ISO 9001:2015: QMS, Determine the risk and opportunities

Revision of ISO 9001:2008

Official final draft international standard (FDIS) ISO 9001:2015 is awaited as submission of comments to Committee Draft is over.

The makeup of the standard is consistent with the expectations of QMS and Clause 4 to 10 will make its implementation easy in any setup (manufacturing and services).

The contents of the proposed new standard compared to current are:

Clause	9001:2015	9001:2008
1	Scope	Scope
2	Normative references	Normative references
3	Terms and definitions	Terms and definitions
4	Context of the organization	Quality management system
5	Leadership	Management responsibility
6	Planning	Resource management
7	Support	Product realization
8	Operation	Measurement, analysis and improvement
9	Performance evaluation	-
10	Improvement	-

Considered changes in the draft are:

• Reconsidering the allowance of ‘exclusion' of specific requirements
• Term ‘goods and services’ in place of ‘product’ to make standard generic and applicable to all types of organizations
• Term ‘improvement’ in place of ‘continual improvement’

Other proposed changes:

Term documented procedure and record has been removed and replaced with ‘documented information’.

Clause 4: Context of the organization provide basis for implementation of QMS in an organization.

In addition to this Process based approach is emphasized in clause 4.4.2 making it an essential part of QMS.

Preventive action has been removed from measurement, analysis and improvement and determination of risk is given precedence during development of QMS. Clause 6 Planning advocates actions to address risk and opportunities. Thought the standard maintains that there is no requirement of risk management however it is inevitable in current scenario.  The standard may evolve into risk based approach to QMS (similar to ICH Q10).

Knowledge management is emphasized in clause 7.5.1 (similar to ICH Q10). The clause expects that knowledge shall be maintained, protected and made available as necessary.

Management representative is removed and management directly involved in QMS through the clause 5: Leadership.

Clause 8 Operation replaces Product Realization. Clause 8.5 Development of goods and services discusses development process, development control and development transfer (technology transfer, as in ICH Q10). The process of design and development is not detailed as in current standard, hopefully the current requirements stays.

Control of external provision of goods and services is presented in detail in Clause 8.6.

Clause 9 'Performance evaluations' replaces the current clause 8 and evaluation of performance (of process and QMS) is emphasized. Management review forms the part of this clause.

Improvement is presented in a separate clause, Clause 10.

Reference:

ISO 9001:2008 Quality management systems — Requirements

ICH Q10 Pharmaceutical Quality System

Quality Handbook: Quality Gurus.net- http://www.qualitygurus.net/ISO+9001%3A2015+Draft+International+Standard+(DIS) (they have given very good links...do check the website)