DIS Approved and Progresses to FDIS. ISO 9001:2015 Development Process Remains on Time

The buzz about voting on the ISO 9001:2015 has been all over the internet recently. There has been an unbelievable amount of dissent in the discussions from the American camp. Does nobody out there except my colleagues and I think this is a great evolution of the standard? Everybody seems to be moaning about it. They don’t like “risk” – it’s not defined enough. Requirements are thin. There is no management rep. They don’t like the change in terminology. They don’t like “strategic” stuff. Often they don’t explain, they just whine! Very little of the discussion is positive or even hopeful. You don’t have to look far.

So with the doom and gloom group leading the way, we went into the vote. The vote from the US TAG group was to vote to disapprove the DIS standard. They didn’t like “risk”, they didn’t like……you get the idea. The detail is not officially available yet but again, you don’t have to look far. The US TAG voted among them to disapprove. They wanted to stop this DIS and cause a rewrite which would probably create a 6-9 month delay in the process – delaying ISO 9001:2015 well into 2016. Why?

The vote among the US group was about 100+ votes against, and 0 for, and about 40-50 non-abstaining missed votes. They REALLY wanted to kill this standard. Does this make sense to anybody else? How does an unbiased vote get 100% of the vote? This group includes the “experts” and professionals and other interested parties. Who influenced them to all vote one way? Perhaps we should just assume for the moment that they were all-in with the negative comments.

Then we hear tentative information about the international vote. The DIS passed the international vote with a 90% vote in favor. It was “pointed out” that those that disapproved are mostly involved in the working groups (who work on the wording etc.). I read this to mean that generally the world thinks it’s a pretty good standard. I can’t wait to hear why the US “experts” think the rest of the world is wrong.

And so the development of basically a good new standard moves forward, on time. In this camp, we are looking forward to the FDIS in early/mid 2015.

Source :  http://www.cavendishscott.com/articles-news/dis-approved-and-progresses-to-fdis-iso-90012015-development-process-remains-on-time/

TIMELINE ISO 9001:2015 - ROLE OF MANAGEMENT REPRESENTATIVE

GENEVA, SWITZERLAND, 6 MARCH 2013 - As part of its ongoing revision and development process, the International Organisation for Standardisation (ISO) has been preparing for the next major revision to ISO 9001 (the last, minor amendment to the Standard was made in 2008). The ISO Working Group (TC176-SC2-WG24) is currently forecasting final publication in the last quarter of 2015.  Before then, however, there are a number of preparatory stages which have to be carried out.

ISO 9001 REVISION TIMETABLE

The current ISO timeline anticipates that a draft version of the revised Standard (DIS) will be available in Q2 of 2014. Subject to comment and voting on its content, a final draft version (FDIS) could be available during the final quarter of 2014 with publication of the revised version of the Standard approximately a year later. Clearly this timeline may be subject to delay and date slippage.

REVISED CONTENT

At this stage in the revision process, it is uncertain what the precise requirements of the final revised version of ISO 9001 will be. However, it is already known that certain structural changes will be made. 

Following the adoption by ISO of ‘Annex SL’ in 2012, all technical committees developing management system standards have to use the same structure, terms and definitions. Management system standards have already been published using this harmon­ised structure (e.g. ISO 20121:2012, Event Sustainability Management Systems) and ISO 9001 will follow this new format during its revision process.

For this reason, we know that the revised version of ISO 9001 will have ten sections:

1.       Scope

2.       Normative references: Both of these sections will have wording that is specific to the Standard (including its intended outcome)

3.       Terms and definitions: This will reference the common terms and core definitions outlined in Annex SL as well as any which are specific solely to QMS

4.       Context of the organisation: This section will include requirements relating to understanding the organisation implementing the Standard, the needs and expectations of interested parties, the scope of its QMS and the QMS itself.

5.       Leadership: Top management leadership and commitment, the QMS policy, as well as organisational roles, responsibilities and authorities.

6.       Planning: Actions to address risks and opportunities, QMS objectives and plans to achieve them.

7.       Support: Resources needed for the QMS, personnel competence and awareness, communication and documented information.

8.       Operation: Operational planning and control.

9.       Performance evaluation: Monitoring, measurement, analysis and evaluation, internal audit and management review.

10.   Improvement: Non-conformity, corrective action and continual improvement.

Aside from some general wording changes (using the term ‘documented information’ to replace references to ‘documentation’ and ‘records’, for example), the text that Annex SL requires to be used contains no specific requirements for ‘preventive action’. Although it is made clear that this is because one of the principal purposes of any management system as a whole is to act as a tool for preventing non-conformity in the first place, ‘preventive action’ may still yet be included in the final revised version of ISO 9001.

