Part 1. An explicit requirement for risk based thinking to support and improve the understanding and application of the process approach. Fewer prescribed requirements. Less emphasis on documents.Improved applicability for services. A requirement to define the boundaries of the QMS.

Others, there were increased emphasis on organizational context, increase leadership requirements and finally greater emphasis on achieving desired outcomes to improve customer satisfaction.

There were briefing organize by SIRIM for free of charge to have a better understanding on the new changes. You may refer to below location, venue and date as adressed.

Location: Penang
Venue: The light hotel, Seberang Jaya
Date: 5 August 2015 (Wednesday)

Location: Johor
Venue: The Puteri Pacific Johor Bahru
Date: 12 August 2015 (Wednesday)

Location: Klang Valley
Venue: SACC Convention Centre Shah Alam
Date: 13 August 2015 (Thursday)

Location: Klang Valley
Venue: SACC Convention Centre Shah Alam
Date: 18 August 2015 (Tuesday)

Location: Sabah
Venue: Grand Borneo Hotel, Kota Kinabalu
Date: 26 August 2015 (Wednesday)

Location: Sarawak
Venue: Pullman Kuching
Date: 27 August 2015 (Thursday)


Location: Pahang
Venue: The Zenith Hotel, Kuantan
Date: 3 September 2015 (Thursday)

Monday, July 27, 2015

ISO/DIS 9001 - OPERATION - Determination of requirements for products and services - Customer communication

Requirements in clause 8.2.1 of ISO/DIS 9001 are similar to clause 7.2 of ISO9001:2008 QMS standard, however now organization needs to establish the processes for customer communication. As per requirements of ISO/DIS 9001, the organization needs to establish processes for communicating with customers for - products and services information, - enquiries, - contracts, - order handling, - changes with regard to enquiries, contracts, order handling, - obtaining customer views, - obtaining customer perceptions, - obtaining customer complaints, - handling of customer property, if applicable, - handling treatment of customer property, if applicable, - contingency actions' specific requirements, when relevant. Effective customer communication plays a important role in all above activities. Make sure that the organization understand the importance of customer communication. The organization can meet customer's requirements in a better way when it has effective customer communication processes. Effective customer communication can be done by establishing processes for providing product information, catalogues, specifications, samples etc. Product information may also be communicated in hard copy or soft copy. For handling enquiries, contracts, order handling and obtaining customer's views, perceptions, complaints, the organization must establish processes for dealing them. ISO/DIS 9001 has also included the significance of establishing processes for handling and treating customer property and also for contingency (a future or possible event or circumstance which is possible but cannot be predicted with certainty) actions.