DOCUMENTATION

ISO/IEC 17025:2005

Documentation

Welcome

ISO What is it?ISO What is it? 1 What are the requirementsWhat are the requirements 2 Road Map to AccreditationRoad Map to Accreditation 3 Today’s Overview

6 ISO/IEC DOCUMENTATIONS DOCUMENTATION PREPARATION

7 OBJECTIVES  To know the different levels of documentation  To be able to identify required documentation – Quality manual – Procedures – Work instructions

8 ADVANTAGES  Transparency and rationalization  Early recognition of failures, problems etc.  Easier introduction of new employees  Improved co-ordination  Avoidance of duplication of work

9 ADVANTAGES CONT……..  Improvement of the personnel structure  Transparency of laboratory quality management  Correct allocation of tests  The requirement for formal accreditation  The availability of evidence to customers

10 OVERVIEW The quality manual Procedures Methods Work instructions Technical specifications Quality plans Test instructions Technical records (evidence of test) Technical reports SYSTEM DOCUMENTATION SPECIFIC DOCUMENTATION

11 STEP ONE: BUILDING AN EFFECTIVE SYSTEM To have Good Documentation

12 GOOD DOCUMENTATION All elements, requirements and provisions adopted by an organization must be documented in a;  Simple  Systematic  Clear  And orderly manner

13 GOOD DOCUMENTATION Cont…. and should basically be;  Understandable  Adequately detailed  Accurate  Complete  Traceable so that they are auditable

14 AVOID TOO MUCH DETAIL “ The purpose of this procedure is to document the aforementioned activities, herein after referred to as the prescribed tasks in terms that prelude their execution in an inconsistent manner, wherein such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible” ???????

15 POORLY WRITTEN PROCEDURE Why use ten words when one will do?  “The items hereunder referenced in some cases fell excessively outside normal parameters.”

16 USE OF DOCUMENTATION  To consult  For training purposes  External assessment  To show evidence on operation

17 PROVISION  Identification  Approval  Issue  Distribution  Controlling  Removal of obsolete ones  Maintaining documents  List of records operated by organization

18 DOCUMENT CHANGES Changes to documents must be authorized & provide a method for;  Initiation  Development  Reviewing  Control  Issue and  Recording NB: Provide for use of un-controlled copies for proposal & customer use

19 LABORATORY MANAGEMENT SYSTEM  Quality manual  Documented procedures as required by the standard  Documentation needed by organization to ensure effectiveness in operation  Maintain records required by standard

20 DEFINE CONTROLS  Identity  Storage  Protection  Retrieval  Retention time  Disposal

21 LEVELS Remarks The number of levels may adjusted to meet the organization ’ needs Forms may be applicable at all levels of the hierarchy Quality manual (Level A) System procedures (Level B) Work instructions (forms, sheets, test instructions) (Level C) CONTENTS OF DOCUMENTS Describes the quality system in terms of the demonstrated quality policy,the quality objectives and applicable ISO/IEC standard Cross-reference Description of the activities of the individual functional units,which are required for the application of the system elements Cross-reference Detailed work instruction

22 QUALITY MANUAL Elements  Title and scope  Table of contents  Review, approval and revision  Quality policy and objectives  Organization, responsibility and authority  References  Laboratory management system description  Appendices

23 PROCEDURES A procedure is a sequence for undertaking various activities. Shall detail;  What shall be done  Who shall do it  How it shall be done  When it shall be done  Where it shall be done  Which (materials, documents etc) shall be used  What if

24 PROCEDURES cont….. Contents  Title  Purpose  Scope  Responsibility and authority  Description of activities  Records  Appendices

25 PROCEDURE FORMAT XYZ LAB. LTD DOC. NO. …………………………….. SECTION: QUALITY MANAGER ISSUE NO …. …………REV. ……….. SUBJECT: DOCUMENT CONTROL DATE OF ISSUE………………………. ISSUED BY………….. ………………… AUTHORIZED BY……………………… 1.TITLE 2. PURPOSE 3. SCOPE 4. REFERENCES 5.TERMS (DEFINITIONS) 6. RESPONSIBILITIES 7. METHOD 8. APPENDICES