Annex SL includes a specific requirement that organisations determine the risks that need to be addressed to ensure that their management system can achieve its intended outcomes, prevent or reduce undesired effects and achieve continual improvement. Each management system standard can define risk in terms that are relevant to their specific discipline; so the revised version of ISO 9001 may do so in relation to product or service conformity and customer satisfaction.

Clearly at this stage in the revision process  no organisation can be sure of the additional QMS specific content that will be included in the final revised version of ISO 9001. Until the final draft is issued towards the end of 2014, no organisation can realistically make any definite forecast about requirements, detailed plans for internal process or procedural revisions, or for ISO 9001 certificate transition arrangements.

We have seen through several years transformations in ISO 9001 which substantiates the important role of Management Representatives (MRs)  from Managing Procedures to Managing Processes to Managing Results .  ISO 9001 has gone past the 25 years since its inception last 1987 and is here to stay. The concepts of customer, process, management review and continual improvement among others have been stable through many organisations and so is the application of the ISO 9001 standard. Everyone can associate with the requirements that guided organisations in managing the assurance for quality products and services all towards increasing assurance for customer satisfaction and the drive for continual improvement. 

With its silver years of existence and 4 revisions, it has seen through the transformation of the role of management representatives in various organisations and is yet to see some further developments to address the emerging issues that we have today. Through the years, with the observed  revisions of related management system standards and the emerging revision for ISO 9001:2015, we are about to see further challenges for the post of being the management representative, be it a QMR : Quality Management Representative or the increasing role of being the IMR: Integrated Management Representative. A growing question then arises in every practitioner for Management System.

(Q) What do we anticipate for ISO 9001:2015? What is in store for the new QMR?

The technical experts behind the ISO 9000 series of standards have been chartering the change and soliciting data from user communities and reviewing the feedback from the market. With the results of such studies are two key directions: 

The first being intention is that ISO 9001:2008 would be revised with only minor changes, and this had  already been witnessed approximately 5 years ago where the revision was only on terminologies, linkage with relevant standard and provisions for managing competence particularly for auditors as has been supported with the ISO 19001 version 2011. 

Second, ISO 9001:2015 which is its target date of release would result in a more extensive revision, addressing global and technological changes in the marketplace.  There are areas of consideration that will go into the next revision, and they are those that relates to (1) sector - specific standards and to improvements and changes in technology, supply chain management, and globalisation.

(1)    Sector-specifics and related management system standards

Over the years, there’s been a proliferation of sector-specific standards based on ISO 9001. In the last two years, standards have been added relating to food safety - ISO 22000,   road safety management – ISO 39001, and the petroleum industry - ISO 29001. They join the now-mature standards in such areas as medical device - ISO 13485, automotive - ISO/TS 16949, telecommunications - TL 9000, and aerospace - AS9100. These sector-specific standards are mostly founded on ISO 9001 and their sector-specific nature revolves around the addition of requirements that are unique to a particular industry. For example, automotive suppliers, registered to ISO/TS 16949, deal with customer specific requirements and application of core tools. 

The standards field has been further augmented by standards relating to environmental issues - ISO 14001, health and safety - OHSAS 18001, energy management – ISO 50001, sustainable events management – ISO 20121 and competence in laboratory testing and calibration - ISO 17025.  The above related standards are now growing to be not just an effort for environmental integrity and societal accountability but are becoming to be a customer contractual requirement. 

It can be challenging for an organisation complying with such commitments with customers and to develop a QMS that incorporates the requirements of multiple sector-specific standards effectively and efficiently.  Though reality prevails that meeting customer requirement entails that you manage the business risks and related risks that will lead to its disruption. And such is where the auditors’ competence and the integrative function of the management representative are headed in the future of ISO 9001:2015- the ability of your present management system to integrate or link with related management system standards and the accompanying objectives.

Some of the future concepts being addressed are the integration of risk-based thinking. The objective of other management system standards i.e.  ISO 14001 and OHSAS 18001 differ significantly from this quality management system standard but the model being espoused in the ISO 14001 and the OHSAS 18001 as has been summarised in PAS 99 is being looked at as the integrative model for effective reconciliation of management plans, processes and performance results. This is expected to be another significant input in the next major revision of ISO 9001 to formally adopt the wider perspective of planning which incorporates risk-based thinking.

With such, the QMR: Quality Management Representative or the IMR: Integrated Management representative has to consider the completeness of his knowledge regarding the risks prevalent to the business that will affect customer requirements and their satisfaction. Likewise, this necessitates the challenge on the currency and completeness of the Quality Management Principle to manage uncertainties on its objectives and not only its process and system interfaces. An auditor and a management representative thus not only must possess process and systemic approach of thinking but a risk-based approach for the decisions he must make.

(2)    Improvements and changes in technology, environmental factors, information management, supply chain management, and globalisation.

