ISO NEW CLAUSE STRUCTURE
From the latest information available to me, the ISO9001:2015 will carry new clauses from 1 – 10. Clauses 1, 2, 3 will be Scope, Normative references and Terms and Conditions, as before. Clauses 4,5,6,7 will fall within PLAN; Clause 8 under DO; Clause 9 under CHECK; Clause 10 under ACT.
Many of the clauses will cross-reference. The information below is my interpretation of what the new clauses mean for quality system development based on my experience and development of quality systems over 27 years. They are simply based on good business practice. Much of this is covered in the QUALIDOC INTERNAL AUDIT CHECKLIST which is available free of charge on this website.
I invite you to follow my blogs in which I explain, line by line, the application of the new clauses to current quality systems. (See sample QUALIDOC documentation available at www.qualidoc.co.uk also). The text in bold is my indication to pay particular attention to the statement. When you are answering the questions implied in the clauses, always ask yourself the question: WHO NEEDS TO KNOW?
Clause 4: Context of the organization
- · Understanding the organization and its context
- · Needs and requirements
- · Scope
- · Management System
4.1 Understanding the organization and its context
Here’s where you identify external and internal issues that affect your business. Ideally these should be covered whenever a contract is in the offing. Consider how the requirements of the quality system, e.g., ISO9001, AS9100D (AS9101 Revision E issued recently) can affect your organization. Include this in your Contract Review (Customer Requirements) NOTE: MAKE SURE YOUR MEASUREMENTS (e.g.,KPIs) DO NOT LAG BEHIND DEVELOPMENTS SUCH AS THOSE IN:
- · key drivers and trends which can have an impact on the objectives of the organization, including customers changing needs;
- · relationships with, and perceptions, values and expectations of, external interested parties;
- · the social and cultural, legal, regulatory, financial, technological, economic, natural and competitive environment (international, national, regional or local);
INTERNALLY: review organizational structure (including Board of Directors level), roles and accountabilities, (responsibilities and authorities) especially those with signing authority and responsibility at critical stages of product or service planning, development and delivery.
Do you have the policies, procedures, objectives, including strategies to achieve the organization’s objectives? Are resources in place including information (e.g., capital, time, people (skills, experience), processes, systems and technologies)?
Are reliable information systems in place to allow uninterrupted, timely and accurate flow, responsibility and authority (e.g., approval for processes and management decisions, formal and informal)?;
What are the standards, guidelines and models adopted by the organization?
Contractual relationships: do these include “grouping” with other subcontractors?
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