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  • 9月 23 週三 200909:01
  • 如何申請ISO?



很多公司與人員,在第一次想要申請ISO品質管理系統時,不知該如何下手。
在此將為您做說明解析..
申請流程:
確認公司預執行之ISO系統別→尋訪顧問公司→顧問公司簡報、報價→顧問公司確認→顧問師到廠輔導→輔導進入最後階段、文件彙整→接洽驗證公司→驗證公司簡報、報價→驗證公司到廠驗證→缺失改善→缺失回覆驗證公司→認證單位核發證書
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isoedisonwang 發表在 痞客邦 留言(1) 人氣(3,946)

  • 個人分類:ISO 認證申請
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  • 9月 16 週三 200910:49
  • 人力資源與ISO9001的關聯性

ISO 9001與人力資源管理人力資源單位如何透過ISO 9001的驗證,自我檢視HR該做什麼?能做什麼?要如何做?是否做到?如何藉由ISO 9001的精神,讓HR不再只會唱高調,而是扮演好顧客導向與持續改善的後勤支援角色。
作者:孫弘岳
曾經有事業單位的部門主管對HR主管說,你們一天到晚都在挑戰公司的主管缺乏領導與管理職能,要我們為HR一大堆專案背書。可是,我卻發現你們HR好像不太檢討自己的管理品質,人事行政程序不但沒有效率,跟你們要什麼沒什麼,只會拿HR政策為理由來塘塞我們,還要求要參加我們的業務會議,說要當我們的策略夥伴?
上述的對話是真實的案例,或許該事業單位的部門主管不太客氣,但是當HR把自己當作一家服務機構,全面檢視ISO 9001所有條款與HR的作業流程時,就會發現自己很容易也犯上相同的錯誤。然而,一想到ISO 9001,大家就會直接聯想到製造業或作業中心,一大堆繁瑣的文件和品質管制程序,很少人會將它跟人力資源管理聯想在一起。如果有幸(或不幸)處在需要進行ISO 9001驗證的組織,人力資源單位也是配合性地產出辦法、標準作業流程(SOP)、表單等文件,進行文件編碼,並提供相關人事和培訓記錄,以符合ISO 9001中「6.2 人力資源管理」僅僅一百多個字的條文要求。
若真正去了解ISO 9001品質管理系統架構與條文內涵,可以發現該標準是提升人力資源單位服務品質的有效工具,也能作為建置人力資源共享服務中心(HR Shared Service Center)的基準。本文以ISO 9001八個章節及其對HR的意義進行簡單整理如下:
第1章在描述ISO 9001:2008,己經修訂到第4版。第2章則是描述其版本差異性為何,對於各類文件的要求更彈性,條文用字更白話,並將資訊系統納入基礎建設的要求中。第3章則是條例品質管理的8大原則:以顧客為中心、領導、全員參與、過程管理、系統性管理、持續改進、以事實為決策根據、互利的供應商關係。以上的廢話對HR單位而言就是要先釐清:
1. HR的顧客是誰?(這是非常重要的議題,搞錯對象,後面全盤皆錯)
2. HR應該要提供什麼服務給顧客?(此範疇將定位HR是人事行政單位、人力資源單位、亦或策略性人力資本的管理單位?)
3. HR如何滿足顧客對服務內容與水平的期待?(即服務品質)

在上述3個問題釐清後,就進入ISO 9001的精華4-8章,即說明HR如何透過規劃(Plan)、執行(Do)、檢驗(Check)、改善行動(Action)之持續過程以達成顧客所要求的服務品質。為了便於理解,本文將第4章的概念放在最後說明。
第5章管理階層的責任,意即為了實現顧客導向和持續改善,管理人員應該要知道的目標和方向。套用在HR的思考議題如下:
5.1. HR主管欲滿足顧客要求的決心如何展現?
5.2. HR主管如何了解顧客的要求?
5.3. 滿足顧客要求的HR策略是什麼?
5.4. HR策略的短中長期目標為何?
5.5. HR是否有指派管理代表來處理顧客服務品質的議題?並在HR內部進行溝通宣導?
5.6. HR是否有針對服務品質定期進行內部稽核,並提出改善建議?