The developments we see in the technology will likewise give rise to enhancements in processes that deals with Knowledge   Management, Technology and changes in Infrastructure and Communications technology, Lifecycle Management including Outsourcing and Offshoring.

Outsourcing has been addressed in the 2008 version as such that refers to those processes needed by the organisation that are performed by an external entity. It is recognised that outsourcing is a growing aspect of many organisations in focusing on its core competencies and managing cost-effectiveness in managing its processes. The outsourcing strategies also lead the way for globalisation and the growing dependence in supply chain management. Challenges in the management of supply chain abound such as managing least-cost and least-distance including the medium and frequency of shipments that challenges the paradigm towards an efficient and optimal way of doing things.

The growing pace of information growth creates a challenge for application systems to manage documentation and the convenience gives rise to certain risks on information security. 

The future of ISO 9001 depends on its ability to retain the generic and universal concepts that make it work among organisations to be workable in managing its most important stakeholder- its customers and its ability to give a framework for managing emerging needs to ensure its continued applicability in our ever-changing world. The thrust for the PDCA cycle might bring further enhancements on the way we improve things utilising principles beyond improvement and on to innovation taking the premise to manage  Performance Effectiveness through Product Conformity and Process Efficiency and the incorporation of Quality Tools and Best Practices.

It is still an anticipated revision but the manner in which such will be addressed will have a long-range effect on the continued viability of ISO 9001 and its value-add to the business. Being an MR then may mean that you manage the emerging concerns abound the industry that your business is in and focus not only on the customer satisfaction but its linkage with the emergence of developments on the global market-place, and such entails managing risks in the business setting. The risks may not be exactly on higher perspectives such as environmental integrity and social accountability just yet but there are risks that go beyond quality that matters to your customers and the top management that you represent.

So as ISO 9001: Quality Management System is here to stay , so does the Management Representative in their role for managing the system along with the risks that goes with it. Way to go FORWARD for all MRs will be to learn Risk-Based Process Management and Auditing and towards Business Risk Management. Risks comes in the picture as creating uncertainties in achieving our objectives, and so we journey from Managing Results and on to the future of Managing Risks and Value Chain in the continuing developments in ISO 9001.

Source of this article: http://www.allanta.be/nl/page/700/timeline-iso-90012015-role-of-management-representatives

Original Source: ISO.org, SGS & Neville Clark

THE FUTURE OF ISO 9001

By :  Yasuhiko Yoneto

Yasuhiko Yoneto discusses the Japanese view of ISO 9001 and his suggestions for the revised version of the standard in 2015

When ISO 9000 was first published in 1987, many Japanese companies showed a strong resistance to the requirements of western-style documentation. ISO 9001:2000 was expected to breathe new life into Japanese companies that were suffering from the collapse of the bubble economy, and to help restore their competitiveness. However, we found out that the quality management system on its own was not enough to strengthen the economic results of Japanese companies' operations. The revision in 2008 was not a full-scale one and there were only minor modifications. With this in mind, from a personal point of view, expectations are high for the revised version of ISO 9001 (expected to be released in 2015).

Today, you would be hard pressed to find an organisation that is unaffected by the wave of globalisation.  It is now common to procure materials, components for products, and even services, from abroad. For example, a company in the US might be continuously carrying out around-the-clock development work on computer software in collaboration with an Indian company. Despite this situation, the only wording that reflects this in the current version of the standard is "evaluation of suppliers". So it is difficult to say that the standard places enough emphasis on the management of suppliers. Many companies have responded by creating a supplier qualification process using their own rating criteria, such as supply capability and quality control level. There has been a host of challenges for international supply chains recently, which demonstrate the need for supply chains to be strengthened. It's therefore desirable that a clear statement about the requirement for supplier evaluation is made in the revised ISO 9001 standard, addressing the presence or absence of supply chain management and need for periodical second-party auditing.

According to a recent ISO survey on the relationship between financial results and the concept of zero defects, a financial disadvantage can surface when the management system for the manufacturing process aims to achieve a zero-defect product infinitely through the principle of 'quality first'. The survey also found that many companies are seeking economic benefits through the utilisation of the ISO 9001 quality management system. In Japan it is not as prevalent as the rest of the world, but some companies do seek third-party certification of their management system for the sole purpose of increasing their commercial advantage. This is a particularly strong pattern among small and medium-sized companies. To avoid such improper trends, one option for the revised ISO 9001 standard would be that 'management review' requires organisations to discuss investment efficiency as well as cost reduction.

