ISO 9001:Countdown to 2015

Presented by Ellen DiggsEllen Diggs Consultingekdiggs@verizon.net

February 11, 2015

It’s Not Just for Manufacturing Anymore!

ISO 9001 facts

• International standard for quality management systems

• Originally published in 1987• Underwent major revision in 2000• Implemented by more than one million

organizations in over 170 countries• Applies to any organization regardless of size or

industry

Standards are “enablers for other major business processes” – The Boeing Company

Reasons for 2015 revision

• Maintain relevance for increasing diversity of 9001 users (industry, size, customer)

• Increase focus on effective process management to achieve desired results

• Facilitate integration with other management system standards – Standard structure, text, definitions

• Recognition of supply chain complexity

• Formalize need for risk-based thinking within the context of the organization

Major Changes• Structure – 10 clauses• Understand organizational context • Language – new terminology

- Products and services- Risks and opportunities- Context and interested parties - Effective resource management- Systematic control of changes

• Business strategy and QMS integration- Focus on process approach and effective process management- Emphasis on objectives, risks and opportunities within context

Major Changes (continued)

• Language – new terminology- Products and services - Risks and opportunities (preventive action)- Context and interested parties (customers)- Documented information (documents and records)- Relation with context and interested parties (as suitable)- External providers of goods and services (suppliers)- Effective resource management- Systematic control of changes

• Deleted- Quality manual- Management representative- Verification and validation- Product realization

Quality Management Principles (QMPs)

7 QMPs1. Customer focus

2. Leadership3. Engagement of people4. Process approach

5. Improvement6. Evidence based decision-

making7. Relationship

management

8 QMPs1. Customer focused

organization2. Leadership3. Involvement of people4. Process approach5. System approach6. Continual improvement7. Factual approach to

decision-making8. Mutually benefit supplier

relationships

High Level Structure

Improvement (10)

Context (4)

Planning (6)

Performance evaluation (9)

Operations (8)

Support (7)

Leadership (5)

Comparing the two…

ISO 9001: 2008 ISO/DIS 9001:2015

4. General management system4.2.3 Control of Documents4.2.4 Control of Records

4. Quality management system (QMS)

7.4 Documented information4.4. Process Approach

5. Management Responsibility5.4 Planning5.4.1 Quality objectives5.4.2 QMS planning5.5.2 Management representative5.6 Management review

5. Leadership

6. Planning for the QMS 9.3 Management review

6. Resource Management6.2 Human resources6.4 Work environment

7.1 Resources7.2 Competence7.1.4 Environment for the operation of processes

Comparing the two…(continued)

ISO 9001: 2008 ISO/DIS 9001:2015

7. Product realization7.1 Planning of product realization7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing

7.4.3 Verification of purchased product

7.5.2 Validation of processes

7.6 Control of monitoring and measuring equipment

8. Operations8.1 Operational planning and control8.2 Determine requirements for products and services

8.3 Design and development of products and services

8.4 Control of externally provided goods and services8.4.3 Release of products and services

8.5.1 Control of product and services7.1.5 Monitoring and measurement resources

Comparing the two…(continued)

ISO 9001: 2008 ISO/DIS 9001:2015

8. Monitoring, analysis and improvement

8.2.3 Monitoring of process8.2.4 Monitoring of product 8.3 Control of nonconforming

product

8.4 Analysis of data8.5 Improvement

8.5.2 Corrective Action

8.5.3 Preventive Action

9.1 Monitoring, measurement, analysis, and evaluation

8.6 Release of products and services

8.7 Control of nonconforming process outputs, products and services

8.1.3 Analysis and evaluation10 Improvement

10.2 Nonconformities and corrective action 6.1 Actions to address risks and opportunities

The text…

• Context of the organization (4)- Relevant to strategic direction- Understand and anticipate customer needs and

expectations- The organization shall apply a process approach

• Leadership (5)- With respect to the QMS and the customer (context)- Shall be accountable for the effectiveness of the QMS- Assign responsibility and authority

The text….(continued)

• Planning (6)- Consider context to identify risks and opportunities that

need to be addressed- Identify the need and opportunity for change- Take change in a planned matter

• Support (7)- Resources (infrastructure, process environment, monitoring

and measurement devices, and knowledge)- Competence and awareness- Communication- Documented information

The text… (continued)

• Operations (8)- Determination of market needs and interactions with

customers- Operational planning process- Control of external provision of goods and services- Development of goods and services- Production of goods and services- Release of goods and services- Nonconforming goods and services

The text…(continued)• Performance Evaluation (9)

- Monitoring, measurement, analysis and evaluation- Internal audit and Management Review- Analysis of data reinforced and clarified- QMS performance indicators

• Improvement (10)– Shall improve the QMS, processes, and goods and services, as

appropriate, in response to:• Results of analysis of data • Changes in organizational context• Changes in identified risk and new opportunities

– Shall evaluate, prioritize and determine the improvement to be implemented

Where’s the risk??

Risk-based thinking…the organization is required to:• 4 (Context) Determine the risks to product or service

conformity and customer satisfaction • 5 (Leadership) Commit to Clause 4• 6 (Planning) Take action to identify risks and opportunities• 8 (Operation) Implement process to address risks and

opportunities• 9 (Performance) Monitor, measure, analyze and evaluate

risks and opportunities• 10 (Improvement) Respond to changes in risk

ISO 9001:2015 timeline

June 2013: Committee Draft (CD)

Mid 2014: Expected publication of Draft International Standard (DIS)

Mid 2015: Expected publication of Final Draft International Standard (FDIS)

End 2015: Publication of International Standard as ISO 9001:2015

Currently certified to ISO 9001:2008?• Transition period begins when new revision is

published• Expect to have three years before ISO 9001:2008

becomes out of date• Certify to ISO 9001:2015 before transition period ends

(expected late 2018)