Description

Communicate information on legal and other requirements to people within your organization who need corresponding information

What is your knowledge about ISO 9000 standards and the Quality Management System?

Has your organization maintained documented information on the quality objectives?

Is your organization evaluating the performance and the effectiveness of the quality management system?

Should your software Quality Management and process improvement efforts be based on ISO 9001 or on the CMM?

...Find the answers to these, and more, questions with this Manufacturing ISO 9001 Toolkit:

Communicate information on legal and other requirements to people within your organization who need information.
Obtain information relating to customer views and opinions of your products and services.
Build corresponding principles into your process and realize tangible improvements.
Continually improve the Quality Management System in accordance with ISO 9001 requirements.
Find out whether the quality objectives set by your organization are appropriate.
Build principles into your process and realize tangible improvements.
Use ISO 9001 standards in your daily work.
Have confidence that your supplier meets ISO 9001.
Communicate with your organization on environmental issues.

HOW THIS TOOLKIT WORKS:

Save time, empower your teams and effectively upgrade your processes with access to this practical Manufacturing ISO 9001 Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Manufacturing ISO 9001 related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated Manufacturing ISO 9001 specific requirements:

STEP 1: Get your bearings

Start with...

The latest quick edition of the Manufacturing ISO 9001 Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a data driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 992 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Manufacturing ISO 9001 improvements can be made.

Examples; 10 of the 992 standard requirements:

Does the personnel responsible for inspection have relevant knowledge of the technology used for the manufacture of the products inspected, the operation of processes and the delivery of services?
Are current instructions on the use, safety and maintenance of equipment, including any relevant manuals and directions for use provided by the manufacturer of the equipment and readily available?
Are the characteristics and performance of the medical device protected during transport or storage, taking into account the Manufacturers instructions and information for transport and storage?
Are all measured / weighed raw materials filled into clean and suitable containers labelled with appropriate identification and / or directly into the equipment used for bulk manufacturing?
Are current instructions for use, safety and maintenance of equipment, including any relevant manuals and directions for use that have been provided by the manufacturer, readily available?
Have adverse incidents and accidents that can be attributed directly to specific equipment investigated and reported to the manufacturer and appropriate authorities, as required?
Are adverse incidents and accidents that can be attributed directly to specific equipment, investigated and reported to the manufacturer and appropriate authorities, as required?
Is newly recruited personnel provided with basic training on the theory and practice of Good Manufacturing Practices as well as training appropriate to the duties assigned to it?
Does your organization monitor the performance of manufacturing processes to demonstrate compliance with customer requirements for product quality and efficiency of the process?
Do manufacturers who use suppliers to provide finished medical devices have documented procedures in place to ensure that the finished medical device is safe and effective?

Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

The workbook is the latest in-depth complete edition of the Manufacturing ISO 9001 book in PDF containing 992 requirements, which criteria correspond to the criteria in...

Your Manufacturing ISO 9001 self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

The Self-Assessment Excel Dashboard; with the Manufacturing ISO 9001 Self-Assessment and Scorecard you will develop a clear picture of which Manufacturing ISO 9001 areas need attention, which requirements you should focus on and who will be responsible for them:

Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
Gives you a professional Dashboard to guide and perform a thorough Manufacturing ISO 9001 Self-Assessment
Is secure: Ensures offline data protection of your Self-Assessment results
Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:

STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Manufacturing ISO 9001 projects with the 62 implementation resources:

62 step-by-step Manufacturing ISO 9001 Project Management Form Templates covering over 1500 Manufacturing ISO 9001 project requirements and success criteria:

Examples; 10 of the check box criteria:

Initiating Process Group: Do you understand the quality and control criteria that must be achieved for successful Manufacturing ISO 9001 project completion?
Executing Process Group: Is the Manufacturing ISO 9001 project making progress in helping to achieve the set results?
Activity Duration Estimates: Does a process exist for approving or rejecting changes?
Activity Duration Estimates: On which process should team members spend the most time?
Project Portfolio management: Why would the Governance Board want to know the current portfolio opportunity?
Lessons Learned: How well did the scope of the Manufacturing ISO 9001 project match what was defined in the Manufacturing ISO 9001 project Proposal?
Activity Duration Estimates: Who has the PRIMARY responsibility to solve this problem?
Project Performance Report: To what degree will the team adopt a concrete, clearly understood, and agreed-upon approach that will result in achievement of the teams goals?
Team Member Status Report: Does the product, good, or service already exist within your organization?
Procurement Audit: Was the dynamic purchasing system set up following the rules of open procedure?