Due to advances in information technology, it's become common practice for management systems and various documents to be digitalised. This practice encourages the internal sharing of various documents so that they can be facilitated at every level of an organisation. Today, many organisations use information technology to strengthen their internal communications and share knowledge of customer information and personal experiences. However, the current international standard does not specifically mention the utilisation of information technology, other than referring to "documents containing digital data". An active utilisation of information technology could be encouraged in the standard, by adding a requirement regarding documentation.

The difference between corrective and preventive actions is not so clear, although these are major requirements in the current international standard. Not only that, but the requirement for preventive action cannot be described as a proactive approach, but rather a reactive approach. In addition, 'preventive action' is often synonymous with risk assessment, hence it has to be positioned at the 'plan' stage in Deming's plan-do-check-act cycle. Very fortunately, the newly proposed high level structure for international standards follows this direction and emphasises risk management in the planning stage as a part of the management system. The risk-based approach adopted for another standard – PAS 99:2006 – might be one of options to encourage organisations to carry out a simple risk assessment. Therefore, my final suggestion for the revised ISO 9001 standard is to add a note referring to the risk-based approach of PAS 99.

Yasuhiko Yoneto is a quality commentator, former employee of ExxonMobil Chemical, and former quality improvement engineer in Japan, the US and Singapore

Source :  http://www.irca.org/en-gb/resources/INform/archive/Issue38/opinion/

Ten Tips on Making ISO 9001 Effective for You

1       Top management commitment is vital if the system is to be implemented successfully. Make sure senior managers are actively involved, approve resources and agree the key processes in the business.

2       Look at what systems, policies, procedures and processes you have in place at the moment. Then compare those with what ISO 9001 asks for. You may be surprised at how much you already do. ISO 9001will allow you to keep the things that work for you while refining those that don’t.

3       Make sure you have good internal communication channels and processes within the organization. Staff need to be involved and kept informed of what’s going on.

4       Give some thought to how departments work together. It’s important that the people within your organization don’t work in isolation but work as a team for the benefit of the customers and the organization.

5       Don’t ignore the impact that introducing these systems will have on your customers and suppliers. Speak to them to gain insight as to how they view your service and how they feel improvements could be made.

6       Clearly lay out a well-communicated plan of activities and timescales. Make sure everybody understands them and their role in achieving them.

7       The nature and complexity of your documentation will depend on the nature and complexity of your organization. ISO 9001 only defines the need for six procedures. What you have in addition to this is up to you. Consider using  your IT systems or software such as BSI’s Entropy® Software to manage your system and documentation more efficiently.

8       Make the achievement of ISO 9001 engaging and fun. Use competitions, such as for the first completed process. These will increase motivation.

9       Train your staff to carry out audits of the system. Auditing can help with an individual’s development and  understanding as well as providing valuable feedback on potential problems and opportunities for improvement.

10                     And finally, if you feel that you are doing something just for the sake of ISO 9001 and it doesn’t add any value to you as a business, question whether it’s necessary. Nine times out of ten it won’t be needed.

Source :  www.bsigroup.com

ISO 9001 - THE REVISION PROCESS COMMENCES

In March 2012, ISO members voted to revise the ISO 9001:2008 standard and, at the invitation of SPRI (the Basque Government Society for Innovation), held their first meeting in Bilbao, Spain during the week of 18 to 22 June 2012.

Bilbao is a city which symbolises renewal and it is a very appropriate origin in the journey to revise ISO’s most popular standard. Symbolic of this renewal is the Guggenheim Museum (1997) and the Iberodrola Tower (2011); both associated with famous architects, Frank Gehry and César Pelli.

What are the architects of ISO 9001:2015 planning?


ISO standards are balloted for reveiw every five years – not because the committee wants to perpetuate
itself, but to ensure that the standard is maintained as relevant and contemporary. The last revision to ISO 9001 (in 2008) was not regarded as a significant change and most of the changes were seen as “editorial”; many of the changes made then were to aid translation and to make it more readable (the change in clause 8.3, non-conforming product was a good example of this).

There is a very significant reason for revision ISO 9001 and this has been caused by the publication of Annex SL in the ISO/IEC Directive Part 1 (see page 3). This rather dull sounding publication from 2011 is very significant as it contains the template for a management system standard. All ISO management system committees are now required to reorganise the clauses to suit the template.

ISO 14001, which is also under revision, has already a six month start on ISO 9001 and has been re-organising the familiar clauses 4.1 to 4.6 into the new framework. So the first change to anticipate is that the 2015 version of ISO 9001 will be structured differently and, further, the text will change as the template text, considered to be generic for any management system standard, must be maintained unless special permission is obtained from the ISO Secretariat. It is not expected that permission will be granted lightly and only standards such as ISO 13485 (Medical Devices) will be given dispensation - in this case because ISO 13485 does not have a requirement for continual improvement.

