Quality Management: Co-ordinated activities to direct and control an organisation with regards to quality ISO9000

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1 Plan the Development of Your Quality System Half a day spent thinking and planning how you will approach your ISO 9001 accreditation and certification will leave you with a project scope that makes sense, that explains what you are doing, that connects people, project activities and the financing of the project together. Work your way through this example of what you need to put into your own ISO 9001 Project Plan. Four Questions to Focus Your Improvement Efforts Are we doing it right? (Is the process in control and in specification?) Can we keep on doing it right? (Is it stable and continuous and will it so remain?) Are we doing it the best way? (Simpler, easier, quicker, cheaper?) Is it the right thing to be doing? (Are we aiming at the right thing? Do we need new performance standards? Will it optimise organisational performance?) What is a Quality Management System? Quality Management: Co-ordinated activities to direct and control an organisation with regards to quality ISO9000 Quality Management System: The organisation structure, procedures, process and resources needed to implement quality management ISO9000 Quality Systems Handbook QMS is the set of interrelated and interacting processes that achieve the quality policy and quality objectives. For your success Your QMS is not part of the business management systems. It is the business management system! It is the parent system of which all other management systems arise in response to the achievement of the corporate mission and the objectives needed to attain it. All business objectives are quality objectives... because they arise to satisfy interested party s needs and expectations. C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 1

2 Steps in Developing a Quality System Responsibility Management Commitment (5.1) Organisational Purpose and Policy (5.3) Customer Requirements (5.2) Organisational Objectives (5.4.1) Management Responsibility Planning Planning (5.4) o Quality Objectives (5.4.1) o Management System (5.4.2) Processes Needed to Meet Objectives o Management System Processes (4.1) Sequence and Interaction o Product Realisation (7.0, 7.1) Customer (7.2) Design and Development (7.3) Purchasing (7.4) Production and Service (7.5) Control of Monitoring and Measuring Devices (7.6) o Measurement Analysis and Improvement (8.0) o Responsibility, Authority and Communication (5.5) o Management Review (5.6) Resources (6.0) o Human Resources (6.2) o Infrastructure (6.3) o Work Environment (6.4) Documentation Requirements (4.2) Communication General Requirements Resource Management Quality Manual o Procedures o Records o Resources o Information o Document Control o Monitor o Measure o Analysis o Continual Improvement o Implementation Compliance Quality Control Audit Product Realisation Measurement, Analysis and Improvement C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 2

3 Clearly Scope Your ISO 9001 Compliance Project Plan Project Team Management Representative Document Controller LRS ISO 9001 Consultant and Auditor Operations Representative Quality reps from each branch as required Exec Quality Team. Senior Executive Sponsor Group Operations Manager Management Representative Branch Managers Communication Plan and Meting Requirements. Daily informal meeting with operational team. Formal operational meeting once per week. Minutes distributed to broader team. Management Representative to report to Exec Team once per week on content of minutes and progress. Project roles and workflow. LRS ISO 9001 Consultant. Identify and define requirements with a view to implementing and passing ISO 9001external accreditation by required date. Estimate 2 days/wk for initial 4 weeks, dropping back to 1 day/wk for next 4 weeks. We will likely require LRS ISO 9001 Consultant to advise on an adhoc basis after that, estimate 1 day fortnight ongoing. Management Representative. Project manager. Identify and manage resources to meet the requirements identified by LRS ISO 9001 Consultant. Resources include existing process mapping and quality documents, department managers and key staff. Where such resources are unavailable, Management Representative will fill the gap and produce the requirements himself. Document Controller. Format and manage documentation in line with ISO standards. Assign document numbers, maintain version records. Group Operations Manager. Site and branch contact for LRS ISO 9001 Consultant. Project Tasks. Gap Analysis: First activity by LRS ISO 9001 Consultant. Stage One. Draft the Quality Manual use this as a means to establish the system documentation framework and identify all the necessary documents to go into the quality system Initial supporting documentation: Due end of February. (Alternate is for LRS ISO 9001 Consultant to come in for 4-s solid and develop a draft of the Qulaity Manual to identify what documents are already present and what documents are missing. This will also allow us to develop a plan of action for the outstanding work to be completed.) 1. High level business map: A3 size. LRS ISO 9001 Consultant (lead), Management C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 3

4 Representative (major resource) a. Use existing process mapping to create an overview flow chart showing structure and configuration of QMS/business, and the applicable controlling documents. Some of these documents exist, some need to be written. LRS ISO 9001 Consultant to identify the requirement, Management Representative to produce the documents, Document Controller to format and assign numbers. 2. Quality policy. Write quality policy and distribute. Management Representative. Use examples from other corporate guidance documents 3. Quality representative. Senior Executive Manager. Assign senior manager as quality representative, alter job description to suit. The Quality Representative likely becomes the ISO implementation sponsor. 4. Structure of storage and numbering. Document Controller Build appropriate structure within company database to store the quality manual. Stage Two. Complete the Quality Manual and necessary documents. Due end of March. Assemble the contents of the quality framework done under guidance LRS ISO 9001 Consultant (This can be done by internal company resources or LRS ISO 9001 Consultants can provide a person to do the clerical activities. If new documents are required then the appropriate company person is made available to write them.): business management information collection and reporting business and departmental procedures (draw the existing procedures together and then develop any missing procedures), compile work instructions, compile job description, approval authorities, training identification and records, write new documents where identified as being necessary Quality Manual: o Define scope of quality manual. i.e., nominate which parts of the business are to be quality assured. o Compliance matrix. o Document control procedure Numbering. o Registers of documents. Control of records. Numbering etc Develop ISO9001 required procedures audit process, nonconforming product corrective process, preventative process, documents and records management. Using the gap analysis as a template, and building on any quality system work done by others, layout and write the quality manual ovrviewing he entire QMS. LRS ISO 9001 Consultant to identify the requirements needed to comply with ISO 9001, Management Representative to coordinate the meeting of the requirement, department managers to produce the actual content, Document Controller to format and assign numbers C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 4