第6章資源管理,為了實現管理的目標和方向,需要規劃那一些軟硬體的資源。套用在HR的思考議題如下:
6.1. HR的組織架構是否符顧客服務的流程設計?
6.2. HR人員的專業程度和訓練是否足以滿足顧客服務?
6.3. HR人員的辦公設備與資訊系統是否足以支持顧客服務?

第7章產品實現,規範如何與顧客溝通服務或產品需求、針對需求設計、開發、採購、品管、驗收、保護、及售後服務。套用在HR的思考議題如下:
7.1. HR要滿足顧客需求的具體服務是什麼?
7.2. HR如何確定這些服務真的是客戶要的?
7.3. HR設計與開發這些服務的流程與方法是什麼?
7.4. HR如何甄選專業人員或外部廠商/顧問來設計與開發這些服務?
7.5. HR如何管理內/外部作業流程來服務顧客?
7.6. HR如何管理辦公設備與資訊系統以確保服務不中斷且做好資訊安全?

第8章量測、分析和改進,規範顧客滿意度評量、內部稽核、及任何造成不良品的預防和矯正措施,並持續改善5-7章的所有流程,追求符合顧客期待的品質。套用在HR的思考議題如下:
8.1. HR如何評量顧客對所提供服務的滿意度?
8.2. HR如何稽核內部作業程序,以確保服務品質的一致性和遵法性?
8.3. HR如何預防顧客不滿?
8.4. HR如何處理顧客抱怨或修正不符顧客需要的服務?
8.5. HR如何持續改善或強化5-7章關於管理階層的工作、資源管理、產品實現的流程,來提昇顧客滿意度?

回到第4章,即針對上述5-8章的議題與答案,建立一套品質管理系統,加以制度化和文件化。對HR單位而言,就是建立HR四階文件:
4.1. HR品質手冊:將5-8章的內容和HR具體措施進行對照說明、列出HR相關政策、目標、辦法與標準作業流程清單、規範權責單位、並描述如何新增、修改、刪除、保存、公告HR相關文件的做法。
4.2. HR相關辦法:將5-8章需要制度化的部份,用準則、辦法、或要點等不同等級的文件加以規範。該文件可以是數位化或實體化的任何形式。
4.3. HR標準作業流程:針對HR相關辦法,具體描述每一個辦法下的操作程序與作業流程(Standard Operation Procedure, SOP),並加以文件化。同樣地,該文件可以是數位化或實體化的任何形式。
4.4. HR作業表單或記錄:需有歷史表單或記錄來證明HR內部真的按照標準作業流程來執行,該表單或記錄同樣可以是數位化或紙本的形式。