The meeting in Bilbao did not draft a single word of a proposed ISO 9001:2015. The committee met to draft the design specification (new work item proposal) for the new standard. This is a very important document as it establishes the boundaries for the revision as well as the timeframe for the various approval stages from WD (Working Draft), to CD (Committee Draft), to DIS (Draft International Standard) to FDIS (Final Draft International Standard). Each issue from CD is translated to the main ISO languages (French and Russian) and a standard period is allowed for this translation; it is this translation time, as well as voting / comment periods, that accounts for most of the time taken to revise a standard.

This November in St. Petersburg, when the group next meets, it is hoped that the design specification will be approved and the drafting team can start the process of putting revised words on paper.

If you took part in the ISO survey, your comments are being reviewed in depth (the early results did not
include comments in foreign languages and did not look at additional comments which were not part of the “survey monkey” menu). Progressive Certification are taking part in this review and, if you have any  additional comments, please forward to us so that we can include in our national position which will be  ubmitted prior to the next meeting.

Source :  www.progressive-cert.com/

KENDALA AUDIT INTERNAL

Rekan-rekan Quality Club. Berikut ini rangkuman hasil diskusi kendala penerapan audit internal.

Beberapa masukan dari teman-teman saya hapus karena ada kesamaan isi.

Dari masalah yang teridentifikasi ini bisa diambil tindakan perbaikan yang sesuai guna meningkatkan kinerja kegiatan audit internal.

Kendala-kendala pelaksanaan audit internal:

1. Kurang Respon dari Manajemen (atasan) prioritas utama tetep produksi harus jalan - jadi Internal audit, hanya buang waktu

2. Pass atau Fail dalam proses Internal Audit tidak ada efek yang berarti, tidak seperti halnya audit dari Customer.

3. Internal auditor yg ditugaskan melakukan audit tetap memiliki tanggung jawab thd pekerjaan utamanya, akibatnya kesulitan untuk menjadwal audit dan pelaksanaan audit tidak efektif.

4. Seringkali auditor internal mengkaitkan tidak adanya reward tambahan sbg seorang auditor.

5. Auditee kurang merespon baik saat diaudit oleh internal auditor, bahkan beberapa orang merasa bahwa audit mengganggu pekerjaan utama.

6. Hasil temuan audit internal biasanya tidak di follow up dengan baik, karena tidak ada sangsi jika tidak difollow up.

7. Top management seringkali tidak melihat audit internal sbg alat u mendapatkan feedback untuk improvement bisnis perusahaan, mereka lebih melihat sebagai pesyaratan formal belaka u mempertahankan sertiikat iso 9001.

8. Komitmen manajemen yaitu mengenai pelaksanaan yang cenderung tertunda
karena terganggunya aktifitas utama masing2 section terkait pelaksanaan audit.

9. Auditor kurang punya power karena auditor internal berasal dari dalam organisasi sehingga temuan2 direspon tidak sepenuh hati.

10. kontrol dari superordinat atau manajemen atas follow up hasil audit lemah (ini jg berkaitan dengan komitmen)

11. pemahaman auditee tentang audit itu sendiri (kadang masih dianggap sebagai beban tambahan pekerjaan, belum mengganggap bahwa audit membantu proses perbaikan berkelanjutan)

12. kita selaku auditee kadang masih menganggap bahwa audit dilakukan untuk mencari2 kesalahan kita. padahal mestinya kita menganggap audit dilakukan untuk menunjukkan kepada kita bahwa masih ada kelemahan atas apa yang kita kerjakan selama ini.

13. kita selaku auditor internal terkadang sok telah mengetahui apa saja yang dikerjakan oleh auditee. sehingga yang kita lakukan hanya terfokus pada mencari dokumen ini dan dokumen itu dan seringkali tidak menyentuh esensi dari proses yang dijalani oleh auditee. sehingga auditee akhirnya terfokus pada menyiapkan dokumen operasional, bukan pada level mengapa dokumen ini perlu dibuat, mengapa dokumen ini perlu disimpan dsb.

14. Komitmen manajemen yang ditunjukan oleh jajaran manajemen seringkali setengah hati. Sebagian contohnya respon jajaran manajemen yang kurang suka bila ada temuan yang berasal dari bagian yang dipimpinnya.

15. Tidak adanya semangat perbaikan system melalui audit internal yang ditunjukan oleh auditor internal yang notabene di rekrut dari seluruh bagian dalam organisasi karena mengganggap audit intenal adalah tambahan pekerjaan dan seharusnya menjadi pekerjaan divisi mutu.

16. Tidak adanya punish and reward atas kegiatan audit internal. Misal tidak adanya sangsi bagi divisi dengan temuan terbanyak atau punishment bagi divisi yang terlambat atau ogah2an menutup temuan yang dihasilkan.

