ISO 9001:2015 Quality Management System

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Marjorie Rice
9 years ago
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1 ISO 9001:2015 Quality Management System For First-Time Registration and Renewing ISO 1

2 The New ISO Standard Why should you care? Because you have to change whether you want to or not. 2

3 The New ISO Standard When will you change? You get up to 3 years, starting mid September Auditors are recommending at the next re-certification audit. Enterprise Minnesota adds after mid-year

4 Quality or Business Management System? Besides customer requirements, why are you using ISO? How many managers would say I use ISO because I have to? As the company leader, how do you want your employees and managers to answer the question? 4

5 Quality or Business Management System? Context of the Organization Leadership Planning Support Operation Performance Evaluation Improvement 5

6 Process Approach This style/recommendation existed before. AS9100 really upped the visibility and benefits of the process approach in QMS. The new revision requires the Process Approach. Personal experience. 6

7 Process Description What Equipment, facilities, material needed Resources Who Responsibility & authority competency Input Information and material from other processes or customers Major Activities Output Information and material to other processes or customers How Instructions Requirements Risks Controls Measure Monitoring and Measuring Goals Results

8 Process Definition Process Description Process Owner Inputs Risks and Opportunities Procedures for this Key Process Competency Other Resources Outputs/Customers Process Effectiveness 8

9 Example Processes Sales, Estimating and Quoting Design Purchasing Production Service 9

10 Example Support Processes Quality Management Quality Management System 10

11 Quality Manual The quality manual is no longer required by the standard. Next question: Do you want a QM? How will you use it? 11

12 Leadership Top management. Accountable for effectiveness Integration into the business Process approach and risk based thinking, etc. 12

13 Management Representative Classically, this has been the Quality Manager. No longer a requirement. Risks, Opportunities and Process Approach. Consider: splitting the responsibilities: ISO owner Process owner Opportunities 13

14 Planning: Risks and Opportunities Requirement: Formally address risks and opportunities Actions Proportional 14

15 Risks and Opportunities Consider: Define risks within the description of the process. Identification and action toward opportunities may fit here, or may be in the Context/Strategic/Marketing plan. 15

16 Quality Objectives Requirement: Objectives at relevant functions. and levels. Measurable Monitored Communicated 16

17 Organizational Knowledge Knowledge necessary for the operation of processes. Maintained and available. Changing needs and trends: Consider its current knowledge. Determine how to acquire any necessary additional knowledge. 17

18 Organizational Knowledge Knowledge specific to the organization. Gained by experience. Information that is used and shared to achieve the organization s objectives. 18

19 Next Steps You will need to update your certificate by 2018 at the latest. Opinion: Auditors won t be up to speed before mid-year

20 Gap Audit Registrars and Enterprise Minnesota will be offering Gap Audits. Consider implementing the elements in this presentation before going through this optional gap audit which will then be the first test of the changed system. Consider using these gap audits to train existing internal auditors. 20

21 Certification Upgrade Most cost effective approach is to upgrade during the recertification audit. Upgrades during a surveillance audit will have the same number of days as a recertification audit. Upgrades will include a Stage 1 and Stage 2. 21

22 Certification Upgrade Management review and internal audit on the basis of ISO 9001:2015 have to be completed before a certificate on ISO 9001:2015 can be issued. Stage 1 (readiness review) can be carried out before management review and a complete audit but need to complete it before stage 2. 22

23 What Can I Do Now? Context/Strategic/Marketing plan Robust Process Approach Risk and Opportunity Upgrade Skills Matrix and Process Description with as many Organizational Knowledge elements as you can think of. 23

24 THANK YOU! Kent Myhrman Enterprise Minnesota (651)

ISO 9001:2015 Transition Guide

ISO 9001:2015 Transition Guide Updated May 12, 2016 ISO 9001:2015 Transition Guide It Doesn t Need to be Difficult Whether your organization is transitioning from ISO 9001:2008 to the new ISO 9001:2015,