綜上,若把人力資源單位當作一個虛擬的獨立事業單位,可以應用ISO 9001每一項條款來檢視HR的策略、辦法、作業流程是否符合顧客導向與持續改善的基準,也可用來進行HR流程再造、整合,或導入人力資源資訊系統(Human Resource Information System, HRIS)前置準備的基礎工程。若能輔以ISO驗證,更可以檢驗HR是否真的有執行力,按照所有想的和寫的去做,而不再是說的比唱的好聽。
知名的人力資源實務專家Ralph Christensen曾在”Roadmap to Strategic HR”一書中提到一家跨國企業的CEO對HR Head說:「如果連薪資發放這種基本工都做不好,HR如何有足夠的信譽來當策略夥伴?」全球知名的HR教授Dave Ulrich也在人力資源管理最佳實務第二版” The HR value Proposition”一書中提到,研究發現HR效能與職能的高低關鍵在於HR是否能說到做到,並把選育用留的傳統人力資源管理功能做好,遠勝於HR是否擁有營運知識、策略思維、和最新的HR資訊技術。
「回到根本」,先做好組織真正期待HR扮演的角色,是筆者爬文撰寫的ISO 9001與HR的理由。然而,從實務經驗發現,很多組織導入ISO,不管是9001或者是其他ISO系列(例如: 與培訓品質相關的ISO 10015或與資訊安全相關的ISO 27001等),大都是為了認證而認證,卻忘了其根本的精神,讓ISO不再是International Organization for Standardization,反而變成International Stupid Organization。新增一大堆文件與流程來通過驗證,服務品質反而下降?當顧客問到,為什麼手續變得這麼複雜?作業速度變這麼慢?權責單位卻回答:「因為要符合ISO規定」?這完全是本末倒置的做法,僅追求形式,卻誤解ISO的本意。
有朋友曾在筆者演講相同主題的會後問到,上述5-8章都是用問答題的方式呈現,那答案在那裏?筆者的回答是:「答案是你們應該要想的」。因為每個組織不同,顧客要求不會相同,對HR的定位不同,HR的能力也不同,HR開發與產出服務的流程自然不容易相同。畢竟,ISO 9001是規範各行各業的最大公約數,不是針對HR,縱然引用ISO 10015系列也只有培訓的功能而已。如果要找出值得標竿的HR最佳實務,可以參考人力資源成熟度模型(People Capability Maturity Model, P-CMM),其架構與ISO 9001同樣建立在全面品質管理系統(Total Management Quality, TQM)的基礎上,可完全相互搭配,並且有分級的概念,供大家參考。
參考資料:
Christensen, R. (2005). Roadmap to Strategic HR: Turning a Great Idea into a Business Reality. AMACOM/American Management Association.

Ulrich, D & Brockbank, W. (2005). The HR Value Proposition. Harvard Business School Press. HBSP.
International Standard ISO9001:2008. (Fourth edition). Quality management systems-
Requirements, 1-18.

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isoedisonwang 發表在 痞客邦 留言(0) 人氣(2,341)

  • 個人分類:ISO 驗證經驗
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  • 9月 10 週四 200909:56
  • QC080000系列--無鹵測試的建議


無鹵材料控管的建議
因應Apple、Dell、Hp等公司的無鹵材料需求,及IPC的電路板行業標準,Br和Cl的900ppm濃度標準已被定為行規。
 
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  • 個人分類:ISO 認證國際標準
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  • 9月 10 週四 200908:50
  • HACCP、GMP和SSOP的關係是什麼???


企業在推行食品安全管理體系認證的過程及審核員在認證審核過程中,總是被HACCP危害分析、GMP (良好操作規範)、SSOP(標準衛生操作程式)三者所困擾,其抽象性和關聯性使審核員感到比較茫然,也是業內經常探討的一個問題,筆者收集有關資料,對三者的關係做如下描述供業內人士參考。
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isoedisonwang 發表在 痞客邦 留言(0) 人氣(10,649)

  • 個人分類:ISO 認證國際標準
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  • 9月 07 週一 200909:01
  • ISO22000申請驗證需知

ISO 9001品保系統驗證
ISO是國際標準組織(International Organization for Standardization)的簡稱,於1947年2月23日 正式成立,其總部設在瑞士日內瓦,成立之主因是歐洲共同市場為了確保流通全歐洲之產品品質令人滿意,而制訂世界通用的國際標準,以促進標準國際化,減少技術性貿易障礙。
歐洲單一市場現已擴張為全世界最大的自由貿易區,其整體利益推及東歐諸國,如波蘭、匈牙利、捷克等國,而美國又是歐洲共同體之最大貿易伙伴,於是世界各國之商人沒有不正視這塊歐洲大陸的貿易大餅,職是之故,具公信力之ISO 9000之認證正暢行於世。
ISO 9000
品保認證系統藉由第三者的認證,提供買方在資訊不對稱下能對賣方的產品或服務品質深具信心,故賣方的挑戰點便是建立品保系統之標準,及一致性的稽核程序之要求,以確保產品品質保證管理進而塑造企業形象。ISO 9001:2000強調QMS品質管理系統的有效性,除將產品或服務的品質保證視為組織存在的基本條件外,更以提高顧客滿意度及持續性改善為其焦注關鍵。
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isoedisonwang 發表在 痞客邦 留言(2) 人氣(172)