17. Belum adanya pemahaman tentang system ISO dikalangan pegawai, sehinga kegiatan audit intenal di anggap aktifitas eksklusif yang tidak berpengaruh tehadap pegawai di level terbawah ( baca : mayoritas )

18. Belum seragamnya informasi yang di miliki oleh auditor internal terkait pelaksanaan audit internal. Misalnya bagaimana membuat laporan ketidaksesuaian dan potensi ketidaksesuaian. Ketidakjelasan ruang lingkup audit internal diantara auditor internal.

19. Kompetensi koordinator audit intenal yang kurang cakap bahkan terlihat tidak tahu bagaimana mengelola kegiatan audit intenal.

Salam
Zulkifli Nasution
http://zulkiflinasution.blogspot.com/

Sumber :  Milis QualityClub

ISO 9001:2008 SIMPLIFIED

Part 1: Scope, Part 2: References, Part 3: Terms and definitions

Part 4: Quality management system
General concept is to:
- Say what you do and do what you say (PDCA)
Documentation requirements
- Write down the important things
- Get organized to achieve quality
- Make directions available to users
- Keep directions up-to-date (as long as needed)
- Identify needed records and maintain them

Part 5: Management responsibility
Provide vision and commitment to quality
Plan to achieve quality
- Establish quality objectives
- Keep the quality management system current
Define duties and responsibilities
- Define and communicate responsibilities and authorities
- Put someone in charge of the quality program
- Communicate within the organization
Monitor the operations
- Periodically, to ensure suitability, adequacy and effectiveness of quality management system
- Inputs from both internal and external sources
- Outputs to cover QMS, product, and resources
- Keep records

Part 6: Resource management
Determine and provide resources for:
- Implementing and maintaining the QMS (including improving effectiveness)
- Enhancing customer satisfaction
Allow people to excel in their work
- Determine competencies and provide training
- Give them the tools and equipment to do the job
- Determine and manage the work environment

Part 7: Product realization
Define the process steps before doing it
- Product specifications
- Processes, instructions, and resources to make it
- Quality control (test and inspection) needed
- Records to prove it to outsiders
- Called "quality, production, or run plans"
Know what the customer wants
- Determine all the requirements
- Make sure you can do it (contract review)
- Keep the customer in the loop
Design for quality
- Create a design plan
- Define the design input (requirements)
- Capture the design in useful documents
- Periodically review the design process
- Verify that you did what you promised
- Validate the design to see if it really works
- Control changes to the design
Use good stuff from your suppliers
- Know what you want
- Check out your suppliers and monitor them
- Verify you received what you ordered
Control your production and service
- Make it under controlled conditions
- Validate processes that can’t be measured
- Match the job to the specs and show the status
- Keep track of what you make (if required)
- Don’t break your customer’s stuff
- Keep it good as it proceeds through production and delivery
Check the work with good equipment
- Identify information needed for monitoring (process) and measuring (conformity)
- Identify the devices needed for both
- Control monitoring and measuring processes
- Make sure measuring equipment is good

Part 8: Measurement, analysis and improvement
Develop ways to measure QC, QA, QM
Monitor your customer’s perception of your quality
Audit your quality management system
Monitor your internal processes
Measure the product characteristics
Don’t accidentally ship or use bad stuff
Properly dispose of bad stuff
Collect information and analyze it
Continually improve the QMS effectiveness

That's it!
Labels: quality


Source: http://auditguy.blogspot.com/2011/06/iso-90012008-simplified.html

USING STATISTICAL METHOD TO IMPROVE THE EFFECTIVENESS OF ISO 9001

Ref.: 875

2003-10-16

A new technical report is expected to help users of the ISO 9000 series identify statistical techniques that will improve the effectiveness of their quality management system.

Statistical techniques offer insight into the nature, extent and causes of variability in products and services and, in so doing, help control and reduce problems that could arise from such variability, and which exists throughout the life cycle of products, from market research to customer service and final disposal.

Published by ISO (International Organization for Standardization), the new technical report, ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000, is intended to assist managers in their decision-making processes by identifying statistical techniques that could help improve the quality of products and processes.

"The effective deployment of statistical techniques is largely governed by how well their potential application and benefit are understood by management," says Lally Marwah, Convenor of the working group that developed the new standard. "This need is well served by the recently published technical report, which offers a clear and concise view of a range of widely used statistical techniques, and their potential role and value in driving quality improvement."

It can be used by organizations in developing, implementing, maintaining and improving a quality management system based on ISO 9001:2000, although the use of ISO/TR 10017 is not a requirement for certification/registration purposes.