5 Stage Three. Head Office Implementation. 1. Implement quality manual in Head Office by aligning broader processes with quality manual. End of April. For example a. Training personnel in quality system requitements b. Quality KPIs. Assign to business units and individuals, adjust JD's c. Minutes and meetings. Adjust templates to include quality requirements. Implement with relevant work groups. d. Internal Audit. Templates and how-tos: by Group Operations Manager. End of March. e. Aim for internal audit on pilot site end of June. Stage Four. Pilot Site Implementation. May/June Stage Five. Internal audit and readiness check. External Audit (accreditation) Second half of the year once a good body of historic data is collected and the QMS is in use. C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 5

6 Your Company ISO Accreditation Plan Building a quality management system (QMS) that complies with ISO as simply and as quickly as possible is the approach taken in the accreditation project plan listed in Table 1. Item Activity Description Resource Total Time Develop thoroughly detailed, line-of-site Project Plan to 1 achieve accreditation for national organisation and regions Project Manager 2 day Develop Document Control and Records Management 2 Procedure (i.e. complete the current one, including Project Manager 1 day document control provisions) Develop framework in SharePoint for documents, records Clerk who knows 3 and archive SP 1 day Train selected Best Bar persons in ISO 9001 development 4 basics so they can compile documents and give numbers Training course 1 day Develop Department Manuals to connect ISO 9001 requirements with a list of every related documents in P: 5 and SharePoint, such as policies, procedures, work instructions, forms, registers, databases, etc (see Figure 1) 5.1 Business Development and Project Management Clerk who knows (including numbering documents and a register) 5.2 Sales and Marketing (including numbering documents Clerk who knows and a register) 5.3 Estimating and Scheduling (including numbering Clerk who knows documents and a register) 5.4 Production and Manufacturing (including numbering Clerk who knows documents and a register) 5.5 Asset Maintenance and Properties (including Clerk who knows numbering documents and a register) 5.6 Human Resources Management (including numbering Clerk who knows documents and a register) MP&L / SCM (including numbering documents and Clerk who knows 5.7 establishing a register) 6 Develop Audit Procedure Project Manager 1 day Review Control of Non-conforming Product, Corrective 8 Action and Preventive Procedures Project Manager 1 day 9 Update Lead Quality Manual Project Manager 2 day 10 Perform a Table Top Internal Gap Analysis Audit Project Manager 11 Include Gap Analysis recommendations Project Manager 12 Start QMS on a definite date CEO 1 day 13 Run QMS for 3 months and use it fully Everyone 90 day 14 Certifying Body preliminary audit Certifying Body 1 day 15 Include Certifying Body audit recommendations Project Manager 16 Certifying Body accreditation audit Certifying Body 2 day Table 1 Proposed Plan for ISO 9001 Accreditation Est Cost C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 6

7 Company Quality Manual Asset Maintenance and Properties Manual (by Region) Production and Manufacturing Manual (by Region) Sales and Marketing Manual (by Region) Business Development and Project Management Manual (by Region) Estimating and Scheduling Manual (by Region) Human Resources Management Manual (by Region) MP&L / SCM Manual (by Region) Figure 1 (Initial) Structure of CompanyISO 9001 Quality Management System C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 7

8 Initially retain all documents in the P:, where their Users are comfortable to work, and link all documents into a QMS via new department manuals. The manuals will be little more than a register listing the relevant ISO 9001 clauses to which is matched all the applicable documents in the department P: folder that form the Company QMS. An example layout for a typical manual is shown in Table 2. Typical Department Manual Structure (by Region if necessary) Each department manual will list a compliance matrix that connects relevant ISO 9001 requirements with the documents already existing in the department. If operations in the various regions use different documents then they develop their own manuals with a compliance matrix that lists their own documents. 4 Quality management system Business Development and Project Management Manual Clause Applicable Department Name Document No 4.1 General requirements 4.2 Documentation requirements General Quality Manual Control of Control of Records 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication 5.6 Management review General Review input C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 8

9 5.6.3 Review output Business Development and Project Management Manual Clause Applicable Department Name Document No 6 Resource management 6.1 Provision of resources 6.2 Human resources General Competence, training and awareness 6.3 Infrastructure 6.4 Work environment 7 Product realization 7.1 Planning of product realization 7.2 Customer-applicable processes Determination of requirements related to the product Review of requirements related to the product Customer communication 7.3 Design and development 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 7.5 Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product 7.6 Control of monitoring and measuring equipment 8 Measurement, analysis and improvement C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 9

10 8.1 General 8.2 Monitoring and measurement Business Development and Project Management Manual Clause Applicable Department Name Document No Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement Continual improvement Corrective action Preventive action Best regards, Mike Sondalini website: mob/cell: (+61) (0) fax: (+61 8) C:\Users\Mike\\Lifetime Reliability\Consulting Work\Quality Systems\How_to_Develop_ISO_9001_Accreditation_Plan.docx 10

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