  • 個人分類:ISO 認證申請
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  • 9月 07 週一 200908:37
  • 提供各家驗證公司證書查詢功能

公司/組織在申請ISO後,可以上各家驗證機構查詢,目前整理幾家驗證機構的查詢功能,會陸續補上,也歡迎驗證機構告知,我會將訊息補上。
查詢步驟: 找到公司證書上的證書註冊號碼-> 確認是哪一間驗證機構(若不知道可以聯繫我幫您確認!)->
                   點選以下網站就可以找的到了。
 
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  • 個人分類:ISO 認證申請
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  • 9月 02 週三 200910:17
  • 快樂--是一種習慣

一大早,我跳上一部計程車,要去台北郊區做企業內訓。
因正好是尖峰時刻,沒多久車子就卡在車陣中,
此時前座的司機先生開始不耐地嘆起氣來。
隨口和他聊了起來:「最近生意好嗎?」
後照鏡的臉垮了下來,聲音臭臭的:
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  • 個人分類:ISO 認證佳文分享
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  • 9月 01 週二 200915:56
  • NIKE 2009路跑活動--一起來跑吧



報名網站: http://www.sportsnet.org.tw/20091024nike/race_detail.php?race_no=20091024
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  • 個人分類:活動訊息
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  • 9月 01 週二 200914:35
  • ISO家族各項標準



ISO R594
Conical fittings for syringes, needles and other medical equipment

ISO 594/1
Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment-- Part 1: General requirements

ISO 594-2
Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment-- Part 2: Lock fittings

ISO 780
Packaging-Pictorial marking for handling of goods

ISO 1219
Fluid power systems and components-Graphic symbols

ISO 1797-1

Dental rotary instruments--Shanks       Part 1: Shanks made of metals




ISO 2859-0
Sampling procedures for inspection by attributes Part 0: Introduction to the ISO 2859 attribute sampling system

ISO 2859-1
Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection

ISO 2859-2
Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection

ISO 2859-3
Sampling procedures for inspection by attributes Part 3: Skip-lot sampling procedures

ISO 2859-4
Sampling procedures for inspection by attributes Part 4: Procedures for assessment of stated quality levels

ISO 3040
Technical drawings--Dimensioning and tolerancing-- Cones

ISO 3696
Water for analytical laboratory use--Specification and test methods

ISO 3746
Acoustics-Determination of sound power levels of noise sources using sound

ISO 3964
Dental handpieces - Coupling dimensions

ISO 5356-1
Anesthetic and respiratory equipment-Conical connectors Part 1: cones and sockets

ISO 5367
Breathing tubes intended for use with anaesthetic apparatus and ventilators

ISO 5457
Technical drawings-Sizes and layout of drawing sheets

ISO 5725-2
Accuracy of measurement methods and results, Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method

ISO 5941
Compressors, pneumatic tools and machines--Preferred pressures

ISO 6009
Hypodermic needles for single use--Color coding for identification

ISO 6360-1
Dental rotary instruments- Number coding system Part 1: General characteristics

ISO 6440
Wheelchairs-Nomenclature, terms and definitions

ISO 6710
Single-use containers for venous blood specimen collection

ISO 7000
Graphical symbols for use on equipment-Index and synopsis

ISO 7176-1
Wheelchairs-- Part 1: Determination of static stability

ISO 7176-2
Wheelchairs-- Part 2: Determination of dynamic stability of electric wheelchairs

ISO 7176-3
Wheelchairs-- Part 3: Determination of efficiency of brakes

ISO 7176-4
Wheelchairs-- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

ISO 7176-5
Wheelchairs-- Part 5: Determination of overall dimensions, mass and turning space