ISO/TR 10017:2003 replaces ISO/TR 10017:1999. It is aligned with ISO 9001:2000 and will serve as a strategic tool for managers who may not necessarily be experts in statistical techniques.

http://www.iso.org/iso/pressrelease.htm?refid=Ref875

PERUBAHAN, SUATU KENISCAYAAN YANG HARUS DILALUI

(Dari Pelantikan Jabatan Baru, Kepala Cabang dan Rotasi Kepala Cabang FPS Indonesia)


Di dunia ini tidak ada yang abadi selain perubahan. Kalimat ini tentunya sudah demikian akrab di telinga kita karena seringnya dilontarkan oleh para tokoh masyarakat dan cerdik cendikia melalui media massa. Pertanyaannya, apakah kita sudah siap terhadap segala perubahan baik yang cepat atau lambat yang harus kita lalui?

Manajemen Perubahan
Perjalanan hidup setiap orang bisa saja dijadikan model bagi perubahan yang terjadi di setiap fase kehidupan. Lihatlah, setiap orang memulai kehidupannya dari bayi, lalu menjadi kanak-kanak, lantas remaja, dewasa, berkeluarga, tua dan seterusnya. Demikian juga dari aspek yang lain, perubahan selalu menjadi tuntutan baik karena dorongan dari sisi internal kita maupun faktor eksternal yang mengharuskannya.

Atas dasar keniscayaan tersebut, manajemen sudah sepatutnya harus terus memberikan kesadaran (awareness) kepada seluruh karyawan betapa serangkaian perubahan harus diambil manajemen termasuk yang mungkin tidak terencanakan. Secara khusus, pemberian kesadaran itu dilakukan di setiap kesempatan, baik pada saat orientasi karyawan baru maupun di setiap kesempatan pertemuan (rapat, RTM, pelatihan, dsb.) dengan antara lain diberi tajuk “manajemen perubahan”.

ISO 9004:2009 1) (“Pengelolaan organisasi untuk sukses berkelanjutan”) secara khusus memberikan panduan agar organisasi dapat melewati masa-masa kedewasaan (maturity level) agar sukses berkelanjutan dapat dicapai. Standar ini memberikan panduan 5 tingkatan kedewasaan yang harus dilalui sampai pada tingkatan organisasi yang dinamakan organisasi dengan sukses berkelanjutan (sustainable organization).

OHSAS 18002:2008 2) (“Panduan implementasi OHSAS 18001:2007”) secara lebih khusus pula memberikan panduan dalam klausul 4.3.1.5 dengan judul klausul “manajemen perubahan” yang merupakan bentuk antisipasi bahwa potensi bahaya (baca : resiko, dalam konteks manajemen secara lebih luas) senantiasa berubah mengikuti pola hidup masyarakat baik lokal maupun global. Dan, manajemen perubahan, menurut standari ini, harus pula diterapkan dalam penegakan sistem manajemen.

Dari subjek “Perubahan Organisasi” RTM-12
Subjek tentang perubahan organisasi, yang merupakan “tinjauan wajib”, telah disampaikan dalam kesempatan Rapat Tinjauan Manajemen (RTM) ke-12 pada Desember 2010 yang lalu. Terdapat hal baru yang diperkenalkan maupun issue lama yang coba dipertegas dalam struktur organisasi yang baru itu. Termasuk dalam hal yang baru adalah terdapatnya General Manager (GM) dan dua Assitant General Manager yang masing-masing untuk wilayah barat (Asst. GM – West Area) dan wilayah timur (Asst. GM – East Area) di dalam struktur.

Tanggung jawab area barat meliputi kinerja dari cabang-cabang : Medan, Jakarta, Cikarang, Bandung, dan Cirebon. Sedangkan untuk wilayah timur meliputi kinerja cabang-cabang : Semarang, Jepara, Solo, Yogya, Denpasar dan Mataram.

Dengan ditetapkan “pos” baru tersebut diharapkan dapat diterapkan penajaman prioritas terutama dalam menerapkan strategi penetrasi pasar di masing-masing area sesuai kekhasan dan potensinya.

Issue lama adalah menyangkut penegasan kembali tentang posisi keuangan cabang dalam kaitan pengkoordinasian dengan kepala cabang terkait serta hubungan supervisinya dengan keuangan pusat.



Wacana tentang perubahan-perubahan manajemen yang akan dilakukan di tahun 2011 juga telah disampaikan tim manajemen utamanya terkait dengan pembenahan di sisi manajemen sumber daya manusia yang secara vertikal mengharuskan adanya perubahan dan pembakuan struktur organisasi.