26 How many ? STEP TWO: HAVE THE RIGHT AMOUNT OF DOCUMENTATION But how much documentation do I need

27 NUMBER OF PROCEDURES The number will depend on;  Complexity of the operations  The organization of the business  The need of the organization  The standard requirements

28 STEPS FOR DEVELOPING PROCEDURES  Identifying the need It`s absence will adversely affect quality  Authorizing the development of procedure empowered person must authorize  Defining the scope Author establishes precise scope  Collecting & documenting current information Document how the activity is carried out step by step

29 STEPS FOR DEVELOPING PROCEDURES Cont ….  Preparing a draft procedure Those involved in the implementation of procedure should be involved in drafting  Obtaining comments on draft procedure Persons & departments concerned should review initial draft to see if it is workable Modifications should be incorporated  Obtain authorization for use of procedure Appropriate person approves procedure once amendments are incorporated & checked Issue procedure  Review the procedure After implementation for some time(say six months) it should be reviewed & if necessary amendments or revised procedure issued

30 WORK INSTRUCTION Work instructions provide detailed activities and requirements for activities defined in procedures (work instruction is a subset of a procedure). Examples – - operating computer, - instruction on sterilization of instruments

31 ISSUE AND CONTROL OF DOCUMENTS All documents should be subject to the following control;  A central register detailing issue & changes  Checking on authorization before use  Availability at places needed  An effect change control system

32 DISTRIBUTION LIST DOCUMENT TITLE………………. DOCUMENT NO. ………… REVISION NO. RECIPIENTDEPARTMENTDATE RECEIVED BY RECIPIENT DATE RECEIVED BY DOCUMENT CONTROLLER

33 TRANSMITAL FORM TO :……………………………….. DEPARTMENT :………………………………. DOCUMENT OR PAGE IDENTIFICATION :………………………………. NAME/NO/SUBJECT :……………………………… NEW :………………………………. AMENDED :……………………………… REPLACEMENT :……………………………… EFFECTIVE DATE :…………………………….. DATE DISPATCHED :……… DISPATCHED BY :……… DATE RECEIVED :………..RECEIVED BY :………… AMENDMENT EFFECTED ON :…………………………. AMENDED/REPLACED PAGE/ DOCUMENT RETURNED ON :………………………….. I CONFIRM THAT I KNOW AND UNDERSTAND THE DOCUMENT AND THAT I HAVE ENSURED THAT ALL PERSONNEL UNDER MY CONTROL HAVE BEEN INFORMED THEREOF AND THAT THEY UNDERSTAND AND WILL IMPLEMENT IT. SIGNATURE :……………… DATE………………………….

34 Establishing a process  Prepare  Implement  Achieve  Maintain  Review  Improve

35 Expectations Customers Suppliers Employees Shareholders Society

36 Success factors Market share Sales Service provision Results Efficiency Recognition

37 Quality Manual Document all requirements of the Standard and Implement – Clause Management system

38 Procedures References clauses - Management requirements – Organization – 4.1.5(c), 4.1.5(d) – Document control – 4.3.1, – Review of requests, tenders and contracts – – Purchasing services and supplies – – Complaints – 4.8 – Control of nonconforming testing and/or calibration work – – Corrective action – – Preventive action – – Control of records – , – Internal audits – – Management reviews –

39 Procedures cont… References clauses – Technical requirements – Personnel – – Test and calibration methods and method validation – 5.4.1, , , (b), – Equipment – 5.5.6, , , – Measurement traceability – 5.6.1, , , – Sampling – 5.7.1, – Handling of testing and calibration items – 5.8.1, – Assuring the quality of test and calibration results – 5.9

40 Test Methods Defined by a tripod!: method validation – am I measuring what I set out to measure? (Fit for the purpose) uncertainty – how well do I know the result of what I’ve measured? (Uncertainty budget) traceability of result – can I compare this result with other results? (the ‘standard’)

41 Implementation We must take the first step. But…………… need to implement the system and move forward

42 THANK YOU

Q UESTIONS ?