ISO 7176-6
Wheelchairs-- Part 6: Determination of maximum speed, acceleration and retardation of electric wheelchairs

ISO 7176-7
Wheelchairs-- Part 7: Measurement of seating and wheel dimensions

ISO 7176-8
Wheelchairs-- Part 8: Requirements and test methods for static, impact and fatigue strengths

ISO 7176-9
Wheelchairs-- Part 9: Climatic tests for electric wheelchairs

ISO 7176-10
Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs

ISO 7176-11
Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs

ISO 7176-13
Wheelchairs--Part 13: Determination of coefficient of friction of test surfaces

ISO 7176-14
Wheelchairs--Part 14: Power and control systems for electric wheelchairs- Requirements and test methods

ISO 7176-15
Wheelchairs-- Part 15: Requirements for information disclosure, documentation and libeling

ISO 7176-16
Wheelchairs-- Part 16: Resistance to ignition of upholstered parts-- Requirements and test methods

ISO 7176-19
Wheelchairs-- Part 19: Wheeled mobility devices for use in motor vehicles

ISO 7176-22
Wheelchairs-- Part 22: Set-up procedures

ISO 7176-23
Wheelchairs-- Part 23: Requirements and test methods for attendant-operated stair-climbing devices

ISO 7376-1
Laryngoscopic fittings-- Part 1: Conventional hook-on type handle-blade fittings

ISO 7376-2
Laryngoscopic fittings-- Part 2: Miniature electric lamps--Screw threads and sockets for conventional blades

ISO 7376-3
Laryngoscopic fittings-- Part 3: Fiber-illuminated re-usable rigid laryngoscopes

ISO 7193
Wheelchairs-Maximum overall dimensions

ISO 7711-1
Dental rotary instruments- Diamond instruments Part 1: Dimensions, requirements, marking and packaging

ISO 7864
Sterile hypodermic needles for single use

ISO 7785-1
Dental handpieces-- Part 1: High-speed air turbine handpieces

ISO 7785-2
Dental handpieces-- Part 2: Straight and geared angle handpieces

ISO 7886-1
Sterile hypodermic needles for single use Part 1: Syringes for manual use

ISO 7886-2
Sterile hypodermic needles for single use Part 2: Syringes for use with power-driven syringe pumps

ISO 7930
Wheelchairs--Type classification based on appearance characteristics

ISO 8320
Optics and optical instruments--contact lenses--vocabulary and symbols

ISO 8320-1
Contact lenses and conact lens care products--Vocabulary   Part 1: Contact lenses

ISO 8320-2
Contact lenses and conact lens care products--Vocabulary   Part 2: Contact lens care products

ISO 8321-1
Optics and optical instruments--contact lenses Part 1: specification for rigid corneal and sclera contact lenses

ISO 8321-2
Optics and optical instruments--contact lenses Part 2: Specifications for single-vision hydrogen contact lenses 

ISO 8382
Resuscitators intended for use with humans

ISO 8536-1
Infusion equipment for medical use-- Part 1 : Infusion glass bottles

ISO 8536-2
Infusion equipment for medical use-- Part 2 : Closures for infusion bottles

ISO 8536-3
Infusion equipment for medical use-- Part 3 : Aluminium caps for infusion bottles

ISO 8536-4
Infusion equipment for medical use-- Part 4 : Infusion sets for single use, gravity feed

ISO 8536-5
Infusion equipment for medical use-- Part 5 :  Burette type infusion sets

ISO 8536-6
Infusion equipment for medical use-- Part 6 :  Freeze drying closures for infusion bottles

ISO 8536-7
Infusion equipment for medical use-- Part 7 :  Caps made of aluminium--plastics combinations for infusion bottles

ISO 8537
Sterile single-use syringes, with or without needle, for insulin

ISO 8599
Optics and optical instruments--Contact lenses-Determination of the spectral and luminous transmittance