Step-by-step and complete Manufacturing ISO 9001 Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

1.1 Manufacturing ISO 9001 project Charter
1.2 Stakeholder Register
1.3 Stakeholder Analysis Matrix

2.0 Planning Process Group:

2.1 Manufacturing ISO 9001 project Management Plan
2.2 Scope Management Plan
2.3 Requirements Management Plan
2.4 Requirements Documentation
2.5 Requirements Traceability Matrix
2.6 Manufacturing ISO 9001 project Scope Statement
2.7 Assumption and Constraint Log
2.8 Work Breakdown Structure
2.9 WBS Dictionary
2.10 Schedule Management Plan
2.11 Activity List
2.12 Activity Attributes
2.13 Milestone List
2.14 Network Diagram
2.15 Activity Resource Requirements
2.16 Resource Breakdown Structure
2.17 Activity Duration Estimates
2.18 Duration Estimating Worksheet
2.19 Manufacturing ISO 9001 project Schedule
2.20 Cost Management Plan
2.21 Activity Cost Estimates
2.22 Cost Estimating Worksheet
2.23 Cost Baseline
2.24 Quality Management Plan
2.25 Quality Metrics
2.26 Process Improvement Plan
2.27 Responsibility Assignment Matrix
2.28 Roles and Responsibilities
2.29 Human Resource Management Plan
2.30 Communications Management Plan
2.31 Risk Management Plan
2.32 Risk Register
2.33 Probability and Impact Assessment
2.34 Probability and Impact Matrix
2.35 Risk Data Sheet
2.36 Procurement Management Plan
2.37 Source Selection Criteria
2.38 Stakeholder Management Plan
2.39 Change Management Plan

3.0 Executing Process Group:

3.1 Team Member Status Report
3.2 Change Request
3.3 Change Log
3.4 Decision Log
3.5 Quality Audit
3.6 Team Directory
3.7 Team Operating Agreement
3.8 Team Performance Assessment
3.9 Team Member Performance Assessment
3.10 Issue Log

4.0 Monitoring and Controlling Process Group:

4.1 Manufacturing ISO 9001 project Performance Report
4.2 Variance Analysis
4.3 Earned Value Status
4.4 Risk Audit
4.5 Contractor Status Report
4.6 Formal Acceptance

5.0 Closing Process Group:

5.1 Procurement Audit
5.2 Contract Close-Out
5.3 Manufacturing ISO 9001 project or Phase Close-Out
5.4 Lessons Learned

Results

With this Three Step process you will have all the tools you need for any Manufacturing ISO 9001 project with this in-depth Manufacturing ISO 9001 Toolkit.

In using the Toolkit you will be better able to:

Diagnose Manufacturing ISO 9001 projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
Implement evidence-based best practice strategies aligned with overall goals
Integrate recent advances in Manufacturing ISO 9001 and put process design strategies into practice according to best practice guidelines

Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Manufacturing ISO 9001 investments work better.

This Manufacturing ISO 9001 All-Inclusive Toolkit enables You to be that person.

Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.

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Checklists:

Checklists:Manufacturing ISO 9001 Checklist Report on PROCESS.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on INFORMATION.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on QUALITY.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on ISO.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on ORGANIZATION.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on MANAGEMENT.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on PRODUCT.pdf

Checklists:Manufacturing ISO 9001 Checklist Report on MANUFACTURER.pdf

STEP 1 Get your bearings:

STEP 1 Get your bearings:Manufacturing_ISO_9001_Quick_Exploratory_Self-Assessment_Guide.pdf

STEP 1 Get your bearings:Manufacturing ISO 9001 Self-Assessment Pre-Filled EXAMPLE.xlsx

STEP 2 Set concrete goals tasks dates and numbers you can track:

STEP 2 Set concrete goals tasks dates and numbers you can track:Manufacturing_ISO_9001.pdf

STEP 2 Set concrete goals tasks dates and numbers you can track:Manufacturing ISO 9001 Self-Assessment.xlsx

..and the Project Management resources in 'STEP 3: Implement, Track, follow up and revise strategy' as described above.

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Manufacturing ISO 9001 Toolkit