Get set ...
Tema RTM-12 “On your mark” yang merupakan aba-aba awal, dilanjut dengan aba-aba kedua “Get set ...” dengan ditandainya pelantikan “pejabat-pejabat” baru di lingkungan FPS Indonesia. Perubahan yang terjadi adalah sebagaimana tabel berikut ini :


Nama "Pos" Lama "Pos" Baru
Marsanto Kepala Cabang Jakarta Kacab Jakarta & Asst.GM - West Area
Husni Kepala Cabang Surabaya Kacab Surabaya & Asst.GM - East Area
Ahmad Zuher Kepala Cabang Tangerang Kepala Cabang Cikarang
Eko Sutiono Kepala Cabang Semarang Kepala Cabang Solo
Dwi Asis Budianto Kepala Cabang Solo Kepala Cabang Bandung
Moh. Nurdin Pjs.Kepala Cab. Yogya Kepala Cabang Yogyakarta
Eka Kamiadi Kepala Cabang Bandung Cargo Consultant Bandung
Wenda Wipayana Koord.CS/Doct Ekspor Kepala Cabang Tangerang
Hasto Hanarto Kepala Cabang Bandung Interlogistik Pusat
Okky Hanipradja Kepala Cabang Cikarang Manajer Konsol Intans Segara

Meskipun perubahan yang dilakukan bukanlah hal yang luar biasa, namun dalam sambutan pelantikan Pak Hendi mengharapkan bahwa orang-orang “luar biasa” yang sudah dilantik itu mampu juga membentuk tim yang luar biasa pula untuk mendukung pencapaian target khususnya di tahun 2011 mendatang bagi cabangnya masing-masing. Sebagaimana telah diberitakan sebelumnya, target-target telah ditetapkan dengan rata-rata target secara keseluruhan sebesar 200%.

Pak Fentje, yang juga hadir dalam pelantikan person “baru” di lingkungan Intans Segara mengajak agar kita senantiasa memperbarui paradigma kita termasuk dalam mendefinisikan arti “jatuh” yang dengan mengutip karya John C Maxwel, artinya menjadi “jatuh ke depan (falling forward)”, bahwa selalu ada hal positif yang bisa diambil hikmahnya untuk memulai lagi (opportunity for improvement).

Pada kesempatan yang sama dalam sambutannya, Pak Iskandar berpesan pentingnya kita membekali diri menuju pribadi “sukses dan beruntung”. Beberapa langkah yang harus dilakukan yaitu : lakukan hal yang terbaik, gunakan intuisi, gunakan imajinasi, fokus menjadi pemenang, sikap mental positif, dan networking atau perbanyak pertemanan.

Upacara pelantikan dilakukan di lantai 10 Graha Iska 165, Jakarta pada hari Senin tanggal 21 Februari 2011 dengan dihadiri oleh jajaran manajemen pusat.

Selanjutnya, kepada “pejabat baru” kami ucapkan selamat bertugas dan menempati pos yang baru.


(JS)

Catatan :
1) ISO 9001:2009 – Managing for the sustained succes of an organization adalah salah satu panduan dalam menerapkan ISO 9001:2008 yang merupakan keluarga Standar ISO 9000.
2) OHSAS 18002:2008 – Occupational health and safety management systems – Guidelines for the implementation of OHSAS 18001:2007 adalah panduan utama dalam penerapan OHSAS 18001:2007 atau SMK

PT FPS Indonesia Opens for Business in Tangerang ... Secures ISO 9001 Quality Re-Certification

PT FPS Indonesia, a member of the international forwarding and logistics network - Famous Pacific Shipping (FPS Group) - has opened a new branch office at Tangerang to consolidate the forwarder’s growing business in Indonesia.

Tangerang, Indonesia, January 27, 2010 --(PR.com)-- The new branch office will support cargoes moved by PT FPS Indonesia through Tanjung Priok port, Jakarta’s primary harbour.

According to PT FPS Indonesia managing director, Hendi Hendratmoko: “The investment we have made in this office shows that we are in the market for the long term. At a time when business optimism in much of the market is low, this strategic opening shows our clients that FPS is a brand they can continue to trust.

“In the vicinity of the new office, there are more than 140 companies involved in the import and export of commodities. There is massive logistics business potential in the furniture, shoe, metal, textile and chemical industries."

The contact details for the new office are: PT FPS Indonesia, Jl. Raya Serang Km. 19,5, Cikupa, Tangerang 15710, Banten, Indonesia

Tel: +6221 5940 1517
Fax: +6221 5940 1641
e-mail: tangerang@fpsindonesia.co.id

Coincidental to opening a new branch office, the company has secured re-certification for ISO9001:2008 for its three main branch offices: Jakarta, Semarang, and Surabaya.

Certification was undertaken by independent certification organisation NQA Indonesia.

According to Mr Hendratmoko, the re-certification demonstrates PT FPS Indonesia’s commitment to good value and timely service for its customers. “While global trading is down, we ensure that improvements being made allow us to adapt and continue to provide the best services to customers.”

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Source : http://www.pr.com/press-release/207678