ISO 8601
Data elements and interchange formats--Information interchange--representation of dates and times

ISO 8980-1
Ophthalmic optics--finished single-vision corrective lenses-- Part 1: General requirements

ISO 8980-2
Ophthalmic optics-- Uncut finished spectacle lenses Part 2: Specifications for progressive power lenses

ISO 9000
Quality management systems- Fundamentals and vocabulary

ISO 9000-4
Quality management and quality assurance standards-

ISO 9001
Quality management systems- Requirements

ISO 9004
Quality management systems - Guidelines for performance improvements

ISO 9004-1
Quality management and quality system elements-- Part 1: Guidelines

ISO 9004-2
Quality management and quality system elements-- Part 2: Guidelines for services

ISO 9004-3
Quality management and quality system elements-- Part 3: Guidelines for processed materials

ISO 9004-4
Quality management and quality system elements-- Part 4: Guidelines for quality improvement

ISO 9168
Dental handpieces-- Hose connectors

ISO 9336-1
Optics and optical instruments--Optical transfer function--application Part 1: Interchangeable lenses for 35mm still cameras

ISO 9336-2
Optics and optical instruments--Optical transfer function--application Part 2: Lenses for office copiers

ISO 9336-3
Optics and optical instruments--Optical transfer function--application Part 3: Telescopes

ISO 9338
Optics and optical instruments-contact lenses-determination of the diameters

ISO 9339-1
Optics and optical instruments-contact lenses-determination of the thickness Part 1: rigid contact lenses

ISO 9340
Optics and optical instruments-contact lenses-determination of strains for rigid contact lenses

ISO 9341
Optics and optical instruments-contact lenses-determination of inclusions and surface imperfections for rigid contact lenses

ISO 9342
Optics and optical instruments--Test lenses for calibration of foci meters

ISO 9360-1
Anaesthetic and respiratory equipment--Heat and moisture exchangers (HMEs) for humidifying respired gases in humans- Part 1: HMEs for use with minimum tidal volumes of 250ml

ISO 9360-2
Anaesthetic and respiratory equipment--Heat and moisture exchangers (HMEs) for humidifying respired gases in humans- Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250ml

ISO 9363-1
Optics and optical instruments--Contact lenses- Determination of cytotoxicity of contact lens material

ISO 9614-1
Acoustics-Determination of sound power levels of noise sources using sound.  Part 1: Measurement at discrete points 

ISO 9626
Stainless steel needle tubing for manufacture of medical devices

ISO 9680
Dental operating light

ISO 9687
Dental equipment-- Graphical symbols

ISO 9913-1
Optics and optical instruments- contact lenses Part 1: Determination of oxygen permeability and transmissibility by the FATT method

ISO 9914
Optics and optical instruments- contact lenses-- Determination of refractive index of contact lens materials

ISO 9919
Medical electrical equipment--Particular requirements for the basic safety and essential performance pulse oximeters requirement for medical use

ISO 9999
Technical aids for disabled persons Classification

ISO 10005
Quality management- Guidelines for quality plans

ISO 10006
Quality management- Guidelines to quality in project management

ISO 10007
Quality management- Guidelines for configuration management

ISO 10012-1
Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment

ISO 10012-2
Quality assurance requirements for measuring equipment Part 2: Guidelines for control of measurement processes

ISO 10013
Guidelines for developing quality manuals

ISO 10014
Guidelines for managing the economics of quality

ISO 10015
Quality management- Guidelines for training

ISO 10017
Guidance on statistical techniques for ISO 9001:1994

ISO 10079-1
Medical suction equipment Part 1: electrically powered suction equipment--Safety requirements

ISO 10079-2
Medical suction equipment Part 2: Manually powered suction equipment

ISO 10079-3
Medical suction equipment Part 3: Suction equipment powered from vacuum or pressure source

ISO 10338
Optics and optical instruments- contact lenses- determination of curvature

ISO 10339
Ophthalmic optics--contact lenses--Determination of water content of hydrogel lenses

ISO 10322-1
Ophthalmic optics--Semi-finished lens blanks Part 1: specifications for single-vision and multifocal lens blanks

ISO 10340
Optics and optical instruments- contact lenses-- Method for determining the extractable substances

ISO 10344
Optics and optical instruments- contact lenses- saline solution for contact lens testing

ISO 10725
General requirements for the competence of testing and calibration laboratories

ISO 10993-1
Biological evaluation of medical devices- Part 1: evaluation and testing

ISO 10993-3
Biological evaluation of medical devices- Part 3: test for genotoxicity carcinogenicity and reproductive toxicity

ISO 10993-4
Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.

ISO 10993-5
Biological evaluation of medical devices- Part 5: test for in vitro cytotoxicity

ISO 10993-7
Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals

ISO 10993-10
Biological evaluation of medical devices- Part 10: Tests for irritation and delayed-type hypersensitivity

ISO 10993-11
Biological evaluation of medical devices- Part 11: Tests for systemic toxicity

ISO 11134
Sterilization of health care products--Requirements for validation and routine control-- Industrial moist heat sterilization

ISO 11135
Medical devices--Validation and routine control of ethylene oxide sterilization

ISO 11137
Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization

ISO 11137-1: 2006
Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization

ISO 11137-2: 2006
Sterilization of health care products--Radiation--Establishing the sterilization dose

ISO 11137-3: 2006
Sterilization of health care products--Radiation-- Guidance for dosimetric aspects

ISO 11199-1
Walking aids manipulated by both arms-- Requirements and test methods---  Part 1: Walking frames

ISO 11199-2
Walking aids manipulated by both arms-- Requirements and test methods---  Part 2: Rollator

ISO 11987
Ophthalmic optics--contact lenses--Determination of shelf-life

ISO 12864
Ophthalmic optics-- contact lenses- determination of scattered light

ISO 13402
Surgical and dental hand instruments--Determination of resistance against autoclaving, corrosion and thermal exposure

ISO 13485
Quality systems- Medical devices- Particular requirements for the application of ISO 9001

ISO13485                        ( 2000 : Draft )
Quality management systems- Medical devices- System requirements for regulatory purposes

ISO13485                        ( 2003/07/15 )
Medical devices--Quality management systems--Requirements for regulatory purposes

ISO 14001
Environmental management systems--Specification with guidance for use

ISO 14155
Clinical investigation of medical devices

ISO 14534
Ophthalmic optics-Contact lenses and contact lens care products-fundamental requirements

ISO 14602
Non-active surgical implants---Implants for Osteosynthesis Particular requirements

ISO 14630
Non-active surgical implants---General requirements

ISO 14889
Ophthalmic optics-Spectacle lenses-Fundamental requirements for uncut finished lenses

ISO 14969
Quality systems-Medical devices- Guidance on the application of ISO 13485 and ISO 13488

ISO 14971: 2003
Medical devices---Application of risk management to medical devices

ISO 14971: 2007
Medical devices---Application of risk management to medical devices

ISO 15197
In vitro diagnostic test systems-- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

ISO 15223
Medical devices-- Symbols to be used with medical device labels, labeling and information to be supplied

ISO / TS 16949
Particular requirements for the application of ISO 9001: 2000 for automotive production and relevant service part organizations

ISO 17025
General requirements for the competence of testing and calibration laboratories

ISO 17511
In vitro diagnostic medical devices-- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials

ISO 17664
Sterilization of medical devices-- Information to be provided by the manufacturer for the processing of resterilizable medical devices

ISO 17799
Information technology-Code of practice for information security management

ISO 19011
Guidelines for quality and/or environmental management systems auditing

ISO 21647
Medical electrical equipment--Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 22000
Food safety management systems-- Requirements for any organization in the food chain

ISO 22716
Cosmetics-- Guideline on Good Manufacturing Practices
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